Accu-Tell® HAV IgM Rapid Test Cassette

Accu-Tell® HAV IgM Rapid Test Cassette (Serum/Plasma)

Accu-Tell® HAV IgM Rapid 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.

HAV Rapid Test

CATALOG

KEY POINTS

Detection for: IgM anti-HAV in serum or plasma;

Specimen volume: 50 μl;

Reading time: 20 minutes;

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%).

INTRODUCTION of China Infectious Disease Tests

HAV is a positive RNA virus, a unique member of picornavirdae. Its transmission depends primarily on serial transmission from person to person by the fecal-oral route. Although hepatitis A is not ordinarily a sexually transmitted disease, the infection rate is high among male homosexuals, as result of oral-anal contact.

The presence of specific anti-HAV IgM in blood samples suggests acute or recent HAV infection. The IgM antibody rapidly increases in titer over a period of 4-6 weeks post infection, and then declines to non-detectable levels within 3 to 6 months in most patients.

INTENDED USE

ACCU-TELL® HAV IgM Rapid 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.

1. Sample dilution: Add 50μl HAV serum or plasma into the sample dilution bottle first, then mix the solution plenty.

2. Remove the test cassette from sealed pouch and used it within one hour. Best results will be obtained if the assay is performed immediately after opening foil pouch.

3. Hold the dropper vertically, draw the sample dilution up to the Fill Line as shown in illustration below (approximately 5μL).Then transfer the  sample dilution to the sample port (S) which part have been marked. Or using micropipette add 5μl dilution sample into the sample port (S) which part have been marked.

4. Add 2 drops of buffer (approx. 80μl) into the dilution well (B) of the test cassette, start the time.

5. Read the results at 20 minutes; do not interpret after 20 minutes

PERFORMANCE CHARACTERISTICS of Infectious Disease Tests

Sensitivity and Specificity

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

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® HAV IgM Rapid 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. We are also IgG Rapid Test Cassette Supplier.

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