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dc.contributor.authorAttwood, LO
dc.contributor.authorFrancis, MJ
dc.contributor.authorHamblin, J
dc.contributor.authorKorman, TM
dc.contributor.authorDruce, J
dc.contributor.authorGraham, M
dc.identifierpii: S1386-6532(20)30190-6
dc.identifier.citationAttwood, L. O., Francis, M. J., Hamblin, J., Korman, T. M., Druce, J. & Graham, M. (2020). Clinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assay. JOURNAL OF CLINICAL VIROLOGY, 128,
dc.description.abstractBACKGROUND: In the context of the pandemic, the rapid emergency use authorisation of diagnostic assays for SARS-CoV-2 has meant there are few peer-reviewed published studies of clinical performance of commercial assays. AIMS: To evaluate the clinical performance of AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2. METHODS: We reviewed the results following implementation of AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2, and compared with an in-house RT-PCR assay at our State Reference Laboratory. RESULTS: Initial validation using AusDiagnostics coronavirus multiplex tandem PCR assay including SARS-CoV-2 demonstrated good concordance with the State Reference Laboratory. After implementing the AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2, we tested 7839 samples. 127 samples in which SARS-CoV-2 was detected using the AusDiagnostics assay were referred for testing at the State Reference Laboratory, with concordant results in 118/127 (92.9%) of samples. After resolution of discrepancies, 125/127 (98.4%) of AusDiagnostics results were determined to be true positive results. Out of 7839 samples tested for SARS-CoV-2 during this period, only 2 tests (0.02%) were indeterminate results. CONCLUSION: The AusDiagnostics respiratory MT-PCR assay is a reliable assay for detection of SARS-CoV-2.
dc.titleClinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assay
dc.typeJournal Article
melbourne.affiliation.departmentMicrobiology and Immunology
melbourne.affiliation.departmentDoherty Institute
melbourne.source.titleJournal of Clinical Virology
melbourne.openaccess.statusPublished version
melbourne.contributor.authorGraham, Maryza
melbourne.contributor.authorDruce, Julian
melbourne.accessrightsAccess this item via the Open Access location

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