Aspen HIV 3Rd Generation Rapid 50 Test

A rapid test for the diagnosis of Human Immunodeficiency Virus to detect antibodies to HIV type 1, type 2 and Subtype O qualitatively in whole blood.Serum or plasma. For professional in vitro diagnostic use only.

INTENDED USE The HIV 1/2/O Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus(HIV) type 1,type 2 and subtype O in whole blood, serum or plasma to aid in the diagnosis of HIV infection PRINCIPLE The HIV 1/2/O Rapid Test Cassette(Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of antibodies to HIV-1, HIV-2, and Subtype O in whole blood, serum or plasma. The membrane is pre-coated with recombinant HIV antigens in the test line regions, T1 and T2. The T1 test line is pre-coated with HIV-1 and Subtype O antigen and the T2 test line is pre-coated with HIV-2 antigen. During testing, the whole blood, serum or plasma specimen reacts with HIV antigen coated particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with recombinant HIV antigen on the membrane in the test line region. If the specimen contains antibodies to HIV-1 and/or Subtype O, or HIV-2, one colored line will appear in the test line region; if the specimen contains antibodies to HIV-1 and/or Subtype O, and HIV-2, two colored lines will appear in the test line region. Both indicate a positive result. If the specimen does not contain HIV-1, Subtype O, and/or HIV-2 antibodies, no colored line will appear in the test line region indicating 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.

• Store as packaged in the sealed pouch either 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 after the expiration date.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
• If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.

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