New & Noteworthy

March 2024

Multiplex Molecular Platform and PCR Assay

QuidelOrtho Corporation

QuidelOrtho Corporation has received 510(K) clearance from the US FDA for its Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), and varicella-zoster virus (VZV) nucleic acids isolated and purified from swabs of cutaneous or mucocutaneous lesion specimens obtained from symptomatic patients. The Savanna multiplex molecular platform enables users to analyze up to 12 pathogens or targets, plus up to four controls, from a single test run in roughly 25 minutes, depending on the assay. Savanna is an integrated, sample-to-result, automated in vitro diagnostic platform that performs real-time PCR tests. After inserting the customizable test panel cartridge, the instrument performs sample and reagent preparation, nucleic acid extraction and amplification, real-time detection of RNA or DNA target sequence, and qualitative or quantitative result interpretation from a variety of sample types.

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