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{{Medical Device | {{Medical Device | ||
|Health Topic=HIV/AIDS | |Health Topic=HIV/AIDS | ||
|Classification=Diagnosis | |Classification=Diagnosis | ||
|Scope=Commercialized | |Scope=Commercialized | ||
Revision as of 20:59, 19 November 2013
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.