Accu-Tell^® High-Sensitivity CRP Semi-Quantitative Rapid Test Cassette （1/3/10mg/l）(Whole Blood/Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: Semi-quantitative detection of high-sensitivity C-reactive protein in whole blood, serum or plasma.

Reading time: 15 minutes

Relative Sensitivity: 98.9 %

Relative Specificity: 96.4 %

Accuracy: 97.6 %

INTRODUCTION

Recent studies suggest that CRP is a strong predictor of future coronary events in apparently healthy subjects and of prognostic value in patients with acute coronary syndromes.

As per the American Heart Association (AHA) and Centers for Disease Control and Prevention (CDC), CRP concentrations of 1-3 mg/L signify moderate risk and concentration greater than 3 mg/L signify high risk for CVD. However, a CRP level above 10 mg/L does not necessarily signify cardiac risk as it can be indicative of inflammation due to other etiologies or infection. CRP concentrations below 1 mg/L signify low risk.

INTENDED USE

ACCU-TELL^® High-Sensitivity CRP Semi-Quantitative Rapid Test Cassette （1/3/10mg/l）(Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the semi-quantitative detection of C-reactive protein in whole blood, serum or plasma.

TEST PROCEDURE

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

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2. Place the cassette on a clean and level surface.

For Serum or Plasma specimen:

Hold the bottle vertically and add 5 drops of buffer (approximately 200µl) into the extraction tube.

Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10 μl) and transfer specimen to the extraction tube. Compress the bottom of tube 15 times to mix the solution.

Fit the dropper tip on top of the extraction tube.

For Venipuncture Whole Blood specimen:

Hold the bottle vertically and add 5 drops of buffer (approximately 200µl) into the extraction tube.

Use a disposable pipette to transfer 1 drop of whole blood (approximately 20ul) to the extraction tube. Compress the bottom of tube 15 times to mix the solution.

Fit the dropper tip on top of the extraction tube.

For Fingerstick Whole Blood specimen:

Hold the bottle vertically and add 5 drops of buffer (approximately 200µl) into the extraction tube.

Fill the capillary tube and transfer approximately 20µL of fingerstick whole blood specimen to the extraction tube. Compress the bottom of tube 15 times to mix the solution.

Fit the dropper tip on top of the extraction tube.

3. Add 3 full drops of the extracted solution (approximately 120ul) to the specimen well of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well.

4. Wait for the colored line(s) to appear. The test result should be read at 15 minutes. Do not interpret the result after 20 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and specificity

ACCU-TELL^® High-Sensitivity CRP Semi-Quantitative Rapid Test Cassette （1/3/10mg/l）(Whole Blood/Serum/Plasma) has been tested in comparison with a leading commercial CRP EIA test using clinical specimens.

Relative Positive Agreement: 98.9 %( 97.1%~99.7)*

Relative Negative Agreement: 96.4 %( 93.9%~98.1)*

Relative Accuracy: 97.6 %( 96.2%~98.6%)*     

*95% Confidence Interval

Precision

Intra-Assay

Assays were carried out to determine assay reproducibility using replicates of 10 tests in three different runs for each of three lots using CRP specimen levels at 0 mg/l, 1 mg/l, 3 mg/l, 10 mg/l and 20 mg/l. The specimens were correctly identified >99.9% of the time.

Inter-Assay

Between-run precision has been determined by using the five CRP specimen levels at 0mg/l, 1mg/l, 3mg/l, 10mg/l and 20mg/l of CRP in 3 independent assays. Three different lots of ACCU-TELL^® High-Sensitivity CRP Semi-Quantitative Rapid Test Cassette （1/3/10mg/l）(Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99.9%of the time.

Interfering Substances

The following substances do not interfere with the test results at the indicated concentrations: Human Albumin at 20mg/ml, Bilirubin at 6mg/ml, Hemachrome at 10mg/ml, Cholesterol at 5mg/ml and Triglyceride at 15mg/ml.

LIMITATIONS

1. ACCU-TELL^® High-Sensitivity CRP Semi-Quantitative Rapid Test Cassette （1/3/10mg/l）(Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of C-reactive protein in whole blood, serum or plasma specimen.

2. ACCU-TELL^® High-Sensitivity CRP Semi-Quantitative Rapid Test Cassette （1/3/10mg/l）(Whole Blood/Serum/Plasma) will only indicate the semi-quantitative level of CRP in the specimen and should not be used as the sole criteria for evaluating cardiac risks r inflammatory conditions.

3. This test is only used for detecting whole blood / serum / plasma samples of C reaction protein, not as the unique standard for diagnosis. Even if the result is positive, the comprehensive analysis of the clinical symptoms and other detection methods should be considered either.

4. The presence of some rheumatoid factors clinical positive sample will probably interfere the test result.

5. There is a slight possibility that some whole blood specimens with a very high viscosity or stored more than 2 days may not run properly on the test device. Repeat the rest with a serum or plasma specimen from the same patient using a new test device.

6. The elevated results of CRP in oral contraceptive (OC) users should be reported with caution as The American Physiological Society has recommended further studies on impact of OC use on CRP and inflammatory paramerers.4

7. High concentrations of CRP may produce a dose hook effect, resulting in false negative results. High dose hook effect has not been observed with this test up to 2000mg/L of CRP.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.