You are viewing Golden Time — our IVD brand
Infectious Disease

HIV 1/2 Antibody Rapid Test

Colloidal gold lateral flow immunoassay for qualitative detection of HIV-1 and HIV-2 antibodies in whole blood, serum, or plasma samples.

Format

Cassette

Reading Time

15 minutes

MOQ

5,000 tests

Shelf Life

24 months

Sample Types
Whole Blood Serum Plasma

Product Specifications

Format Cassette
Sample Type Whole Blood, Serum, Plasma
Accuracy >99.5% sensitivity, >99% specificity
Reading Time 15 minutes
Storage 2-30°C
Shelf Life 24 months
Methodology Lateral Flow Immunoassay (Colloidal Gold)

Testing Methodology

This product uses lateral flow immunoassay (LFIA) technology with colloidal gold conjugates. The immunochromatographic test strip provides rapid qualitative detection through antigen-antibody reactions. When the sample is applied, it migrates along the membrane by capillary action, interacting with pre-coated reagents to produce visible colored lines indicating the result. No laboratory equipment is required.

Product Details

Product Overview

The Golden Time HIV 1/2 Antibody Rapid Test is a qualitative immunochromatographic assay designed for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in human whole blood, serum, or plasma specimens. This lateral flow immunoassay utilizes colloidal gold conjugate technology to deliver reliable results in just 15 minutes.

Intended Use

This rapid diagnostic test is intended for:

  • Point-of-care HIV screening in hospitals and clinics
  • Voluntary counseling and testing (VCT) centers
  • Blood bank screening programs
  • Public health surveillance initiatives
  • Field testing in resource-limited settings

Key Features

  • One-step procedure — No special equipment required
  • Rapid results — Visual results in 15 minutes
  • Multiple sample types — Accepts whole blood (fingerstick or venous), serum, or plasma
  • High accuracy — >99.5% sensitivity, >99% specificity validated against reference methods
  • Room temperature storage — No refrigeration required (2-30°C)
  • Long shelf life — 24 months from manufacture date

Specifications

The cassette format includes a built-in procedural control line to verify proper test performance. Each kit contains test cassettes, buffer solution, disposable pipettes, lancets (for fingerstick collection), and instructions for use in multiple languages.

Target Users

This HIV rapid test is designed for professional use by trained healthcare personnel in clinical laboratories, hospitals, private clinics, and public health programs. It is particularly well-suited for settings where laboratory infrastructure is limited.

OEM/ODM Customization

We offer comprehensive OEM and private label services for distributors:

  • Custom box design and branding
  • Private label packaging with your logo
  • Multi-language instructions (English, French, Portuguese, Spanish, Arabic)
  • Custom kit configurations
  • Regulatory documentation support for market registration

Regulatory Status

This product is CE marked and manufactured in an ISO 13485 certified facility following GMP guidelines. Documentation packages are available to support regulatory submissions in target markets across Africa, Southeast Asia, the Middle East, and Latin America.

Contact our sales team for bulk pricing, OEM options, and technical documentation.

Certifications & Compliance

CE Marked
ISO 13485
GMP

Target Markets

Africa Southeast Asia Middle East Latin America

Inquire About HIV 1/2 Antibody Rapid Test

Get pricing, MOQ details, and OEM customization options. Our sales team responds within 12 hours.