FDA Clears Dual Molecular Diagnostic Test for Chlamydia/Gonorrhea

Yael Waknine

June 30, 2010

June 30, 2010 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for an in vitro polymerase chain reaction (PCR) assay (RealTime Chlamydia trachomatis/Neisseria gonorrhoeae; Abbott Molecular) and an automated instrument (m2000 System; Abbott Molecular) to be used together for the simultaneous detection of gonorrhea and chlamydia in symptomatic and asymptomatic individuals.

"Because many people with chlamydia are co-infected with gonorrhea, it's important to test for both diseases simultaneously," said Klara Abravaya, PhD, senior director, research and development, Abbott Molecular, in a company news release. "Left untreated, chlamydia and gonorrhea can lead to pelvic inflammatory disease, urethritis and sterility."

The molecular test offers higher sensitivity and specificity compared with traditional culture methods, featuring a limit of detection of 320 copies of C trachomatis plasma DNA/N gonorrhoeae genomic DNA per assay and no cross-reactivity to 111 organisms phylogenetically related to C trachomatis and N gonorrhoeae or those that can be found in the urogenital tract.

The chlamydia assay also detects a variant strain of chlamydia that was recently discovered in Sweden. Although no cases of the new strain have been reported in the United States, chlamydia often goes undiagnosed because of a lack of symptoms. Even so, it remains the most commonly reported sexually transmitted disease, with 1.2 million infections reported to the Centers for Disease Control and Prevention in 2008 — a 9% increase from 2007.

Also cleared by FDA was the company's multi-Collect specimen collection kit, a single device that can be used to collect, transport, and store multiple samples of varying types used for the dual assay, including first-catch urine samples and endocervical, vaginal, and male urethral swab specimens.

The chlamydia/gonorrhea assay and automated system previously were approved by the European Commission for use in the European Union.


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