HBV Ag, HIV 1/2 and HCV Ab Combo Test

HBV Ag, HIV 1/2, and HCV Ab Combo Test

HBV Ag, HIV 1/2 and HCV Ab Combo Test is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B surface antigen (HBV Ag), antibodies specific to HIV-1, HIV 2 and HCV C virus in human whole blood. This test is for research use and intended as an aid to the diagnosis of HBV, HIV and HCV infection for patients with signs and symptoms of HBV/HIV/HCV. It provides only an initial screening test result. More specific alternative diagnosis methods should be performed in order to obtain the confirmation of infection.

Basic Details

 

  • Test Type: Rapid chromatographic immunoassay.
  • Purpose: Qualitative detection of Hepatitis B surface antigen (HBV Ag) and antibodies specific to HIV-1, HIV-2, and HCV in human whole blood.
  • Intended Use: For research use and as an aid in the diagnosis of HBV, HIV, and HCV infection in patients with symptoms of these infections.
  • Screening Test: Provides an initial screening result. Confirmation of infection should be done using more specific diagnostic methods.

 

Test Principle, Material Provided, Kit Storage

TEST PRINCIPLE
The HBV Ag, HIV 1/2 and HCV Ab Combo Test is an chromatographic immunoassay test for the detection of antibodies and antigens in whole blood. The membrane is pre-coated with the specific antigen or antibody in the test line regions. When the specimen is added to the sample well the specimen reacts with recombinant antigens or specific antibodies. The mixture then migrates laterally through the nitrocellulose membranes chromatographically by capillary action and reacts with recombinant antigen or antibody complexes on the membrane in the test line region. If the specimen contains the specific antigen or antibody being tested for, colored line will appear in the test line region. This indicates a positive result for each test. If the specimen does not contain the specific antigen or antibody being tested for, no colored line will appear in the test line region indicating a negative result. To serve as a procedural control, colored line will always appear in the control line regions indicating that the proper volume of specimen has been added.

MATERIALS PROVIDED

  1. Individual pouches, each containing:
    • Test card
    • Desiccant
  2. Sample applicator
  3. Sterile Lancet
  4. Alcohol Swab
  5. Buffer Vial
  6. Disposal Bag
  7. Instructions for use

KIT STORAGE AND STABILITY
Store the pouch and the buffer provided in the kit at 2-40°C, and ensure that the test card is brought to room temperature before opening. Keep out of direct sunlight, Kit materials are stable until the expiration date printed on the outer box. Do not freeze the kit or expose the kit to temperatures over 40°C.

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