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Chembio's DPP(R) HIV-Syphilis Multiplex Test Demonstrates 100% Sensitivity And Specificity In Evaluation By Mexico's Institute Of Epidemiological Diagnosis And Reference

Stock quotes in this article: CEMI

MEDFORD, N.Y., May 14, 2013 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care diagnostic tests for infectious diseases, announces receipt of an evaluation report from Mexico's Institute of Epidemiological Diagnosis and Reference (InDRE) regarding the Company's DPP ® HIV-Syphilis multiplex test, which showed the Company's assay performed with 100% agreement for both markers on all 941 samples tested.

In evaluating the sensitivity and specificity of the Chembio DPP ® HIV-Syphilis product, 527 biological samples were tested on the HIV line, of which 158 were true negative and 369 were true positive, and 414 were tested on the Syphilis line, of which 108 were true negative and 306 were true positive. The Chembio DPP ® HIV-Syphilis test performed with 100% sensitivity and 100% specificity on all samples.

The Chembio DPP ® HIV-Syphilis Assay is a single-use immunochromatographic, rapid screening test for the detection of antibodies both to Human Immunodeficiency Virus Types 1 and 2 (HIV 1/2) and to Syphilis Treponema pallidum in fingerstick whole blood, venous whole blood, serum or plasma samples. The Chembio DPP ® HIV-Syphilis Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV and/or syphilis.

Commenting on today's announcement, Javan Esfandiari, Chembio's Senior Vice President of Research and Development, said, "We are very pleased with the outstanding results of this evaluation, which is the first of a number of ongoing external studies, evaluations and registration submissions for this product. This multiplex test adds the syphilis marker to our recently FDA-approved DPP ® HIV 1/2 test, and should greatly strengthen the prevention of mother-to-child transmission (PMTCT) of syphilis. We are seeing strong interest in this product from global health programs for the PMTCT of HIV, both because of its potential to reduce the adverse outcomes from untreated maternal syphilis and the potential to reduce the risk of mother-to-child HIV transmission."

Globally, far more pregnant women are estimated to have syphilis than HIV, and untreated maternal syphilis always results in an adverse pregnancy outcome such as fetal death, stillbirth, premature birth, low birth weight or congenital syphilis infection. A dual rapid test for HIV and syphilis could greatly strengthen PMTCT of syphilis, because programs for the PMTCT of HIV are much better financed and because they have stronger external and internal stakeholders. In addition, program costs and supply chains could be more effectively managed. Also syphilis commonly co-exists in patients with HIV (prevalence is 14–36%). Genital sores caused by syphilis make it easier to transmit and acquire HIV infection. The risk of acquiring HIV is estimated to be two- to-five-times higher if exposed to the virus when syphilis is present.

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