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Chlamydia, gonorrhea DNA tests cleared by FDA
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BD Diagnostics recently announced that the company has received 510(k) clearance from the FDA for two of its molecular assays, one to detect Chlamydia trachomatis and the other Neisseria gonorrhoeae.
The BD ProbeTec Qx amplified DNA assays are indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial and gonococcal urogenital disease. Both tests are used with BD Diagnostic’s Viper LT System, a bench-top molecular platform that provides automated sample liquid handling, nucleic acid extraction, amplification, detection and result reporting.
“[The tests] are designed to meet the needs of today’s clinical laboratories, providing automated, accurate and reliable detection of Chlamydia trachomatis and Neisseria gonorrhoeae, for all genital sample types,” Doug White, vice president and general manager of molecular diagnostics and women’s health at BD Diagnostics, said in a press release.
According to the company, both assays have been developed for low- and mid-volume clinical laboratories and are capable of detecting chlamydia and gonorrhea in a range of samples, including female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens, male and female urine specimens and gynecological specimens.
WHO estimates that 105.7 million new cases of chlamydia and 106.1 million new cases of gonorrhea are diagnosed each year worldwide. According to the CDC, chlamydia is the most frequently reported sexually transmitted bacterial infection in the United States, with nearly 2.86 million people infected each year. More than 820,000 people in the United States acquire gonorrhea annually. STIs accounted for nearly $16 billion in total medical costs in the United States in 2010.
For more information:
WHO. Globalprevalence and incidence of selected curable sexually transmitted infections–2008. 2012.