Gima CRP TEST User guide

CRP Test Cassette

Concentrations

Clinical Reference

＜1.0 mg/L

Low CVD risk

1.0～3.0 mg/L

Moderate CVD risk (No Inflammation)

＞3.0 mg/L

High CVD risk (No Inflammation)

＞10 mg/L

Probable infections (bacterial infections or viral infections)

10～20 mg/L

Generally indicates viral infections or mild bacterial infection

20～50 mg/L

Generally indicates moderate bacterial infection

＞50 mg/L

Generally indicates serious bacterial infection

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Hangzhou AllTest Biotech Co., Ltd.

MedNet EC-REP GmbH

Borkstrasse 10
48163 Muenster
Germany

(Whole Blood/Serum/Plasma)

Package Insert

A test for the diagnosis of inflammatory condition and ACS by measuring CRP/hs-CRP in
whole blood, serum or plasma with the use of Fluorescence Immunoassay Analyzer.

【

INTENDED USE】

CRP Test Cassette (Whole Blood/Serum/Plasma) is based on Fluorescence Immunoassay for
the quantitative determination of C-reactive protein (CRP) in serum, plasma or whole blood as
an aid in the evaluation of infection, tissue injury and inflammatory disorders along with
measurement of high sensitivity CRP (hs-CRP) for evaluation of acute coronary syndromes
(ACS).

【SUMMARY】

C-reactive protein is an acute-phase reactant that precipitated with Pneumococcal
C-polysaccharide, and is a non-specific immune response component. CRP has wide
distribution in our body, and is an acute-phase protein produced in the liver in response to
microbial infection or tissue injury, it measures general levels of inflammation in the body, and
the hs-CRP can be used to detect lower concentrations of CRP in serum or plasma. Studies
revealed hs-CRP levels seem to be correlated with Atherosclerosis and Acute Myocardial
Infarction. And the hs-CRP is an inflammation “marker” for ACS patient and is helpful for
primary prevention and risk assessment of cardiovascular disease. Its combination with the
ratio of total cholesterol to HDL-C is more accurate than other risk factors in predicting
cardiovascular disease.
The American Heart Association and US Centers for Disease Control and Prevention have
advocated hs-CRP as a predictor of cardiovascular disease (CVD) to define risk groups: less
than 1.0 mg/L indicates low risk, 1.0 to 3.0 mg/L means moderate risk, and the amount above

3.0 mg/L (lower than 10 mg/L) strongly suggests a high risk of CVD. Moreover, higher CRP
levels are found in late pregnant women, mild inflammation and viral infections (10~40 mg/L),
active inflammation, bacterial infection (40~200 mg/L), severe bacterial infections and burns
(>200 mg/L).

【PRINCIPLE】

CRP Test Cassette is detects CRP based on Fluorescence Immunoassay. The sample moves
through the strip from sample pad to absorbent pad. If the specimen contains CRP, it attaches
to the fluorescent microspheres-conjugated anti-CRP antibodies. Then the complex will be
captured by the capture antibodies coated on the nitrocellulose membrane (Test line). The
concentration of CRP in the sample correlates linearly with the fluorescence signal intensity
captured on the T line. According to the fluorescence intensity of the test and standard curve,
the concentration of CRP in the sample can be calculated by Analyzer to show CRP
concentration in specimen.

REAGENTS】

【

The test include anti-CRP antibody coated fluorophore and anti-CRP antibody coated on the
membrane.

【PRECAUTIONS】

1. For professional in vitro diagnostic use only.

2. Do not use after the expiration date indicated on the package. Do not use the test if the foil
pouch is damaged. Do not reuse.

3. Avoid cross-contamination of specimens by using a new specimen collection container for
each specimen obtained.

4. Do not eat, drink or smoke in the area where the specimens and tests are handled. Handle
all specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and follow standard procedures for
proper disposal of specimens. Wear protective clothing such as laboratory coats,
disposable gloves and eye protection when specimens are assayed.

5. Do not interchange or mix reagents from different lots.

6. Humidity and temperature can adversely affect results.

7. Used testing materials should be discarded in accordance with local regulations.

8. Read the entire procedure carefully prior to any testing.

9. The CRP Test Cassette should only be used with the Analyzer by approved medical
professionals.

【

STORAGE AND STABILITY】

1. The test should be stored at 4-30 °C until the expiry date printed on the sealed pouch.

2. The test must remain in the sealed pouch until use.

3. Do not freeze.

4. Care should be taken to protect the components of the test from contamination.

5. Do not use if there is evidence of microbial contamination or precipitation. Biological
contamination of dispensing equipment, containers or reagents can lead to false results.

SPECIMEN COLLECTION AND PREPARATION】

【

Blood Sample Taking

1. Collect the specimens according to standard procedures.

To collect Fingerstick Whole Blood specimens:

Wash the patient’s hand with soap and warm water or clean with an alcohol swab.

Allow to dry.
Massage the hand without touching the puncture site by rubbing down the hand
towards the fingertip of the middle or ring finger.

Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over

the puncture site.

2. Do not leave specimens at room temperature for prolonged periods. Serum and Plasma
specimens may be stored at 2-8°C for up to 3 days, for long term storage, specimens
should be kept below -20 °C. Whole blood collected by venipuncture should be stored at
2-8 °C if the test is to be used within 2 days of collection. Do not freeze whole blood

REF FI-CRP-402 English

specimens. Whole blood collected by finger stick should be tested immediately.

3. Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of
specimens. Only clear, non-hemolyzed specimens can be used.

4. EDTA, Heparin sodium, can be used as the anticoagulant tube for collecting the blood
specimen.

Sample Dilution/Sample Stability

1. Administer the blood-filled end-to-end capillary into the plastic tube with buffer.
Alternatively, the specimen can be added directly with the micro pipette into the buffer.

2. Close the tube and shake the sample by hand vigorously for approximately 10 seconds to
mix the sample and dilution buffer.

3. Let the diluted sample homogenize for approximately 1 minute.

4. The diluted sample can then be used immediately or stored for up to 8 hours.

【

MATERIALS】

• Test Cassettes • Specimen Collection Tubes with buffer

• ID Card • Package Insert

• Droppers • Lancets

• Timer • Centrifuge • Fluorescence Immunoassay Analyzer

• Pipette • Specimen Collection Containers

【

DIRECTIONS FOR USE】

Refer to Fluorescence Immunoassay Analyzer Operation Manual for the complete instructions
on use of the Analyzer. The test should be in room temperature.

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30 °C)
prior to testing.

1. Turn on the Analyzer power. Then according to the need, select “Standard test” or “Quick
test” mode.

2. Take out the ID card and insert it into the Analyzer port.

3. To use a pipette: Pipette 10 μL of sample into the buffer tube; mix the specimen and the
buffer well.
To use a dropper: Without squeezing the dropper, put the glass capillary tube end in
contact with the liquid sample surface tilted. Liquid sample will migrate into the capillary
tube automatically. Note: Make sure do not take the plastic part of the dropper in contact
with the sample.
Then release the sample into the buffer tube by squeezing the bulb at the top end of the
dropper vertically. Wash the tube 2-3 times by squeezing the top bulb. Mix the sample and
the buffer well.

4. To use a pipette: Pipette 75 μL of diluted specimen into the sample well of the cassette.
Start the timer at the same time.
To use a dropper: Immerse the tube end (plastic tube) into the diluted sample; squeeze
the top bulb to absorb the solution into the lower bulb (no more than the lower bulb).
Squeeze the top bulb vertically to release the diluted solution into the sample well of the
test cassette and start the timer.

5. There are two test modes for Fluorescence Immunoassay Analyzer, Standard Test mode
and Quick Test mode. Please refer to the user manual of Fluorescence Immunoassay
Analyzer for details.

“Quick test” mode: Insert the test cassette into the Analyzer at 3 minutes after sample

application click “QUICK TEST”, fill the test information and click "NEW T EST" immediately.
The Analyzer will automatically give the test result after a few seconds.

“Standard test” mode: Insert the test cassette into the Analyzer immediately after sample

application, cl ick “STANDARD TEST ”, fill the test information and click "NEW TEST" at the
same time, the Analyzer will automatically counting down 3 minutes. After the countdown, the
Analyzer will give the result at once.

【

INTERPRETATION OF RESULTS】

Results read by Fluorescence Immunoassay Analyzer.

The result of tests for C-reactive protein is calculated by Fluorescence Immunoassay Analyzer
and display the result on the screen. For additional information, please refer to the user manual
of Fluorescence Immunoassay Analyze.
Assay range of CRP is 0.5 - 200 mg/L.

【

QUALITY CONTROL】

Each CRP Test Cassette contains internal control that satisfies routine quality control
requirements. This internal control is performed each time a sample is tested. This control

Materials Provided

Materials Required But Not Provided

indicates that the test cassette was inserted and read properly by Fluorescence Immunoassay
Analyzer. An invalid result from the internal control causes an “N/A” message on Fluorescence
Immunoassay Analyzer. Insufficient specimen volume or incorrect procedural techniques are
the most likely reasons for control failure. Review the procedure and repeat the test with a new
test. If the problem persists, discontinue using the test kit immediately and contact your local
distributor.

【LIMITATIONS】

1. The CRP Test Cassette (Whole Blood/Serum/Plasma) is for professional in vitro diagnostic
use, and should only be used for the quantitative detection of C-reactive protein.

2. The CRP Test Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of
CRP antigen in the specimen and should not be used as the sole criterion for evaluating
inflammatory conditions.

3. As with all diagnostic tests, a confirmed diagnosis should only be made by a physician after
all clinical and laboratory findings have been evaluated.

4. High concentrations of CRP may produce a dose hook effect, resulting in incorrect
interpretation of CRP levels. High dose hook effect has not been observed with this test up
to 200 mg/L of CRP.

5. The test assay range of this test kit is 0.5-200 mg / L. When the concentration of the sample
exceeds the upper limit of the test, the high-concentration sample should be diluted with calf
serum or negative samples, and the maximum dilution factor should not exceed 4 times.

6. The results of CRP Tests are based on measuring the levels of CRP in a specimen. It should

not be used as the sole criterion for treatment decisions. If the result is positive, other clinical
findings and alternative test methods are recommended to reach proper medical treatments.

【

EXPECTED RESULTS】

【PERFORMANCE CHARACTERISTICS】

1. Accuracy

The test deviation is ≤±15%.

2. Assay Range and Detection Limit

 Assay Range: 0.5 – 200 mg/L
 Minimum Detection Limit (Analytical Sensitivity): 0.5 mg/L

3. Linearity Range

0.5 – 100 mg/L, R≥0.990

4. Precision

Intra-lot precision

Within-run precision has been determined by using 10 replicates of 2 specimens containing 1.0
mg/L, 10.0 mg/L of CRP. C.V. is ≤ 15%.

Inter-lot precision

Between-run precision has been determined by using 10 replicates for each of three lots using
2 specimens containing 1.0 mg/L, 10.0 mg/L of CRP. C.V. is ≤15%。

6. Method comparison

The assay was compared with CRP test of Maccura Biotechnology Co.,Ltd with 110 samples.
The correlation coefficient(r) is 0.986.

【

BIBLIOGRAPHY】

1. Morley JJ, Kushner (1982) Serum C-reactive protein levels in disease. In: Kushner I,

Volanakis JE, Gewurz H,eds. C-reactive protein and the plasma protein response to tissue
injury. Ann. NY Acad. Sci. 389: 406-417.

2. Peltola HO (1982) C-reactive protein for rapid monitoring of infections of the central

nervous system. Lancet:980-983.

3. Macy EM, Hayes TE and Tracy RP (1997) Variability in the measurement of C-reactive

protein in healthy subjects: implications for reference intervals and epidemiological
applications. Clin. Chem. 43, 52-58.

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Revision date: 2022-09-19

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