• The test card is packaged in aluminum foil pouch for
It is recommended to
RapidForTM C-reactive Protein (hsCRP&CRP)
Rapid Test Kit
Catalog Number: VMPO11
For professional use only
INTENDED USE
This test is suitable for in vitro quantitative
detection of the concentration of C-reactive
protein in human serum, plasma, and whole blood.
This product is provided for testing by medical
and health institutions and is used for auxiliary
diagnosis of patients' inflammation and other
related diseases.
C-reactive protein (CRP) is an acute phase
reaction protein (APRP) synthesized by
hepatocytes and can react with C-polysaccharide
of Streptococcus pneumonia; molecular weight is
100,000-144,000. It is composed of five identical
subunits aggregated by non-covalent bonds to
form a ring-shaped symmetric pentamer. It exists
in blood, cerebrospinal fluid, arthrosynovitis,
liquor amnii, pleural effusion and blister fluid, and
is part of non-specific immune mechanism.
The main biological function of CRP is to activate
complement and mononuclear phagocytic system
by binding with ligands (phosphorylcholine of
apoptotic and necrotic cells, or invasive bacteria,
fungi, parasites, etc.) to clear pathogens or
pathological cells with ligands. When infections,
tissue damage and inflammatory diseases occur,
CRP rises rapidly, up to a thousand times, and its
content drops sharply after the disease is cured.
Therefore, CRP detection can provide valuable
information for the diagnosis, treatment and
monitoring of inflammation and related diseases.
CRP at low levels is closely related to the
occurrence, severity, and prognosis of
cardiovascular and cerebrovascular diseases
such as atherosclerosis and acute cerebral
infarction. Therefore, hypersensitive CRP
(hsCRP) can be used as an assistant means of
cardiovascular disease risk identification.
PRINCIPLE OF THE PROCEDURE
This kit uses double antibody sandwich method
principle and fluorescence immuno-
chromatography analysis technology to
quantitatively detect the concentration of CRP
antigen in human serum, plasma, whole blood
samples.
This product is pre-embedded with fluorescent
microspheres-labeled mouse anti-CRP antibody 1
and rabbit IgG antibody on the conjugate pad and
coated with mouse anti-CRP antibody 2 and goat
anti-rabbit IgG antibody respectively on the test
line and control line of nitrocellulose membrane.
When the sample is tested, the CRP antigen in the
sample is combined with the fluorescent
microspheres-labeled mouse anti-CRP antibody 1
embedded on the conjugate pad to form the
fluorescent microspheres-labeled mouse anti-
CRP antibody 1-CRP immune complex. Under the
action of chromatography, the immune complex
flows along the nitrocellulose membrane to the
end of the absorbent filter paper. On the test line,
the immune complex is captured by the mouse
anti-CRP antibody 2 pre-coated, forming the
double-antibody sandwich structure of
fluorescent microspheres labeled mouse anti-
CRP antibody 1-CRP-mouse anti-CRP antibody 2
and enriching. When the samples pass the control
line, the rabbit IgG antibody labeled with
fluorescent particles is enriched by combining
with the pre-coated goat anti-rabbit IgG antibody.
The concentration of CRP in the sample is
positively correlated with the fluorescence
intensity of the test line. The concentration of CRP
in the sample is obtained through the test and
analysis by the Immunofluorescence Analyzer.
COMPONENT
Component 25 Tests/box
Test Device 25 Test cassettes (1 Test/pouch x 25 pouches)
Sample Diluent
25 single-use bottles, each with 1 ml/vial
extraction buffers
Pipette tip 25 single-use micropipette tips
ID Chip 1 ID Chip
Packing Insert 1 instruction for use
Note: The components in different batches of the
kit cannot be mixed.
flat operating table.
single serving, containing CRP test card and restore the sample to room temperature before
desiccant. The main components on the test card sampling.
are the backplane, sample pad, conjugate pad, 3.Sampling: take 5μL serum, plasma, or whole
nitrocellulose membrane, absorbent paper and blood sample at one time with a pipette and be
plastic parts, the test line (T) was coated with anti- careful not to inhale air bubbles.
CRP antibody, the control line (C) was coated with Fingerstick Whole Blood
goat anti-rabbit IgG antibody, and the conjugate
pad was embedded with fluorescent microspheres
labeled anti- CRP antibody and rabbit IgG antibody.
• The identification code of the test card contains the Venipuncture Whole Blood
project name, batch number, ID chip card contains
the name, batch number, calibration curve,
concentration unit, detection time and other
information of the kit.
• The main component of the sample diluent is Serum
20mM, pH7.4 PBS solution.
• The components in different batches of kits are not
interchangeable.
Plasma
MATERIALS REQUIRED BUT NOT PROVIDED
• The immunofluorescence analyzer
• Transfer Pipette
• Specimen Collection Containers
4.Mix: add the absorbed samples to the sample
• Centrifuge (for serum/plasma specimen only) diluent and fully mix them for 60 seconds.
• Timer
STORAGE AND STABILITY
1.Kits should be stored at 2°C~30°C in a cool, dark, dry
place, valid for 24 months; do not freeze or use after
the period of validity.
5.Add sample: use pipette to absorb 100μL
2.The test card should be used within 60 minutes mixed samples and add them into the sample
after being taken out of the aluminum foil pouch. well of the test card.
3.Sample diluent should be used immediately after
broken seal.
4.MFD date and EXP date: marked on the label.
APPLICABLE INSTRUMENT
This product is applicable to the immunofluorescence
analyzer VMFIA1001 produced by Vitrosens 6.Detection:
Biyoteknoloji Ltd. Şti. Standard test: insert the test card into the
instrument after the sample is added, and the
SAMPLE COLLECTİON AND STORAGE
instrument will be automatically timed. After the
1.Applicable to serum, plasma, or whole blood reaction countdown of 3 minutes, the
samples. Clinical commonly used anticoagulants instrument will detect automatically.
(heparin sodium, EDTA or sodium citrate) have no Quick test: after adding samples, after 3
effect on the detection results of this kit. minutes of timing, insert the test card into the
2.Samples should be collected according to routine instrument, and the instrument will
clinical methods and avoid hemolysis. automatically test the card. And record, read and
3.If fresh serum or plasma specimens are not tested print the test results.
immediately, they should be stored at 2°C~8°C and If the test card fails to be tested in time after the
tested within 7 days. For long-term storage, freeze at 5 minutes countdown, it will be deemed invalid,
-20°C. Avoid repeated freezing and thawing. and the sample shall be re-tested with a brand-
4.Collection of whole blood samples: collect venous new test card.
blood with disposable vacuum blood collection
containing anticoagulant without separation and CALIBRATION
directly as the test sample. Whole blood samples can Traceability: Calibrator for calibration curve
be stored at 2°C~8°C in refrigerator, do not freeze, establishment is traceable to internal reference
and run the test within 5 days of collection. standards. This method has been standardized
5.Sample stored at low temperature should be against the Roche CRP kit (scatter turbidimetry)
balanced to room temperature before test. assay.
6.Obvious hemolysis, lipohemia and jaundice samples The calibration curve of the reagent is
should not be used.
embedded in ID chip. The fluorescence analyzer
substitutes the test signal of the detection card
TEST PROCEDURE into the calibration curve to calculate the
Before the test, the instruction manual of the product concentration of CRP in the sample.
and the operation manual of the immunofluorescence
analyzer must be read completely, and the reagent REFERENCE INTERVAL
should be restored to room temperature before the 1.Normal reference value: hsCRP <1.0mg/L;
test. The test operation cannot be carried out under Routine CRP<10mg/L.
the condition that the room temperature is not 2.Due to differences in geography, ethnicity,
restored, so as not to affect the accuracy of the test and age, it is recommended that each laboratory
results. establish a CRP reference interval with relevant
Operation process: clinical significance for the population of the
1.Instrument preparation: turn on the power of the region.
immunofluorescence analyzer, select the test mode
(quick test / standard test), read the reagent ID chip, INTERPRETATION OF TEST RESULTS
select the sample type, and test items. The specific Item Clinical application
operation of the instrument shall be carried out name Test results recommendations
according to the operating instructions of the It suggests mild inflammation
(detritus of the bladder,
corresponding type of instrument. bronchitis, edema), surgery,
2.Preparation of reagents: balance the reagent or CRP 10mg/L~50mg/L trauma, myocardial infarction,
deep venous thrombosis, inactive
sample to room temperature, tear open the aluminum rheumatism, malignant tumors,
foil pouch, take out the test card, and lay it flat on a viral infection, etc.
V01-P11-001

It suggests that there is a
50mg/L~100mg/L general bacterial infection
It is suggested that intravenous
antibiotics should be used in the
treatment of severe bacterial
>100mg/L infections, and CRP still
maintains a high level during the
treatment, suggesting that the
treatment is ineffective.
When there was no inflammation, hsCRP was
used as the cardiovascular risk index evaluation
index:
Item Clinical application
Test results
name recommendations
hematocrit deviates by 40%, in order to obtain more 8.Components in different batch should not be
accurate results, individual CRP test results (C0) and mixed.
hematocrit (P) can be substituted into the following 9.If you have any questions or suggestions in the
formula for further correction, and the calculated process of using this product, please contact us.
results (C1) can be used as the final test results.
C1=0.625*C0/(1-P) SYMBOLS USED
Or the corresponding correction coefficients of the
Material Included
test results C0 multiplied by the table below can be
used as the final test results.
Test Card
Hct (%) 0.2 0.25 0.30 0.35 0.40 0.45 0.50
Instruction for Use
CC (K) 0.78 0.83 0.89 0.96 1.04 1.14 1.25
Consult Instruction for Use
Hct (%) 0.55 0.60 0.65 0.70 0.75 0.80

Cardiovascular disease risk was CC (K) 1.39 1.56 1.79 2.08 2.50 3.13 Store at 2℃ ~ 30℃
＜1.0mg/L rated as low risk.
Cardiovascular disease risk was Result (mIU/mL) C0
hsCRP Expiration Date
assessed as moderate risk and
1.0-3.0mg/L Final result (mIU/mL) C1 = C0*K
anti-inflammatory treatment were
recommended. Manufacturer
10.As with all diagnostic reagents, the final diagnosis
The above is for reference only, not as clinical should be made by the doctor after the combination ID Chip
diagnostic criteria. The test results should be of various indicators and clinical symptoms.
combined with other clinical symptoms and
Keep Dry
examination results. PRODUCT PERFORMENCE INDEX
Internal calibration products were used for
Lot Number
QUALITY CONTROL evaluation, and the performance indicators of the kit
This product used in conjunction with met the standards. The specific performance
immunofluorescence analyzer contains internal indicators are as follows: Sample Buffer
control for routine quality control requirements.
This internal control is performed each time when 1.Linearity range: CRP 0.5mg/L~200mg/L, Linear Date of Manufacture
a patient sample is tested. This control indicates correlation coefficient(r)≥0.9900.
whether the test cartridge was inserted and read 2.Accuracy: the relative deviation of kit accuracy is Do Not Reuse
properly by immunofluorescence analyzer. An within ±15%.
invalid result from the internal control causes an 3.Detection limit: CRP≤ 0.5mg/L. Catalogue Number
error message on analyzer indicating that the test 4.Within-run precision: the same batch of reagents
should be repeated. were randomly selected to detect the enterprise Keep Away From Sunlight
precision reference product with the concentration of
LIMITATIONS 20mg/L. The test was carried out in parallel for 10
Tests per Kit
1.The positive results of this reagent can only be times, and the results met the coefficient of variation
used as a basis for the diagnosis of diseases. It is CV≤15%.
In Vitro Diagnostic Medical Device
suggested that the diagnosis be confirmed by 5.Between-run precision: three batches of reagents
combining other pathological features and test were randomly selected to detect the enterprise
methods. precision reference product with the concentration of Do not use if the package is damaged
2.This reagent is suitable for the detection of 1000pg/mL. The test was carried out in parallel for 10
human whole blood samples, and the detection times, and the results met the coefficient of variation This product fulfils the requirements of
the Directive 98/79/EC on in vitro
results of other samples may be wrong. CV≤15%. diagnostic
3.The reagent is used to detect the concentration 6.HOOK effect: when the CRP concentration medical device

of C-reactive protein by immunological principle. >300mg/L, the result may no longer show > 200mg/L,
Temperature will affect the results. and the HOOK effect starts to appear.
The reagent should be balanced to room 7.Interference experiment: The following substances
temperature before use after cryopreservation. were tested at the concentration shown, and no
Direct use of cryogenic reagents will affect the interference was found.
Vitrosens Biyoteknoloji LTD. ŞTİ
test results. 8. Cross reaction: no cross reaction with Serum Address: Şerifali Mh., Şehit Sk. No:17,
4.This reagent is used to quantitatively detect the amyloid A (SAA), procalcitonin (PCT), interleukin-6 34775, Ümraniye/İstanbul
concentration of C-reactive protein and the test (IL-6), rheumatoid factor (RF). Telephone:0(216) 784 41 01
E-mail: info@vitrosens.com
reagent; ID card and the applicable instrument Web: www.vitrosens.com
should be used together. Please make sure that PRECAUTIONS Date of issue: 04.10.2022
the batch number of the test reagent and ID card 1.The reagent is a disposable in vitro diagnostic
are the same before use. The instrument is the reagent, which is only used for the detection of
applicable model, please check the integrity and human whole blood. The operation should be carried
expiry date of the kit package before use, and the out strictly according to the instructions. Do not use
correct test result cannot be obtained after expired and damaged products.
exceeding the expected use. 2.The kit should be sealed and kept away from
5.Different batches of sample diluents cannot be moisture. Reagents or samples stored at low
mixed. temperature should be balanced to room temperature
6.Improper operation and other factors may affect before they can be used.
the accuracy of the results. 3.Do not use samples that have been placed for too
7.Human anti-mouse antibody (HAMA) may be long.
present in patients who have been treated with 4.Reagents should be used as soon as possible after
mouse-derived antibody drug. This kit has been removal from aluminum foil pouch, so as to avoid
developed to minimize the impact of these exposure to air for too long and affecting test results
antibodies on test results through special due to dampness.
methods. However, test results should be 5.Do not use samples that have been placed for too
carefully evaluated when patients are known to long, bacteria and odor.
have these antibodies. 6.Please operate in accordance with the laboratory
8.For samples whose CRP concentration may be testing procedures for infectious diseases. Waste
greater than the linear range, it is necessary to after use should be treated in accordance with
measure with normal saline after appropriate infectious substances and should not be discarded at
dilution, and the maximum dilution ratio of normal will.
saline is 5 times. 7.Incorrect operation may affect the accuracy of the
9.The hematocrit (hematocrit) of the whole blood results, such as insufficient sample mixing, incorrect
sample has an influence on the test results. The sample adding amount, wet display window or
test result has been corrected and compensated inaccurate detection time, etc.
for whole blood sample. But when the sample

V01-P11-001