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Impact of coronavirus disease 2019 (COVID-19) pre-test probability on positive predictive value of high cycle threshold severe acute respiratory coronavirus virus 2 (SARS-CoV-2) real-time reverse transcription polymerase chain reaction (RT-PCR) test results.
Gubbay, Jonathan B; Rilkoff, Heather; Kristjanson, Heather L; Forbes, Jessica D; Murti, Michelle; Eshaghi, AliReza; Broukhanski, George; Corbeil, Antoine; Fittipaldi, Nahuel; Hopkins, Jessica P; Kristjanson, Erik; Kus, Julianne V; Macdonald, Liane; Majury, Anna; Mallo, Gustavo V; Mazzulli, Tony; Melano, Roberto G; Olsha, Romy; Perusini, Stephen J; Tran, Vanessa; Allen, Vanessa G; Patel, Samir N.
  • Gubbay JB; Public Health Ontario, Toronto, Ontario, Canada.
  • Rilkoff H; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
  • Kristjanson HL; Division of Infectious Diseases, Department of Paediatrics, The Hospital for Sick Children, Toronto, Ontario, Canada.
  • Forbes JD; Public Health Ontario, Toronto, Ontario, Canada.
  • Murti M; Public Health Ontario, Toronto, Ontario, Canada.
  • Eshaghi A; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
  • Broukhanski G; Public Health Ontario, Toronto, Ontario, Canada.
  • Corbeil A; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
  • Fittipaldi N; Public Health Ontario, Toronto, Ontario, Canada.
  • Hopkins JP; Public Health Ontario, Toronto, Ontario, Canada.
  • Kristjanson E; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
  • Kus JV; Public Health Ontario, Toronto, Ontario, Canada.
  • Macdonald L; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
  • Majury A; Public Health Ontario, Toronto, Ontario, Canada.
  • Mallo GV; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
  • Mazzulli T; Public Health Ontario, Toronto, Ontario, Canada.
  • Melano RG; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
  • Olsha R; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
  • Perusini SJ; Public Health Ontario, Toronto, Ontario, Canada.
  • Tran V; Public Health Ontario, Toronto, Ontario, Canada.
  • Allen VG; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
  • Patel SN; Public Health Ontario, Toronto, Ontario, Canada.
Infect Control Hosp Epidemiol ; 43(9): 1179-1183, 2022 09.
Article in English | MEDLINE | ID: covidwho-1586120
Preprint
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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 the positive predictive value of SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) assays by retesting positive specimens from 5 pre-test probability groups ranging from high to low with an alternate assay.

METHODS:

In total, 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 4 groups with higher pre-test probability (individual group range, 50.0%-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-positive results and consequent potential for harm at the individual and population level.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Nucleic Acids / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Humans Language: English Journal: Infect Control Hosp Epidemiol Journal subject: Communicable Diseases / Nursing / Epidemiology / Hospitals Year: 2022 Document Type: Article Affiliation country: Ice.2021.369

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Nucleic Acids / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Humans Language: English Journal: Infect Control Hosp Epidemiol Journal subject: Communicable Diseases / Nursing / Epidemiology / Hospitals Year: 2022 Document Type: Article Affiliation country: Ice.2021.369