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Surecheck assay.jpg
FA info icon.svg Angle down icon.svg Medical equipment data
Health topic HIV/AIDS
Health classification Diagnosis
FA info icon.svg Angle down icon.svg Project data
Location New York, United States
Status Commercialized
OKH Manifest Download

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.

FA info icon.svg Angle down icon.svg Page data
Part of Global Health Medical Device Compendium
SDG SDG03 Good health and well-being
Authors Eva Shiu
License CC-BY-SA-3.0
Language English (en)
Related 0 subpages, 1 pages link here
Aliases SURE CHECK HIV 1/2 Assay
Impact 311 page views
Created January 27, 2012 by Eva Shiu
Modified June 1, 2023 by Felipe Schenone
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