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AusDiagnostics Gets CE Mark for Multiplex Coronavirus, Flu, RSV Assay

NEW YORK — AusDiagnostics said on Monday that it has received CE marking for its multiplex PCR assay for SARS-CoV2, influenza, and respiratory syncytial virus (RSV).

The firm also said that the panel has been included in the Australian Register of Therapeutic Goods.

The test includes two targets for SARS-CoV-2: one in ORF 1a and one in ORF 8, according to the Mascot, Australia-based company. It achieved 100 percent sensitivity and 100 percent specificity in a study of 210 samples that included 44 from COVID-19 patients. Thirteen of the samples were from patients with either influenza or RSV.

The assay is based on AusDiagnostics' multiplexed-tandem PCR technology, which enables the detection of low concentrations of multiple pathogens in samples with high concentrations of other pathogens.

Versions of the panel are available for both 24-sample and 96-sample instruments manufactured by the company are now available, AusDiagnostics Managing Director Keith Stanley said in a statement.