Accu-Tell^® CRP Semi-Quantitative Rapid Test Cassette 10/40/80 mg/l (Whole Blood/Serum/Plasma)

Product Description

CATALOG

KEY POINTS

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

Reading time: 5 minutes.

Relative Sensitivity: 99.4%

Relative Specificity: 97.1 %

Accuracy: 98.5 %

INTRODUCTION

C-reactive protein (CRP) in patient’s sera has been found in association with acute infections, necrotic conditions and a variety of inflammatory disorders. There is a strong correlation between serum levels of CRP and the onset of the inflammatory process. Monitoring the levels of CRP in patient’s sera indicates the effectiveness of treatment and the assessment of patient recovery. It is used in particular to differentiate bacterial infections from virus infections.

INTENDED USE

ACCU-TELL^® CRP Semi-Quantitative Rapid Test Cassette (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 or venipuncture Whole Blood specimen:

Use a disposable pipette to transfer 5 mL of the serum or plasma specimens or 1 drop of whole blood (approximately 10µl) and add to the dilution tube with buffer.

Bottom up and down the tube for several time to mix the specimens well.

Add 3 drops of diluted specimen above to the specimen well and start the timer.

Wait for the colored line(s) to appear. The test result should be read at 5 minutes. Do not interpret the result after 8 minutes.

For Fingerstick Whole Blood specimen:

Fill the capillary tube and transfer approximately 10µL of fingerstick whole blood specimen to the dilution tube with buffer.

Bottom up and down the tube for several time to mix the specimens well.

Add 3 drops of diluted specimen above to the specimen well and start the timer.

Wait for the colored line(s) to appear. The test result should be read at 5 minutes. Do not interpret the result after 8 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and specificity

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

Relative sensitivity: 168/169=99.4% (CI*: 96.7%~100%)

Relative specificity: 99/ (99+3) =97.1 % (CI*: 93.9%~98.1%)

Relative Accuracy: (99+168)/ (99+3+169) =98.5 % (CI*: 91.6%~99.4%)  

*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, 10 mg/l, 40 mg/l, 80 mg/l and 200 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, 10mg/l, 40mg/l, 80mg/l and 200mg/l of CRP in 3 independent assays. Three different lots of ACCU-TELL® CRP Semi-Quantitative Rapid Test Cassette (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 10mg/ml, Hemachrome at 10mg/ml, acetoaminophen at 20mg/dl and Creatine at 200mg/dl.

LIMITATIONS

1. ACCU-TELL^® CRP Semi-Quantitative Rapid Test Cassette (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^® CRP Semi-Quantitative Rapid Test Cassette (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 inflammatory disorders risks.

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 parameters.

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.