Chembio announces WHO Prequalification approval for HIV Self-Test

The test senses antibodies to HIV 1 and HIV 2, demonstrated specificity of 100% and sensitivity of 99.4%, when comparing amateur HIV self-test users to skilled professionals.

Chembio Diagnostics, Inc., has reportedly announced that its SURE CHECK HIV Self-Test has secured World Health Organization (WHO) Prequalification authorization. The WHO Prequalification of In Vitro Diagnostics (IVD) is a thorough assessment of every IVD, where they are passed  through a set standardized procedures,  including review of a product dossier, examination of the production site, performance evaluation  with respect to labelling review, and operational characteristics.

Apparently,  Prequalification is the hallmark of a product’s  adherence to global standards of safety, performance, and quality. It also indicates that such products  influence the purchase decision of  international entities such as United Nations and other procurement agencies including UNITAID, the Global Fund, and PEPFAR.

As per reliable sources, the SURE CHECK HIV Self-Test offers  unprecedented leverage in terms of ease of use.  The product utilizes the world’s smallest blood sample deployed by any rapid HIV test  and delivers results in just 15 minutes. The exclusive design of SURE CHECK HIV Self-Test is equipped with a buffer solution and capillary device, eliminating the requirement for separate buffer solution bottles and collection devices needed by other HIV self-tests. The test senses antibodies to HIV 1 and HIV 2, and demonstrated specificity of 100% and sensitivity of 99.4%, when compared inexpert HIV self-test users to skilled professionals.

John Sperzel, Chief Executive Officer, Chembio, reportedly stated that the company is gratified to secure WHO Prequalification approval for its advanced HIV self-test, as it will facilitate commercialization in a lucrative HIV testing segment.

Reportedly, the vital element of the newly WHO Prequalified HIV Self-Test is Chembio’s SURE CHECK HIV 1/2 Assay. The  same been approved by FDA, CE marked, CLIA waived, WHO Prequalified, and trusted by health care specialists throughout the world. The company’s SURE CHECK HIV 1/2 Assay was also integrated into two CE marked private label varieties of HIV self-tests. Both the versions were noted to commence European commercialization in the year 2015.
 

Source links: http://chembio.com/news-and-events/press-releases/