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Products

C-reactive Protein Test
CRP Semi-Quantitative Whole Blood Test Cassette

Catalog No.     Product Name

ABT-CT-B209     CRP Semi-Quantitative Whole Blood Test Cassette

INTENDED USE

ACCU-TELL® Rapid CRP Semi-Quantitative 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.

PERFORMANCE CHARACTERISTICS

Sensitivity and specificity

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

Method

EIA

Total

Negative

Positive

ACCU-TELL® Rapid CRP Semi-Quantitative Test Cassette

Result

0-10

mg/l

10-40

mg/l

40-80

mg/l

80

mg/l

0-10mg/l

99

1

0

0

100

10-40mg/l

3

52

1

0

56

40-80mg/l

0

3

25

5

33

80mg/l

0

0

3

79

82

Total

102

56

29

84

271

% Relative Accuracy

97.1%

92.9%

86.2%

94.0%

98.5%

99.4%

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® Rapid CRP Semi-Quantitative 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® Rapid CRP Semi-Quantitative 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® Rapid CRP Semi-Quantitative 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.