A manufacturer of medical diagnostic and collection devices now has World Health Organization backing on its HIV Self-Test.
OraSure Technologies Inc. of Bethlehem said this morning that the WHO pre-qualified the company’s OraQuick HIV Self-Test. The test allows a person to detect antibodies to both HIV-1 and HIV-2 with an oral swab and can provide a result in 20 minutes.
“This is the WHO version of FDA approval,” Douglas Michels, president and CEO of OraSure, this morning about the federal Food and Drug Administration.
The designation allows global public health funding agencies to buy the product.
The WHO has a membership that includes health ministries from countries all over the world, and those countries look to the WHO for approval, Michels said.
WHO pre-qualification is used by the United Nations and other procurement agencies such as the U.S. president’s Emergency Plan for AIDS Relief, Unitaid, and the Global Fund to make purchasing decisions regarding diagnostics, medicines and vaccines.
“These organizations will look to WHO and the list of WHO pre-qualified products to inform their purchasing decisions,” Michels said. “They know it’s gone through rigorous testing.”
The pre-qualification strives to ensure that diagnostic tests for these types of diseases meet global standards of quality, safety and efficiency with a process that involves a rigorous testing of a product’s technical performance that involved hundreds of people, he said.
“The data is important because the product is tested in the market for its intended use,” Michels said. “It’s a truly consumer-driven use environment. It performed extremely well compared to the best of the best.”
Based on its performance, OraQuick HIV Self-Test was selected and is being used in the Unitaid/Population Service International HIV Self-Testing Africa Project. The company said the first part of the STAR project aims to improve access to HIV testing through simple HIV self-tests in three high-burden African countries – Malawi, Zambia and Zimbabwe.
OraSure has other products that are WHO pre-qualified. As the company develops new products and sells them in the market, it will continue to pursue that WHO pre-qualification, Michels said.