Org 280 - Ifu - en - FR - Es - It - CS - Hu - QM131061 - 2013-12-16 - 1.2

Machine Translated by Google
ORGENTEC Diagnostika GmbH SUMMARY AND EXPLANATION OF THE TEST

Carl-Zeiss-Strasse 49-51 Abdominal pain, diarrhea, and fever are symptoms of conditions ranging from chronic inflammatory bowel
55129 Mainz - Germany disease (IBD) to infections of the digestive tract or irritable bowel syndrome (IBS).
General inflammatory parameters in the blood (CRP, ESR, complete blood count) are also not specific to
Phone: inflammation localized in the intestines, so diagnoses of inflammatory bowel disease are often made with
+49 (0) 61 31 / 92 58-0
considerable delay. The detection of calprotectin in stool samples complements basic laboratory diagnostics
Fax: +49 (0) 61 31 / 92 58-58
with a highly diagnostic intestinal inflammatory marker, increasing the certainty of diagnosis, particularly in
Internet: www.orgentec.com pediatric patients.
Calprotectin is a calcium- and zinc-binding protein that has antimicrobial properties and is ubiquitous
throughout the body. The cytoplasm of polymorphonuclear granulocytes contains up to 60% calprotectin. It is
Instructions For Use
also found in trace concentrations in monocytes and macrophages.
2013-12
The faecal calprotectin level is a measure of inflammation-induced migration of granulocytes into the intestinal
lumen and correlates directly with the intensity of the inflammatory reaction of the intestinal mucosa.
Elevated calprotectin levels in the stool are found in cases of chronic inflammatory bowel disease, infectious
gastroenteritis, necrotizing enterocolitis, cystic fibrosis, and colorectal carcinoma.
For functional disorders like irritable bowel syndrome, calprotectin levels lie in the normal range.
ORG 280 Calprotectin The detection of faecal calprotectin is a simple, non-invasive test that can reasonably be carried out before any
imaging or endoscopy. Calprotectin in stool is a sensitive marker for inflammatory bowel disease and is
particularly useful for differentiating irritable bowel syndrome. In addition, measurement of the calprotectin
NAME AND INTENDED USE level facilitates evaluation of disease activity and thus also aids in monitoring progression of the disease and its treatment.
Calprotectin is an ELISA-based test system for the quantitative measurement of Calprotectin in human stool
PRINCIPLE OF THE TEST
samples. This product is intended for professional in vitro diagnostic use only.
Calprotectin contained in a stool sample has to be released from the stool with extraction medium. Then,
®
extracted Calprotectin can be analyzed Calprotectin assay.
USED SYMBOLS with the Alegria The Alegria® assay features barcoded 8-well-microstrips, called Alegria® Test Strips. Each
strip is designed for a single determination of one patient sample. The Alegria® Test Strip holds a complete set
V In vitro diagnostic medical device of reagents. Included are enzyme conjugate, enzyme substrate, sample buffer and a test specific control.
Furthermore each strip has two antibody-coated wells which serve as reaction wells for one control and one patient sample.
M Manufacturer The determination is based on an indirect enzyme linked immune reaction with the following steps: Calprotectin
present in control / positive samples binds to the surface of the reaction wells forming an antibody-antigen-complex.
h Catalog number After incubation, a first washing step removes unbound and unspecifically bound molecules. Subsequently
Sufficient for ... determinations added enzyme conjugate binds to the immobilized antibody-antigen-complex. After incubation, a second
X24
washing step removes unbound enzyme conjugate. Addition of enzyme substrate solution results in
Batch code hydrolization and color development during incubation. The intensity of the blue color correlates with the
g
concentration of the antibody-antigen-complex and can be measured photometrically at 650 nm. The Alegria®
H Use by Test Strip is based on the proprietary SMC®-Technology (Sensotronic Memorized Calibration): information
about the assay, analysis and ® evaluation, and the lot-specific expiration date is contained Test Strip.
2:r30: Temperature limitation on the barcode printed on each Alegria The Alegria® Test Strip can be used with the diagnostic instrument
Alegria® - a fully automated Random Access Analyzer. By means of SMC®-Technology data encoded on the
Yo Consult instructions for use
barcode are transferred from the Alegria® Test Strip to the instrument and the assay is automatically processed
w Keep away from sunlight and evaluated. The instrument reads the date of expiration and rejects further processing if the Alegria® Test Strip is out of
WARNINGS AND PRECAUTIONS

• All reagents in this kit are intended for professional in vitro diagnostic use
Alegria® Test Strips only. • The internal control contains material of human origin. Since no test can guarantee the absence of infective
®
Wash Buffer agents in human material, we recommend handling AlegriaTest Strips as potentially infective
System Fluid material. • Bovine serum albumin (BSA) used in components has been tested for BSE and
Extraction Medium found negative. • Avoid contact with the substrate TMB (3,3´,5,5´-
Tetramethyl-benzidine). • System fluid contains acid, classification is non-
Ready to use
hazardous. Avoid contact with skin. • Control, sample buffer, extraction medium and wash buffer contain sodium azide 0.09%
concentration is classified as non-hazardous.
• Enzyme conjugate contains ProClin 300 0.05% as preservative. This concentration is classified as
non-hazardous.
During handling of all reagents, controls and serum samples observe the existing regulations for laboratory
safety regulations and good laboratory practice:
ORG 280_IFU_EN_QM131061_2013-12-16_1.2 page 1 ORG 280_IFU_EN_QM131061_2013-12-16_1.2 page 2

• First aid measures: In case of skin contact, immediately wash thoroughly with water and soap. Remove STORAGE AND STABILITY
contaminated clothing and shoes and wash before reuse. If system fluid comes into contact with skin, wash • Store test kit at 2-8 °C in the
thoroughly with water. After contact with the eyes carefully rinse the opened eye with running water for at dark. • Do not expose reagents to heat, sun, or strong light during storage
least 10 minutes. Remove contact lenses if this can be done easily. Get medical attention if necessary. and use. • Store Alegria® Test Strips sealed and desiccated in the clip
Respiratory tract: take person to the fresh air. Swallowing: Rinse the mouth and spit the fluids out. Drink 1 - bag provided. • Shelf life of the unopened test kit is 15 months from day of production.
2 glasses of water immediately. During spontaneous vomiting hold the head of the casualt low with the body Unopened reagents are stable until expiration of the kit. See labels for individual
in a prone position in order to avoid the penetration batch. • Diluted Wash Buffer and System Fluid are stable for at least 30 days when stored at 2-8 °C.
of vomit into the air tube. • Personal precautions, protective equipment Once transferred to the reagent container we recommend consumption on the same day.
and emergency procedures: Observe laboratory safety regulations. Avoid contact with skin and eyes. Don't swallow. Do not pipette by mouth.
Do not eat, drink, smoke or apply makeup in areas where specimens or kit reagents are handled. When PROCEDURAL NOTES
spilled, absorb with an inert material and put the spilled material in an appropriate • Do not use kit components beyond their expiration
waste disposal. • Exposure controls / personal protection: Wear protective gloves of nitril rubber or natural latex. dates. • All materials must be at room temperature (20-28 °C)
Wear protective glasses. Used according to intended use no dangerous reactions prior to use. • To avoid carryover or contamination, change the pipette tip between samples.
®
• Conditions to avoid: Since substrate solution is light-sensitive. Store known. strips in the dark.
Alegria • For disposal of laboratory waste the national or regional legislation has to be observed. SPECIMEN COLLECTION, PREPARATION, STORAGE AND HANDLING
Observe the guidelines for performing quality control in medical laboratories by assaying controls and/or pooled Collecting stool samples
be. Stool Sample Collector (SSCO) may be
used. • Avoid contamination with toilet water containing
CONTENTS OF THE KIT disinfectants. • Keep the collected stool sample no longer than 5 days at 2-8 °C. Alternatively, store at -20°C.
X24 ORG 280 Sufficient for 24 determinations
Preparing stool sample
Alegria® Test Strips are modules of 8 wells each composed Extraction of Calprotectin using Stool Exctraction Tube (ORG 280)
of: Wells 1 + 2: empty and not coated (wells for the sample dilution) For the Alegria® Calprotectin assay the stool sample has to be diluted 1:50 in the extraction medium provided.
Wells 3 + 4: coated with antibody (reaction wells) Inhomogeneous samples should be homogenized prior to sampling, eg by using an inoculation loop.
Well 5: Control; yellow; containing Calprotectin, PBS, BSA, detergent, preservative For liquid stool samples we recommend to weigh out sample (see below method without extraction tube).
sodium azide 0.09%. 1 Prepare Stool Extraction Tube (ORG 282)
Well 6: Enzyme Conjugate; light red; containing anti-Calprotectin antibodies, Stool sample and extraction medium have to be at room temperature.
HRP labeled; PBS, BSA, detergent, ProClin preservative 0.05%. Fill 750 µl Extraction Medium into the transparent tube (part 1) and lock with the spatula (part 2) with the blue
Well 7: Sample Buffer: yellow; containing PBS, BSA, detergent, preservative closure thread at the tube.
sodium azide 0.09%.
2 Pick stool sample
Well 8: TMB Substrate: clear; containing 3,3', 5,5'- Tetramethylbenzidin. Open tube and pull out spatula at the orange closure thread.
Anti-Calprotectin antibodies are coated onto microwells. Remove the stool sample by picking the spatula into the stool. The notches of the spatula need to be fully
Product code on barcode: Calprotectin covered with stool sample. This results in picking 15 mg of stool.
1x 20ml Wash Buffer, containing Tris, detergent, preservative sodium azide 0.09%; 50 x 3 Portion stool sample
concentrate. Put the orange dosing spatula into the blue cone insert of the tube and turn to close. The surplus stool is
1x 2.5ml System Fluid, contains acid; 1000 x concentrate. wiped off by the cone insert. The resulting dilution is 1:50.
1x 20 ml Extraction medium; containing TBS, stabilizing protein, extraction reagent, 4 Extraction
preservative sodium azide 0.09%. Ready to use. Vortex 30 sec at 1800 rpm to remove stool sample from the notches of the spatula. Further homogenize for
ii 1 Alegria® Instruction for Use: Alegria® Mini-DVD 30 min at 1000 rpm on a rocking shaker.
1 Certificate of Analysis
MATERIALS REQUIRED
• Vortex mixer, rocking shaker, benchtop centrifuge, optional: precision
scales • Pipettes
for 10 µl • Measuring cylinder for 1000 ml and 2500 ml,
microtubes • Distilled or deionized water
AUXILIARY IVD REAGENTS

• ORG 283 Calprotectin Stool Extraction Medium; contains 125 ml extraction medium. Ready to use. Open the tube at the blue cone insert and transfer the homogenate to a microtube. Centrifuge for 2 min at 3000xg.
Composition identical with the Extraction medium in the test kit. Transfer clear fluid to another microtube and test for Calprotectin immediately.
FURTHER ACCESSORIES • Such an extracted stool sample may be stored at 2-8 °C for up to 5 days or at -20 °C for up to 4 months.
ORG 282 • The extracted stool sample is not stable at room temperature!
Stool Extraction Tubes; containing 100 tubes.
SSCO Stool Sample Collector Extraction of Calprotectin without Stool Exctraction Tube (ORG 280) •
These auxiliaries are available separately. Stool sample and extraction medium have to be at room temperature.
• Weigh out empty tube. Pick stool sample and transfer to tube. Weigh out and determine net weight of sample.

• Fill Calprotectin Stool Extraction Medium (ORG 283) into the tube: 49-times net weight of sample needed to gain PERFORMANCE CHARACTERISTICS
at 1:50 dilution
Measuring range
stool sample + extraction medium stool sample + extraction medium
The calculation range of this Alegria® assay is 0 - 1000 µg/g
15 mg + 0.75 ml 20 mg 60mg 2.9ml+
+ 1.0 ml 30 mg + 1.5 70 mg + 80 3.4ml Expected values
ml 40 mg + 2.0 ml 50 mg + 90 mg 3.9ml
In a normal range study with samples from healthy donors the following ranges have been established with this
mg + 2.5 ml + 4.4ml
Alegria® assay: Cut-off 50 µg/g
100mg + 4.9ml
Close tube. Vortex 30 sec at 1800 rpm. Further homogenize for 30 min at 1000 rpm on a rocking shaker. Interpretation of results
Open tube. Transfer the homogenate to a microtube. Centrifuge for 2 min at 3000xg. Transfer clear fluid to another
Normal range: < 50 µg/g
microtube and test for Calprotectin immediately.
Slightly elevated values: 50 - 200 µg/g
PREPARATION OF REAGENTS Significantly elevated values: > 200 µg/g
Calprotectin level in the normal range: gastrointestinal inflammation nearly ruled out; further invasive diagnosis
measures are generally not required.
Dilute the content of the Wash Buffer concentrate (50x) with distilled or deionized water to a final volume of 1000
Calprotectin level slightly elevated: low level of inflammatory activity in the gastrointestinal tract (eg IBD in
ml prior to use. Transfer the diluted Wash Buffer into the instrument reagent container. If only one Alegria run is to
remission); Repeated test and further diagnostic measures are recommended.
be performed on one day we recommend transferring only 500 ml diluted Wash Buffer.
Calprotectin level significantly elevated: active organic disease of the gastrointestinal tract; further intensive
diagnostic tests and treatment by a specialized gastroenterologist are urgently advised.
Dilute the content of the System Fluid concentrate (1000x) with distilled or deionized water to a final volume of
2500 ml prior to use. Transfer the diluted System Fluid into the instrument reagent container.
Linearity
Take the required number of Alegria® Test Strips out of the clip bag and let them reach room temperature ®
Technology.
assay. Activity for each dilution was calculated by means of SMC
(20-28°C). Do not remove foil covering the empty wells until you are ready to start the assay.
sample Dilution Observed Expected O/E
Ready to use . . [µg/ [µg/ [%]
1 1:100 g] g] 100
TEST PROCEDURE . 1:200 746.8 366.7 746.8 373.4 98
Alegria® Test Strips with SMC® technology are used with the Alegria ® diagnostic instrument. . 1:400 186.7 186.7 100
Detailed information about operating the instrument can be taken from the Instrument User Manual. . 1:800 89.5 93.4 96
®
(1) Remove the foil from the empty wells 1 to 4 of the Test Strip. 2 1:100 625.5 626.5 100
Alegria Do not remove foil with printed barcode, covering wells 5 to 8. . 1:200 325.0 313.3 104
(2) Pipette 10 µl extracted stool sample at the bottom of well 1. . 1:400 151.1 156.6 97
(3) Insert the strip into the SysTray. . 1:800 65.2 78.3 83
(4) Place loaded SysTrays into the correct position in the Alegria® instrument and start run. All further steps will be 3 1:100 112.9 112.9 100
done automatically. The test run is completed when the instrument starts printing the results. . 1:200 59.5 56.5 105
. 1:400 26.5 28.2 94
. 1:800 14.6 14.1 103
Sensitivity
.Lowest detectable concentration: 5.2 µg/g
Reproducibility
Intra-assay precision: Coefficient of variation (CV) was calculated for each of three samples from the results of 20
determinations in a single run. Results for precision-within-assay are shown in the table below.
Inter-assay precision: Coefficient of variation (CV) was calculated for each of three samples from the results of 6
CALIBRATION determinations in 5 different runs. Results for run-to-run precision are shown in the table below.
The assay system is calibrated against EQAS samples provided by: INSTAND eV, Germany (EQAS No 120, .Samples containing Calprotectin were serially diluted in sample buffer to demonstrate the dynamic range of the
batch 2012 / 2013). Intra-Assay Inter-Assay
sample mean . sample mean .
CALCULATION OF RESULTS . µg/g %CV . µg/g %CV
By means of SMC® Technology (Sensotronic Memorized Calibration), all test data are transferred to the system 1 49.5 5.5 1 47.8 8.7
through individual barcodes on the Alegria® Test Strip. Calculation and interpretation of results will be performed 2 218.2 6.1 2 107.1 6.5
automatically. 3 847.9 9.9 3 335.8 7.1

Interfering substances not diseases of the bowel.

tested 15. Layer et al.: "S3-Leitlinie Reizdarmsyndrom: Definition, Pathophysiologie, Diagnostik und Therapie.
Gemeinsame Leitlinie der Deutschen Gesellschaft für Verdauungs- und Stoffwechselkrankheiten (DGVS) und der
Study results Deutschen Gesellschaft für Neurogastroenterologie und Motilität (DGNM)". Z.
n Gastroenterol. 2011; 49:237-293
Study population n pos % 97.8
Inflammatory bowel disease 186 182
abdominal disorders 144 10 6.9
healthy donors 18 0 0.0
diagnostic result
Pos Neg
ORG 280 Pos 182 10
Neg 4 152
. . 186 162 348
Sensitivity: 97.8 %
Specificity: 93.8 %
Overall agreement 96.0 %
LIMITATIONS OF THE PROCEDURE

This assay is a diagnostic aid. A definite clinical diagnosis should not be based on the results of a single test, but should be
made by the physician after all clinical and laboratory findings have been evaluated concerning the entire clinical picture of
the patient. Also every decision for therapy should be taken individually.
The above pathological and normal reference ranges for antibodies in patient samples should be considered as
recommendations only. Each laboratory should establish its own ranges according to ISO 15189 or other applicable laboratory
guidelines.
REFERENCES
1. Burri; Beglinger: “Faecal calprotectin – a useful tool in the management of inflammatory bowel disease.” Swiss Med Wkly.
2012; 142: w13557 2. Van
Rheenen et al.: “Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-
analysis.” BMJ. 2010; 341: c3369 3. Johne; Fagerhol
et al.: “Functional and clinical aspects of the myelomonocyte protein calprotectin.” J Clin
Pathol: Mol Pathol. 1997; 50:113-123
4. Berni et al.: “Faecal calprotectin is a useful diagnostic tool in pediatric gastroenterology.” Ital J Pediatr. 2005;
31:89-94
5. Canani et al.: „Diagnostic value of faecal calprotectin in pediatric gastroenterology clinical practice“. Digestive
and Liver Disease. 2004; 36:467-470
6. Costa et al.: “Role of faecal calprotectin as non-invasive marker of intestinal inflammation.” Digestive and Liver
Disease. 2003; 35:642-647
7. Carroccio et al.: “Diagnostic accuracy of faecal calprotectin assay in distinguishing organic causes of chronic diarrhea from
irritable bowel syndrome: a prospective study in adults and children.” Clinical Chemistry. 2003; 49:6:861-867
8. Chapaiboon et al.: „Calprotectin S100A9 calcium binding loops I and II are essential for keratinocyte resistance
to bacterial invasion“. The Journal of biological Chemistry. 2009; Vol 284; No. 11: 7078-7090
9. Costa et al.: “Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn's disease.” Gut. 2005;
54: 364-368 10. Fagerberg et al.:
„Fecal calprotectin levels in healthy children studied with an improved assay“. Journal of
Pediatric Gastroenterology and Nutrition. 2003; 37:468-472
11. Montalto et al.: “Fecal calprotectin in first-degree relatives of patients with ulcerative colitis.” Am J
Gastroenterol. 2006; 101:1-5
12. Roseth et al.: „Normalization of faecal calprotectin: a predictor of mucosal healing in patients with inflammatory
bowel disease“. Scand J Gastroenterol. 2004; 39:1017-1020
13. Whitehead et al.: “Between-assay variability of faecal calprotectin enzyme-linked immunosorbent assay kits”.
Annals of Clinical Biochemistry. 2013; 50: 53-61 14.
NICE Diagnostics guidance 11, Oct. 2013, Faecal calprotectin diagnostic tests for inflammatory

ORGENTEC Diagnostika GmbH PRINCIPE DU TEST

Carl-Zeiss-Strasse 49-51
The calprotectine contained in a batch of stamps is extracted from the stamps at the aid of a milieu of extraction.
®
55129 Mainz - Germany Ensuite, the calprotectine extracted can be analyzed by the Alegria Calprotection.
test. The Alegria® test is four with the microtitration barrettes carrying a code with 8-point barrettes, appelées
Phone: +49 (0) 61 31 / 92 58-0 Alegria® test barrettes. Chaque barrette est à usage unique, sur un seul échantillon patient. The Alegria®
Fax: +49 (0) 61 31 / 92 58-58 barrette test is four with a complete set of reactants, composed of enzymatic conjugation, enzyme substrate,
chantillon diluent and a specific control of the test. Additionally, the barrette test will present two puits
Internet: www.orgentec.com
containing specific anticorps in the test, which will provide feedback puits for a control and a échantillon patient.
The reaction is based on the principle of the indirect ELISA, with the subsequent steps: the calprotectine
Notice d'utilisation present in the control/positifs channels is on the surface of the reaction points, also forming an anticorpus-
2013-12 antigen complex.
. After incubation, a first washing step eliminates non-liées and non-specified molecules. Le conjugaté
enzymatique fourni ajouté par la suite se lie aux complexes antigènes-anticorps qui se formed. After incubation,
a second stage of washing eliminates superfluous enzymatic conjugation. L'ajout de solution de substrate
d'enzyme entraîne l'hydrolyse et le développement de coloration pendant l'incubation.
The intensity of the blue color varies depending on the concentration of antigenic-antibody complexes and is
ORG 280 Calprotectin measured at 650 nm by an optical module.
The Alegria® barrette test is based on the proprietary SMC® (Sensotronic Memorized Calibration) technology:
the Alegria® barrette test contains information on the test, analysis and evaluation as well as the expiration
DESCRIPTION ABREGEE date specified in the lot that they are. printed on the code in bars.
Alegria® Calprotectin is a quantitatif ELISA test for calprotectine in the human seal échantillons. This product The Alegria® test bar can be used with the Alegria® diagnostic instrument, an analyzer with completely
is intended for use exclusively by qualified personnel in the in vitro diagnostic system. automated access. The SMC® technology allows you to transfer the encoded données of the Alegria® test bar
to the instrument and the test is automatically processed and evaluated. The instrument lit the date of expiration
®
and refuses to continue the treatment if the date of the barrette testest dépassée.
Alegria
USED SYMBOLS
AVERTISSEMENT ET PRECAUTIONS D'USAGE
V In vitro diagnostic medical device • All the reactions of this test system are conçus for being used exclusively by qualified personnel in the in
vitro diagnostic cadre. • The
M Manufacturer
internal control contains the original human material. This test is not intended to guarantee the absence of
h infectious agents in the human material, our recommendations are to handle the Alegria® test bands with
Catalog reference
potentially infectious materials.
X24 Suffisant pour • The bovine serum albumine (BSA), contains the components, is tested by the ESB and the results are
negatifs.
Code du lot • Avoid all contact with the TMB enzyme substrate (3,3´,5,5´-Tetraméthylbenzidine).
g
• The liquid of the system containing acids. Leur concentration n'est pas dangereuse. Avoid all contact with
H utiliser jusqu'au la peau
• Le control, le diluant de chantillon et la solution de nettoyage contiennent 0.09 % d'azide de sodium comome
2:r30: Temperature limits
conservateur. Sa concentration n'est pas
Yo Consult the notice of use dangereuse. • I conjugated enzymatique contient 0.05% of ProClin 300 as a conservateur. Sa concentration n'est pas
dangereuse.
w Keep the sunlight open Lors de la manipulation des réactifs, des contrôles et des échantillons patient, les directives de security en
application dans le laboratoire et les bonnes pratiques de laboratoire doivent être
respectées: • Mesures de firsts secaurs: In cas de contact avec la peau, laver immédiatement et abondamment
à l'eau et au savon. Remove the clothing and contaminated shoes and nets before the porter. In case of
Alegria® test barrettes
contact with the liquid of the system with the water, wash thoroughly. In case of projection in the eyes, rinse
wash buffer the eyes in grand ouverts sous l'eau courante pendant au moins 10 minutes. Remove your contact lenses if
System fluid you can easily remove them. Voies respiratoires: prenez de l'air frais. In case of ingestion: Rincez-vous la
bouche et crachez le liquide. Buvez un ou two verres d'eau immédiatement. In case of spontaneous vomiting,
Milieu d'extraction
maintain the body plus bas the body on the belly to prevent the vomit from passing through the respiratory
Ready to use tract. • Measurements in case of accidental liquid spill: respect the safety directives of good laboratory
practices. Avoid all contact with dirt and debris. Ne pas avaler. Ne pas pipetter avec la bouche. Do not handle,
smoke, smoke or make up your makeup in the areas of manipulation of the échantillons or the components
of the product. Absorb with an inert material and return to the appropriate manner.
• Personal protective equipment: wear protective gloves in nitrile or latex. Porter of protective lunettes. Dans le
cadre d'une utilisation appropriée, aucun réactif n'est dangereux.
ORG 280_IFU_FR_QM131929_2013-12-16_1.1 page 1 ORG 280_IFU_FR_QM131929_2013-12-16_1.1 page 2

®
• Special conditions: If the TMB substrat is photosensitive, keep the Alegria® test barrettes in the open air. • Les in a day.
2 and 8 °C. Our recommendations for using the solution of the Alegria reagent bottle
déchets doivent être mis au rebut
conformément aux réglementations nationales et locales sur la protection RECOMMANDATIONS •
de l'environnement. The analysis kit cannot be used after the expiration date. • Avant le
It is advisable to respect the quality control directives of medical laboratories in the handling of control serums début du test, la barrettes réactive et les prélèvements devraient être mis à disposition durant
and/or tests. 30 minutes at room temperature.
• To avoid contamination, apply a new pipette with a new pipette point.
CONTENU DU COFFRET
X24 ORG 280 Suffisant pour 24 doses PRÉLÈVEMENT, STOCKAGE ET MANIPULATION OF ECHANTILLONS Prélèvement
d'échantillons de selles Un collecteur
Alegria® test barrettes: composed of 8 chacun pins. "Stool Sample Collector" (SSCO) peut être utilisé. • Avoid all
Puits 1 et 2: vines et non enduits (puits pour dilution de l'échantillon) contamination with the toilet water that contains disinfectants. • Store the
Puits 3 et 4: puits recuverts d'anticorps (puits de réaction) collected sold chantillon for a maximum of 5 days at a temperature between 2 and 8 °C.
Puit 5: Control: yellow; contient anti-Calprotectin, PBS, BSA, detergent; 0.09 % However, keep it at a temperature of -20 °C.
d'azide de sodium comme conservateur.
Preparation of the chantillon of stamps
Puit 6: Conjugated enzymatique: rouge clair; Contient des anticorps de Calprotectin Extraction of the calprotectine à l'aide du "Stool Exctraction Tube" (ORG 280)
couplés à la peroxidase, PBS, BSA, détergent ; 0.05% ProClin as conservateur. Pour the Alegria® Calprotectin test, the solder chantillon is diluted at 1:50 in the milieu of four extractions. Les
échantillons non homogènes doivent être homogénésés avant le treatmentement, par example à l'aide d'une
Puit 7: Diluant d'échantillon: jaune ; PBS, BSA, detergent; 0.09 % d'azide de anse d'inoculation. Pour les échantillons de seles liquides, nous recommendations deser l'échantillon (see ci-
sodium comme conservateur.
dessous la méthode sans tube d'extraction).
Puit 8: TMB substrate solution: 3,3', 5,5'-tetraméthylbenzidine. 1 Prepare the tube "Stool Extraction Tube" (ORG 282)
Les anticorps anti-calprotectine recouvrent les micropuits. The soldering iron and the extraction milieu doivent être utilisés à ambient temperature.
Product code on the bar code: Calprotectin Washing Versez 750 µl de milieu d'extraction dans le tube transparent (partie 1) et fermez-le à l'aide de la spatule (partie
1x 20ml tampon; Tris buffer container, detergent, 0.09% as preservative, concentrated (50 2) et du bouchon bleu sur le tube.
x) 2 Prélevez l'échantillon de selles
1x 2.5ml The fluid of the acid-containing system, concentrated (1000 x) Ouvrez le tube et removez la spatule au level du bouchon orange.
1x 20 ml Milieu d'extraction, contenant du TBS, une stabilisante protein, un réactif d'extraction, Prélevez l'échantillon de seles en utilisant la spatule. The rains of the spatule doivent être recouvertes de
de l'azoture de sodium en tant que preservateur (0.09 %). Ready to use. seals. Pour ce faire, prélevez 15 mg de selles.
3 Divisez l'échantillon de selles
ii 1 Mode of employment Alegria®: Mini-DVD Alegria® Insert the orange dosage spatula into the blue tube and turn it into the pot. The surplus of sales is suppressed
1 Quality control certificate in the cône. The dilution is less than 1:50.
4 Extraction
MATERIAL REQUIREMENTS MAIS NON Agitez pendant 30 seconds à 1 800 tours/minute to preview the seals of the spatule rains.
FOURNI • Vortex agitator, agitator, centrifuge of paillasse, optional: precision balances Homogénéisez ensuite l'échantillon pendant 30 minutes à 1 000 tours/minute dans un agitateur.
• Micropipettes with the cônes à usage unique pour 10
µl • Eau distillée ou
désionisée • Eprouvette graduated pour 1000 ml and 2500 ml
AUXILIARY IN VITRO DIAGNOSTIC REACTIFS • ORG 283

contains 125 ml of extraction buffer. Ready to use.
Composition identify the extraction milieu in the test kit.
OTHER ACCESSORIES
• ORG 282 Stool Extraction Tubes; containing 100 tubes. •
SSCO Stool Sample Collector These Ouvrez le tube dans le cône bleu et transferez l'échantillon homogène dans un microtube. Centrifuge pendant 2
auxiliaries are sold separately. minutes at 3 000 xg. Transfer the transparent liquid into another microtube and test immediately the preparation
to detect the calprotectine. This soldering iron is removed from the stock at a temperature between 2 and 8 °C
STOCKAGE AND STABILITE • for a maximum of 5 days or at -20 °C for a maximum of 4 days. The release of extra sells is not stable at ambient
Stock the test kit between 2 and 8 °C when the light is temperatures!
open. • Do not expose the reactions to the chalet, soleil or a strong light pendant, stockage and light.
utilization. Extraction of the calprotectine without tube "Stool Exctraction Tube" (ORG
• Keep the Alegria® test barrettes in the referable sachet fourni with the dessicateur. • 280) • The soldering iron and the extraction milieu doivent être utilisés à ambient
temperature. • Pesez watched him. Prélevez un échantillon de selles et transférez-le dans le tube. Pesez l'échantillon et
The product has been kept for 15 months from the day of its production when it is not open.
The reactions that do not occur remain stable until the expiration date of the product. déterminez son poids
Se reporter à l'étiquette de chaque lot. net. • Remplissez le milieu "Calprotectin Stool Extraction Medium" (ORG 283) in the tube: Poids net de l'échantillon
• The washing pad and the diluted system liquid remain stable until 30 days, between 49 fois pour a dilution 1:50
échantillon de selles + milieu d'extraction échantillon de selles + milieu d'extraction

15 mg + 0.75 ml 20 mg + 60 mg + 2.9ml PERFORMANCE CHARACTERISTICS

1.0 ml 30 mg + 1.5 ml 40 70 mg + 80 3.4ml
Measurement range
mg + 2.0 ml 50 mg + 2.5 mg + 90 mg + 3.9ml
4.4ml The plage de mesure is 0 - 1000 µg/g
ml 100 mg + 4.9
ml Valeur normale
Fermez had him. Agitez 30 seconds at 1 800 tours/minute. Homogénésez ensuite l'échantillon pendant 30 minutes In the frame of a study of the normal beach with the échantillons of donneurs de sains, the valeurs suivantes
à 1 000 tours/minute with an agitator. ont definitions: value limit 50 µg/g
Ouvrez had him. Transfer the homogeneous chantillon into a microtube. Centrifuge pendant 2 minutes at 3 000 xg.
Interpretation of the results
Transfer the transparent liquid into another microtube and test immediately the preparation for detection.
Normal beach < 50 µg/g
calprotectin.
Valeurs légèrement élevées 50 - 200 µg/g
PREPARATION OF REACTIFS Valeurs très élevées > 200 µg/g
Level of calprotectine in the normal beach: gastro-intestinal inflammation presque excludes; d'autres measurements
The contents of the bottle of concentrated washing buffer solution (20 ml) are diluted - ahead.
Invasive diagnostics are not generally useful.
l'utilisation – pour d'eau distillée jusqu'à un final volume de 1000 ml (1 liter). The wash buffer solution is
ensuite transfer the container before it becomes effective. If a seul run d'Alegria® is carried out on a day, we Level of calprotectine légèrement élevé : faible level of inflammatory activity in the gastro-intestinal tractus
Recommands to transfer separately 500 ml of diluted nettoyage solution in the bottle of Alegria ® reagent. (for example, MII in rémission) ; A repeat test and other diagnostic measures are recommended.
Level of calprotectine très élevé: maladie organique active du tractus gastro-intestinal; d'other tests diagnostics
The fluid content of the système fluid concentrate (1000x) is diluted to a final volume of 2500 intensifs and a treatment for a gastro-enterologist are urgently required.
ml par ajout d'eau distillée. The liquid is ensuite transferred in the bouteille before it is effective.
Linéarité
Three échantillons patient presentants une concentration calprotectine elevée sont dilués de manière linéaire dans
Avant toute utilisation, remove the necessary name of barrettes test Alegria® du sac refermable and acclimater à
The dilution solution, to represent the dynamic zone of the échantillon, even if the lower limits et
ambient temperature (20 to 28 °C). Remove the film from the bottom of the vines just before the debut of the test.
supérieure de la linéarité. The activity of the dilution step is measured by the SMC ® technology.
.
Ready to use Echantillon Dilution I watched Escompté O/E

. . [µg/g] [µg/g] [%]
OPERATOR MODE 1 1:100 746.8 746.8 100
The Alegria® Random Access analyzer is totally automated using the Alegria® test barrettes with the technology . 1:200 366.7 373.4 98
SMC®. The mode of employment of the automate presents the precise information on the fonctionnement of the automate. . 1:400 186.7 186.7 100
(1) Remove only the film recovering the cavities vide 1 to 4 from the barrette test. . 1:800 89.5 93.4 96
The film on the code in bars is printed and recovers the cavités 5 to 8 2 1:100 625.5 626.5 100
ne doit pas être retiré . 1:200 325.0 313.3 104
(2) Dispense 10 µl of undiluted preparation from the patient at the bottom of cavity 1. . 1:400 151.1 156.6 97
(3) Insert the Alegria® test barrettes into the SysTray. . 1:800 65.2 78.3 83
(4) Turn the SysTray into the correct position at the level of the Alegria® automation and start it running. Les autres
3 1:100 112.9 112.9 100
étapes are automatically fonted. A run is finished as the primer of the Alegria® automat begins.
. 1:200 59.5 56.5 105
print the results.
. 1:400 26.5 28.2 94
. 1:800 14.6 14.1 103
Detection limit
Concentration detectable at the lowest level: 5.2 µg/g
Reproductibilité
Intra-test precision: the coefficient of variation (CV) is calculated for three échantillons from 24 réalisées in a
seoul run. The results of intra-test precision are summarized in the table.
Inter-test precision: the coefficient of variation (CV) is calculated for three échantillion from 6 realises in
CALIBRATION
5 runs. The results of inter-test precision are summarized in the table.
The test system is calibrated by rapport with the EQAS échantillons four by: INSTAND eV, Germany (EQAS No .
120, batch 2012 / 2013). Intra-test Inter-test

Echantillon Moyenne . Echantillon Moyenne .
CALCULATION OF RESULTS . µg/ %CV . µg/ %CV
The Alegria® test barrettes are transferred to the Alegria® automated system to the aid of the 1 g 49.5 5.5 1 g 47.8 8.7
SMC® technology (Sensotronic Memorized Calibration). The calculation and interpretation of the results by way of work 2 218.2 6.1 2 107.1 6.5
automatic entry. 3 847.9 9.9 3 335.8 7.1

. Annals of Clinical Biochemistry. 2013; 50: 53-61

14. NICE Diagnostics guidance 11, Oct. 2013, Faecal calprotectin diagnostic tests for inflammatory diseases of the
Interférences bowel.
pas testé 15. Layer et al.: "S3-Leitlinie Reizdarmsyndrom: Definition, Pathophysiologie, Diagnostik und Therapie.
Results of studies Deutschen Gesellschaft für Neurogastroenterologie und Motilität (DGNM)". Z.
Study population n pos %
Inflammatory bowel disease 186 182 97.8
Diagnostic clinic
Valeurs tres Plage
ORG 280 Valeurs tres 182 10
. Beach 4 152
Sensitivity . 186 162 348
Specificity 97.8 %
Diagnostic efficiency 93.8 %
96.0 %
LIMITS OF THE TEST

This test is an aid to diagnosis. A clinical diagnosis does not have to be based on the results of a seul test, but it is also
useful for a doctor after evaluating the ensemble of laboratoire results and clinical elements, fully entenant of all the
patient's clinic. In addition, this is the time when the traitement is decided upon individuellement. Les plages de
référence ci-dessus pathologiques et normaux d'anticorps dans les échantillons des patients doivent être considérés
que comme des recommendations. Chaque laboratoire doit fondée ses propres gammes fonction de la norm ISO 15189
ou d'autres lignes guidelines applicables en laboratoire.
REFERENCES 1.
Burri; Beglinger: “Faecal calprotectin – a useful tool in the management of inflammatory bowel disease.” Swiss Med
Wkly. 2012; 142: w13557 2. Van
Rheenen et al.: “Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic
meta-analysis.” BMJ. 2010; 341: c3369 3. Johne;
Fagerhol et al.: “Functional and clinical aspects of the myelomonocyte protein calprotectin.” J Clin
31:89-94
Disease. 2003; 35:642-647
7. Carroccio et al.: “Diagnostic accuracy of faecal calprotectin assay in distinguishing organic causes of chronic
diarrhea from irritable bowel syndrome: a prospective study in adults and children.” Clinical Chemistry. 2003;
49:6:861-867
9. Costa et al.: “Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn's disease.”
Gut. 2005; 54: 364-368 10.
Fagerberg et al.: „Fecal calprotectin levels in healthy children studied with an improved assay“. Journal of

ORGENTEC Diagnostika GmbH METHODOLOGY

Carl-Zeiss-Strasse 49-51 To extract the calprotectin present in a fecal sample, it is necessary to use extraction culture. The extracted
®
55129 Mainz - Germany calprotectin can then be analyzed with the Alegria assay. The Calprotection.
Alegria® assay kit has 8-well barcoded microstrips, called Alegria® assay strips. Each strip is designed to
Phone: determine a single patient sample. The Alegria® test strip has a complete set of reagents, including enzyme
+49 (0) 61 31 / 92 58-0
conjugate, enzyme substrate, sample buffer and a specific assay control. Additionally, each strip has two
Fax: +49 (0) 61 31 / 92 58-58
antibody-coated wells that serve as reaction wells for a control and a patient sample.
The determination is based on an indirect enzyme-linked immunological reaction with the following steps: The
Instructions for use calprotectin present in the reference/positive samples is fixed to the surface of the reaction wells, creating an
antigen-antibody complex. After incubation, a first washing step removes unbound molecules and non-specific
2013-12
bound molecules. The enzyme conjugate added is then ligated to the immobilized antibody-antigen complex.
Following incubation, a second washing step removes unbound enzyme conjugate. Addition of the enzyme
substrate solution results in hydrolysis and color development during incubation. The intensity of the blue
color is related to the concentration of the antibody-antigen complex and can be measured photometrically at
650 nm.
ORG 280 Calprotectin The Alegria® test strip is based on patented SMC® (Sensotronic Memorized Calibration) technology: information
about the test, analysis and evaluation and the lot-specific expiration date are found in the barcode printed on
each strip Alegria ® trial.
BRIEF DESCRIPTION The Alegria® test strip can be used with the Alegria® diagnostic instrument - an automated random access
Alegria® Calprotectin is a test system based on the ELISA system for the quantitative measurement of analyzer. Using SMC® technology, data encoded in the barcode is transmitted from the Alegria® test strip to
calprotectin in human fecal samples. This product is intended exclusively for professional use in in vitro the instrument and the assay is automatically processed and evaluated. The instrument reads ® the expiration
diagnostics. date and rejects further processing if the Alegria test strip is expired.
WARNINGS AND PRECAUTIONS • All

SYMBOLS USED reagents in this kit are for professional use for in vitro diagnostics. • Internal control
contains material of human origin. Since no test can guarantee the absence of infectious agents in human
V Medical device for in vitro diagnosis material, we recommend that you handle Alegria® test strips as possible infectious material.
M Maker
• The BSE test has been carried out on the bovine serum albumin (BSA) used in the components and the
result has been negative.
h Catalog number
• Avoid contact with the TMB substrate (3,3', 5,5'-tetramethylbenzidine).
X24 Valid for • The system fluids contain acids, whose classification is non-hazardous. Avoid contact with skin. •
Control, sample and wash buffers contain 0.09% sodium acid as a preservative. This
g Batch code concentration is classified as non-hazardous.
• Conjugated enzymes contain 0.05% ProClin 300 as a preservative. This concentration is classified
H Date of Expiry
as not dangerous.
During the treatment of all reagents, controls and serum samples, comply with current regulations on laboratory
2:r30: Temperature limitation safety and good laboratory practices: First aid measures: in case of contact with the
Yo Consult instructions for use skin, Carefully wash the area with soap and water.
Remove contaminated clothing and shoes and wash them before reuse. If skin comes into contact with system
w Stay out of sunlight fluids, wash the area carefully with water. In case of eye contact, carefully rinse open eye with running water
for at least 10 minutes. If you can do it easily, remove your contact lenses. Respiratory tract: Remove person
to fresh air. Ingestion: Rinse mouth and spit out liquid.
Drink 1- 2 glasses of water immediately. In case of spontaneous vomiting, hold the head down with the body in
Alegria® Test Strip a prone position to prevent vomit from entering the airways. • Personal
Washing solution precautions, protective equipment and emergency procedures: Follow
System fluid laboratory safety regulations. Avoid contact with skin and eyes. Do not ingest the product. Never pipette with
your mouth. Do not eat, drink, smoke, or apply makeup in areas where you are working with samples or kit
Cultivation for extraction
reagents. In the event of a spill, absorb the product with an inert material and dispose of the spilled product
Ready for use
accordingly. • Exposure controls/personal protection: Use protective
nitrile rubber or natural latex gloves.
Wear protective glasses. There are no known dangerous reactions if used as intended.
• Conditions to avoid: The substrate solution is sensitive to light, so Alegria® strips should be stored in a dark
place. • Follow national or regional
regulations to dispose of laboratory waste.
ORG 280_IFU_ES_QM131927_2013-12-16_1.1 page 1 ORG 280_IFU_ES_QM131927_2013-12-16_1.1 page 2

Follow the guidelines for conducting quality controls in medical laboratories through controls with a clean pipette tip.
test and/or mixture of sera.
SAMPLE COLLECTION AND PREPARATION
KIT CONTENTS Collection of fecal samples

You can use the Stool Sample Collector (SSCO).
X24 ORG 280 Valid for 24 determinations
• Avoid contamination with toilet water containing disinfectants.
Alegria® test strip: consisting of 12 modules of 8 wells each.
• Store the stool sample obtained for less than 5 days at 2-8 º C. Another option is to store it at
Wells 1 and 2: empty and uncoated (sample solution wells) -20º C.
Wells 3 and 4: antibody coated (reaction wells)
Well 5: Control; yellow; contains Calprotectin, PBS, ASB, detergent, Preparation of the fecal sample
sodium acid preservative 0.09%. Extraction of calprotectin with the "Stool Exctraction Tube" (ORG 280)
Well 6: Conjugated enzyme; light red; contains anti-Calprotectin antibodies, For the analysis of Alegria® Calprotectin, the stool sample must be diluted in the culture for extraction
HRP labeling; PBS, ASB, detergent, ProClin 0.05% preservative. supplied at 1:50. Heterogeneous samples should be homogenized before sampling, e.g.
Well 7: Sample buffer: yellow, contains PBS, ASB, detergent, using a sowing loop. For liquid stool samples, we recommend that you weigh the sample (see
sodium acid preservative 0.09%. method explained below without the extraction tube).
Well 8: TMB substrate solution: 3,3', 5,5'-tetramethylbenzidine. 1 Prepare the "Stool Extraction Tube" (ORG 282)
The stool sample and culture for extraction should be at room temperature.
Reaction wells: coated with anti-Calprotectin antibodies.
Fill the transparent tube (part 1) with 750 µl of the culture for extraction and close it with the spatula (part 2)
Barcode Product Code: Calprotectin
with the blue closing thread on the tube.
1x 20ml Washing solution; contains Tris, detergent, sodium acid preservative 0.09%;
50x concentrated 2 Collect stool sample
1x 2.5ml Open the tube and remove the spatula through the orange closing thread.
The system fluid; contains acid; 1000x concentrated
Collect the stool sample by inserting the spatula into the stool. The spatula slots should be
1x 20 ml Culture for extraction; contains TBS, stabilizing protein, reagent for
completely covered with the stool sample, for which you must collect 15 mg of stool.
extraction, preservative sodium azide 0.09%. Ready to use.
3 Divide the stool sample
Yo 1 Alegria® Instructions for use: Alegria® Mini-DVD
Insert the orange measuring spatula into the blue conical insert of the tube and twist to close. He
Yo 1 Quality control certificate
Excess feces will be removed by the conical insert. The resulting dilution is 1:50.
REQUIRED LABORATORY EQUIPMENT 4 Extraction

Shake for 30 seconds at 1800 rpm to remove the stool sample from the spatula grooves. TO
• Vortex mixer, oscillating shaker, tabletop centrifuge, optional: precision scales
Then homogenize for 30 minutes at 1000 rpm on an oscillating shaker.
• Micropipettes with single-use syringes for 10 µl
• Distilled or deionized water
• Graduated cylinder for 1000 ml, 2500 ml
AUXILIARY REAGENTS FOR IN VITRO ANALYSIS

• ORG 283 Calprotectin Stool Extraction Medium; contains 125 ml of extraction buffer.
Ready to use. Composition identical to the culture for extraction in the test kit.
OTHER ACCESSORIES
• ORG 282 • Stool Extraction Tubes; with 100 tubes.
SSCO Stool Sample Collector
Open the tube at the blue conical insert and transfer the homogenate to a microtube. Centrifuge during
These accessories are sold separately.
2 min. at 3000 xg. Transfer the clean liquid to another microtube and check the calprotectin immediately.
CONSERVATION AND STABILITY Fecal samples collected in this way can be stored at 2-8ºC for a maximum of 5 days or at
-20º C for a maximum of 4 months.
• Store the test set at 2-8ºC in a dark place.
• Do not expose reagents to heat, sun, or bright light during storage or use. Please note that the stool sample is not stable at room temperature.
• Store sealed Alegria® test strips in the supplied clip-on pouch with a blotter.
Extraction of calprotectin without the "Stool Exctraction Tube" (ORG 280)
• The shelf life of unopened test kits is 15 months from the date of manufacture. The
• The stool sample and culture for extraction should be at room temperature.
Unopened reagents are stable until the expiration date of the set. Check the labels of each
• Weigh the empty tube. Take a stool sample and transfer it to the tube. Reweigh the tube and calculate the weight
individual lot.
sample net.
• Diluted wash buffers and system fluids are stable for at least 30 days if used
• Fill the tube with "Calprotectin Stool Extraction Medium" (ORG 283): it will be necessary 49 times the net weight of the
stored at 2-8ºC. We recommend that it be used on the same day once it has been transferred to the container
sample to achieve a 1:50 dilution. stool
of the reagent.
sample + culture extraction 0.75 ml 1.0 ml 1.5 stool sample + culture extraction
15 mg + 20 ml 2.0 60 mg + 70 2.9ml
TECHNICAL NOTES
mg + 30 mg + ml 2.5 mg 80 + 3.4ml
• The test kit should not be used after the expiration date. ml + 3.9ml
40 mg + 50 mg 90
• The test paper and samples should be placed at approx. room temperature. 30 minutes before + 4.4ml
mg + mg 100
start the test. 4.9ml
mg +
• Pipet the sample into the bottom of the cavity. To prevent carryover, the sample should always be pipetted
Close the tube. Shake for 30 sec. at 1800 rpm. Then homogenize for 30 seconds. at 1800 rpm in a

oscillating shaker. Open the tube. Transfer the homogenate to a microtube. Centrifuge for 2 min. to 3000 Expected values
xg. Transfer the clean liquid to another microtube and check the calprotectin immediately. In a routine interval study with serum samples from healthy donors the following have been established
intervals with the Alegria ® assay: limit value 50 µg/g
PREPARATION OF REAGENTS
Results analysis
The contents of each bottle of washing solution concentrate (20 ml) must be diluted by adding water Normal range < 50 µg/g
distilled to obtain a final volume of 1000 ml (1 liter). The washing solution is then poured into a Values a little high 50 - 200 µg/g
intended container. If only one Alegria series is to be performed in one day, we recommend transferring only Considerably high values > 200 µg/g
500 ml of diluted wash buffer. Calprotectin level within the normal range: gastrointestinal inflammation almost ruled out; generally not
Other invasive diagnostic tests are necessary.
Before use, dilute the contents of each bottle of system fluid concentrate (1000x) with water. Slightly elevated calprotectin level: low level of inflammatory activity in the gastrointestinal tract (e.g. IBD in
distilled until reaching a total volume of 2500 ml. The system fluid will then be led to the referral process); Repeat testing and other diagnostic tests are recommended.
container provided for it.
Considerably elevated calprotectin level: active organic disease of the gastrointestinal tract; HE
recommends that other intensive diagnostic tests be urgently performed and that you go to a
Take the required number of Alegria® test strips from the clip bag and wait until they reach the specialist gastroenterologist to follow treatment.
room temperature (20-28ºC). Do not remove the foil covering empty wells until you are ready to
start the test. Linearity
demonstrate the dynamic range of the test at the upper/lower limit of linearity. The activity was calculated for each dilution
Ready for use
using SMC ® technology.
.
PROCEDURE Sample Dilution Observed Expected O/E
Alegria® test strips with SMC® technology are used with Alegria ® diagnostic equipment. . . [µg/ [µg/g] [%]
In the User Manual of the equipment you will find more information about its use. 1 1:100 g] 746.8 100
(1) Of the sheets that cover cavities 1 - 4, only the one that covers the strips of . 1:200 746.8 366.7 373.4 98
required testing . 1:400 186.7 186.7 100
Do not remove the barcoded sheets covering cavities 5 - 8. . 1:800 89.5 93.4 96
(2) Pipette 10 µl of undiluted patient sample into the bottom of cavity 1.
2 1:100 625.5 626.5 100
(3) Insert the strip into the SysTray.
. 1:200 325.0 313.3 104
(4) Place the loaded Systrays in the correct position on the Alegria® equipment and start the series. The following
. 1:400 151.1 156.6 97
steps will be carried out automatically. The test series will be over when the team starts to
print the results. . 1:800 65.2 78.3 83
3 1:100 112.9 112.9 100
. 1:200 59.5 56.5 105
. 1:400 26.5 28.2 94
. 1:800 14.6 14.1 103
Detection limit
Minimum detectable concentration: 5.2 µg/g
Reproducibility
CALIBRATED Intra-analytical precision: the coefficient of variation (CV) of each of the three (3) samples was calculated from
Calibration of the analysis method is carried out in relation to EQAS samples supplied by: INSTAND the results of 24 analyzes in a single series. The following table shows the results for precision
intraanalytical.
eV, Germany (EQAS No 120, batch 2012 / 2013).
Inter-assay precision: the coefficient of variation (CV) of each of the three samples was calculated from
INTERPRETATION OF RESULTS the results of six (6) analyzes in five (5) different series. The results for the serial accuracies in
Using SMC® (Sensotronic Memorized Calibration) technology, all test data is transferred to the
series are shown in the following table.
Three patient samples with high calprotectin levels were serially diluted in sample buffer to
system through an individual barcode on the Alegria ® test strip.
Intra-Assay Inter-Essay
The evaluation and interpretation of the results is done completely automatically.
Sample Average %CV Sample Average %CV
OPERATING CHARACTERISTICS . [µg/ [%] . [µg/ [%]

1 g] 49.5 5.5 1 g] 47.8 8.7
Measuring range 2 218.2 6.1 2 107.1 6.5
® is
The calculation interval of this Alegria essay 0 - 1000 µg/g 3 847.9 9.9 3 335.8 7.1

Interferences 14. NICE Diagnostics guidance 11, Oct. 2013, Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel.
have not been evaluated
15. Layer et al.: "S3-Leitlinie Reizdarmsyndrom: Definition, Pathophysiologie, Diagnostik und Therapie.
Study results Deutschen Gesellschaft für Neurogastroenterologie und Motilität (DGNM)". Z.
Study population n pos % 97.8
Inflammatory bowel disease 186 182
Clinical diagnosis
Values Interval
ORG 280 Values 182 10
Interval 152
. 4 186 162 348
Sensitivity 97.8 %
Specificity 93.8 %
PROCEDURE LIMIT
This test is a diagnostic aid. The definitive clinical diagnosis should not be based on the results of a test, but should be made
by the doctor after all, the clinical and laboratory findings have been evaluated against the complete clinical picture of the
patient. Also all treatment decisions must be taken into account individually.
The above reference ranges should be considered as a guide only. It is recommended that each laboratory establish its own
normal and pathological ranges of antibodies in patient samples.
BIBLIOGRAPHY
1. Burri; Beglinger: “Faecal calprotectin – a useful tool in the management of inflammatory bowel disease.” Swiss
Med Wkly. 2012; 142:w13557
2. Van Rheenen et al.: “Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic
meta-analysis.” BMJ. 2010; 341: c3369 3. Johne;
Fagerhol et al.: “Functional and clinical aspects of the myelomonocyte protein calprotectin.” J Clin
31:89-94
Disease. 2003; 35:642-647
7. Carroccio et al.: “Diagnostic accuracy of faecal calprotectin assay in distinguishing organic causes of chronic diarrhea from
irritable bowel syndrome: a prospective study in adults and children.” Clinical Chemistry. 2003; 49:6:861-867
9. Costa et al.: “Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn's disease.” Gut. 2005;
54: 364-368 10. Fagerberg et al.:
„Fecal calprotectin levels in healthy children studied with an improved assay“. Journal of
Annals of Clinical Biochemistry. 2013; 50:53-61

ORGENTEC Diagnostika GmbH METHODOLOGY

Carl-Zeiss-Strasse 49-51 Calprotectin contained in a fecale campione must be stratified from feci with a mezzo di strazione.
®
55129 Mainz - Germany Quindi, it is possible to analyze calprotectin with the Alegria Calprotection.
analysis. The Alegria® test is characterized by microstrisce with 8 pozzetti equipped with a barre code, called
Phone: +49 (0) 61 31 / 92 58-0 Alegria® reattive strisce. Ciascuna striscia è destinata a'unique determinazione su un singolo campione
Fax: paiente. The Alegria® reagent kit contains a complete reagent set that includes: enzyme conjugate, enzyme-
+49 (0) 61 31 / 92 58-58
substrate, campion buffer and a specific control for the determination. Inoltre ciascuna striscia has two
sensitive pozzetti with anticorpi che servono de pozzetti de reazione para un controllo e un paziente campione.
The determination is based on an immune reaction indirectly linked to an enzyme with the following steps:
Calprotectin contains no control/positive fields if it reaches the surface of the reaction site forming an antigen-
Istruzioni per
l'uso 2013-12 antibody complex. Dopo an incubation period, a first phase of lavaggio rimuove the molecole non legate and
the molecole non specifiche legate.
Successivamente l'enzime coniugato aggiunto lega il complesso antigene-anticorpo fissato. After an incubation
period, a second washing phase removes the enzyme from being completed. The addition of the enzyme-
substrate solution causes hydrolysis and color change during incubation. The intensity of the blue color is
correlated to the concentration of the antigen-antibody complex and can be measured photometrically at 650 nm.
ORG 280 Calprotectin The Alegria® reactive strisce is based on its proprietary SMC® (Sensotronic Memorized Calibration) technology:
information on its test, analysis, valutazione and data of the specific sequence is contained in the code to barre
stampato its ciascuna Alegria® reactive striscia.
BRIEF DESCRIPTION The Alegria® test can be used with the Alegria® diagnostic instrument, a completely automatic Random
Alegria® Calprotectin is a test system based on its ELISA for the quantitative measurement of fecal calprotectin. Access analyzer. Using SMC® technology, the data is coded in the code and the data is transferred from the
This product is intended exclusively for professional use in in vitro diagnostics. Alegria® reagent to the instrument and the test is processed and analyzed in automatic mode. The instrument
reads the data of the scadenza and does not proceed to the analysis of the strisce reattive Alegria ®scadute.
INDICAZIONI AND MISURE PRECAUZIONALI

UTILIZATIONAL SYMBOLS
• All information about this promotional package is intended exclusively for personal use.
V In vitro medical-diagnostic device specialized in in vitro diagnosis.
• The internal control contains material of human origin. Since there is no test to guarantee the detection of
M Manufacturer
infectious agents in the material, we will handle the stress of the Alegria® test on potentially infectious
materials.
h Catalog Reference
• Bovine animal albumin (BSA), containing none of its components, is this data to reveal the presence of ESB and è
X24 Enough for negative result.
• Avoid contact with the enzyme substrate TMB (3,3', 5,5'-tetramethyl benzidine).
Lotto code • The system fluid contains acid. This concentration is classified as non-periculous. I will avoid contact
g
with gli occhi.
H I will use it
• The control unit, the buffer and the lavage buffer contain no more than 0.09% sodium azotide.
preservative. This concentration is not classified as pericolosa.
2:r30: Temperature limit
• The enzyme conjugate contains 0.05% of ProClin 300 as a preservative. This concentration is classified
Yo Please consult the instructions for use. eat non pericolosa.
During the handling of reagents, control measures and peace of mind if you should observe normal safety
w I will keep the riparo from the solar light standards and good laboratory practice: • Make
sure you get prompt help: in case of contact with ice, wash immediately and accurately with water and soap. .
Remove contaminated scars and wash them before using them again. If the liquid from the dovesse system
comes into contact with the unit, wash it thoroughly with water. Douse the contact with dark water, rinse it
Strisce reattive Alegria®
with running water for at least 10 minutes with the eye open. Opening the phone slowly to contact is possible
Lavaggio tampon with ease. Respiratory tract: carry the person all'aria aperta. Inghiottimento: sciacquare the mouth for far
fluid system fuoriuscire and liquidi. Immediately drink 1-2 water bottles. If the patient vomits spontaneously, keep the
head low with the body in a prone position to avoid the vomit entering the trachea. • Measure in case of
Mezzo di estrazione
involuntary leaks: observe the safety standards of good laboratory practice. I will avoid contact with occhi and
Ready for use cute. Do not ingest. Don't pipettare with your mouth. Do not handle, bere, smoke or touch the product in any
way that it has been handled or opened, or any components of the product. Raccogliere eventuali versamenti
con inert material ed esguire un smaltimento adeguato dei rifiuti.
• Individual protection devices: wear protective gloves in lattice or nitrile. Indossare occhiali de protezione.
In case of conformal use, no pericolose reactions are noted.
• Conditions to avoid: make the TMB substrate photosensitive, immagazzinare the card to immersion Alegria® al
Wow.
ORG 280_IFU_IT_QM131931_2013-12-16_1.1 page 1 ORG 280_IFU_IT_QM131931_2013-12-16_1.1 page 2

• I rifiuti devono essere smaltiti in conformità alle dispositioni environmentali nationali e locali. AVVERTENZE OPERATIVE
We will observe the directives for the control of quality in the medical laboratories and ensure the transport of the waste products • The test kit cannot be used when the chain data is in use. • The start of
and/or pool of supplies. the campioni must be prepared 30 minutes after the start of the temperature test.
atmosphere.
KIT CONTENT
• Pipette and campioni at the bottom of the cavity. To avoid misplacement, if you do not pipe the campione di
X24 ORG 280 Enough for 24 volta in volta with a fresh pipetta prop.
Strisce reattive Alegria®: costituita da 12 modules con 8 pozzetti ciascuno. RACCOLTA, CONSERVATION, MANIPOLAZIONE DEI CAMPIONI
Pozzetti 1 and 2: vuoti e non rivestiti (pozzetti per la diluizione del campione) Raccolta dei campioni di feci I will
Pozzetti 3 e 4: cavità revestito con anticorpi (cavità di reazione) use the “Stool Sample Collector” (SSCO) raccoglitore. • Avoid
Pozzetto 5: Control it; giallo; Contains Calprotectin, PBS, BSA, detergent and 0.09% contamination with toilet water that contains disinfectants. • Store freshly grown
sodium azide preservative.”
campions within 5 days at 2-8°C. Oppure, store at -20°C.
Pozzetto 6: Enzyme coniugato: rosso chiaro; contains anticorpi Calprotectinmarcati with
Preparation of the fields of feci Estrazione
perossidasi, PBS, BSA, detergent; 0.05% ProClin eats preservative.
della calprotectina con la fiala "Stool Exctraction Tube" (ORG 280)
To use the Alegria® Calprotectin, the product must be diluted with a proportion of 1:50 in the middle of the baking tray. I campioni
Pozzetto 7: Tampone del campione: giallo; PBS, BSA, sodium azotide detergent
0.09% eat preservative. non omogenei devono essere omogeneizzati prima della campionatura, ad es. with an inoculation connection. For the campions of
these liquids, we weigh the campione (see the method without being damaged).
Pozzetto 8: Soluzione di substrate TMB: 3,3', 5,5'-tetramethylbenzidine.
Gli anticorpi anti-calprotectin were exposed to the microsite.
1 I will prepare the "Stool Extraction Tube" file (ORG 282)
Barre product code: Calprotectin Lavaggio Tampone; The feci campione and the mezzo de estrazione devono essere at room temperature. Insert 750 µl of the same stretch into the
1x 20ml Contains elettrophoresis triacetate, detergent, sodium azotide 0.09% and preservative.; transparent fiala (part 1) and touch the spatola (part 2) with the blue thread fillet tap of the fiala.
concentrate (50 x)
1x 2.5ml fluid system; contains acid; concentrate (1000 x) 2 Raccogliere il campione di feci
1x 20 ml Estrazione Mezzo: contains TBS, stabilizing protein, estrazione reagent, Press the lever and remove the spatola from the arancione filettato cap. Rimuovere el campione di feci inserting the spatola nelle
sodium acid preservative 0.09%. Soon for use. feci. The moon of the devono spatola is completely rich with the campione of the feci. Ciò means that it came prelevati 15 mg di
®
ii 1 Alegria® Istruzioni per l'uso: Alegria Mini-DVD feci.
1 Certificate of analysis 3 Porzione campione di feci
Inserte la spatola de dosaggio arancione nel cone blue della fiala e rotate per chiudere. Le feci in eccesso vengono rimosse
NECESSARY MATERIALS dall'inserto a cone. The dilution of the product is 1:50.
• Vortex Mixer (Vortex Mixer) sbattitore, centrifuge of the bench, in option: precision bilancia. • Micropipette 4 Strazione
with single-use tip 10 µl • Water distilled oppure Apply the Vortex for 30 sec at 1800 turns/minute to restart the campione of the lights on the spatola. Continue to omogeneizzare
deionized • Cylinder size per 1000 ml, for 30 minutes at 1000 turns/minute in the sbattitore.
2500 ml
REAGENTI IVD AUSILIARI • ORG

283 l'utilizzo Calprotectin Stool Extraction Medium; Contains 125 ml of estrazione buffer. Soon per
Composizione identical to the strazione mezzo in the kit for the test.
OTHER ACCESSORIES
• ORG 282 Stool Extraction Tubes; contains 100 fiale. • SSCO Stool
Sample Collector These accessories are sold
separately.
Press the line at the top of the blue cone and transfer the homogenized product into a micro-line. Centrifuge for 2 minutes at 3000xg.
Transfer the fluid into another microfiber and immediately test the calprotectin.
CONSERVATION AND STABILITÁ °
These raw materials must be stored at 2-8°C for a period not exceeding 5 days or at -20 C for a period of up to 4 months.
• Immagazzinamento della confezione de prova a 2-8 °C al buio. • During
immagazzinamento and use, do not spray or react with excessive heat, sun or light. • Immagazzinare the card
Campione di feci stratte is not stable if stored at room temperature!
to immersione Alegria® in the bag with clip in kit, sealed and with illumination.
dissecting.
Estrazione della calprotectina senza fiala "Stool Exctraction Tube" (ORG 280) • Il campione de
• The proof packaging does not open because it is kept for 15 months from the production data. feci e il mezzo de estrazione devono essere at room temperature. • I will weigh the fiala vuota.
The reagents did not open and were stable in the process of the test packaging. See the tag of the lotto singolo. Raccogliere il campione di feci e inserterlo nella fiala. Weigh it and determine the net weight of the
campione.
• The diluted washing buffer and the diluted system liquid are stable for at least 30 days at a time. • Insert the “Calprotectin Stool Extraction Medium” (ORG 283) insert into the line: occorre un peso
temperature 2-8°C. We advise you to consume the solutions immediately before using them in the bottle of Alegria Netto x 49 per dilution of 1:50
® reagent.

campione fecale + mezzo di estrazione campione fecale + mezzo di estrazione using SMC® (Sensotronic Memorized Calibration) technology. The analysis and interpretation of the results
15 mg + 0.75 ml 20 mg + 60 mg + 2.9ml avvengono in fully automatic mode.
1.0 ml 30 mg + 1.5 ml 40 70 mg + 80 3.4ml
mg + 2.0 ml 50 mg + 2.5 mg + 90 mg 3.9ml PRODUCT CHARACTERISTICS
ml + 100 mg + 4.4ml
Chiudere la 4.9ml Measurement field
fiala. Apply the Vortex operation for 30 sec at 1800 turns/minute. Omogenizzare subsequently per 30 The measured field is for 0 - 1000 µg/g
min to 1000 turns/minute in one sbattitore.
Tighten the blade. Transfer the feci omogeneizzate in a microfiala. Centrifuge for 2 minutes at 3000xg. I will transfer Normal value
fluid and immediately test the calprotectin. Nell'ambito de un studio sul campo de riferimento con campioni de donatori de sani sono stati relevati and seguenti
valuei: limit value 50 µg/g
PREPARATION OF REAGENTS
Interpretation of results
The content of the ogniflacone of the concentrated washing buffer (20 ml) is diluted first for fine use for a Gamma in the mean < 50 µg/g
Final volume of 1000 ml (1 liter), adding distilled water. The washing solution is only available after transfer. Highly elevated values 50 - 200 µg/g
®
immediately in the container provided by the scope. I know if there is only one cycle of Joy per ogni giorno di Very high value > 200 µg/g
®
I work, consigliamo transfer in the bottiglietta di reagent Alegria diluito. only 500 ml of lavaggio buffer
Livello di calprotectina in the media: almost guarita gastrointestinal inflammation; I don't usually sound
Necessary further analysis to diagnose invasive.
The content of the light bottle of the concentrated fluid system (1000x) is diluted first after use, adding water Livello di calprotectina leggermente elevated: leggera infiammazione nel tratto gastrointestinale (ad es. IBD in
distilled fine to a final volume of 2500 ml. The ottenuto fluid system comes by transfer into the container apposite. guarigione); If you consult further analysis and test results.
Livello elevated calprotectin: organic pathology of the gastrointestinal tract; urgently conduct further testing
First of all, prelevare the bag with clip the necessary number of the card to immersione Alegria ®, carry it to
diagnosed by a gastroenterologist.
room temperature (20-28°C). Remove the film that is rich in the cavità vuote only immediately first
dell'inizio del test.
Three peaceful campions with a high concentration of Calprotectin specifici are stati sottoposti a diluizione
Ready for use linearity in the pad to stabilize the dynamic field of the analysis without checking the bottom and top end of it
linearità. The activity of the anticorpi of the ogni stages of dilution is stata calculated using SMC ® technology.
EXECUTION OF THE TEST .Linearità
®
The random access analyzer Alegria completely automatic use cardboard to immersion Alegria ® with
Campione Dilution Osservate Expected O/P
SMC® technology. The manual contains the necessary instructions for using the appliance. . . [µg/ [µg/ [%]
(1) Remove the film that covers the cavità vuote from 1 to 4 only the strip necessary to carry out the test
1 1:100 g] 746.8 g] 746.8 100
The film that covers the cavità from 5 to 8, stamped with the code a barre, does not go away.
. 1:200 366.7 373.4 98
(2) Pipette volta in volta 10 µl of campione of the patient at the bottom of cavity 1.
. 1:400 186.7 186.7 100
(3) Insert the Alegria® immersion card into the SysTray.
® . 1:800 89.5 93.4 96
(4) Insert the SysTray caricature into the Alegria Apparecchiatura In the right position and start the cycle.
® 2 1:100 625.5 626.5 100
Tutte le altre fasi sono automatiche. A cycle does conclude when the stampante dell'apparecchiatura Alegria starts
to stampare and risultati. . 1:200 325.0 313.3 104
. 1:400 151.1 156.6 97
. 1:800 65.2 78.3 83
3 1:100 112.9 112.9 100
. 1:200 59.5 56.5 105
. 1:400 26.5 28.2 94
. 1:800 14.6 14.1 103
Limit of determination
Relevant minimum concentration: 5.2 µg/g
Reproduction
Intra-assay precision: the coefficient of variation (CV) is stato calcolato per tre campioni ognuno con 24 definizioni
CALIBRATION
in a cycle. The results of the precision in the series are also reflected in the table.
The analysis system is calibrated against the EQAS fields provided by: INSTAND eV, Germany (EQAS No 120, batch
Intra-assay precision: the coefficient of variation (CV) is calculated by three fields respectively 6
2012 / 2013).
definitions in 5 cycles. The precision results cycle by cycle sound on the table.
INTERPRETAZIONE DEI RISULTATI

®
The data from the individual cards to immersion Alegria® are not transferred to the Alegria appliance system.

. 10. Fagerberg et al.: „Fecal calprotectin levels in healthy children studied with an improved assay“. Journal of
Intra-test Inter-test Pediatric Gastroenterology and Nutrition. 2003; 37:468-472
Campione Mezzo % CV [µg/g] Campione Mezzo % CV [µg/g] 11. Montalto et al.: “Fecal calprotectin in first-degree relatives of patients with ulcerative colitis.” Am J
. [%] . [%] Gastroenterol. 2006; 101:1-5
49.5 47.8
1 5.5 1 8.7 12. Roseth et al.: „Normalization of faecal calprotectin: a predictor of mucosal healing in patients with inflammatory
2 218.2 6.1 2 107.1 6.5
3 847.9 9.9 3 335.8 7.1
Annals of Clinical Biochemistry. 2013; 50:53-61
Interference 14. NICE Diagnostics guidance 11, Oct. 2013, Faecal calprotectin diagnostic tests for inflammatory
diseases of the bowel.
not testate
Gemeinsame Leitlinie der Deutschen Gesellschaft für Verdauungs- und Stoffwechselkrankheiten
Risultati dello studio
(DGVS) und der Deutschen Gesellschaft für Neurogastroenterologie und Motilität (DGNM)". Z.
Study population n n pos % Gastroenterol. 2011; 49:237-293
Clinical diagnosis
Most Gamma Values
ORG 280 Great value 182 10
. Gamma 4 152
Sensitivity . 186 162 348
Specificity 97.8 %
96.0 %
LIMITATION OF THE PROCEDURE

This test is a diagnostic aid. The definitive clinical diagnosis cannot be based on the results of a syndrome.
test, ma dovrebbe essere fatta dal medico, dopo tutto i risultati clinici e di laboratories sono state valutate
concerning the entire clinical picture of the patient. Inoltre, any decision for therapy dovrebbe essere prey
individually.
Gli intervalli di ferimento sopra pathologiche e normale per gli anticorpi nei campioni dei pazienti devono essere
consideri come raccomandazioni alone. Ogni laboratory must be stable and proper range according to ISO 15189 or ad
other line guide of the laboratory applicabili.
BIBLIOGRAPHIC RIFERIMENTI
1. Burri; Beglinger: “Faecal calprotectin – a useful tool in the management of inflammatory bowel disease.” Swiss
Med Wkly. 2012; 142:w13557
2. Van Rheenen et al.: “Faecal calprotectin for screening of patients with suspected inflammatory bowel disease:
diagnostic meta-analysis”. BMJ. 2010; 341:c3369
3. Johne; Fagerhol et al.: “Functional and clinical aspects of the myelomonocyte protein calprotectin.” J Clin
31:89-94
Disease. 2003; 35:642-647
7. Carroccio et al.: „Diagnostic accuracy of faecal calprotectin assay in distinguishing organic causes of chronic
“diarrhea from irritable bowel syndrome: a prospective study in adults and children.” Clinical Chemistry. 2003;
49:6:861-867
9. Costa et al.: “Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn's
“disease”. Gut. 2005; 54:364-368

ORGENTEC Diagnostika GmbH PRINCIPLE TESTU

Carl-Zeiss-Strasse 49-51 Kalprotektin obsažený ve vzorcích lidské stolice je tÿeba separovat ze stolice pomocí extrakÿního média. Poté
®
55129 Mainz - Germany lze extrahovaný kalprotektin analyzovat pomocí analyzy Calprotection.
Alegria Test Alegria® obsahuje mikrostripy s nazvem Alegria® Test Strips. Mají 8 jamek a jsou oznaÿené ÿárovým kodem.
Phone: Každý proužek je urÿen pro jedno stanovení z jednoho vzorku od paienta. Alegria® Test Strip obsahuje
+49 (0) 61 31 / 92 58-0
kompletní sadu reagencií: enzymatický konjugát, enzymatický substrát, vzorek pufru a kontrolní vzorek
Fax: +49 (0) 61 31 / 92 58-58
specifický pro daný test. Na každém proužku jsou dále dvÿ jamky protilátková povrchová úprava, které slouží
Internet: www.orgentec.com jako reakÿní jamky pro jeden kontrolní vzorek a jeden vzorek od patienta.
Stanovení je založeno na nepÿímé imunitní reakci navázaného enzymu, která má tyto fáze: Kalprotektin
pÿítomný v ÿídícím / zkoumaném vzorku se váže na plochu reakÿní kavity, což vytváÿí komplex protilátkového
Návod k použití
antigenu. Po inkubaci se pÿi prvním promytí odstraní nenavázané a nespecificky navázané molekuly. Následnÿ
2013-12
pÿidaný enzymatický konjugát se naváže na mobilizovaný komplex protilátky a antigenu. Po inkubaci se pÿi
druhém promytí odstraní nenavázaný enzymatický konjugát. Po pÿidání enzymatického substrátu dojde k
hydrolýze a ke vzniku zbarvení v prÿbÿhu inkubace. Intenzita modrého zbarvení odpovídá koncentraci
complexu protilátky a antigenu a lze ji fotometricky mÿÿit pÿi vlnové delce 650 nm.
Principal testu Alegria® Test Strip vychází z patentované technologie SMC® (Sensotronic Memorized
ORG 280 Calprotectin Calibration): údaje o testu, analýze a hodnocení a dále datum exspirace dané šarže jsou obsaženy v ÿárovém
kódu vytištÿném na každém proužku testu A legria® Test Strip.
Alegria® Test Strip can be used to diagnose the test Alegria® – plnÿ automatickým analyzátorem s pÿímým
KRÁTKÝ POPIS pÿístupem (Random Access). Pomocí technology SMC® jsou data zakódovaná v ÿárovém kódu pÿenesena z
Alegria® Calprotectin je testovací systém ELISA pro kvantitativní mÿÿení kalprotektinu ve vzorcích lidské stolice. proužku Alegria® Test Strip do pÿístroje, který automaticky provided test a vyhodnotí jej. Pÿístroj odeÿte
Tento výrobek je urÿen pouze profesionální in vitro diagnostiku. datum exspirace a je-li test Alegria® Test Strip prošlý, odmítne jeho další zpracování.
UPOZORNÿNÍ A PREVENCE
POUŽÍVANÉ SYMBOLI • Všechna ÿinidla teto sady jsou navržena pouze pro profesionální in vitro
diagnostiku. • Interní ÿízení obsahuje materiál lidského pÿvodu. Protože žádný test nemÿže zajistit absenci
V Diagnostický zdravotnický prostÿedek in vitro infekÿních ÿinitelÿ v lidském materiálÿ, doporuÿujeme manipulovat s testovacími proužky Alegria® jako s
možným infekÿním materiálem.
M Výrobce • Bílkovina hovÿzího séra (BSA) použitá v komponentách byla otestována na BSE a to
negativnÿ. • Vyhnÿte se contaktu se substratem TMB (3,3´,5,5´-
h Katalogové ÿíslo
tetramethyl benzidine). • Systémová kapalina obsahuje kyselinu, dle klasifikace je bezpeÿná.
X24 Zabraÿte kontaktu s pokožkou. • Kontrola, vzorkový roztok a mycí roztok obsahují 0.09% azidu sodného jako ochranný pro
Dostaÿuje pro
koncentrace je klasifikována jako bezpeÿná.
Kód šarže • Enzym konjugace obsahuje 0.05% ProClinu 300 jako ochranného prostÿedku. This concentration does not
g
have classifications.
H Spotÿebujte do Bÿhem manipulace se všemi ÿinidly, kontrolami vzorky séra sledujte stávající naÿízení pro laboratorní
bezpeÿnost a správnou
2:r30: Teplotni omezeni laboratorní práci: • První pomoc: V pÿípadÿ kontaktu s pokožkou ihned dÿkladnÿ opláchnÿte vodou a
saponátem. Sundejte kontaminovaný odÿv a boty a pÿed dalším použitím je omyjte. Dojde-li ke kontaktu
Yo Viz návod k použití
systémové kapaliny s kÿží, opláchnete dÿkladnÿ vodou. Po contaktu se zrakem dÿkladnÿ oplachujte otevÿené
w Chraÿte pÿed sluneÿním svÿtlem oÿi tekoucí vodou po dobu alespoÿ 10 minut. Pÿjde-li to bez obtíží, sundejte kontaktní ÿoÿky. Dýchací cesty:
pÿemístÿte osobu na ÿerstvý vzduch. Požití: vypláchnÿte ústa a tekutinu vyplivnÿte. Ihned vypijte 1 - 2
sklenice vody. Pÿi nenuceném zvracení umístÿte hlavu postiženého smÿrem k zemi pÿi poloze tÿla na bÿiše,
abyste zabránili vniknutí zvratkÿ do dýchací trubice.
Alegria® Testovací stripy • Osobní opatÿení, ochranné vybavení a postup v pÿípadÿ
Promývací pufr nouze: Sledujte naÿízení laboratorní bezpeÿnosti. Vyvarujte se contaktu s pokožkou a oÿima. Nepožívejte.
Systémová kapalina Nenasávejte ústy. Nejezte, nepije, nekuÿte nebo nenanášejte make up v oblastech, kde se manipuluje se
Extrakce media vzorky nebo sadou ÿinidel. Pÿi vylití absorbujte inertním materiálem a politý
materiál ÿádnÿ zlikvidujte. • Limity vystavení / ochrana osob: Noste ochranné rukavice z nitrilové nebo z
Pÿipraven k použití pÿirodního latexu. Noste ochranné brýle. Pÿi používání dle urÿeného
použití nejsou známy nebezpeÿné reakce. • Situace, kterým je tÿeba pÿedcházet: Roztok substrátu je citlivý na svÿtlo. Proto
tmavém mistÿ.
• Pÿi likvidaci laboratorního odpadu je tÿeba dodržovat mistní a národní pÿedpisy.
Dodržujte smÿrnici provádÿní ÿízení kvality ve zdravotnických laboratoÿích analyzaÿními kontrolami a/nebo
sdruženými séry.
ORG 280_IFU_CS_QM131924_2013-12-16_1.1 page 1 ORG 280_IFU_CS_QM131924_2013-12-16_1.1 page 2

OBSAH SOUPRAVY • Vzorky stolice neúchovávejte dele než 5 dní pÿi 2-8 °C. Popÿípadÿ skladujte pÿi -20 °C.
X24 ORG 280 Dostaÿuje pro 24 Pÿíprava vzorku stolice

Alegria® testovací stripy: destiÿka obsahující 12 modulÿ po 8 jamek. Extrakce kalprotektinu pomocí trubiÿky "Stool Exctraction Tube" (ORG 280)
Jamky 1 to 2: prázdné a bez ÿinidla (jamky pro ÿedÿní vzorku) Pro Alegria® Calprotectin analyzu je nutné vzorek stolice naÿedit 1:50 v poskytnutém extrakÿním médiu.
Jamky 3 to 4: protilátková povrchová úprava (reakÿní jamky) Nehomogenní vzorky lze homogenizovat pÿed odebíráním vzorku, napÿíklad pomocí inokulaÿní smyÿky.
Jamky 5: Kontrola: žlutá; obsahuje Calprotectin, PBS, BSA, detergent, ochranný U tekutých vzorkÿ stolice doporuÿujeme vzorek zvážit (viz metoda níže bez extrakÿní trubiÿky).
prostÿedek azid sodný 0.09% 1 Pÿíprava trubiÿky "Stool Extraction Tube" (ORG 282)
Jamky 6: Enzymový konjugát: svÿtle ÿervená; obsahující protilátky anti- Vzorek stolice a extrakÿní medium musí mit pokojovou teplotu.
Calprotectin, oznaÿene HRP; PBS, BSA, detergent, ochranný prostÿedek Nalijte 750 µl extrakÿního média do prÿhledné trubiÿky (ÿást 1) a uzavÿete pomocí stÿrky (ÿást 2) modrým
ProClin 0.05%. závitovým uzávÿrem na trubiÿce.
Jamky 7: Vzorkový pufr: žlutá; obsahuje PBS, BSA, detergent, ochranný 2 Odebrání vzorku stolice
prostÿedek azid sodný 0.09% . Otevÿete trubiÿku a vytáhnÿte stÿrku na oranžovém závitovém uzávÿru.
Jamky 8: TMB substrátový roztok: 3,3', 5,5'- tetramethyl-benzidine. Odeberte vorek stolice zasunutím stÿrky do stolice. Dražky na stÿrce je nutné plnÿ pokrýt vzorkem stolice.
Antikalprotektinové protilátky jsou povrchovÿ upraveny pro mikrokavity. Výsledkem je odebrání 15 mg stolice.
Product code in the box code: Calprotectin 3 Díl vzorku stolice
1x 20ml Promývací pufr; Obsahuje Tris, detergent, ochranný prostÿedek azid sodný 0.09%; Vložte oranžovou dávkovací stÿrku do modré kuželové vložky trubiÿky a pro uzavÿení otáÿejte. Nadbytek stolice
50x concentration se otÿe o kuželovou vložku. Výsledný roztok je 1:50.
1x 2.5ml ÿedÿná systémová kapalina; obsahuje kyselinu; 1000x concentration 4 Extrakce
1x 20 ml Extrakÿní medium; obsahuje TBS, stabilizaÿní protein, extrakÿní reagentii, Viÿte 30 s pÿi 1800 ot./min. pro odstranÿní vzorku stolice z drážek stÿrky. Homogenizujte pot 30 min. pÿi 1000 ot.
konzervant azid sodný 0.09%. Pÿipraveno k použití. /min. on vibraÿním trepadle.
®
Yo 1 Alegria® Pokyny pro použití: Alegria Mini-DVD
1 Certifikát kontroly kvality
Yo
POTÿEBNÉ VYBAVENÍ
• Vírový mixér, vibraÿní tÿepadlo, stolní odstÿedivka, volitelnÿ: pÿesná mÿÿidla

• mikropipety are dispensed in 10 µl
• destilovaná nebo deionizovaná voda
• odmÿrný válec na 1000 ml, 2500 ml
POMOCNÉ IVD REAGENCIE Otevÿete trubiÿku in the modré kuželové vložce apÿemístÿte homogenát do mikrotrubiÿky. Odstÿeÿujte 2 min. pÿi
• ORG 283 Calprotectin Stool Extraction Medium; obsahují 125 ml extrakÿního tlumicího roztoku. 3000xg. Pÿemístÿte ÿistou tekutinu do další trubiÿky a ihned otestujte na kalprotektin. Takový extrahovaný vzorek
Pÿipraveno k použití. Složení je stejné jako extrakÿní médium v testovací sadÿ. Stolice lze skladovat pÿi 2-8 °C až 5 dní nebo pÿi -20 °C až 4 mÿsíce.
DALŠÍ PÿÍSLUŠENSTVÍ Eextrahovaný vzorek stolice není stabilní pÿi pokojové teplotÿ!
• ORG 282 Stool Extraction Tubes; obsahuje 100 tub.
Extrakce kalprotektinu bez trubiÿky "Stool Exctraction Tube" (ORG 280)
• SSCO Stool Sample Collector
• Vzorek stolice a extrakÿní médium musí mit pokojovou teplotu.
Tyto doplÿky se prodávají zvlášÿ.
• Zvažte prázdnou trubiÿku. Odeberte vzorek stolice a pÿemístÿte jej do trubiÿky. Zvažte jej a zjistÿte ÿistou
hmotnost vzorku.
SKLADOVÁNÍ TO STABILITA
• Nalijte extrakÿní médium "Calprotectin Stool Extraction Medium" (ORG 283) do trubiÿky: 49násobkem ÿisté
• Skladujte testovací sadu pÿi 2-8°C na tmavém mistÿ. hmotnosti vzorku získáte roztok 1:50 dilution
• Bÿhem skladování a používání nevystavujte ÿinidla horku, sluneÿnímu záÿení nebo silnému svÿtlu. vzorek stolice + extrakÿní medium vzorek stolice + extrakÿní medium
®
• Skladujte testovací proužky Alegria • hermeticky uzavÿeny av suchu v dodaném zásobníku. 15 mg + 20 0.75ml 60 mg + 70 mg 2.9ml
Uchovatelnost neotevÿené testovací je 15 mÿsícÿ od data výroby. Neotevÿená ÿinidla jsou stabilní do konce mg + 30 mg + 1.0ml 80 mg + 3.4ml
expire sady. Viz štítky pro individuální dávku. 40 mg + 50 mg 1.5ml 90 mg + 3.9ml
• Rozÿedÿný mycí roztok a systémová kapalina jsou stabilní minimálnÿ 30 dní, jsou-li skladovány pÿi 2-8°C. Pro + 2.0ml 100 mg + 4.4ml
pÿemístÿní do nádoby s ÿinidlem doporuÿujeme spotÿebovat v tentýž den. 2.5ml + Uzavÿete 4.9ml
trubiÿku. Viÿte 30 s pÿi 1800 ot./min.. Homogenizujte pot 30 min. pÿi 1000 ot./min. on vibraÿním trepadle.
POZNÁMKY K PRACOVNÍMU POSTUPU
Otevÿete trubiÿku. Pÿemístÿte homogenát do mikrotrubiÿky. Odstÿeÿujte 2 min. pÿi 3000xg. Pÿemístÿte ÿistou
• Testovací sada nemÿže být po uplynutí data použití používána. Tekutinu do další trubiÿky a ihned otestujte na kalprotektin.
• Veškerý materiál musí být ponechán pÿed použitím pÿi pokojové teplotÿ (20-28 st C).
• Aby se zabránilo kontaminaci, vymÿÿujte špiÿky mikropipet mezi vzorky. PÿÍPRAVA REAGENCIÍ
ODEBÍRÁNÍ VZORKÿ, JEJICH PÿÍPRAVA TO UCHOVÁVÁNÍ

Naÿeÿte obsah Promývacího pufru koncentrátu (50x) s destilovanou nebo deionizovanou vodou na koneÿný objem
Sbÿr vzorkÿ stolice
1000ml (1l). Promývaccí roztok se podé pÿeleje do výhradnÿ k tomu urÿené nádoby. Pokud je tÿeba provést pouze
Lze využít sbÿraÿ vzorku stolice "Stool Sample Collector" (SSCO) jeden cyklus Alegria v jednom dni, doporuÿujeme transfer pouze 500 ml zÿedÿného Promývacího pufru.
• Vyhnÿte se kontaminaci se záchodovou vodou obsahující dezinfekci.

Úroveÿ kalprotektinu znaÿnÿ zvýšena: aktivní organické onemocnÿní gastrostÿevního traktu; doporuÿeny jsou
Naÿeÿte obsah ÿedÿné systémové kapaliny koncentrátu (1000x) s destilovanou nebo deionizovanou vodou na
okamžité intenzívní diagnostické testy a léÿba specializedizovaným gastroenterologem.
koneÿný objem 2500ml pÿed použitím. Systémová kapalina se následnÿ pÿelije do pÿipravené nádoby.
Linearite
®
Vyjmÿte požadovaný poÿet testovacích proužkÿ Alegria -28°C). ze zásobníku a nechejte je ohÿát na pokojovou teplotu (20 Tÿi vzorky pacientÿ obsahující vysokou úroveÿ urÿité kalprotektinu byly sériovÿ zÿedÿny ve vzorkovém roztoku pro
Nesundávejte fóliový obal prázdných jamek, dokud nebudete pÿipraveni zaÿít analyzu. ukázku dynamického rozsahu analyzy a horního / spodního konce linearity. Aktivita pro každý roztok byla
spoÿítána pomocí SMC® technology.
Pÿipraven k použití
Vzorek ÿedÿní Pozorovaná Oÿekávaná P/O
PÿÍPRAVA SLOŽEK . . [µg/g] [µg/g] [%]
Testovací proužky Alegria® s technology SMC® se používaní s diagnostickým zaÿízením Alegria ®. 1 1:100 746.8 746.8 100
Podrobné informace o obsluze nástroje naleznete v návodu k obsluze pro zaÿízení. . 1:200 366.7 373.4 98
(1) Sejmout fólii, která pokrývá prázdné jamky 1 až 4 z potÿebného testovacího proužku . 1:400 186.7 186.7 100
Fólie otištÿná ÿárkovým kódem, jenž pokrývá kavitu 5 až 8, není k sejmutí. . 1:800 89.5 93.4 96
(2) Na dno kavity 1 napipetovat jamky 10 µl nezÿedÿného vzorku patient. 2 1:100 625.5 626.5 100
(3) Vložte proužek do SysTray.
® . 1:200 325.0 313.3 104
(4) Use SysTrays to start polohy v nástroji Alegria a spusÿte test. Všechny další kroky se
. 1:400 151.1 156.6 97
provenou automaticky. Testovací chod je dokonÿen, když nástroj zaÿne tisknout výsledky.
. 1:800 65.2 78.3 83
3 1:100 112.9 112.9 100
. 1:200 59.5 56.5 105
. 1:400 26.5 28.2 94
. 1:800 14.6 14.1 103
Limit detection
Nejnižší zjistitelná koncentrace: 5.2 µg/g
Reproduction
Intraanalyzaÿní pÿesnost: Koefficient variace (CV) byl spoÿítán pro každý ze tÿí vzorkÿ z výsledkÿ 24 nálezÿ v
KALIBRACE
jednom cyklu. Výsledky pro pÿesnost analyzy jsou uvedeny v tabulce níže.
Analyzaÿní system je kalibrován na vzorky EQAS poskytnuté: INSTAND eV, Germany (EQAS No 120, batch Interanalyzaÿní pÿesnost: Koefficient variace (CV) byl spoÿítán pro každý ze tÿí vzorkÿ z výsledkÿ 6 nálezÿ pÿi 5
2012 / 2013). rÿzných cyklech. Výsledky pÿesnosti mezi cykly jsou uvedeny v tabulce níže.
VÝPOÿET VÝSLEDKU
Intra-Assay Inter-Assay
Pomocí technology SMC® (Senzotronicky zapamatovaná calibration) se všechna data pÿevádí del systému pomocí
Vzorek Prÿmÿr % CV Vzorek Prÿmÿr % CV
individuálních ÿárových kódÿ na testovacím proužku Alegria ®. Vyhodnocení a interpretace výsledkÿ probíhá plnÿ
. [µg/g] [%] . [µg/g] [%]
automaticky.
49.5 5.5 47.8 8.7
PRACOVNÍ CHARAKTERISTIKY 12 218.2 6.1 12 107.1 6.5
3 847.9 9.9 3 335.8 7.1
Rozsah mÿÿení
®
Vypoÿet rozsahu analyzy Joy heh 0 - 1000 µg/g Interference
netestováno
Pÿedpokládané hodnoty
V bÿžném rozsahu studie vzorkÿ dárcÿ zdravé byly stanoveny následující rozsahy pomocí analyzy: hranice
hodnoty 50 µg/g Výsledky studio
Study population n n pos %
INTERPRETACE VÝSLEDKÿ
Normálíní rozsah < 50 µg/g abdominal disorders 144 10 6.9
Mírnÿ zvýšené hodnoty 50 - 200 µg/g
Znaÿnÿ zvýšené hodnoty > 200 µg/g
Klinická diagnosis
Úroveÿ kalprotektinu v normálním rozsahu: Gastrostÿevní zánÿt témÿÿ vylouÿen; následná opatÿení invazivní Znaÿnÿ Normální
diagnostiky nejsou obecnÿ vyžadovány. ORG 280 Znaÿnÿ 182 10
Úroveÿ kalprotektinu mírnÿ zvýšena: Nízká úroveÿ zánÿtlivé aktivity gastrostÿevním traktu (napÿíklad zmírnÿné Normalí 4 152
IBD); opakovaný test a další diagnostická opatÿení jsou doporuÿena. . 186 162 348

sensitivity 97.8 %
specificita 93.8 %
diagnostická efektivita 96.0 %
HRANICE METODY
Toto vyšetÿení je diagnostická pomÿcka.Definitivní klinická diagnóza by nemÿla být založena na výsledcích jediného testu, ale mÿly by
být lékaÿ po všech klinických a laboratorních nálezÿ byly hodnoceny o celé klinick I am patient. Také každé rozhodnutí pro terapii by
mÿla být pÿijata individuálnÿ.
Výše pathologické a normalní referenÿní rozmezí pro protilátek u vzorkÿ pacientÿ je tÿeba považovat za doporuÿení pouze. Každá
laboratoÿ by si mÿla stanovit svá vlastní rozmezí podle normy ISO 15189 nebo jiné použitelné laboratory pokyny.
REFERENCE
1. Burri; Beglinger: “Faecal calprotectin – a useful tool in the management of inflammatory bowel disease.” Swiss Med Wkly. 2012; 142:
w13557 2. Van Rheenen et al.:
“Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis.” BMJ. 2010; 341:
c3369 3. Johne; Fagerhol et al.: “Functional and clinical
aspects of the myelomonocyte protein calprotectin.” J Clin
31:89-94
Disease. 2003; 35:642-647
7. Carroccio et al.: “Diagnostic accuracy of faecal calprotectin assay in distinguishing organic causes of chronic diarrhea from irritable
bowel syndrome: a prospective study in adults and children.” Clinical Chemistry. 2003; 49:6:861-867
9. Costa et al.: “Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn's disease.” Gut. 2005; 54:
364-368 10. Fagerberg et al.: „Fecal
calprotectin levels in healthy children studied with an improved assay“. Journal of
NICE Diagnostics guidance 11, Oct. 2013, Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel.
Gemeinsame Leitlinie der Deutschen Gesellschaft für Verdauungs- und Stoffwechselkrankheiten (DGVS) und der Deutschen
Gesellschaft für Neurogastroenterologie und Motilität (DGNM)". Z.

ORGENTEC Diagnostika GmbH METHODICA

Carl-Zeiss-Strasse 49-51 A székletmintában lévÿ kalprotektint extrakciós oldat segítségével kell kivonni. Ezután a kivont kalprotektint
55129 Mainz - Germany az Alegria® Calprotectin vizsgálattal lehet elemezni.
Az Alegria® teszt vonalkódos 8-cellás mikroszalagot tartalmaz, amelynek a neve Alegria® tesztcsík. Minden
Phone: szalag egyetlen beteg mintájának egyszeri meghatározására szolgal. Az Alegria® tesztcsík egy komplett
+49 (0) 61 31 / 92 58-0
reagens szettet tartalmaz. Találhatók benne enzim konjugátok, enzim szubsztrátok, minta puffer és egy teszt-
Fax: +49 (0) 61 31 / 92 58-58
specifikus ellenÿrzÿanyag. Emellett minden csík két antitesttel bevont cellát tartalmaz, amelyek reakciós
Internet: www.orgentec.com cellaként szolgálnak egy kontroll és egy beteg minta számára.
A meghatározás alapja egy közvetetten kapsolodó enzimes immun-reakció az alábbi lépések során: A
Használati utasítás kontrollmintákban vagy pozitív mintákban jelen lévÿ kalprotektin a reakciós cellák felületéhez kötÿdik, így
antitest-antigén komplexumot hozva létre . Az inkubáció után, az elsÿ lépésben a mosás eltávolítja a kötetlen
2013-12
és a nem specifikus kötött molekulákat. Ezt követÿen a hozzáadott enzim konjugátum kötÿdik az immobilizált
antitest-antigén komplexhez. Az inkubáció után, a második mosás eltávolítja a nem kötÿdÿ enzim konjugátumot.
Enzim szubsztrát oldat hozzáadása az inkubáció során hydrolizálást és színelÿhívást okoz. A kék szín
intenzitása megfelel az antitest-antigén-komplex koncentrációjának és fotometriásan mérhetÿ 650 nm-en.
Az Alegria® tesztcsík a saját SMC®-technological ban van tárolva.
ORG 280 Calprotectin
Az Alegria® tests haveználható az Alegria® diagnosztikai mÿszerrel – egy teljesen automatizált, véletlen
RÖVID YOU elérésÿ analyzer. az SMC®-segítségével technology a vonalkódon tárolt adatok továbbíthatók az
WILL READ Alegria® Calprotectin egy ELISA-alapú tesztrendszer, amely a kalprotektin mérésére szolgál az Alegria®tesztcsíkról a mÿszerbe és a mÿszer automatikusan feldolgozza és értékeli a teszt eredményeket. A készülék beolv
®
emberi székletmintákban. A termék rendeltetésszerÿen csak a professzionális in vitro diagnosztikában használható! lejárati idÿt és ha az Alegria teszcsík elavult, automatikusan elutasítja to további feldolgozást.
FIGYELMEZTETÉSEK ÉS ÓVINTÉZKEDÉSEK • A készlet
HASZNÁLT SZIMBÓLUMOK minden egyes reagense kizárólag professzionális, in vitro diagnosztika celjára szolgál. • A belsÿ
kontrollanyag emberi eredetÿ anyagot tartalmaz. Mivel semmilyen teszt nem tudja kizárni a fertÿzÿ anyagokat az emberi
V In vitro diagnosztikai orvostechnikai eszköz eredetÿ anyagokból, azt javasoljuk, hogy az Alegria® tesztcsíkokat kezeljék potentiálisan fertÿzÿ anyagként.
M Gyártó • Az összetevÿkben használt szarvasmarha szérum albumin (BSA) tekintetében BSE vizsgálat történt, negatív
eredménnyel.
h Katalógusszám
• Kerülni kell a TMB-vel (3,3´,5,5´-Tetramethyl-benzidine) történÿ
X24 Elegendÿ érintkezést. • A rendszerben lévÿ folyadék savat tartalmaz, mely nem veszélyes kissorolású.
Bÿrrel ne érintkezzen! • A kontroll, a mintapuffer is a mosópuffer 0.09%-os nátrium-azid tartósítószert tartalmaz. Ez az említ
g Gyártási tetelszám koncentrációban nem veszélyes kissorolású.
• Az enzim konjugátumban 0.05% PROCLIN 300 található tartósítószerként. Ez az említett koncentrációban nem
H Lejárat napja veszélyes kissorolású.
A reagensekkel, kontrollokkal és mintákkal való munkavégzés során figyelembe kell venni a laboratóriumi
2:r30: Megengedett hÿmérseklet biztonságra és a jó laboratóriumi munkavégzési gyakorlatra vonatkozó meglévÿ
Yo Olvassa el a használati utasítást! szabályokat. • Elsÿsegélynyújtás: ha az anyag bÿrre került, azonnal alaposan le kell mosni vízzel és szappannal.
A szennyezett ruhát és cipÿt le kell venni és ismételt hordás elÿtt ki kell mosni. Ha a rendszerben lévÿ
w Napfénytÿl védve tárolandó folyadék a bÿrre került, vízzel alaposan le kell mosni. Ha a szembe jutott, akkor az érintett szemet nyitva
tartva óvatosan, legalább 10 percen át folyó vízzel öblíteni kell. Ha ezt könnyedén megteheti, távolítsa el a
contaktlencséket. Belégzés: vigye az érintett személyt friss levegÿre. Lenyelés: öblítse ki a száját, és köpje
ki a folyadékot. Azonnal igyon meg 1-2 pohár vizet. Ha spontán hányás következik be, hason fekvÿ helyzetben
Alegria® tesztcsík tartsa a fejét a testénél alacsonyabban, hogy a hányadék ne jusson be a légútba.
Mosópuffer • Személyi óvintézkedések, védÿfelszerelés és sürgÿsségi
Rendszerfolyadék intézkedések: Be kell tartani a laboratóriumi biztonsági szabályokat. Az anyagok ne kerüljenek a szembe és a
Extrakciós oldat bÿrre, valamint lenyelésre! Szájjal pipettázni tilos! Olyan területeken, ahol minták vagy reagenskészletek
kezelése folyik, nem szabad enni, inni, dohányozni és sminkelni. A kiömlött anyagokat intert anyaggal fel kell
Használatra kész
itatni és a felitatáshoz használt anyagot megfelelÿ
hulladékgyÿjtÿbe kell dobni. • Fertÿzésvédelem / személyi védelem: Nitrilgumiból vagy természetes latexbÿl készült védÿke
Védÿszemüveget is viselni kell. Az elÿírások szerinti használat esetén veszélyes reakciók nem
®
ismertek. • Elkerülendÿ helyzetek: Mivel a szubsztrát-oldat tesztcsíkokat sötétben kell tárolni.
fényérzékeny, az Alegria • A laboratóriumi hulladékokra vonatkozó nemzeti vagy a regionalalis szabályozást be kell tartan
Az orvosi laboratóriumokra vonatkozó a minÿségellenÿrzési szabályokat be kell tartani, assay-kontroll és
poolozott szérumok használatával.
ORG 280_IFU_HU_QM131930_2013-12-16_1.1 page 1 ORG 280_IFU_HU_QM131930_2013-12-16_1.1 page 2

• A minták legfeljebb 5 napig tárolhatók 2–8 °C-os hÿmérsekleten. Alternatively, store at -20°C.
TO KÉSZLET TARTALMA
Székletminta elÿkészítése
X24 ORG 280 Elegendÿ 24 meghatározásra A kalprotektin kivonata széklet "Stool Exctraction Tube" (ORG 280) segítségével
Alegria® tesztcsík: 12 module mindegyik 8 cellával. Az Alegria® Calprotectin vizsgálathoz a székletmintákat a mellékelt extrakciós oldattal 1:50 arányban kell vegyíteni.
Lyukak 1 + 2: üresek és bevonat néküliek (a minta hígítására szolgaló lyukak) Az inhomogén mintákat a vizsgálat elÿtt homogenizálni kell, pl. inokulálási hurokkal. Folyékony halmazállapotú
Lyukak 3 + 4: antitesttel bevont lyukak (reaktív lyukak) minták esetében javasolt kimérni a mintát (ha nem használ extrakciós csövet, lásd az alábbi módszert).
Lyukak 5: Kontroll; serge; Calprotectin, PBS-t, BSA-t, detergent is 0.09%-os natrium- 1 "Stool Extraction Tube" (ORG 282) elÿkészítése
azid tartósítószert tartalmaz. A székletmintának is az extrakciós oldatnak szoba-hÿmérsekletÿnek kell lennie.
Lyukak 6: Enzim konjugatatum; világos piros; HRP-jelzett anti-Calprotectin antitesteket, Töltsön 750 µl extrakciós oldatot az átlátszó csÿbe (1. lépés), és zárja le a spatulával (2. lépés) úgy, hogy a kék
PBS-t, BSA-t, detergent is 0.05% ProClin tartósítószert tartalma. záróelem a csÿ szájánál legyen.
Lyukak 7: Mintapuffer: sárga, ; PBS-t, BSA-t, detergent, 0.09%-os natrium-azid 2 Mintavétel
tartósítószert. Nyissa fel a csövet, és húzza ki a spatulát a narancs záróelemnél fogva.
Lyukak 8: TMB szubsztrát oldat; 3,3', 5,5'-tetramethyl-benzidine. Dugja be a spatulát a székletmintába. A mintának teljesen be kell fedni a spatula hornyait. Ezzel 15 mg-nyi mintát
Az antikalprotektin antitestek beburkolják a mikrocellákat. vesz.
Termék kod vonalkód: Calprotectin 3 A minta kimérése
1x 20ml Mosópuffer; Tris-t, detergent is 0.09%-os nátrium-azid tartósítószert tartalmaz; 50x-es Dugja a narancs spatulát a csÿ kék záróelembe, és forgassa el a záráshoz. A kúp alakú betét eltávolítja a
koncentratum felesleges mintát. Az így kapott keverék 1:50 arányú.
1x 2.5ml Rendszerfolyadék; savat tartalmaz; 1000x-es koncentrátum 4 Extraction
1x 20 ml Extrakciós oldat; TBS-t, stabilizáló proteint, extracts reagenst és tartósítószerként Keverje vortex keverÿvel 30 másodpercig 1800 fordulat/perc sebességen, hogy a minta kijöjjön a spatula
0.09% natrium-azidot tartalmaz. Azonnal felhasználható. hornyaibol. Homogenizálja 30 percig 1000 fordulat/perc sebességen rázógépben.
®
Yo 1 Alegria® használati utasítás: Alegria mini-DVD
Yo 1 Minÿségellenÿrzési tanúsítvány
SZÜKSÉGES LABORATORIUMI ESZKÖZÖK

• Vortex keverÿ, rázógép, asztali centrifuge, optional: precíziós mérleg
• Micro pipetták egyszer használatos hegyekkel 10 µl-hez
• Desztillált vagy deionizált víz
• Mérÿhenger 1000 ml-fez ; 2500 ml-drug
KIEGÉSZÍTÿ IVD-REAGENSEK Távolítsa el a kék záróelemet, és töltse át a keveréket mikrocsÿbe. Centrifuge 2 percig 3000xg sebességen.
• ORG 283 Calprotectin Stool Extraction Medium; 125 ml extrakciós puffert tartalmaz. Azonnal Töltse át az átlátszó folyadékot egy másik mikrocsÿbe, és azonnal tesztelje kalprotektinre.
felhasználható. Összetétele megegyezik a tesztkészletben található extrakciós oldatéval. Az extraction utáni mintát 2-8 °C-on legfeljebb 5 napig, mig –20 °C-on legfeljebb 4 hónapig lehet tárolni.
TOVÁBBI KIEGÉSZÍTÿK Az extraction utáni minta szobahÿmérsekleten nem stabil!
• ORG 282 Stool Extraction Tubes; 100 kémcsÿ.
• SSCO Stool Sample Collector A kalprotektin kivonata széklet "Stool Exctraction Tube" (ORG 280) nélkül
• A székletmintának és az extrakciós oldatnak szoba-hÿmérsekletÿnek kell lennie.
Ezeket a kiegészítÿket külön lehet megvásárolni.
• Mérje le az üres csövet. Vegyen mintát, es tegye a csÿbe. Mérje le, majd számítsa ki a minta nettó súlyát.
TÁROLÁS IS STABILITÁS • Öntsön extractions oldatot "Calprotectin Stool Extraction Medium" (ORG 283) a csÿbe: az 1:50 keverékarányhoz
a minta nettó súlyának 49-szeresét kitevÿ mennyiség szükséges.
• At temperatures of 2-8 °C hÿmérsékleten, sötét helyen kell tárolni. székletminta + extrakciós oldat székletminta + extrakciós oldat
• A tárolás és a használat során ne tegye ki a reagenseket hÿ, napfény vagy erÿs fény hatásának. 0.75ml 2.9ml
15 mg + 20 60 mg + 70
• Az Alegria® tesztcsíkokat a hozzájuk tartozó zárható zsákban, nedvességtÿl védve, lezártan kell tartani.. 1.0ml + 3.4ml
mg + 30 mg mg 80
• To bontatlan készlet to gyártástól számítva 15 hónapig tárolható. A bontatlan reagensek a készlet lejárati idejéig 1.5ml + 3.9ml
+ 40 mg + 50 mg 90
stabilak maradnak. Lásd az egyes csomagokra vonatkozó feliratokat. 2.0ml + 4.4ml
mg + mg
• A higított mosópuffer is rendszerfolyadék 2-8°C hÿmérsékleten tárolva legalább 30 napig stabil marad. 2.5ml + 4.9ml
100 mg
Javasoljuk, hogy ha már bekerült a reagens-tartóba, akkor az adott napon kerüljön felhasználásra.
Zárja le a csövet. Keverje vortex keverÿvel 30 másodpercig 1800 fordulat/perc sebességen. Homogenizálja
AZ ELJÁRÁSOKKAL KAPCSOLATOS MEGJEGYZÉSEK 30 percig 1000 fordulat/perc sebességen rázógépben.
Nyissa fel a csövet. Öntse a keveréket egy mikrocsÿbe. Centrifuge 2 percig 3000xg sebességen. Töltse át az
• A tesztkészlet a szavatossági határidÿ lejárta után nem használható fel.
átlátszó folyadékot egy másik mikrocsÿbe, es azonnal tesztelje kalprotektinre.
• A tesztcsíkot és a mintákat a teszt elkezdése elÿtt 30 percig szobahÿmérsékleten kell kész állapotba helyezni.
• Az átszennyezés elkerülése érdekében, használj új pipettahegyet minden mintához. REAGENSEK ELÿÁLLÍTÁSA
MINTAVÉTEL ÉS -TÁROLÁS
Székletminta gyÿjtése A mosópuffer-koncentrátum minden üvegének tartalmát (20 ml) a használat elÿtt desztillált víz hozzáadásával
Széklet-mintavételi edény használható "Stool Sample Collector" (SSCO) hígítsuk fel 1000 ml (1 liter) végsÿ térfogatra. A mosóoldatot ezután vezessük át az erre tervezett konténerbe.
• Vigyázzon, hogy ne érintkezzen fertÿtlenítÿszert tartalmazó öblítÿvízzel. Amennyiben egy nap csak egyszer történik mérés az Alegria®-val, akkor javasoljuk, hogy csak 500 ml higított

mosópuffer kerüljön áttöltésre.

A kalprotektin szintje a normál tartományban van: a gasztrointesztinális gyulladás nagy valószínÿséggel kizárható,
további invazív diagnosztikai eljárások általában nem szükségesek.
A rendszerfolyadék koncentrátum mindegyik üvegének tartalmát (1000x) használat elÿtt desztillált víz
hozzáadásával 2500 ml végsÿ térfogatra kell higítani. Ezt követÿen a rendszerfolyadékot át kell vezetni az arra A kalprotektin szintje enyhén emelkedett: alacsony fokú gyulladás van jelen a gasztrointesztinális traktusban (pl.
szolgaló konténerbe. enyhülÿ IBD), ismételt tesztelés és további diagnosztikai eljárások javasoltak.
A kalprotektin szintje jelentÿsen emelkedett: a gasztrointesztinális traktus aktív megbetegedése, javasolt, hogy
Használat elÿtt vegye ki a szükséges számú Alegria® tesztcsíkot a zárhatótasakból és hagyja ÿket gasztroenterológus szakorvos javasolt sürgÿsen végezzen további diagnosztikai eljárásokat és kezelést.
szobahÿmérsekletre (20-28°C) melegedni. A mélyedéseket takaró fóliát csak közvetlenül a teszt megkezdése elÿtt Linearitas
távolítsa el.
Három, nagy mennyiségÿ kalprotektin tartalmazó betegminta mintapufferben végzett sorozathigítása történt az
assay dinamikus tartományának és a linearitás felsÿ/also határának bemutatására. Minden egyes higitásra
Használatra kész vonatkozóan SMC® Technológiával történt az aktivitás kiszámítása.
VIZSGÁLATI ELJÁRÁS
Minta Hígitás Megfigyelt Várt M/V
Az SMC® technologiával mÿködÿ Alegria® tesztcsíkokat Alegria® diagnosztikus berendezésben lehet használni. TO . . [µg/ [µg/ [%]
készülék mÿködésére vonatkozó részletes ismereteket az eszköz Kezelési Útmutatója tartalmazza. 1 1:100 g] g] 100
(1) A fóliát, amely az üres üregeket fedi be 1–tÿl 4-ig, kizárólag azokról a tesztcsíkokról eltávolítani, . 1:200 746.8 366.7 746.8 373.4 98
amelyekre szükség van. A vonalkód nyomtatással ellátott fóliát, amely az 5-tÿl 8-ig terjedÿ . 1:400 186.7 186.7 100
üregeket fedi be, el nem távolítani.
. 1:800 89.5 93.4 96
(2) Adagoljunk pipettaval egyenkent 10 µl higitatlan paciensmintat az 1. lyuk aljara.
2 1:100 625.5 626.5 100
(3) Helyezze a csíkot a tálcára (SysTray).
. 1:200 325.0 313.3 104
(4) A feltöltött tálcát a megfelelÿ pozícióban tegye az Alegria® berendezésbe és indítsa el a mÿveletet. Minden
további lépés automatikusan követi egymást. A tesztnek akkor van vége, amikor a készülék elkezdi nyomtatni az . 1:400 151.1 156.6 97
eredmenyeket. . 1:800 65.2 78.3 83
3 1:100 112.9 112.9 100
. 1:200 59.5 56.5 105
. 1:400 26.5 28.2 94
. 1:800 14.6 14.1 103
Eszlelési határ
Legalacsonyabb észlelhetÿ koncentráció: 5.2 µg/g
Reprodukalhatóság
Assay-n belüli pontosság: a variációs koefficiens mindhárom mintára vonatkozóan az egy menetben 24
meghatározásból kapott eredményekbÿl került kiszámításra. Az alábbi táblázat tartalmazza az assay-n belüli
KALIBRÁLÁS
pontosságra vonatkozó eredményeket.
A vizsgálati rendszert egészséges donorok által adott EQAS minták: INSTAND eV, Germany (EQAS No 120, Assay-k közötti pontosság: a variációs koefficiens mindhárom mintára az öt különbözÿ menetben végzett 6
batch 2012 / 2013). meghatározásból kapott eredményekbÿl került kiszámításra. Az alábbi táblázat tartalmazza az egyes menetek
közötti pontosságra vonatkozó eredményeket.
AZ EREDMÉNYEK INTERPRETÁCIÓJA
Az SMC® technology (Sensotronic Memorized Calibration) értelmében valamennyi adat az egyes Alegria®
Vizsgálaton belül Vizsgálat között
tesztcsíkokon található egyedi vonalkódokhoz rendelten kerül továbbításra a rendszerben. Az eredmenyek
automatikus kiszámítása is értelmezése. Minta Középértek % CV Minta Középértek % CV
. [µg/ [%] . [µg/ [%]
TELJESÍTMÉNYMUTATÓK 1 g] 49.5 5.5 1 g] 47.8 8.7
2 218.2 6.1 2 107.1 6.5
Mérési tartomány 3 847.9 9.9 3 335.8 7.1
Az Alegria® mérÿmÿszer számítási tartománya 0 - 1000 µg/g

Interference
Várható értékek Nem került sor az interference megfigyelésére szérumtartalmú hemolitikummal (legfeljebb 1000 mg/dL),
Az Alegria® mérÿmÿszer számítási tartománya 50 µg/g lipemikummal (legfeljebb 3g/dL triglyceridek), illetve billirubinnal (legfeljebb 40 mg/dL). Továbbá, nem került sor
zavaró haás megfigyelésére antikoagulánsok (EDTA, heparin, citrát) használatánál sem.
Az eredmények interpretation
Normal tartomány < 50 µg/g Kutatási eredmények
Enyhén emelkedett szint 50 - 200 µg/g Study population n n pos %
Jelentÿsen emelkedett szint > 200 µg/g Inflammatory bowel disease 186 182 97.8

Klinikai diagnostics
Jelentÿsen Normal
ORG 280 Jelentÿsen 182 10
Normal 4 152
. 186 162 348
érzékenysége 97.8 %
fajlagosság 93.8 %
diagnosztikai 96.0 %
AZ ELJÁRÁS HATÁRAI
Ez a vizsgálat egy olyan diagnosztikai támogatás. Határozott klinikai diagnózist nem szabad eredményei alapján egyetlen teszt, de kell
az orvos után, minden klinikai és laboratóriumi leletek kerültek kiértékelésre vonatkozó teljes klinikai képet a beteg. Szintén minden
döntés a kezelést meg kell venni külön-külön.
A fenti kóros is a normalís reference tartományokat antitestek betegmintákban kell tekinteni, csak ajánlások.
Minden laboratóriumnak magának kell megalkotnia a saját tartományok az ISO 15189 vagy más vonatkozó laboratóriumi irányelveket.
HIVATKOZÁSOK 1.
Burri; Beglinger: “Faecal calprotectin – a useful tool in the management of inflammatory bowel disease.” Swiss Med Wkly. 2012;
142: w13557 2. Van Rheenen et al.:
“Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis.” BMJ. 2010; 341:
c3369 3. Johne; Fagerhol et al.: “Functional and clinical
aspects of the myelomonocyte protein calprotectin.” J Clin
31:89-94
Disease. 2003; 35:642-647
7. Carroccio et al.: “Diagnostic accuracy of faecal calprotectin assay in distinguishing organic causes of chronic diarrhea from irritable
bowel syndrome: a prospective study in adults and children.” Clinical Chemistry. 2003; 49:6:861-867
9. Costa et al.: “Calprotectin is a stronger predictive marker of relapse in ulcerative colitis than in Crohn's disease.” Gut. 2005; 54:
364-368 10. Fagerberg et al.: „Fecal
calprotectin levels in healthy children studied with an improved assay“. Journal of
NICE Diagnostics guidance 11, Oct. 2013, Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel.
Gemeinsame Leitlinie der Deutschen Gesellschaft für Verdauungs- und Stoffwechselkrankheiten (DGVS) und der Deutschen
Gesellschaft für Neurogastroenterologie und Motilität (DGNM)". Z.

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ORGENTEC Diagnostika GmbH SUMMARY AND EXPLANATION OF THE TEST

WARNINGS AND PRECAUTIONS

ORG 280_IFU_EN_QM131061_2013-12-16_1.2 page 1 ORG 280_IFU_EN_QM131061_2013-12-16_1.2 page 2

AUXILIARY IVD REAGENTS

ORG 280_IFU_EN_QM131061_2013-12-16_1.2 page 3 ORG 280_IFU_EN_QM131061_2013-12-16_1.2 page 4

ORG 280_IFU_EN_QM131061_2013-12-16_1.2 page 5 ORG 280_IFU_EN_QM131061_2013-12-16_1.2 page 6

Interfering substances not diseases of the bowel.

healthy donors 18 0 0.0

LIMITATIONS OF THE PROCEDURE

ORG 280_IFU_EN_QM131061_2013-12-16_1.2 page 7 ORG 280_IFU_EN_QM131061_2013-12-16_1.2 page 8

ORGENTEC Diagnostika GmbH PRINCIPE DU TEST

ORG 280_IFU_FR_QM131929_2013-12-16_1.1 page 1 ORG 280_IFU_FR_QM131929_2013-12-16_1.1 page 2

AUXILIARY IN VITRO DIAGNOSTIC REACTIFS • ORG 283

ORG 280_IFU_FR_QM131929_2013-12-16_1.1 page 3 ORG 280_IFU_FR_QM131929_2013-12-16_1.1 page 4

15 mg + 0.75 ml 20 mg + 60 mg + 2.9ml PERFORMANCE CHARACTERISTICS

Ready to use Echantillon Dilution I watched Escompté O/E

120, batch 2012 / 2013). Intra-test Inter-test

ORG 280_IFU_FR_QM131929_2013-12-16_1.1 page 5 ORG 280_IFU_FR_QM131929_2013-12-16_1.1 page 6

. Annals of Clinical Biochemistry. 2013; 50: 53-61

LIMITS OF THE TEST

ORG 280_IFU_FR_QM131929_2013-12-16_1.1 page 7 ORG 280_IFU_FR_QM131929_2013-12-16_1.1 page 8

ORGENTEC Diagnostika GmbH METHODOLOGY

WARNINGS AND PRECAUTIONS • All

ORG 280_IFU_ES_QM131927_2013-12-16_1.1 page 1 ORG 280_IFU_ES_QM131927_2013-12-16_1.1 page 2

KIT CONTENTS Collection of fecal samples

REQUIRED LABORATORY EQUIPMENT 4 Extraction

AUXILIARY REAGENTS FOR IN VITRO ANALYSIS

ORG 280_IFU_ES_QM131927_2013-12-16_1.1 page 3 ORG 280_IFU_ES_QM131927_2013-12-16_1.1 page 4

OPERATING CHARACTERISTICS . [µg/ [%] . [µg/ [%]

ORG 280_IFU_ES_QM131927_2013-12-16_1.1 page 5 ORG 280_IFU_ES_QM131927_2013-12-16_1.1 page 6

healthy donors 18 0 0.0

Diagnostic efficiency 96.0 %

ORG 280_IFU_ES_QM131927_2013-12-16_1.1 page 7 ORG 280_IFU_ES_QM131927_2013-12-16_1.1 page 8

ORGENTEC Diagnostika GmbH METHODOLOGY

INDICAZIONI AND MISURE PRECAUZIONALI

ORG 280_IFU_IT_QM131931_2013-12-16_1.1 page 1 ORG 280_IFU_IT_QM131931_2013-12-16_1.1 page 2

REAGENTI IVD AUSILIARI • ORG

ORG 280_IFU_IT_QM131931_2013-12-16_1.1 page 3 ORG 280_IFU_IT_QM131931_2013-12-16_1.1 page 4

INTERPRETAZIONE DEI RISULTATI

ORG 280_IFU_IT_QM131931_2013-12-16_1.1 page 5 ORG 280_IFU_IT_QM131931_2013-12-16_1.1 page 6

LIMITATION OF THE PROCEDURE

ORG 280_IFU_IT_QM131931_2013-12-16_1.1 page 7 ORG 280_IFU_IT_QM131931_2013-12-16_1.1 page 8

ORGENTEC Diagnostika GmbH PRINCIPLE TESTU

ORG 280_IFU_CS_QM131924_2013-12-16_1.1 page 1 ORG 280_IFU_CS_QM131924_2013-12-16_1.1 page 2

X24 ORG 280 Dostaÿuje pro 24 Pÿíprava vzorku stolice

• Vírový mixér, vibraÿní tÿepadlo, stolní odstÿedivka, volitelnÿ: pÿesná mÿÿidla

ODEBÍRÁNÍ VZORKÿ, JEJICH PÿÍPRAVA TO UCHOVÁVÁNÍ

ORG 280_IFU_CS_QM131924_2013-12-16_1.1 page 3 ORG 280_IFU_CS_QM131924_2013-12-16_1.1 page 4

Nejnižší zjistitelná koncentrace: 5.2 µg/g

ORG 280_IFU_CS_QM131924_2013-12-16_1.1 page 5 ORG 280_IFU_CS_QM131924_2013-12-16_1.1 page 6

diagnostická efektivita 96.0 %

ORG 280_IFU_CS_QM131924_2013-12-16_1.1 page 7 ORG 280_IFU_CS_QM131924_2013-12-16_1.1 page 8

ORGENTEC Diagnostika GmbH METHODICA

FIGYELMEZTETÉSEK ÉS ÓVINTÉZKEDÉSEK • A készlet

ORG 280_IFU_HU_QM131930_2013-12-16_1.1 page 1 ORG 280_IFU_HU_QM131930_2013-12-16_1.1 page 2

SZÜKSÉGES LABORATORIUMI ESZKÖZÖK

ORG 280_IFU_HU_QM131930_2013-12-16_1.1 page 3 ORG 280_IFU_HU_QM131930_2013-12-16_1.1 page 4