HBsAg Rapid Test
ASPEN HBsAg Rapid 50 Test
The HBsAg Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Surface Antigen in serum or plasma
Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C virus. The complex antigen found on the surface of HBV is called HBsAg. Previous 1designations included the Australia or Au antigen. The presence of HBsAg in serum or plasma is an indication of an active Hepatitis B infection, either acute or chronic. In a typical Hepatitis B infection, HBsAg will be detected 2 to 4 weeks before the ALT level becomes abnormal and 3 to 5 weeks before symptoms or jaundice develop. HBsAg has four principal subtypes: adw, ayw, adr and ayr. Because of antigenic heterogeneity of the determinant, there are 10 major serotypes of Hepatitis B virus. The HBsAg Rapid Test Cassette is a rapid test to qualitatively detect the presence of HBsAg in serum or plasma specimen. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBsAg in serum or plasma.
The HBsAg Rapid Test Cassette is a qualitative, solid phase, two-site sandwich immunoassay for the detection of HBsAg in serum or plasma. The membrane is precoated with anti-HBsAg antibodies on the test line region of the cassette. During testing, the serum or plasma specimen reacts with the particle coated with anti-HBsAg antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-HBsAg antibodies on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
The test device contains anti-HBsAg particles and anti-HBsAg coated on the membrane. Please read all the information in this package insert before performing the test. 1. For professional in vitro diagnostic use only. Do not use after the expiration date. 2. The test should remain in the sealed pouch until ready to use. 3. All specimens should be considered potentially hazardous and handled in the same manner as an infections agent. 4. The used test should be discarded according to local regulations.
Store as packaged at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date. 1. The HBsAg Rapid Test Cassette can be performed using serum or plasma. 2. Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens. 3. Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. 4. Bring specimens to room temperature prior to testing. Frozen specimens 5. If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.
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