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.
| Testing | Specimen | Result | Storage | Certificate | Shelf life |
| HAV IgM | Whole Blood/Serum/Plasma | at 15 mins | 2-30℃ | CE, ISO13485 | 24 months |
【DIAGNOSTIC PRINCIPLE】
Colloidal gold 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 TESTING & RESULTS】
1. Remove the test cassette from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test on a clean and level surface. Transfer whole blood, serum or plasma to the test cassette, then add 3~4 full drops of buffer, and start the timer.
Avoid trapping air bubbles.
3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
RESULTS:
NEGATIVE: 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: 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.
【DETAILED PHOTOS】
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HAV IgM Whole Blood/Serum/Plasma Diagnosis ISO Hepatitis A Virus Rapid Test Cassette Images
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