Clinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assay
Date
2020-07Author
Attwood, Lucy O.
Francis, Michelle J.
Hamblin, John
Korman, Tony M.
Druce, Julian
Graham, Maryza
Metadata
Show full item record
Documentos PDF
Summary in foreign language
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.
Collections
Estadísticas Google Analytics
Comments
Respuesta Comentario Repositorio Expeditio
Gracias por tomarse el tiempo para darnos su opinión.