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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.

CATALOG

Product Name

Specimen

Catalog No.

Certificate

Quantity per box

HAV IgM Rapid Test Cassette

Serum/Plasma

ABT-IDT-B218

CE

40T/20T

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%).

INTRODUCTIONof

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

PERFORMANCE CHARACTERISTICSof

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.

Method

EIA

Total Results

ACCU-TELL®HAV IgM 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. We are also

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



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