| Customization: | Available |
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| Type: | IVD Instrument |
| Test Parameter: | HAV Igm |
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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.
PRINCIPLE
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.
If the specimen contains IgM antibodies to HAV, a colored line will appear in IgM test line region. If the specimen does not contain antibodies to HAV, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
FEATURES
1. Easy to use, it does not require any specialized laboratory equipment;
2. Quick detection, reading results in 15 mins;
3. High accuracy, CE, ISO certificates
CONTENTS&STORAGE
The test consist of Rapid Test+Buffer+Disposable Dropper+IFU.
It should be stored at 2-30°C until the expiry date printed on the sealed pouch; it must remain in the sealed pouch until use. Keep away from direct sunlight, moisture and heat, and do not freeze.
DIRECTION OF USE
1. Remove the test device 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 the specimen by the disposable dropper:
Hold the pipette vertically; draw the specimen up to the Fill Line. Transfer the specimen to the test device, 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.
4. Results reading:
Negative (-) : Only one color line appears on the control region (C).
Positive (+) : Both test region (T) and control region (C) appear color line.
Invalid: No visible line at all, or there is a visible line only in the test region and not in the control region.
About Us
Dewei Medical Equipment Co., Ltd. is a professional manufacturer specialized in developing and marketing of Medical Consmuables like Colloidal Gold Rapid Test Kits, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits, etc.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories in many countries.
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