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

https://doi.org/10.1016/j.jcv.2020.104448Get rights and content

Highlights

  • Coronavirus pandemic has required rapid approval of diagnostic assays.

  • AusDiagnostics multiplex PCR allows integration of SARS-CoV-2 testing.

  • AusDiagnostics PCR has high specificity: 98.4% of positive samples confirmed.

  • AusDiagnostics PCR specificity: 2/7839 tests (0.02%) SARS-CoV-2 indeterminate.

  • AusDiagnostics multiplex tandem PCR is reliable for detection of COVID-19 virus.

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

Coronavirus
MT-PCR
Diagnosis
SARS-CoV-2
COVID-19

Cited by (0)

1

Shared first authorship. These authors contributed equally to the manuscript. Order of names was decided by consensus of senior authors.

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