GHM HIV 1/2 Midstream Antibody Rapid Test (Urine) US – Qualitative Detection of HIV-1/2 Antibodies with Non-Invasive Midstream Urine Collection, 15-Minute Results, and Professional Point-of-Care Use

SKU: GHM HIV 1/2 Midstream Antibody Rapid Test (Urine) US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM HIV 1/2 Midstream Antibody Rapid Test (Urine) US is a lateral flow immunochromatographic assay designed for the qualitative detection of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) in human midstream urine specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of HIV-1 and HIV-2 infection.

HIV remains one of the most significant global public health challenges. An estimated 39.9 million people were living with HIV/AIDS worldwide, and expanding access to testing is critical to achieving the UNAIDS 95-95-95 targets. Rapid HIV tests enable same-day results, facilitate immediate linkage to care, and are suitable for use in decentralized and community-based testing settings. The World Health Organization encourages countries to adopt low-cost, prequalified HIV rapid tests as the first test in their testing strategy.

The GHM HIV 1/2 Midstream Antibody Rapid Test (Urine) US offers a non-invasive, urine-based screening solution that addresses key barriers to HIV testing. Unlike blood-based testing, urine collection is simple, painless, and does not require trained phlebotomy personnel or specialized equipment. This makes the test particularly suitable for use in outreach programs, community screening events, and field-based testing environments where blood collection may be impractical or less acceptable to patients. Published evaluations of urine-based HIV antibody tests have demonstrated a sensitivity of 99.44% and a specificity of 100.00% in large multi-center studies, with an overall agreement rate of 99.93% and a Cohen's Kappa value of 0.998 compared to blood-based testing, indicating near-perfect concordance between the two methods.

The GHM HIV 1/2 Midstream Antibody Rapid Test (Urine) US delivers qualitative results in 15 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with midstream urine specimens, providing a simple and non-invasive sample collection method suitable for a wide range of clinical and community settings.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including physician office laboratories, public health screening programs, community outreach settings, and clinical laboratories. The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers based on immunochromatography.

Key Features & Benefits

Non-Invasive Midstream Urine Collection – Patient-Friendly HIV Screening

The GHM HIV 1/2 Midstream Antibody Rapid Test (Urine) US utilizes midstream urine specimens, providing a non-invasive and patient-friendly sample collection method. Unlike blood-based testing, urine collection is simple, painless, and does not require trained phlebotomy personnel or specialized equipment. This makes the test particularly suitable for use in outreach programs, community screening events, and field-based testing environments where blood collection may be impractical or less acceptable to patients.

Colloidal Gold Immunochromatography – Reliable Qualitative Detection

The GHM HIV 1/2 Midstream Antibody Rapid Test (Urine) US is based on lateral flow immunochromatography technology. The test strip contains colloidal gold-conjugated Protein A (SPA) on the conjugate pad, along with recombinant HIV-1 and HIV-2 antigens coated on the test line. During testing, HIV antibodies in the specimen bind to the colloidal gold-labeled SPA, forming a complex that migrates up the membrane and binds to the immobilized antigens at the test line, producing a visible colored line. A control line coated with IgG antibody serves as an internal procedural control.

Fast Results – 15 Minutes

The GHM HIV 1/2 Midstream Antibody Rapid Test (Urine) US provides qualitative results in 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid HIV tests enable same-day results, facilitate immediate linkage to care, and are critical for achieving global HIV testing and treatment targets.

Clinical Utility – Aid for Diagnosis of HIV-1 and HIV-2 Infection

The GHM HIV 1/2 Midstream Antibody Rapid Test (Urine) US is intended for use as a screening test and as an aid in the diagnosis of HIV-1 and HIV-2 infection. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting linkage to care. Early and accurate identification of HIV infection is essential for reducing HIV-related morbidity and mortality through appropriate clinical management, including initiation of antiretroviral therapy.

The test is particularly valuable in settings where rapid identification of HIV infection supports public health screening and linkage to care. Rapid HIV tests enable same-day results, facilitate immediate linkage to care, and are critical for achieving global HIV testing and treatment targets. The World Health Organization recommends the use of three-test algorithms for HIV diagnosis involving three consecutive reactive tests to confirm an HIV-positive result to ensure high accuracy and reduce the risk of misdiagnosis.

High Accuracy – Trusted Clinical Performance

The GHM HIV 1/2 Midstream Antibody Rapid Test (Urine) US is designed to deliver reliable clinical performance with high sensitivity and specificity. Large multi-center evaluations of urine-based HIV antibody tests have demonstrated excellent diagnostic performance, with a sensitivity of 99.44% and a specificity of 100.00%, and an overall agreement rate of 99.93% with blood-based testing (Cohen's Kappa = 0.998), indicating near-perfect concordance between the two methods.

Performance characteristics based on multi-center evaluations of urine-based HIV antibody rapid tests. Independent studies have reported sensitivities ranging from 88.7% to 99.44% and specificities ranging from 99.9% to 100.00%, depending on the product and population evaluated. The performance of urine-based HIV tests can be influenced by specimen quality and patient status. Failure to collect midstream urine or use of first-morning urine may affect test accuracy. Detection rates may be lower in individuals on antiretroviral therapy (ART) due to reduced antibody levels in urine.

ISO 13485 Certified – Quality and Safety Compliance

The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system, demonstrating compliance with stringent international standards for the design, development, manufacture, and distribution of in vitro diagnostic test kits and analyzers.

CE Marked – European Conformity

The GHM HIV 1/2 Midstream Antibody Rapid Test (Urine) US is CE marked for professional in vitro diagnostic use, demonstrating conformity with applicable European regulatory requirements for diagnostic medical devices.

Product Specifications

Why Clinical Professionals Choose Global Healthcare Medical

About Global Healthcare Medical

Global Healthcare Medical is dedicated to connecting healthcare providers, retailers, and distributors with high-quality medical devices designed for reliable performance. The GHM HIV 1/2 Midstream Antibody Rapid Test (Urine) US is part of our professional diagnostic line, developed to support accurate, efficient, and accessible point-of-care testing in clinical environments.

Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.