US-based point-of-care (POC) diagnostic tests provider Chembio Diagnostics has received CE mark approval for its DPP HIV 1/2 assay.
The DPP HIV 1/2 assay has been developed for rapid and POC detection of HIV and is cleared for marketing in the 28 member states of the European Union.
Using firm’s patented dual path platform (DPP) technology, the assay is said to detect HIV antibodies in oral fluid or blood.
Chembio Diagnostics president and CEO John Sperzel said: "It’s been well-documented that people who are diagnosed early and who receive early treatment can expect nearly the same life expectancy as those who are HIV negative.
"With Chembio’s DPP HIV 1/2 Assay, healthcare professionals in the member states of the European Union will have an exceptionally sensitive, specific and rapid diagnostic to support widespread testing and early treatment."
The assay’s SampleTainer specimen collection bottle is claimed to be a safe and closed system for collecting potentially infectious samples.
The company intends to make the product available for customers in the EU region in the fourth quarter of this year.
According to the firm, the assay is one of only two FDA-approved and CLIA-waived oral fluid HIV 1/2 rapid tests available in the US.
In addition, the firm exclusively markets its Sure Check HIV 1/2 assay in the US as Clearview Complete by a single entity, while through distributors outside the US.
Image: Scanning electron micrograph of HIV-1 budding (in green) from cultured lymphocyte. Photo: courtesy of C. Goldsmith.