HIV ELISA 4th Gen Kit – Microwell-Based Antigen-Antibody Combo Test

Overview

The HIV ELISA 4th Generation Kit is an advanced enzyme-linked immunosorbent assay designed for the qualitative detection of HIV-1 p24 antigen and antibodies to HIV-1 (groups M & O) and HIV-2 in human serum or plasma. As a 4th generation test, it offers earlier detection compared to antibody-only assays by identifying both antigen and antibody markers during seroconversion.

This test is ideal for diagnostic labs and transfusion centres seeking high accuracy and cost-effective HIV screening solutions. If you’re evaluating HIV ELISA test cost, this kit delivers clinical-grade performance with pricing accessible for high-volume testing labs.

Intended Use

This in vitro diagnostic device is intended for:

• Early detection of HIV-1 p24 antigen
• Simultaneous detection of anti-HIV-1 and anti-HIV-2 antibodies
• Use in blood donor screening, hospital laboratories, and public health testing

It forms part of a comprehensive screening panel alongside our HBsAg ELISA Kit and HCV ELISA Kit.

Test Principle

This is a sandwich ELISA, optimised for dual detection:

1. Microwells pre-coated with HIV-1 antigens and anti-HIV p24 antibodies capture target analytes
2. Patient serum or plasma is added — if antibodies or antigen are present, binding occurs
3. A conjugated antibody binds to the immune complexes
4. Addition of TMB substrate produces a colour change proportional to the bound analytes
5. Optical density is measured at 450 nm (ref. 620–630 nm)

This high-sensitivity principle is also applied in our HCV ELISA and Typhoid RT-PCR kit, supporting infectious disease diagnostics.

Kit Components

All components are stable at 2–8°C with a shelf life of 12 months from manufacturing.

Performance Characteristics

• Sensitivity: 100% for HIV-1 p24 antigen detection
• Specificity: 99.76%
• Assay Duration: ~120 minutes total
• Sample Volume: 100 μL
• Sample Type: Serum or plasma (EDTA, citrate, or heparin)
• Window Period Reduction: Detects infection ~2–3 weeks post-exposure

For a full biochemistry panel, this assay complements our clinical chemistry reagents, including SGPT, LDL cholesterol, and uric acid reagents.

Why Choose a 4th Generation HIV ELISA?

4th Gen assays offer:

• Detection of both HIV-1 p24 antigen and antibodies to HIV-1/HIV-2

• Earlier diagnosis during the seroconversion window

• Greater accuracy in blood donor screening

• Alignment with WHO and CDC recommendations for early HIV detection

Frequently Asked Questions (FAQs)

What does the HIV ELISA 4th Gen test detect?

It detects HIV-1 p24 antigen and antibodies to HIV-1 (M & O) and HIV-2, allowing early identification of infection.

How early can HIV be detected with this test?

Within 2–3 weeks post-infection, earlier than 3rd Gen ELISAs that detect antibodies only.

Is this test suitable for blood bank use?

Yes, it is designed for blood donor screening and is compliant with IVD use.

What sample types are accepted?

The test accepts human serum or plasma collected in EDTA, citrate, or heparin.

What is the HIV ELISA test cost?

Pricing depends on procurement volume and distributor. For detailed pricing, contact our team or request a quote through your preferred channel.