“Game changing” syphilis rapid test available in U.S.; Global implications unclear

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The National Coalition of STD Directors (NCSD) announced Thursday that a new ten-minute test for syphilis – that no longer requires long wait times for results, refrigeration, or drawing of blood – is likely to be a “game changer” and a “major advance in the fight against STDs and HIV,” according to a press release from the organization.

Syphilis is a curable disease that can be passed on from mother to child during pregnancy. It is a cause of genital ulcer disease, and as such is associated with a two- to five-fold increased risk of HIV transmission and acquisition, according to the NCSD release.

Although data and possible benefits in the global context were not available, Stephanie Arnold at NCSD did say that Syphilis Health Check, developed by Trinity Biotech, is the first point-of-care test for syphilis to be made available in the U.S., although others have been available in other countries.

“There have been several rapid tests available in other countries, but they have not been of the best or most reliable quality, which is why they have not been available here. This test was the first to be of high enough quality to pass [U.S. Food and Drug Administration] muster and be marketed here,” Arnold said. Trinity Biotech did not respond to Science Speaks’ request for pricing for the new test by the time this article was published.

In 2005 the World Health Organization (WHO) estimated there were more than 12 million new cases of syphilis per year around the world: 4 million in sub-Saharan Africa, an additional 4 million in South and Southeast Asia, and 3 million in Latin America and the Caribbean. Access to syphilis diagnostics has historically been limited in regions of high disease burden.

“In developing countries, three to 15 percent of women of child-bearing age have syphilis. About 30 percent of pregnant women with syphilis will give birth to a dead baby (stillbirth), and another 30 percent to a live baby with congenital syphilis, a condition with a mortality of up to 50 percent,” according to a WHO report on the Use of Rapid Syphilis Tests published in 2006. WHO maintains that syphilis is responsible for more than 50 percent of stillbirths and newborn deaths, yet in 2006 only 30 percent of pregnant women were screened for syphilis in sub-Saharan Africa. The report said that rapid tests could be purchased through the WHO Bulk Procurement Scheme at between $0.19 to $1 per test.

As reported by IRIN PlusNews earlier this month, “A study conducted in Uganda and Zambia by the Elizabeth Glaser Paediatric AIDS Foundation (EGPAF) – identified high rates of syphilis and HIV co-infection in pregnant women in both countries. In Uganda, 14.3 percent of syphilis-positive pregnant women also tested positive for HIV, and the rate was 24.2 percent in Zambia.”

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