Chembio Diagnostics Inc, Medford, NY, has received FDA approval to market the its Dual Path Platform® (DPP) HIV 1/2 assay for the rapid, point-of-care (POC) detection of HIV-1/2 antibodies in either oral fluid or blood samples.
This determination follows a review of its Premarket Approval (PMA) application and marks the first FDA approval of a diagnostic assay using the company’s patented Dual Path Platform® technology. DPP enables samples to bind directly with target analytes before detection reagents are introduced to visualize the test results.
“With more than 1.2 million Americans estimated to be living with HIV and approximately 20% of them unaware they are infected with the virus, rapid HIV tests are playing a critical role in the US, as they have globally, to help identify those with HIV and to prevent disease transmission,” says Lawrence Siebert, Chembio’s CEO. He says the market for these tests is expected to grow significantly with the recent recommendations from the Preventive Services Task Force to mandate insurance reimbursement for routine HIV testing.
The assay detects antibodies to HIV-1 and HIV-2 in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples, and provides a simple reactive/nonreactive result. In a multisite clinical study of approximately 2,800 patients across five clinical settings, including a pediatric hospital, the diagnostic sensitivity of the assay to detect HIV infection resulted in sensitivity of 99.8% for fingerstick samples; 99.9% for venous whole blood, serum, and plasma samples; and 98.9% for oral fluid samples. The specificity of the assay was 100% for fingerstick specimens; and 99.9% for oral fluid, venous whole blood, plasma, and serum samples. The test is intended to be used in the preliminary diagnosis of patients with HIV in point-of-care settings such as public health and other clinics, hospital emergency rooms, and physician offices.
The assay does not use lateral flow or other older flow-through technologies. It is approved to detect HIV in patients 2 years of age and older. The assay delivers visual results within 15 minutes, is simple to use, requires minimal sample size, has a shelf life of 24 months and does not require refrigeration. It features a comfortable swab for collecting oral fluid samples and provides sharp, distinct test lines due to the technology.
A proprietary sample collection system enables each sample to be contained in a convenient, closed collection vial, or Sampletainer™, which may provide additional sample for repeat testing.
“As we finalize our commercial strategy for the launch of this new DPP assay in the US, we will be conducting and submitting our Clinical Laboratory Improvement Amendments (CLIA) waiver trials in order to establish the quality standards for our laboratory testing that provide for the accuracy, reliability, and timeliness of patient tests results regardless of where the tests are performed,” Siebert says. “We plan to make this submission during the first half of 2013 and expect to launch DPP HIV 1/2 in the US during the second half of 2013.”
Chembio has posted animated video, poster presentations, and publications on its Web site at: http://chembio.com/products/human-diagnostics/dpp-hiv-12-assay/.
[Source: Chembio Diagnostics]