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FDA Clears Molecular Trichomonas Assay

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced Tuesday that it has received clearance from the United States Food and Drug Administration (FDA) 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.

According to the Centers for Disease Control and Prevention (CDC), an estimated 3.7 million people in the United States have trichomoniasis. This disease is more common in women and, because only about 30% of those infected develop symptoms of trichomoniasis, most infected persons do not know that they carry the parasite.1 For pregnant women, Trichomonas infection is often associated with preterm delivery and low body weight in newborns. Genital inflammation is often associated with disease and can facilitate infection by other sexually transmitted pathogens, including HIV. Importantly, trichomoniasis can be cured with a single dose of antibiotics, emphasizing the need for rapid, highly sensitive tests that can detect this parasite and prompt immediate treatment.

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.

“Our AmpliVue Trichomoniasis Assay has shown excellent performance with samples from both symptomatic and asymptomatic patients. We believe that our test will play a critical role in quickly diagnosing this disease, creating opportunities for patient treatment and thereby limiting its spread,” said Douglas Bryant, president and chief executive officer of Quidel Corporation.

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: C. difficile, Group A Strep, Group B Strep, Pertussis, HSV1 and HSV2.

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