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Products

HAV Test
HAV IgM Serum Test Cassette

Catalog No.        Product Name

ABT-IDT-B218        Rapid HAV IgM Serum/Plasma Test Cassette


INTENDED USE

ACCU-TELL® Rapid HAV IgM Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgM antibody to Hepatitis A virus (HAV) in serum or plasma.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Rapid HAV IgM Test Cassette (Serum/Plasma) was compared with a leading commercial ELISA HAV IgM test; the results show that ACCU-TELL® Rapid HAV IgM Test Cassette (Serum/Plasma) has a high sensitivity and specificity.

Method

EIA

Total Results

ACCU-TELL® Rapid HAV IgM Test Cassette (Serum/Plasma)

Results

Positive

Negative

Positive

25

2

27

Negative

0

221

221

Total Results

25

223

248

Relative Sensitivity: >99.9% (95%CI*: 88.7%-100%)

Relative Specificity: 99.1% (95%CI*: 96.8%-99.9%)

Accuracy: 99.2% (95%CI*: 97.1%-99.9%)

*95% Confidence Intervals

 

LIMITATIONS

  1. The Assay Procedure and the Assay Result Interpretation must be followed closely when testing the presence of anti-HAV IgM in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.

  2. ACCU-TELL® Rapid HAV IgM Test Cassette (Serum/Plasma)  is limited to the qualitative detection of anti-HAV IgM in human serum or plasma. The intensity of the test band does not have linear correlation with the antibody titer in the specimen.

  3. A negative result for an individual subject indicates absence of detectable anti-HAV IgM. However, a negative test result does not preclude the possibility of exposure to or infection with HAV.

  4. A negative result can occur if the quantity of the anti-HAV IgM present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.

  5. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.

  6. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.