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Gubbay JB, Rilkoff H, Kristjanson HL, et al. Impact of COVID-19 pre-test probability on positive predictive value of high cycle threshold SARS-CoV-2 real-time reverse transcription PCR test results. Infect Control Hosp Epidemiol. 2021;1-18doi: 10.1017/ice.2021.369.
Gubbay, J. B., Rilkoff, H., Kristjanson, H. L., Forbes, J. D., Murti, M., Eshaghi, A., Broukhanski, G., Corbeil, A., Fittipaldi, N., Hopkins, J. P., Kristjanson, E., Kus, J. V., Macdonald, L., Majury, A., Mallo, G. V., Mazzulli, T., Melano, R. G., Olsha, R., Perusini, S. J., Tran, V., Allen, V. G., & Patel, S. N. (2021). Impact of COVID-19 pre-test probability on positive predictive value of high cycle threshold SARS-CoV-2 real-time reverse transcription PCR test results. Infection control and hospital epidemiology, 1-18. https://doi.org/10.1017/ice.2021.369
Gubbay, Jonathan B, et al. "Impact of COVID-19 pre-test probability on positive predictive value of high cycle threshold SARS-CoV-2 real-time reverse transcription PCR test results." Infection control and hospital epidemiology vol. (2021): 1-18. doi: https://doi.org/10.1017/ice.2021.369
Gubbay JB, Rilkoff H, Kristjanson HL, Forbes JD, Murti M, Eshaghi A, Broukhanski G, Corbeil A, Fittipaldi N, Hopkins JP, Kristjanson E, Kus JV, Macdonald L, Majury A, Mallo GV, Mazzulli T, Melano RG, Olsha R, Perusini SJ, Tran V, Allen VG, Patel SN. Impact of COVID-19 pre-test probability on positive predictive value of high cycle threshold SARS-CoV-2 real-time reverse transcription PCR test results. Infect Control Hosp Epidemiol. 2021 Aug 09;1-18. doi: 10.1017/ice.2021.369. Epub 2021 Aug 09. PMID: 34369325.
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Infect Control Hosp Epidemiol. 2021 Aug 09;1-18. doi: 10.1017/ice.2021.369. Epub 2021 Aug 09.

Impact of COVID-19 pre-test probability on positive predictive value of high cycle threshold SARS-CoV-2 real-time reverse transcription PCR test results.

Infection control and hospital epidemiology

Jonathan B Gubbay, Heather Rilkoff, Heather L Kristjanson, Jessica D Forbes, Michelle Murti, AliReza Eshaghi, George Broukhanski, Antoine Corbeil, Nahuel Fittipaldi, Jessica P Hopkins, Erik Kristjanson, Julianne V Kus, Liane Macdonald, Anna Majury, Gustavo V Mallo, Tony Mazzulli, Roberto G Melano, Romy Olsha, Stephen J Perusini, Vanessa Tran, Vanessa G Allen, Samir N Patel

Affiliations

  1. Public Health Ontario, 661 University Avenue, Toronto, Ontario, Canada M5G 1M1.
  2. Department of Laboratory Medicine and Pathobiology, University of Toronto, 1 King's College Circle, Toronto, Ontario M5S 1A8.
  3. Division of Infectious Diseases, Department of Paediatrics, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, Canada M5G 1X8.
  4. Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, ON, Canada M5T 3M7.
  5. Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario, Canada L8S 4K1.
  6. Department of Pathology and Molecular Medicine, Queens University, 88 Stuart Street, Kingston, Ontario, Canada K7L 3N6.
  7. Department of Microbiology, Sinai Health/University Health Network, 600 University Avenue, Toronto, Ontario, Canada M5G 1X5.

PMID: 34369325 DOI: 10.1017/ice.2021.369

Abstract

OBJECTIVES: Performance characteristics of SARS-CoV-2 nucleic acid detection assays are understudied within contexts of low pre-test probability, including screening asymptomatic persons without epidemiological links to confirmed cases, or asymptomatic surveillance testing. SARS-CoV-2 detection without symptoms may represent presymptomatic or asymptomatic infection, resolved infection with persistent RNA shedding, or a false positive test. This study assessed positive predictive value of SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) assays by retesting positive specimens from five pre-test probability groups ranging from high to low with an alternate assay.

METHODS: A total of 122 rRT-PCR positive specimens collected from unique patients between March and July 2020 were retested using a laboratory-developed nested RT-PCR assay targeting the RNA-dependent RNA polymerase (RdRp) gene followed by Sanger sequencing.

RESULTS: Significantly fewer (15.6%) positive results in the lowest pre-test probability group (facilities with institution-wide screening having ≤ 3 positive asymptomatic cases) were reproduced with the nested RdRp gene RT-PCR assay than in each of the four groups with higher pre-test probability (individual group range 50·0% to 85·0%).

CONCLUSIONS: Large-scale SARS-CoV-2 screening testing initiatives among low pre-test probability populations should be evaluated thoroughly prior to implementation given the risk of false positives and consequent potential for harm at the individual and population level.

Keywords: SARS-CoV-2 PCR; asymptomatic PCR testing; cycle threshold; false positive tests; positive predictive value; test performance

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