Chembio Diagnostics Inc. has secured approval to sell its combination test for HIV and syphilis in most of Europe and the Caribbean, officials said.

The Medford-based manufacturer of rapid diagnostic tests received the CE mark, which allows products to be sold in the European Union and the Caribbean, except for Puerto Rico.

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Earlier, Chembio won approval to sell the test in Mexico and Brazil.

The blood test for HIV and syphilis provides a result in about 15 minutes and can be stored at room temperature. It has a shelf life of up to two years.

CEO John Sperzel said last week the test “can play a role in the global initiative to reduce transmission of HIV and syphilis to unborn children, as well as screen certain populations to address growing HIV and syphilis co-infection rates.”

The federal Centers for Disease Control and Prevention estimate there is a two- to fivefold increase in the risk of contracting HIV if the patient has already been exposed to syphilis. The centers also estimate that 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.

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Sperzel said Chembio hopes to introduce the combination test in the United States once a clinical trial is completed. He said the company would apply for U.S. regulatory approval early this year.