HAV IgM Rapid Diagnostic Kit ISO Hepatitis A Virus Test Cassette

HAV IgM Rapid Diagnostic Kit Hepatitis A Virus Test Cassette

【HAV INTRODUCTION】

Hepatitis A is a liver infection caused by the hepatitis A virus (HAV). Hepatitis A(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. The presence of specific anti-HAV IgM in blood samples suggests an acute or recent HAV infection4-6. Anti-HAV IgM 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.

【RAPID TEST INTENDED USE】

HAV IgM Rapid Test is a lateral flow immunoassay for the qualitative detection of IgM antibodies to hepatitis A virus (HAV) in human serum, plasma or whole blood. It is intended to be used by professionals as a preliminary test result to aid in the diagnosis of infection with HAV

【DIAGNOSTIC PRINCIPLE】

Chromatographic Immunoassay

【RAPID TEST SPECIMEN】

Serum/Plasma/Whole blood

【MAIN CONTENTS】

Individually sealed foil pouches containing a Test Cassette with desiccant

Disposable pipettes

Buffer

Instruction for use

【STORAGE AND STABILITY】

The kit should be stored at 2-30°C until the expiry date is printed on the sealed pouch.

The test must remain in the sealed pouch until use.

Keep away from direct sunlight, moisture and heat. Do not freeze.

Care should be taken to protect the components of the kit from contamination. Do not use it if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers, or reagents can lead to false results.

【HAV RESULT INTERPRETATION】

NEGATIVE RESULT:

If only the C line develops, the test indicates that no detectable anti-HAV IgM is present in the specimen. The result is negative or non-reactive.

POSITIVE RESULT:

If both the C and the T lines develop, the test indicates the presence of detectable anti-HAV IgM in the specimen. The result is positive or reactive.

INVALID:

If no C line develops, the assay is invalid regardless of any color development on the T line as indicated below. Repeat the assay with a new device.