ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2020
Interpret with caution: An evaluation of the commercial AusDiagnostics versus in-house developed assays for the detection of SARS-CoV-2 virus.
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.
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28 citing papers in PubMed, 51 citations in OpenAlex.
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- Co-infection with SARS-CoV-2 Omicron and Delta variants revealed by genomic surveillance.Nature communications · 2022Article
- SARS-CoV-2 Within-Host andFrontiers in microbiology · 2022Article
- SARS-CoV-2 Genome Sequencing Methods Differ in Their Abilities To Detect Variants from Low-Viral-Load Samples.Journal of clinical microbiology · 2021Article
- Resource-efficient internally controlled in-house real-time PCR detection of SARS-CoV-2.Virology journal · 2021Article
- Thermodynamic evaluation of the impact of DNA mismatches in PCR-type SARS-CoV-2 primers and probes.Molecular and cellular probes · 2021Article
- Pitfalls in SARS-CoV-2 PCR diagnostics.Transboundary and emerging diseases · 2021Article
- Evaluation of three commercial assays for SARS-CoV-2 molecular detection in upper respiratory tract samples.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2021Article
- Assessment of antiviral potencies of cannabinoids against SARS-CoV-2 using computational and in vitro approaches.International journal of biological macromolecules · 2021Article
- Approaches towards fighting the COVID‑19 pandemic (Review).International journal of molecular medicine · 2021Review
- Shedding of SARS-CoV-2 in feces and urine and its potential role in person-to-person transmission and the environment-based spread of COVID-19.The Science of the total environment · 2020Review
- Review
- Detection of SARS-COV N2 Gene: Very low amounts of viral RNA or false positive?Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2020Article
- Accuracy amidst ambiguity: false positive SARS-CoV-2 nucleic acid tests when COVID-19 prevalence is low.Pathology · 2020Article
- How should a positive PCR test result for COVID-19 in an asymptomatic individual be interpreted and managed?Medecine et maladies infectieuses · 2020Review
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Authors and funding
17 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThere is limited data on the analytical performance of commercial nucleic acid tests (NATs) for laboratory confirmation of COVID-19 infection.
methodsNasopharyngeal, combined nose and throat swabs, nasopharyngeal aspirates and sputum was collected from persons with suspected SARS-CoV-2 infection, serial dilutions of SARS-CoV-2 viral cultures and synthetic positive controls (gBlocks, Integrated DNA Technologies) were tested using i) AusDiagnostics assay (AusDiagnostics Pty Ltd); ii) in-house developed assays targeting the E and RdRp genes; iii) multiplex PCR assay targeting endemic respiratory viruses. Discrepant SARS-CoV-2 results were resolved by testing the N, ORF1b, ORF1ab and M genes.
resultsOf 52 clinical samples collected from 50 persons tested, respiratory viruses were detected in 22 samples (42 %), including SARS CoV-2 (n = 5), rhinovirus (n = 7), enterovirus (n = 5), influenza B (n = 4), hMPV (n = 5), influenza A (n = 2), PIV-2 (n = 1), RSV (n = 2), CoV-NL63 (n = 1) and CoV-229E (n = 1). SARS-CoV-2 was detected in four additional samples by the AusDiagnostics assay. Using the in-house assays as the "gold standard", the sensitivity, specificity, positive and negative predictive values of the AusDiagnostics assay was 100 %, 92.16 %, 55.56 % and 100 % respectively. The Ct values of the real-time in-house-developed PCR assay targeting the E gene was significantly lower than the corresponding RdRp gene assay when applied to clinical samples, viral culture and positive controls (mean 21.75 vs 28.1, p = 0.0031).
conclusionsThe AusDiagnostics assay is not specific for the detection SARS-CoV-2. Any positive results should be confirmed using another NAT or sequencing. The case definition used to investigate persons with suspected COVID-19 infection is not specific.
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