Dx Focus: Quidel Gets FDA OK for HSV 1 and 2 Assay | GenomeWeb

Quidel said last week that it has received 510(k) clearance from the US Food and Drug Administration for its AmpliVue HSV 1+2 assay for the differentiation of herpes simplex viruses 1 and 2.

AmpliVue HSV 1+2 uses helicase-dependent amplification technology, an isothermal amplification method, and as such is easy to use, handheld, and disposable, and does not require expensive thermal cycling equipment, Quidel said.

The assay also requires no upfront extraction of DNA, and generates a result in approximately one hour.

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