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Clinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assay.
J Clin Virol. 2020 07; 128:104448.JC

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.

Authors+Show Affiliations

Department of Microbiology, Monash Health, Clayton, VIC, Australia; Monash Infectious Diseases, Monash Health, Clayton, VIC, Australia.Department of Microbiology, Monash Health, Clayton, VIC, Australia. Electronic address: Michelle.Francis@monashhealth.org.Department of Microbiology, Monash Health, Clayton, VIC, Australia.Department of Microbiology, Monash Health, Clayton, VIC, Australia; Monash Infectious Diseases, Monash Health, Clayton, VIC, Australia; Faculty of Medicine Nursing & Health Sciences, Monash University, Clayton, VIC, Australia.Victorian Infectious Diseases Reference Laboratory, Melbourne Health at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.Department of Microbiology, Monash Health, Clayton, VIC, Australia; Monash Infectious Diseases, Monash Health, Clayton, VIC, Australia; Faculty of Medicine Nursing & Health Sciences, Monash University, Clayton, VIC, Australia; Microbiological Diagnostic Unit Public Health Laboratory, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

32460173

Citation

Attwood, Lucy O., et al. "Clinical Evaluation of AusDiagnostics SARS-CoV-2 Multiplex Tandem PCR Assay." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 128, 2020, p. 104448.
Attwood LO, Francis MJ, Hamblin J, et al. Clinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assay. J Clin Virol. 2020;128:104448.
Attwood, 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 : the Official Publication of the Pan American Society for Clinical Virology, 128, 104448. https://doi.org/10.1016/j.jcv.2020.104448
Attwood LO, et al. Clinical Evaluation of AusDiagnostics SARS-CoV-2 Multiplex Tandem PCR Assay. J Clin Virol. 2020;128:104448. PubMed PMID: 32460173.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assay. AU - Attwood,Lucy O, AU - Francis,Michelle J, AU - Hamblin,John, AU - Korman,Tony M, AU - Druce,Julian, AU - Graham,Maryza, Y1 - 2020/05/19/ PY - 2020/05/12/received PY - 2020/05/15/revised PY - 2020/05/16/accepted PY - 2020/5/28/pubmed PY - 2020/7/7/medline PY - 2020/5/28/entrez KW - COVID-19 KW - Coronavirus KW - Diagnosis KW - MT-PCR KW - SARS-CoV-2 SP - 104448 EP - 104448 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 128 N2 - 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. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32460173/Clinical_evaluation_of_AusDiagnostics_SARS_CoV_2_multiplex_tandem_PCR_assay_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30190-6 DB - PRIME DP - Unbound Medicine ER -