The US Food and Drug Administration (FDA) has given 510(k) clearance for Quidel’s AmpliVue hand-held molecular diagnostic test for the detection of Bordetella pertussis.
Further, Quidel will now be able to promote AmpliVue Bordetella Assay, which is a self-contained, handheld disposable molecular diagnostic test with advanced clinical accuracy.
The assay does not require direct extraction of DNA and delivers précised result in about 75 minutes.
Quidel president and chief executive officer Douglas Bryant said: "We are pleased to receive 510(k) clearance for our AmpliVue Bordetella Assay — our fifth assay in the AmpliVue format.
"We’ve shown that we can harness our proprietary 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 latest 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 latest assay is similar to other FDA-approved AmpliVue assays, which does not necessitate the consumers to spend in costly thermocycling apparatus.
With the AmpliVue platform, laboratories of all sizes will be able to execute highly sensitive and precise molecular tests.
Further, the AmpliVue Bordetella Assay joins the already approved detectable analytes including Pertussis, C. difficile, Group A Strep, Group B Strep, HSV1 and HSV2.