HAV Ag One Step Rapid Test is a coloured chromatographic immunoassay for the qualitative detection of Hepatitis A virus in stool samples. It offers a simple and highly sensitive screening assay to make a presumptive diagnosis of Hepatitis A virus infection.

Hepatitis A is a liver infection caused by the Hepatitis A virus (HAV). The virus is spread when an uninfected (or unvaccinated) person eats or drinks something contaminated by the stool of an HAV-infected person: this is called faecal-oral transmission. The symptoms of Hepatitis A range from mild to severe and can include fever, malaise, loss of appetite, diarrhoea, nausea, abdominal discomfort, dark-coloured urine and jaundice (yellowing of the skin and whites of the eyes). Not everyone who is infected will have all of the symptoms. Adults have signs and symptoms of illness more often than children and the severity of disease and mortality increases in older age groups. Infected children under six years of age do not usually experience noticeable symptoms, and only 10% develop jaundice. Among older children and adults, infection usually causes more severe symptoms, with jaundice occurring in more than 70% of cases. Most people recover in several weeks-or sometimes months-without complications.

STORAGE AND STABILITY

Store as packaged in the sealed pouch at 2-30°C. The test is stable until the expiration date marked on its sealed pouch. The test must remain in the sealed pouch until use. Do not freeze.

SPECIMEN COLLECTION AND PREPARATION

Stool samples should be collected in clean containers. The samples can be stored in the refrigerator (2-8°C) for 1-2 days prior to testing. For longer storage, maximum 1 year, the specimen must be kept frozen at -20°C. 

In this case, the sample will be totally thawed and brought to room temperature before testing. Homogenise stool samples as thoroughly as possible prior to preparation.

SPECIMEN PREPARATION(SEE ILLUSTRATION)

1. Take out the cap of the stool collection tube (1) and use the stick to pick up sufficient sample quantity. Then, introduce the stick once into 4 different parts of the stool sample (2), to collect faecal sample (approx. 125mg) and add it to the stool collection tube. For liquid samples, add approx. 125μL in the stool collection tube using a micropipette. 

2. Close the tube with the diluent and stool sample. Shake the tube to assure good sample dispersion 

(3)

INTERPRETATION OF RESULTS

Positive: A distinct pink coloured band appears on test line regions, in addition to a pink line on the control line region. 

Negative: No line appears in the test line region. A distinct pink line shows on the control line region. 

Invalid: The control line next to the test line does not become visible within 15 minutes after the addition of the sample. 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.

Note: The intensity of the red coloured band in the test line (T) in the results window will vary depending on the concentration of antigens present in the specimen. However, neither the quantitative value nor the rate of increase in antigens can be determined by this qualitative test.

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