FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis

Published: December 15, 2014

FDA
Original Article:  1.usa.gov/1svKC03

The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of health care settings.

According to the U.S. Centers for Disease Control and Prevention (CDC), about 55,000 people in the United States are newly infected with syphilis annually. During the 1990s, syphilis primarily occurred among heterosexual men and women of racial and ethnic minority groups; during the 2000s, however, cases increased among men who have sex with men (MSM). Men who have sex with men accounted for 75 percent of all primary and secondary syphilis cases in 2012. 

This sexually transmitted infection, caused by the bacterium Treponema pallidum, can cause long- term complications or increase the likelihood of HIV transmission if not adequately treated. The syphilis bacterium can also infect the fetus of a woman during her pregnancy, causing infant death, developmental delays and seizures. CDC recommends that all pregnant women be tested for syphilis at the first prenatal visit. Those who are at high risk, live in areas with high rates of syphilis or were previously not tested should be tested in the third trimester and again at delivery. CDC also recommends screening at least once a year for syphilis for all sexually active homosexual, bisexual, and other men who have sex with men.

Full text of article available at link below:  1.usa.gov/1svKC03
 

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