30 individually packed test cassettes for detection and differentiation of anti-hepatitis A virus (HAV) IgG and IgM in human serum, plasma or whole blood
Package contents:
30 test cassettes
30 capillary tube (5 µL)
1 buffer (5 mL)
1 package insert
Exclusively for professional users
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The NADAL® HAV IgG/IgM Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of anti-hepatitis A virus (HAV) IgG and IgM in human serum, plasma or whole blood. The test is intended to be used by professionals as a screening test and as an aid in the diagnosis of a HAV infection. Any reactive result with the NADAL® HAV IgG/IgM Test must be confirmed with alternative testing method(s) and clinical findings.
First isolated in 1973, the hepatitis A virus (HAV) is a nonenveloped RNA virus of the family Picornaviridae, genus Hepatovirus. Its transmission occurs primarily through serial transmissions from person to person by the fecal-oral route. However, HAV can also be contracted from contaminated water, close personal contact, sexual contact, and illicit drug use. Following an incubation period of approximately 28 days (15-50 days), the disease is characterised by a rapid onset of symptoms. Signs and symptoms can include nausea, vomiting, diarrhea, dark urine, jaundice, fever, headaches, weight loss and abdominal pain. The likelihood of symptoms increases with age. Normally, acute illness does not last more than two months. There is no chronic viral shedding and no chronic stage of the disease, though recurrences, acute fulminant hepatitis and other complications may occur. Anti-HAV IgM are detectable at or prior to the onset of clinical illness and decline in about 3 to 6 months. Anti-HAV IgG appear soon after IgM, persist for years after infection and confer lifelong immunity. The presence of anti-HAV IgG and the absence of anti-HAV IgM can be used to differentiate between past and current infections. IgM assays can detect antibodies in individuals who have recently received a hepatitis A vaccine for a short period of time. However, lower concentrations detected 4 to 6 months after the onset of infection typically do not produce a positive test result. The NADAL® HAV IgG/IgM Test detects and differentiates anti-HAV IgG from anti-HAV IgM in human serum, plasma or whole blood after 15 minutes and can be performed by minimallyskilled personnel without the use of laboratory equipment.
