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processed by the ichroma™ Reader which shows the concentration of PCT in the

specimen. The working range for the ichroma™ PCT test is 0.1-100 ng/mL.

COMPONENTS AND REAGENTS COMPONENTS AND REAGENTS

ichroma™ PCT consists of: A 'Test Cartridge', An 'ID Chip', and the 'Detector buffer'.

EXPECTED USE
The test cartridge contains a test strip with mouse antibodies against human
-

ichromaTM PCT along with the ichromaTM Reader is an immunoassay for the
PCT and chicken IgY that have been immobilized on the test line and control
quantitative determination of Procalcitonin (PCT) in human Serum/Plasma. The
line, respectively.
test is useful for the diagnosis of bacterial infections and sepsis.

- Each test cartridge has been individually sealed in an aluminum foil bag containing

a desiccant. 10 sealed cartridges have been packed in a box that also contains
INTRODUCTION the ID Chip.

Sepsis represents a daily challenge in the intensive care unit of every hospital. The -

Detector buffer contains fluorochrome-labeled anti-PCT antibodies, fluorescently-

early evaluation of sepsis is vital for the determination of the appropriate treatment, labeled anti-chicken IgY, bovine serum albumin (BSA) as stabilizer, and
these therapeutic strategies improve the survival of patients with sepsis. In healthy sodium azide in phosphate buffered saline (PBS) as preservative.
people the concentration of PCT is less than 0.1 ng/mL. PCT levels rise rapidly after

- Detector buffer is dispensed into each detector buffer tube. 10 tubes of detector

buffer are separately packed in a box, which is packed in a Styrofoam box with
of a bacterial infection with systemic consequences.
ice packs for transport.
It can also be raised by severe burns, major surgery or in neonates. However, it

also returns to its baseline state quickly. However, in viral infections, bacterial

colonization, localized infections, allergic disorders, autoimmune diseases and CAUTIONS AND WARNINGS CAUTIONS AND WARNINGS
transplants, significant increases in PCT are not usually obtained (PCT < 0.5 ng/

mL).
- For diagnostic use only In Vitro .

- Carefully read the instructions and procedures described in this insert and in the
Therefore, by evaluating the concentrations of
operating manual of the
PCT clinicians are also able to assess the risk of progression to severe sepsis and
Lector ichroma™.
septic shock.
- The lot numbers of all test components (Test Cartridges, ID Chip and Detector

Buffer) must match each other.

Diagnosis of bacterial infection/sepsis

PCT<0.5 Local bacterial infection possible - Do not interchange components from different lots or use test components beyond
0.5<PCT<2 possible infection
the expiration date.
Infection (sepsis) is most likely unless
2<PCT<10
know other causes

PCT>10
- Tests performed using any test component that does not match the lot number or
Severe bacterial sepsis or septic shock
more than the expiration date may produce results

BEGINNING
incorrect.

The test cartridge must remain in its original packaging until ready for use. Do
-

The test uses the sandwich immunodetection method, the detector antibody in the
not use the device if the bag or packaging is damaged or the seal is broken.
buffer binds to the PCT in the sample serum, and the antigen-antibody complexes

are captured by another PCT antibody that has been immobilized on the test strip
If the cartridge is stored in a refrigerator, allow at least 30 minutes for it to
-

while mixing. migrates through the nitrocellulose matrix.

come to temperature.

Detector buffer must reach room temperature

-

So the more PCT antigen in the serum, the more antigen-antibody complexes before performing the analysis.
accumulate on the test strip.
- ichroma™ PCT and ichroma™ Reader must be used away from vibrations and
The intensity of the fluorescence signal of the detector antibody reflects the amount
magnetic fields. During normal use
of captured antigen, this information is
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may produce a slight vibration, which should be Errors in the results include errors in procedures and technique, degradation of
considered as normal. the components/reagents, as well as the presence of interfering substances in

The detector buffer tube should only be used to process a single sample. In the the samples.
-

same way, the cartridge must be used for a single analysis. The detector buffer - Any clinical diagnosis based on test results must be supported by a comprehensive

and cartridge must be discarded after a single use. analysis by a physician, clinical symptoms and any other relevant analysis.

- Used detector buffer, tips and test cartridges must be handled with care and

disposed of by an appropriate method in accordance with local regulations. SAMPLE COLLECTION AND PROCESSING

- Exposure to large amounts of sodium azide can cause damage to health such as
The test can be performed with serum or plasma.
convulsions, low blood pressure and heart rate, loss of consciousness, lung
- Take precautions with collected samples as PCT concentrations have been reported
damage and respiratory failure.
to decrease rapidly when the sample is kept at room temperature or refrigerated.

STORAGE AND STABILITY STORAGE AND STABILITY -

It is highly recommended to analyze the samples before 24

hours after collection.

- Test Cartridges are stable for 20 months (while sealed in the foil pouch) if stored at If the test cannot be performed within 24 hours after the preparation of the
-

4 - 30°C. samples, they should be frozen immediately at -10 degrees Celsius, it is allowed

to keep them in the freezer for only 3 months.

-
Detector Buffer is stable for 20 months if stored

of 2 - 8°C. -

Serum and plasma must be prepared by centrifugation within 3 hours after blood

- Devices must be used immediately once collection.

open - Once samples have been frozen they should only be used once for analysis because

repeated freezing and thawing may decrease test values.

TEST SYSTEM LIMITATIONS

ichroma™ PCT provides accurate and reliable results subject to the following

limitations: MATERIALS PROVIDED MATERIALS PROVIDED

- Use ichroma™ PCT must be used only together

with the ichroma™ Reader. REF CFPC-23

The analysis must always be carried out with serum samples

-

Componentes de chroma™ PCT

fresh.
Test Cartridge Box
- Other anticoagulants other than EDTA should be avoided.
- Sealed cartridges 10
- The sample for the test must be at room temperature before analysis. If test samples
- ID Chip 1

must be transported for the purpose of analysis, appropriate precautions must

- Insert packed 1

be taken.
Box containing the Buffer Detector tubes
- Buffer Detector tubes 10
- The effectiveness of the test depends highly on the storage conditions of the

components and

samples to the prescribed conditions. MATERIALS REQUIRED BUT PROVIDED

- The tests may give false positive results due to cross-reactions between some
ON DEMAND
serum components with the capture/detection antibodies.
The following products can be purchased separately for ichroma™ PCT. Please

contact the sales department for more information.

- Tests may give false negative results because PCT epitopes may be masked by

unknown components.
- Lector ichroma™ REF FR203
False negative results may also be
- Thermal printer
obtained due to instability or degradation of the PCT antigen due to time and/or

temperature.

- Other factors that interfere with the tests and can cause
Machine Translated by Google

The ichroma™ PCT “Cut-off” value is 0.5 ng/ml.

-

PREPARING FOR THE TEST PREPARING FOR THE TEST

- ichroma™ PCT should be considered only as a

screening tool. In case of a positive result (above 0.5 ng/mL), consult with a
1. Check the components of ichroma™ PCT: Cartridges of
physician to discuss the test results. The doctor must decide what else
Sealed test, ID Chip, and detector buffer tubes.

2. Make sure that the lot number of the test cartridges match those of the ID Chip
actions to take
and the Detection Buffer.
- Test results > 2 ng/mL may reflect severe sepsis.
3. Keep the sealed Test Cartridge and Detector Buffer Vial (if previously stored in the

refrigerator) at room temperature for at least 30 minutes prior to testing. Place

the Cartridge on a flat, dust-free surface. QUALITY

QA
CONTROL

Quality control is part of the Good Laboratory Practices to confirm the expected
-

4. Turn on the ichroma™ Reader.

results and the validity of the tests and must be carried out at regular intervals.
5. Insert the ID Chip into the ID Chip port of the Reader
ichroma™ Reader.

6. Press the “Select” key on the ichroma™ Reader. - Before testing a clinical sample using a new batch of

(Please refer to the ichroma™ Reader Operations Manual for more For tests, you should test control reagents to confirm test procedures and to
information and complete instructions.) verify that test results are as expected.

- Quality control analysis should also be performed

ANALYSIS PROCEDURE ANALYSIS PROCEDURE When there is any doubt as to the validity of the
Analysis results.

- Quality control reagents are not supplied with

1. Transfer 150ÿl of sample (serum, plasma or control) using a transfer pipet to the

tube containing the buffer ichroma™ PCT. For more information, contact Boditech Med Inc. Sales Division

detector. for assistance.

2. Close the cap of the detector buffer tube and mix the sample thoroughly by shaking - ichroma™ PCT includes an internal quality control that satisfies routine quality

10 times. (The mixture of control requirements.

sample should be used immediately.) This internal control test is performed automatically each time a clinical sample is

3. Take 75 µL of the sample mix and load it into the well run. An invalid internal quality control result leads to an error message being

sample from the test cartridge. displayed on the ichroma™ Reader screen indicating that the analysis must be

4. Leave the cartridge loaded with the sample at room temperature for 12 minutes. repeated.

5. To read the Test Cartridge with the sample, insert it into the Test Cartridge holder

on the ichroma™ Reader. Be sure to properly orient the Test Cartridge before PERFORMANCE CHARACTERISTICS PERFORMANCE CHARACTERISTICS

pressing it the full length of the holder. An arrow has been marked on the Test

Cartridge especially for this purpose.

1. Interference: The interference study with Bilirubin, Hemoglobin and Triglycerides

with ichroma™ PCT showed the following results.

6. Press the “Select” Button on the ichroma™ Reader to start with

Substance Concentration
the reading process. Interference (%)
interference added
7. The ichroma™ Reader will immediately read the loaded cartridge
bilirubin 50 mg/dL < 4.0
with the sample.
Hemoglobin 1000 mg/dL < 2.0
8. Read the result displayed on the Reader screen triglycerides 1000 mg/dL < 5.0
chroma™.
2. Prozone/Hook Effect: No prozone/Hook effect was observed with ichroma™ PCT

at concentrations up to 100 ng/ml.

INTERPRETATION OF RESULTS INTERPRETATION OF RESULTS

The ichroma™ Reader automatically calculates the result and displays the PCT
-

3. Imprecision: To study intra-assay imprecision, 10 replicates of each of eight

concentration in terms of plasma concentrations
of/mL. Randox control samples were analyzed. To study the

The Working Range of ichroma™ PCT is 0.1-100 ng/mL. inter-assay imprecision, 5 replicates of each of the eight
-
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Concentrations of the Randox control plasma samples were analyzed by three 8. Interference Testing in Clinical Chemistry; Approved Guideline Second Edition. Robert J. McEroe, PhD,
Mary F. Burritt, PhD, Donald M. Powers, PhD, Douglas W. Rheinheimer, MT, Brian H. Wallace, PhD, Clinical and Laboratory
different people on each day for 10 consecutive days. Standards Institute.

ichroma™ PCT Imprecision Studies Note: Please refer to the following table to identify the
symbol
Within Imprecision Inter imprecision
PCT
trial trial
Concentration
Media CV Media CV
See instructions for use
(ng/ml)
(ng/ml) (%) (ng/ml) (%)

0.11 0.12 21.9 0.13 21.3 use before

0.28 0.29 10.5 0.3 10.4

Batch Code
0.73 0.78 3.6 0.73 9.7

1.02 0.96 2.3 0.99 5.4

Catalog number
2.31 2.32 3.28 2.28 6.5

4.06 4.27 3.6 4.33 4.4 Caution

8.15 7.55 4.1 8.09 4.9

do not reuse
43.85 41.08 2.3 43.87 2.9

Manufacturer

4. Comparability: PCT concentrations of 74 sera were independently quantified

Enough for
with ichroma™ PCT and the Elecsys BRAHMS PCT assay (Cobas e411,

Roche Diagnostics) according to the prescribed test procedure. Results were Authorized representative for the European community
compared and comparability investigated with linear regression and correlation
In vitro diagnostic product
coefficient (R). The linear regression and the correlation coefficient (R)

between the two methods were respectively Y = 0.993X + 0.318 and R temperature limitation

This product complies with the requirements of the 98/79/

EC regulations for in-line diagnostic products.
vitro
= 0.998.

For technical assistance please contact:

Comparison between ichroma™ PCT and
Boditech Med Inc.’s Technical Services
Elecsys BRAHMS PCT (Cobas e411, Roche)
Tel: +82 33 243-1400

Email: sales@boditech.co.kr
60

Y = 0.993X+0.318
N = 74
50
R = 0.998

40
Boditech Med Incorporated

43, Geodudanji 1-gil, Dongnae-myeon,

chromaTM
PCT
mL]
[ng/

30

Chuncheon-si, Gang-won-do, 200-883,

20

Republic of Korea
10
Tel: +82 (33) 243-1400

0 Fax: +82 (33) 243-9373

0 10 20 30 40 50 60 www.boditech.co.kr
Elecsys BRAHMS PCT [ng/mL]

Boditech Med Europe 25a,

REFERENCES Hampstead Hill Gardens London,

NW32PJ, United Kingdom.

1. Procalcitonin as a Diagnostic Test for Spesis: Health Technology Assessment in the ICU. Gattas and Cook, J Crit Care.
Tel: +44 207 947 5400
2003, 18:52-8.

2. A new strategy for the development of monoclonal antibodies for the determination of human
Fax: +44 207 947 5401
procalcitonin in serum samples. Kremmer et al, Anal Bioanal Chem. 2012, 402:989-995.
3. Application of procalcitonin (PCT) – Q test for early detection of bacteremia and sepsis. Vetcheva

Dobrevsky et al, R. Vatcheva-Dobrevsky et al, Biotechnol. & Biotechnol. Eq. 2004, 177184 Comparison of Email: jfnewsome@googlemail.com
4. procalcitonin (PCT) and C-reactive protein (CRP) plasma concentrations at different SOFA scores during the course of

sepsis and MODS. Meisner et al, Crit Care. 1999, 3:45-50.

5. Diagnostic Value of Procalcitonin Levels as an Early Indicator of Sepsis. Guven et al, Am J Emerg Review No. 07
With. 2002, 20:202-206.
6. Procalcitonin: how a hormone became a maker and mediator of sepsis. Beat Muller et al, Swiss MED
Date of the last review; July 7, 2014
WKLY, 2001, 595-602
7. Sepsis biomarkers: a review, Charalampos pierrakos et al, 2010, 12-18
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