AIDS test kit

IgAIgGIgM

Product Overview
HIV 1/2 Rapid Test Kit (HWTAI) is a lateral flow immunochromatographic assay for qualitative detection of antibodies (IgG, IgM, IgA) to HIV-1 (including group O) and HIV-2 in human serum, plasma or whole blood. The test is intended for professional use as an initial screening aid in the diagnosis of HIV infection. Reactive results require confirmation using alternative, validated confirmatory methods.

Intended Use
For qualitative detection of antibodies to HIV-1 and HIV-2 in human serum, plasma or whole blood. Intended for use by trained healthcare professionals for screening purposes; any reactive or non-conclusive result should be followed by confirmatory testing and clinical assessment.

Product Description
The HWTAI HIV 1/2 Rapid Test Kit is supplied as a lateral flow cassette or strip using colloidal gold immunochromatographic technology. It is designed for rapid, point-of-care screening to assist clinical decision-making. The device provides a visual result within the specified reading window and is intended as part of a diagnostic workflow, not as a standalone definitive test.

Performance Characteristics
Manufacturer documentation reports diagnostic accuracy metrics with overall agreement approximately 99% under validated conditions. Typical reading time is 10–15 minutes. Results can be affected by sample quality, timing and operator technique; follow laboratory procedures and local regulations for interpretation.

Affordable Testing Initiative
Product information references deployment in programs to increase access to HIV screening in resource-limited settings, emphasizing early detection, community outreach and linkage to care:

• Enhanced access: increased availability in underserved regions
• Early detection: facilitates timely clinical intervention
• Community engagement: supports testing uptake and reduces stigma
• Awareness: promotes testing and prevention strategies
• Transmission reduction: earlier identification supports treatment and reduces onward transmission

Packaging & Presentation
Typically supplied as in vitro diagnostic rapid test cassettes or strips. Common pack configuration: 25 tests per box. Reported shelf life: 24 months when stored according to manufacturer instructions.

Technical specifications

• Product Name: HIV 1/2 Rapid Test Kit HWTAI (cassette or strip)
• Specimen: Whole blood / Serum / Plasma
• Method: Colloidal gold immunochromatographic assay
• Form: In vitro diagnostic rapid test (cassette or strip)
• Reading Time: 10–15 minutes
• Accuracy: Approximately 99% (manufacturer data)
• Format: Strip or cassette
• Certification: ISO 9001 / ISO 13485
• Shelf Life: 24 months
• Package: 25 tests per box