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7th April 2015  Content supplied by: Quidel Corporation

A Hand-Held Molecular Diagnostic Test for Trichomoniasis - FDA Cleared

Quidel Corporation has received FDA clearance to market its AmpliVue Trichomonas Assay for the detection of nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic female patients. This molecular assay aids in the diagnosis of trichomoniasis, a sexually transmitted disease attributable to infection by the Trichomonas vaginalis parasite.

The AmpliVue Trichomonas Assay is an easy-to-use, self-contained, handheld disposable molecular diagnostic test with superb clinical accuracy and with procedural steps consistent with those commonly seen in moderately complex laboratories. The assay requires no upfront extraction of DNA and generates an accurate result in approximately 50 minutes. Like other previously FDA-cleared AmpliVue assays, the AmpliVue Trichomonas Assay does not require the customer to invest in either expensive thermocycling equipment, or any other upfront testing costs. It is anticipated that minimal training will be required, as is the case with Quidel's other five in vitro diagnostic assays that use the AmpliVue platform. Using AmpliVue can therefore significantly lower a laboratory's cost to adopt and maintain the assay's unique molecular testing methods.

Quidel's AmpliVue platform now enables laboratories of all sizes to perform highly sensitive and specific molecular tests. The AmpliVue Trichomonas Assay is Quidel's sixth molecular infectious disease assay to receive 510(k) clearance from the FDA in this hand-held, disposable AmpliVue format. In addition to Trichomonas Quidel offers 510(k)-cleared, in vitro diagnostic products on this novel platform for the diagnosis of six other pathogens: <em>C. difficile,</em>, Group A Strep, Group B Strep, Pertussis, HSV1 and HSV2.


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Date Published: 7th April 2015

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