diagnostic tests for infection,
infectious disease diagnostic tests
A rapid test for the qualitative detection of Hepatitis A virus in serum or plasma. For professional in vitro diagnostic use only.
The HAV IgM Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of IgM antibody to Hepatitis A Virus (HAV) in serum or plasma.
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 4-6 . 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 .
The HAV IgM Rapid Test Cassette is to be used to detect anti-HAV IgM in less than 20 minutes by untrained or minimally skilled personnel, without cumbersome laboratory equipment.
How to use?
Allow the test cassette, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Sample Dilution
Use micropipette to add 50mL specimen into the sample dilution tube. Screw the lid tightly and shake it for 10 seconds to ensure the solution could be well mixed. Use the diluted sample as specimen for testing. See instruction below.
2. Testing Procedures
Remove the test cassette from sealed pouch and use it within one hour. Best results will be obtained if the assay is performed immediately after opening foil pouch.
Hold the dropper vertically, draw the diluted specimen from sample dilution bottle upto the fill line marked on the dropper as shown in illustration below (approx.5 μL), transfer the diluted specimen to the sample area (S) which has been marked on the test cassette. Or use micropipette to add 5L diluted specimen into the sample area (S) which has been marked.
Add 2 drops of buffer (approx. 80 μL) into the buffer well (B) marked on the test cassette, start the timer. See illustration below.
Wait for the colored line(s) to appear . Read the result at 20 minutes, do not interpret the result after 30 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T).
*NOTE: The intensity of the color in the test region (T) will vary depending on the concentration of HAV IgM present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
|HAV IgM Rapid Test Cassette
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