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 (CRP) C Reactive Protein Test
(CRP) C Reactive Protein Test
(CRP) C Reactive Protein Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for semi-quantitative detection of C- Reactive Protein in wholeblood, serum or plasma specimens to aid in evaluating risks of cardiovascular disease.
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INTENDED USE:
(CRP) C Reactive Protein Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for semi-quantitative detection of C- Reactive Protein in wholeblood, serum or plasma specimens to aid in evaluating risks of cardiovascular disease.
TEST PROCEDURE:
1. Bring the pouched test device to room temperature (15-30°C) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from foil pouch by tearing along the notch.
3. Specimen collection.
(CRP) C Reactive Protein Test Device (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or finger stick), serum, or plasma specimens.
a. The serum or whole blood specimen should be collected under standard laboratory conditions.
b. Patient samples performed best when tested immediately after collection. The blood specimen must be tested within 24 hours. If the serum sample cannot be tested within 24 hours, it must be frozen until the test can be performed. Allow sample to reach room temperature before proceeding.Sodium azide can be added as a preservative up to 0.1% without effecting the test results.
4.For Serum or Plasma Specimens: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 30μl) to the specimen well (S) of the test device, then add 1 drop of buffer (approximately 40μl) and start the timer.
5. For Venipuncture Whole Blood Specimens: Hold the dropper vertically and transfer 2 drops of venipuncture whole blood (approximately 60μl) to the specimen well (S) of the test device, then add 1 drop of buffer (approximately 40μl) and start the timer.
6. For Finger stick Whole Blood Specimens: Allow 3 hanging drops of finger stick whole blood (approximately 80μl) to fall into the center of the specimen well (S) on the test device, then add 1 drop of buffer (approximately 40μl) and start the timer.
7. Wait for the red line(s) to appear. Read the results at 10-20 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS:
Positive: Three red bands appeared, quality control line C1, quality control line C2 and Detection Line T. The color of T line was lighter than that of C2, indicating that the CRP content in the sample was 1-3 mg/L, which was weak positive. The T line color was between C1 and C2, indicating that the CRP content in the sample was 3-10mg/L, which was medium positive. The color of T line was deeper than that of C1, indicating that the CRP content in the sample was higher than 10 mg/L, and it was strong positive.
Negative: Two red bands, quality control line C1 and Quality Control Line C2. Test line did not appear, indicating that the sample CRP content is less than 1 mg/L.
Invalid: No Quality Control Line C1 or/And Quality Control Line C2.
Indicate incorrect operation or that the kit has deteriorated or is damaged. In any case, retest. If the problem persists, discontinue use of the lot and contact your local supplier immediately.
SPECIFICATION:
Description Specimen Format Catalog No. Sensitivity Package Size Strip Width Certificate
(CRP) C Reactive Protein Test Whole Blood Cassette H10-21 1ug/mL 25 Tests 4.0 mm CE
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