HIV-Ab/Ag 4th Gen Rapid Test
Athenese DX HIV-Ab/Ag 4th Gen Rapid 10 Test
The TRUSTline HIV-Ab/Ag 4th Gen Rapid Test detects HIV p24 in addition to IgG and IgM enabling HIV infection to be caught as early as 16 days post-infection.
This product features:
A lateral flow immunoassay for the qualitative detection of antibodies (IgG, IgM, IgA) to anti-HIV-1 & 2 virus and HIV-1 p24 antigen in human serum, plasma or whole blood.
- 4th Generation HIV test to detect p24 in addition to IgG and IgM for early detection
- Evaluated by NIB
- Requires only 5 µL of specimen
- Use serum, plasma or whole blood
- Results available within 15 min to allow prompt action to be taken at the point of care
- Performance validated with BBI low titre panel and Chinese FDA HIV Ab Panel
- Sensitivity: 100 %, Specificity: 99.84 %
- Shelf life: 24 month at 1-30 °C
Each kit contains:
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Specimen transfer device
- Sample diluent(5 mL/bottle)
- One package insert (instruction for use)
TEST PRINICPLE :
The TRUSTline HIV-Ab/Ag 4th Gen Rapid Test is a lateral flow immunochromatographic assay. The test strip consists of: 1) a burgundy colored conjugate pad containing recombinant HIV-gp120-41 and gp-36 antigens conjugated with colloidal gold (HIV conjugates), monoclonal anti-HIV-p24 antibody conjugated with colloidal gold (p24 conjugates) and rabbit IgG-gold conjugates (for control line), 2) a nitrocellulose membrane strip containing two test lines (Ag line and Ab line) and a control line (C line). The Ab line is pre-coated with HIV-gp120-41 and HIV-2 gp-36 antigens for the detection of antibodies to HIV-1 including O or HIV-2, the Ag line is pre-coated with another monoclonal anti-HIV-p24 antibody for the detection of p24 antigen, and the C line is pre-coated with goat anti-rabbit IgG antibody.
When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG, IgM or IgA antibodies to HIV-1 or HIV-2, if present in the specimen, migrate through the conjugate pad where they bind to the HIV conjugates. The immunocomplex is then captured on the membrane by the pre-coated HIV-1+2 antigens forming a burgundy colored Ab line, indicating a positive test result. Absence of the Ab line suggests an HIV-1 and HIV-2 antibody negative result.
HIV-1 p24 antigen, if present in the specimen, migrates through the conjugate pad where it binds to the p24 conjugates. The immunocomplex is then captured on the membrane by the pre-coated HIV-p24 antibody, forming a burgundy colored Ag line, indicating a positive test result. Absence of the Ag line suggests a HIV-p24 antigen negative result. The test contains an internal control (C line), which should exhibit a burgundy colored line of the immunocomplex of the control antibodies regardless of color development on the test lines. If the C line does not develop, the test result is invalid and the specimen must be retested with another device.
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