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

6. 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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