2 Assay

Medical equipment data
Parent SURE CHECK HIV 1
Health topic HIV/AIDS
Health classification Diagnosis
Project data
Type
Authors
Location New York, United States
Status Commercialized
Years

Problem being addressed

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

  • Designed by: ChemBio Diagnostic Systems Inc.
  • Manufacturing: New York, USA

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
Authors Evashiu
License CC-BY-SA-3.0
Cite as Evashiu (2012–2025). "SURE CHECK HIV 1/2 Assay". Appropedia. Retrieved November 28, 2025.
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