NEW YORK (GenomeWeb) – Quidel announced today that it has received US Food and Drug Administration 510(k) approval for its Solana assay for the diagnosis of trichomoniasis, a sexually transmitted disease that results from infection from the Trichomonas vaginalis parasite.
The test uses the helicase-dependent amplification technology that underpins Quidel's AmpliVue line of molecular assays, and is designed to detect nucleic acids isolated from clinician-collected vaginal swabs and urine specimens from symptomatic or asymptomatic female patients. It is intended for use only with the company's Solana instrument, which can process up to 12 patient samples in a single 30-minute run.
"We believe that our test can play a vital role in quickly diagnosing this disease in the moderately complex setting, thereby creating opportunities for patient treatment and limiting its spread," Quidel President and CEO Douglas Bryant said in a statement.
The Solana Trichomonas assay received CE marking in June and is the second of Quidel's molecular infectious disease diagnostics to receive FDA approval following the clearance of its Group A Streptococcus assay last year.