Clinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assay

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dc.creatorAttwood, Lucy O.
dc.creatorFrancis, Michelle J.
dc.creatorHamblin, John
dc.creatorKorman, Tony M.
dc.creatorDruce, Julian
dc.creatorGraham, Maryza
dc.date.accessioned2020-08-31T15:51:06Z
dc.date.available2020-08-31T15:51:06Z
dc.date.created2020-07
dc.description.abstractenglishBackground 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.spa
dc.format.extent4 páginasspa
dc.format.mimetypeapplication/pdfspa
dc.identifier.doihttps://doi.org/10.1016/j.jcv.2020.104448spa
dc.identifier.issn1386-6532spa
dc.identifier.otherhttps://www.sciencedirect.com/science/article/pii/S1386653220301906?via%3Dihubspa
dc.identifier.urihttps://hdl.handle.net/20.500.12010/12461
dc.language.isoengspa
dc.publisherJournal of Clinical Virologyspa
dc.rights.accessrightsinfo:eu-repo/semantics/embargoedAccessspa
dc.rights.localAcceso restringidospa
dc.sourcereponame:Expeditio Repositorio Institucional UJTLspa
dc.sourceinstname:Universidad de Bogotá Jorge Tadeo Lozanospa
dc.subjectCoronavirusspa
dc.subject.keywordMT-PCRspa
dc.subject.keywordSARS-CoV-2spa
dc.subject.keywordDiagnosisspa
dc.subject.lembSíndrome respiratorio agudo gravespa
dc.subject.lembCOVID-19spa
dc.subject.lembSARS-CoV-2spa
dc.subject.lembCoronavirusspa
dc.subject.lembDiagnosisspa
dc.titleClinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assayspa
dc.type.coarhttp://purl.org/coar/resource_type/c_6501spa
dc.type.hasversioninfo:eu-repo/semantics/acceptedVersionspa
dc.type.localArtículospa

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