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HIV-syphilis assay, 1/14

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January 2014—Chembio Diagnostics received its first purchase order for its DPP HIV-Syphilis Assay from its distributor in Mexico.

The DPP HIV-Syphilis Assay is based on the company’s patented Dual Path Platform (DPP), a point-of-care testing platform that is suited to multiplexing and that adds a syphilis biomarker to the company’s FDA-approved DPP HIV 1/2 test. The addition of this marker has resulted in a fingerstick whole blood test that can help reduce the transmission of HIV and syphilis from mother to child.

The purchase order from Mexico follows a favorable evaluation of the test’s sensitivity and specificity by Mexico’s Institute of Epidemiological Diagnosis and Reference (InDRE). In the InDRE’s testing, the Chembio assay performed with 100 percent sensitivity and 100 percent specificity on all samples, according to Chembio.

The DPP HIV-Syphilis Assay has been approved for inclusion on the USAID waiver list, making the test eligible for procurements by U.S. government-funded global health programs. Chembio is also pursuing CE marking and FDA approval.

Chembio Diagnostics, 631-924-1135

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