Quidel’s AmpliVue molecular diagnostic test gets FDA clearance

11 December 2014 (Last Updated December 11th, 2014 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Quidel's AmpliVue hand held molecular diagnostic test for the detection of Bordetella pertussis.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Quidel's AmpliVue hand held molecular diagnostic test for the detection of Bordetella pertussis.

Pertussis is a contagious disease caused by the Bordetella pertussis bacteria, which attaches to the cilia that line part of the upper respiratory tract where they cause inflammation.

In addition, Quidel will be able to promote AmpliVue Bordetella Assay, a self-contained, handheld disposable molecular diagnostic test with advanced clinical accuracy.

The company said the assay does not require direct extraction of DNA and delivers precise results in 75 minutes.

Quidel president Douglas Bryant said: "We are pleased to receive 510(k) clearance for our AmpliVue Bordetella Assay, our fifth assay in the AmpliVue format.

"The new assay will be able to detect Bordetella pertussis nucleic acids separated from nasopharyngeal swab specimens taken from patients suffering with respiratory tract infection attributable to Bordetella pertussis."

"We have shown that we can harness our proprietary Helicase Dependent Amplification (HDA) technology to develop fast, accurate molecular diagnostic assays with a menu that matters to our customers.

"Longer-term, we intend to leverage this technology for other molecular diagnostic applications that will be appealing to significant market segments and potentially to public health agencies worldwide."

The new assay will be able to detect Bordetella pertussis nucleic acids separated from nasopharyngeal swab specimens taken from patients suffering with respiratory tract infection attributable to Bordetella pertussis.

Classified by Clinical Laboratory Improvement Amendments (CLIA) as moderately complex, the new assay is similar to other FDA approved AmpliVue assays, which makes it unnecessary for consumers to spend money on costly thermocycling apparatus.

With the AmpliVue platform, laboratories of all sizes will be able to execute highly sensitive and precise molecular tests.

In addition, the AmpliVue Bordetella Assay joins already approved detectable analytes including Pertussis, C difficile, Group A Strep, Group B Strep, HSV1 and HSV2.