New & Noteworthy

July-August 2014

HIV Diagnostic Assays

Chembio Diagnostics Systems, Inc

Chembio Diagnostics announces the launch of its Chembio HIV 1/2 STAT-PAK Assay and its corresponding HIV Rapid Test Control Pack, as well as the proprietary DPP HIV 1/2 Assay and corresponding DPP HIV 1/2 Control Pack. The Chembio HIV 1/2 STAT-PAK Assay is FDA-approved and CLIA-waived. Its ease of use, small (5 µL) specimen requirement, rapid and reliable results, long shelf life, and room temperature storage allow for immediate patient counseling and referral, making it uniquely suited for clinical and outreach settings. The DPP HIV 1/2 Assay detects HIV antibodies in oral fluid or blood and uses patented Dual Path Platform technology, which offers excellent sensitivity and specificity. Its SampleTainer specimen collection bottle is a safe, closed system for collecting potentially infectious samples. The Chembio DPP HIV 1/2 Assay is FDA-approved, and initial marketing of this product will be directed to CLIA moderately complex testing sites. Both the HIV 1/2 STAT-PAK Assay (previously marketed as Clearview HIV 1/2 STAT-PAK) and the DPP HIV 1/2 Assay are manufactured exclusively at Chembio's FDA-registered, cGMP compliant, and ISO 13485 certified facility in Medford, New York.

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