CRP Test Cassette (Whole Blood/Serum/Plasma) is based on Fluorescence Immunoassay for
the quantitative determination of C-reactive protein (CRP) inhuman 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 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.
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
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 (5 μL of serum or plasma / 7.5 μL of whole blood) 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 homegenize for approximately 1 minute.
4. The diluted sample can then be used immediately or stored for up to 8 hours.
【MATERIALS】
Materials Provided
• Test Cassettes
• Specimen Collection Tubes with buffer
• ID Card
• Package Insert
• Samplers
Materials Required But Not Provided
• Timer
• Centrifuge
• Fluorescence Immunoassay Analyzer
• Pipette
• Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to Fluorescence Immunoassay Analyzer User Operation Manual for the complete
instructions for the use of the analyzer. The test should be conducted at room temperature.
Allow the test, specimen and buffer to reach room temperature (15-30 °C) prior to
testing.
1. Turn on the Analyzer power.
2. Take out the ID card and insert it into the ID Card Slot. Choose test mode and/or sample
type according to needs.
3. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best
results will be obtained if the assay is performed immediately after opening the foil pouch.
4. Place the test on a flat and clean surface.
Serum or plasma: Pipette 5 μL of serum or plasma into the buffer tube; mix the specimen
and the buffer well.
Whole blood: Transfer 7.5 μL of whole blood into the buffer tube with sampler provided or
pipette; mix the specimen and the buffer well.
5. Add diluted specimen with a Pipette: Pipette 75 μL of diluted specimen into the sample
well of the cassette. Start the timer at the same time.
6. Add specimen with sampler provided: Discard the first 2 drops, then add 2 drops of
diluted specimen into the sample well of the cassette. Start the timer at the same time.
7. Test results should be interpreted at 3 minutes with the use of Fluorescence Immunoassay
Analyzer.
Caution: There are different test modes of the Fluorescence Immunoassay Analyzer. The
difference between them is incubation of the test cassette is outside or inside the analyzer.
Choose test mode accordingly and confirm sample type. Consult the user manual of the
analyzer for detailed operation information.
Operator must consult the Fluorescence Immunoassay Analyzer User Manual prior to use and
become familiar with the processes and quality control procedures.
