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This Global Health Medical Device is designed for or implemented within resource-limited settings - Browse the devices - Add a device

Surecheck assay.jpg
Health Topic HIV/AIDS
Classification Diagnosis
Scope Commercialized
Location Africa, Asia, South America

Problem being addressed[edit]

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[edit]

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[edit]

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

When and where it was tested/implemented[edit]

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


Peer-reviewed publication[edit]

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[edit]

A PDF of use and instructions is available here.

Approval by regulatory bodies or standards boards[edit]

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