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J Clin Virol
. 2020 May 19;128:104448.
doi: 10.1016/j.jcv.2020.104448. Online ahead of print.
Clinical Evaluation of AusDiagnostics SARS-CoV-2 Multiplex Tandem PCR Assay
Lucy O Attwood 1 , Michelle J Francis 2 , John Hamblin 3 , Tony M Korman 4 , Julian Druce 5 , Maryza Graham 6
Affiliations
- PMID: 32460173
- PMCID: PMC7236671
- DOI: 10.1016/j.jcv.2020.104448
Abstract
Background: 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.
Keywords: COVID-19; Coronavirus; Diagnosis; MT-PCR; SARS-CoV-2.