The US FDA has approved Chembio Diagnostics' Dual Path Platform (DPP) point-of-care HIV 1/2 rapid test.
The DPP HIV 1/2 assay is developed to detect HIV-1/2 antibodies in either oral fluid or blood samples, which will bind directly with target analytes before the introduction of the detection reagents to visualize the test results.
DPP technology improves the test accuracy compared with the existing lateral flow HIV test technologies.
Chembio chief executive officer Lawrence Siebert said the FDA approval to market DPP HIV 1/2 Assay will allow the commercialization of a POC oral fluid rapid diagnostic test.
"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 U.S., as they have globally, to help identify those with HIV and to prevent disease transmission," Siebert added.
The assay is approved to detect HIV in patients two years of age and older and is designed to deliver results within 15 minutes using a minimum amount of sample.
DPP HIV ½, which provides discrete test lines, features a swab for collecting oral fluid samples and a sample collection system allowing every sample to be contained in a closed collection vial, or Sampletainer for further use.