FDA Clears Hand-Held Test for Bordetella Pertussis

The United States Food and Drug Administration (FDA) have cleared an accurate, easy-to-use molecular diagnostic assay for Bordetella Pertussis that employs a unique hand-held platform and requires no pre-extraction of DNA.

The incidence of whooping cough, the very contagious disease caused by B. pertussis attaching to cilia that line part of the upper respiratory tract, has risen over the last few years. Whooping cough can cause serious illness in children and adults, and is most dangerous for infants and babies. Quidel Corporation (San Diego, CA, USA), a developer and provider of new diagnostic solutions, has received the FDA clearance for its AmpliVue Bordetella Assay to detect B. pertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to B. pertussis.

AmpliVue Bordetella is an easy-to-use, self-contained, disposable molecular diagnostic test with superb clinical accuracy. The assay requires no upfront extraction of DNA and generates the result in approximately 75 minutes. The AmpliVue platform is based on Quidel’s novel Helicase Dependent Amplification (HDA) technology that enables rapid nucleic acid amplification without a thermal cycler. So, like all FDA-cleared AmpliVue assays, AmpliVue Bordetella is CLIA-classified as moderately complex and does not require investment in expensive thermocycling equipment. This benefit, plus less laboratory space requirements, can significantly lower cost when adopting new molecular testing methods.

"We are pleased to receive 510(k) clearance for our AmpliVue Bordetella Assay—our 5th 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," said Douglas Bryant, president and CEO of Quidel, "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."

Quidel's novel AmpliVue platform now enables laboratories of all sizes to perform highly sensitive and specific molecular tests, and currently has FDA clearance for B. Pertussis, C. difficile, Group A Strep, Group B Strep, HSV1 and HSV2.

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Quidel Corporation