A fourth-generation enzyme-linked immunosorbent assay (ELISA) designed for the simultaneous qualitative detection of HIV-1 p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum or plasma. Shortens the diagnostic window period significantly by co-detecting p24 antigen alongside viral antibodies.
Fourth-generation HIV assays represent the standard of care for HIV screening. By detecting both HIV-1 p24 antigen and antibodies to HIV-1/HIV-2 simultaneously, these assays can identify HIV infection days earlier than antibody-only tests, reducing the diagnostic window period before seroconversion.
The Genlisa™ HIV (4th Gen.) ELISA Kit Ag/Ab is a microplate-based enzyme immunoassay. The wells are coated with both monoclonal antibodies specific for HIV-1 p24 antigen and purified recombinant antigens corresponding to HIV-1 (gp120, gp41) and HIV-2 (gp36) envelope proteins.
During assay incubation, HIV p24 antigen and anti-HIV antibodies present in the specimen are captured. After washing, HRP-conjugated monoclonal antibodies and recombinant antigens are added to form sandwich complexes, yielding a colorimetric response that is read spectrophotometrically at 450nm.
Advanced molecular diagnostic capabilities engineered for clinical excellence and research-grade precision.
Detects HIV-1 p24 antigen alongside antibodies to HIV-1 (Groups M and O) and HIV-2 in a single run.
Detects early acute HIV infection before antibodies develop, reducing the diagnostic gap.
Clinical evaluation demonstrates 100% sensitivity and 99.8% specificity, ensuring screening safety.
Simple incubation steps with negative and positive controls included for cut-off calculation.
Validated for serum and common anticoagulated plasma samples (EDTA, Heparin, Citrate).
Manufactured under international medical device quality systems, ensuring lot-to-lot consistency.
Designed for diverse diagnostic and research use cases across the clinical spectrum.
Routine screening of blood donations to minimize transfusion-transmitted HIV risk.
Initial screening of patients presenting with symptoms or history of exposure.
Screening pregnant women to identify maternal HIV infection and prevent vertical transmission.
HIV surveillance programs and screening in voluntary counseling and testing centers.
| Parameter | Value / Description |
|---|---|
| Technology | Solid-Phase Enzyme-Linked Immunosorbent Assay (ELISA) |
| Generation | Fourth Generation (4th Gen. Ag/Ab) |
| Targets Detected | HIV-1 p24 antigen, anti-HIV-1 (gp120/gp41), anti-HIV-2 (gp36) |
| Sample Type | Human Serum or Plasma |
| Diagnostic Sensitivity | 100% |
| Diagnostic Specificity | 99.8% |
| Wavelength | 450 nm (reference 620/630 nm) |
| Intended Use | In Vitro Diagnostic (IVD) |
| Storage | 2–8°C |
For in vitro diagnostic use. Contact your regional distributor or ProbGen representative to place an order.
| Product Name | Cat. No. | Pack Size |
|---|---|---|
| Genlisa™ HIV (4th Gen.) ELISA Kit Ag/Ab | GLHIV007 | 96 tests |
| Genlisa™ HIV (4th Gen.) ELISA Kit Ag/Ab | GLHIV001 | 480 tests (5x96) |
Contact our scientific team for technical specifications, bulk pricing, or to request a demonstration of our diagnostics solutions.
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