Chembio Diagnostics has been approved to sell its combination test for HIV and syphilis in most of Europe and the Caribbean.
The single-use test kits offer rapid detection of antibodies to HIV types 1 and 2 and syphilis Treponema pallidum using whole blood from a finger stick, venous whole blood, serum or plasma. The test requires a tiny blood sample, provides results in as little as 15 minutes and has shelf life of up to 2 years.
The test was previously approved for use in Mexico and Brazil. It is undergoing clinical testing in the United States and could be approved for use here later this year, the company said. It also is seeking approvals in Southeast Asia.
The Centers for Disease Control and Prevention estimate that syphilis patients have a two- to five-fold higher risk of contracting HIV. In addition, 2 million pregnancies each year are affected by mother-to-child transmission of HIV and/or syphilis, resulting in high rates of stillbirth, spontaneous abortion, low birth weight and perinatal death.
“We believe the (test) can play a role in the global initiative to reduce transmission of HIV and syphilis to unborn children, as well as to screen certain populations to address growing HIV and syphilis co-infection rates, Chembio CEO John Sperzel said in a statement.”