Device data
Health topic HIV/AIDS
Classification Diagnosis
Scope Commercialized
Manufacturer
location		 New York, United States

Rapid diagnostic kits, which have emerged over the past few years as a result of advancing technology, help detect HIV infection quickly.

Detailed description of the solution

SURE CHECK® HIV 1 / 2, HIV 1/ 2 STAT-PAK® and HIV 1/ 2 STAT-PAK® Dipstick tests are easy-to-perform, single-use diagnostic tests for the rapid, visual detection of antibodies to HIV1 and HIV2. All of these devices are produced by ChemBio Diagnostic Systems, Inc.

Designed by

When and where it was tested/implemented

Due to its inexpensive price and wide distribution, it is available globally. It has been tested and referred to in WHO reports.

References

Peer-reviewed publication

Delaney, Kevin P. et al. (2010). Evaluation of the Performance Characteristics of 6 Rapid HIV Antibody Tests. Oxford Journals. Medicine. Clinical Infectious Diseases Volume 52, Issue 2, pp. 257-263. Link available here.

Other internally generated reports

A PDF of use and instructions is available here.

Approval by regulatory bodies or standards boards

This device received FDA approval in May 2006. Link available here.

Page data
SDG SDG03 Good health and well-being
Authors Evashiu
License CC-BY-SA-3.0
Language English (en)
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Created January 27, 2012 by Evashiu
Last edit September 10, 2026 by Felipe Schenone
Cite as Evashiu (2012–2026). "Global Health Medical Device Compendium/SURE CHECK HIV 1/2 Assay". Appropedia. Retrieved September 30, 2026.
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