How One Company’s Saliva Spit Tubes Dominate the DNA Collection Device Market by Maintaining Specimen Integrity for as Long as Two Years

Jul 26, 2019 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing

From point-of-care diagnostic tests to ancestral DNA home-testing, this company’s spit tubes are used by more medical laboratories than any other brand Most clinical laboratory specialists know that OraSure Technologies of Bethlehem, Pa., was the first company to develop a rapid point-of-care DNA diagnostic test for HIV back in the 1990s. This was a big deal. It meant physicians could test patients during office visits and receive the results while the patients were still in the office. Since...

FDA Panel Recommends Approval for OraSure’s In-Home Consumer HIV Test, Despite Some Concerns about False Positive Results

May 25, 2012 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology

Sensitivity and specificity of test kit for over-the-counter sale does not equal that of HIV assays performed in licensed and accredited clinical laboratories Despite concerns about the potential for false positive results, an in-home rapid HIV test kit designed to be sold to consumers in pharmacies and other retail outlets cleared one more hurdle on the path to winning clearance by the Food and Drug Administration (FDA) to come to market. On May 15, the 17 voting members of FDA’s Blood...
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