NADAL Listeria

General information about this test : The NADAL HAV IgG/IgM Test is a rapid immunoassay for qualitative detection and differentiation of anti-hepatitis A virus (HAV) IgG and IgM in human serum, plasma or whole blood samples. The NADAL HAV IgG/IgM Test is suitable for screening and diagnosis of HAV infection. It is recommended to supplement the results from the NADAL HAV IgG/IgM Test with clinical methods and other in vitro assays. Reagents and material supplied : 30 NADAL HAV IgG/IgM test cassettes (incl. desiccant) 30 capillary tubes (5 μL) 1 Buffer (5 mL/bottle) 1 package insert Test time : 15 min Performance characteristics : The NADAL HAV IgG/IgM Test does not show cross reactivity with : Dengue-positive serum, HCV-positive serum, HIV-positive serum, Syphilis-positive serum, TB-positive serum, H. Pylori -positive serum, HbsAg-positive serum, ANA-positive serum, HAMA- positive serum and RF- positive serum ((≤2,500 IU/ml). The following common fever medicаtions, anticoagulants and blood components: Bilirubin (20 mg/dL), Hemoglobin (2 g/L), Glucose (55 mmol/L), Salicylic acid (1.45 mmol/L), Heparin (3,000 U/L), EDTA (3.4 μmol/L) and Sodium citrate (1.27%) do not interfere with the results from the NADAL HAV IgG/IgM Test. IgM Sensitivity and specificity of the NADAL HAV IgG/IgM Test considering IgM were determined by comparison of the results of this test with those of commercially available HAV IgM EIA assays. Relative sensitivity: >99% Relative specificity: >99% Overall agreement: >99% IgG The performance characteristics of the NADAL HAV IgG/IgM Test were confirmed by comparison with commercially available HAV IgM EIA assays. Relative sensitivity: 98.7% Relative specificity: >99% Overall agreement: 99% Test principles : The NADAL HAV IgG/IgM Test is a qualitative lateral flow immunoassay for the detection and differentiation of anti-Hepatitis A virus IgM and IgG in blood, plasma or serum. The NADAL HAV IgG/IgM test cassette includes two test lines – M and G (for detection of IgM and IgG respectively) and a control line. The M test line is pre-coated with mouse anti-human IgM , mouse anti-human IgG are precoated on the line G and control antibodies are pre-coated on the line (C). After addition of adequate volume of sample and buffer in the respective wells, if anti-HAV IgG and/or IgM are present in the specimen, they interact with HAV antigens conjugated to colloidal gold particles. Further, this immunocomplexes are captured by mouse anti-human IgM and/or mouse anti-human IgG forming burgundy line on the M and/or G test line of the test cassette. A colored line should always appear in the control line region (C), it serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred. Clinical significance : Hepatitis A virus (HAV) was isolated for the first time in 1973. It s a non-enveloped RNA virus belonging to the family Picornaviridae , genus Hepatovirus . HAV is transmitted through the fecal-oral route. HAV can be cought up from contaminated water and foods, close personal contact, sexual contact, and illicit drug use. The incubation period of the Hepatitis A infection is usually around 28 days (15-50 days). The most common symptoms include nausea, vomiting, diarrhea, dark urine,jaundice, fever, headaches, weight loss and abdominal pain. The symptoms likelihood increases with age. Normally, the acute illness does not last for more than two months. Although recurrances, acute fulminant hepatitis and other complications may occur, there is no chronic stage of the disease and no chronic viral shedding. 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. Thus the presence of IgM and IgG is a sign of current infection and presence of IgG while IgM is absent points to a past infection.