Multiplex HIV-Syphilis Assay Launched
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By LabMedica International staff writers Posted on 13 Nov 2013 |
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Image: The Dual HIV 1/2 and Syphilis Treponemal antibodies Point-of-Care test (Photo courtesy of Chembio Diagnostics).
Unique finger-stick whole blood tests can help reduce the transmission of both human immunodeficiency virus (HIV) and Treponema pallidum, the causative agent of syphilis, from mother to child.
Globally, more pregnant women are infected with syphilis than HIV, and prenatal assays using point-of-care diagnostic tests (POCT) is an essential tool to help prevent transmission of both diseases to the unborn child.
The Dual Path Platform (DPP(R)) HIV-Syphilis Assay (Chembio Diagnostics; Medford, NY, USA) a POCT platform that is well suited for multiplexing. A syphilis biomarker has been added to the company's already United States Food and Drug Administration (FDA, Silver Springs, MD, USA)-approved DPP(R) HIV 1/2 test. The Chembio DPP HIV-Syphilis Assay is a single-use, immunochromatographic, rapid screening test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1/2) and Syphilis T. pallidum in fingerstick whole blood, venous whole blood, serum, and plasma.
The DPP(R) HIV-Syphilis Assay has also been approved for inclusion on the United States Agency for International Development (USAID; Washington DC, USA) waiver list, which to the Company's knowledge is the first HIV-Syphilis product to be included on this list according to the USAID's most recently published waiver list. The USAID approval involves laboratory studies of product performance performed by the International Laboratory Branch of the United States Centers for Disease Control (CDC; Atlanta, GA, USA) across multiple production lots to ensure consistent performance. The Company anticipates that the results from the CDC's evaluation will be published in due course. Chembio is also pursuing Conformité Européene (CE) marking and FDA approval of this product.
The company received a purchase order from Mexico following the previously reported favorable evaluation of the sensitivity and specificity of this test by Mexico's Institute of Epidemiological Diagnosis and Reference (InDRE; Escandon, Mexico). In the InDRE's testing, the Chembio DPP(R) HIV-Syphilis test performed with 100% sensitivity and 100% specificity on all samples.
Javan Esfandiari, MSc, Chembio's Senior Vice President of Research and Development, said, “We believe the results of InDRE's tests together with the USAID waiver list approval provide a compelling validation of the Chembio DPP(R) HIV-Syphilis product for global health programs. We also look forward to developing many opportunities for this product around the world where there is a great need for detecting both HIV and syphilis in prenatal testing programs, and the USAID approval will help facilitate these opportunities.”
Related Links:
Chembio Diagnostics
United States Centers for Disease Control
Institute of Epidemiological Diagnosis and Reference
Globally, more pregnant women are infected with syphilis than HIV, and prenatal assays using point-of-care diagnostic tests (POCT) is an essential tool to help prevent transmission of both diseases to the unborn child.
The Dual Path Platform (DPP(R)) HIV-Syphilis Assay (Chembio Diagnostics; Medford, NY, USA) a POCT platform that is well suited for multiplexing. A syphilis biomarker has been added to the company's already United States Food and Drug Administration (FDA, Silver Springs, MD, USA)-approved DPP(R) HIV 1/2 test. The Chembio DPP HIV-Syphilis Assay is a single-use, immunochromatographic, rapid screening test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1/2) and Syphilis T. pallidum in fingerstick whole blood, venous whole blood, serum, and plasma.
The DPP(R) HIV-Syphilis Assay has also been approved for inclusion on the United States Agency for International Development (USAID; Washington DC, USA) waiver list, which to the Company's knowledge is the first HIV-Syphilis product to be included on this list according to the USAID's most recently published waiver list. The USAID approval involves laboratory studies of product performance performed by the International Laboratory Branch of the United States Centers for Disease Control (CDC; Atlanta, GA, USA) across multiple production lots to ensure consistent performance. The Company anticipates that the results from the CDC's evaluation will be published in due course. Chembio is also pursuing Conformité Européene (CE) marking and FDA approval of this product.
The company received a purchase order from Mexico following the previously reported favorable evaluation of the sensitivity and specificity of this test by Mexico's Institute of Epidemiological Diagnosis and Reference (InDRE; Escandon, Mexico). In the InDRE's testing, the Chembio DPP(R) HIV-Syphilis test performed with 100% sensitivity and 100% specificity on all samples.
Javan Esfandiari, MSc, Chembio's Senior Vice President of Research and Development, said, “We believe the results of InDRE's tests together with the USAID waiver list approval provide a compelling validation of the Chembio DPP(R) HIV-Syphilis product for global health programs. We also look forward to developing many opportunities for this product around the world where there is a great need for detecting both HIV and syphilis in prenatal testing programs, and the USAID approval will help facilitate these opportunities.”
Related Links:
Chembio Diagnostics
United States Centers for Disease Control
Institute of Epidemiological Diagnosis and Reference
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