The OnSite 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 diagnosing infection with HAV.
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Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.
HAV, a positive-sense RNA virus, is a unique member of the family Picornaviridae. 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 men who have sex with men as a result of oral-anal contact.
The presence of specific anti-HAV IgM in blood samples suggests an acute or recent HAV infection. Anti-HAV IgM rapidly increases in titer over 4-6 weeks post-infection and then declines to non-detectable levels within 3 to 6 months in most patients.
The OnSite HAV IgM Rapid Test is a lateral flow immunoassay for the qualitative detection of anti-HAV IgM in serum, plasma, or whole blood. This test detects IgM antibodies against the hepatitis A virus (HAV). The test aims to identify recent or current hepatitis A infection. It detects antibodies produced by the immune system in response to HAV. It can be performed within 15 minutes by minimally skilled personnel without the use of laboratory equipment. False negatives can occur during the early phase of infection.
Each Kit Contains:
The OnSite HAV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to the Hepatitis A virus (HAV) in human serum, plasma, or whole blood. It is intended to be used by healthcare professionals to aid in the diagnosis of active and/or past HAV infection.
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Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.
HAV, a positive-sense RNA virus, is a unique member of the Picornaviridae family. HAV is highly contagious and is primarily transmitted by the fecal-oral route, either through person-to-person contact or consumption of contaminated food or water. Although hepatitis A is not ordinarily a sexually transmitted disease, the infection rate can increase following oral-anal contact.
The presence of anti-HAV IgM in blood samples suggests an acute or recent HAV infection. In most infected individuals, anti-HAV IgM rapidly increases in titer over 4-6 weeks post-infection and then declines to non-detectable levels within 3 to 6 months. Anti-HAV IgG can be detected at the onset of symptoms, and levels remain elevated throughout the life of an individual. Protective immunity from infection with HAV is indicated by an anti-HAV IgG level ≥20-33 mIU/mL9, however, these levels do not necessarily ensure protection from a future HAV infection. A patient without protective levels of anti-HAV IgG (< 20-33 mIU/mL) is considered at risk of acquiring an HAV infection.
The OnSite HAV IgG/IgM Rapid Test is a lateral flow immunoassay for the qualitative detection of anti-HAV IgG (LoD 70 mIU/mL) and IgM specific to the hepatitis A virus (HAV) in serum, plasma, or whole blood. The test aids healthcare professionals in diagnosing active or past HAV infections.
Antibodies Detected:
Results can be obtained within 15 minutes by minimally skilled personnel without the use of laboratory equipment. If anti-HAV IgG or IgM is present, colored lines appear (G line for IgG, M line for IgM). The absence of test lines indicates a negative result.
Each Kit Contains:
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