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Diagnostic Kit for Hepatitis A Virus Antibody (Colloidal Gold)
Cat. No.: RH0601E
The HAV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis A type virus (HAV) in human serum/ plasma.
HAV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HAV in human serum/plasma. Mouse anti human-IgM µ strands are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HAV recombinant antigens. If antibodies to HAV are present, a pink colored band will develop on the membrane in proportion to the amount of HAV antibodies present in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of antibodies to HAV.
1. One sealed pouched cassette with desiccant & disposable pipettet.
STORAGE AND STABILITY
Store HAV Rapid Screen Test at temperature ranges 4-30 °C in the sealed pouch. Refer to the expiration date for stability. Do not freeze.
1. Carefully apply 3µl sample into a centrifuge tube with 1.5ml dilution, oscillate and mix them to diluted sample.
2. Remove the test cassette from pouch by tearing.
3. Add 50-80 ul or 2-3 drops of mixture into sample well.
4. Observe the result in 20 minutes.
850 HAV diagnostic samples were tested with the HAV Rapid Screen Test. The results are summarized in the table below.
|Diagnostic Sample type||Number of sample tested||HAV Rapid Screen Test|
Sensitivity=96.6; Specificity=99.2%; Total accuracy=98.9%
In the study, 30 replicate assays were performed with one positive and one negative specimen. Correct negative and positive results were registered in 100% of the assays.
The study involved the same specimens containing one positive and one negative. The samples were analyzed in 30 independent assays with HAV Rapid Screen Test. Originating from three different lots at different times during two months. Again, expected negative and positive results were registered in 100% of the assays.
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