Sensitivity of SARS-CoV-2 RNA polymerase chain reaction using a clinical and radiological reference standard: Clinical sensitivity of SARS-CoV-2 PCR.



Stockdale, Alexander J ORCID: 0000-0002-5828-3328, Fyles, Fred, Farrell, Catriona, Lewis, Joe ORCID: 0000-0002-3837-5188, Barr, David ORCID: 0000-0002-2922-9381, Haigh, Kathryn ORCID: 0000-0003-1901-7315, Abouyannis, Michael, Hankinson, Beth, Penha, Diana, Fernando, Rashika
et al (show 17 more authors) (2021) Sensitivity of SARS-CoV-2 RNA polymerase chain reaction using a clinical and radiological reference standard: Clinical sensitivity of SARS-CoV-2 PCR. The Journal of infection.

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Abstract

<h4>Objectives</h4>Diagnostic tests for SARS-CoV-2 are important for epidemiology, clinical management, and infection control. Limitations of oro-nasopharyngeal real-time PCR sensitivity have been described based on comparisons of single tests with repeated sampling. We assessed SARS-CoV-2 PCR clinical sensitivity using a clinical and radiological reference standard.<h4>Methods</h4>Between March-May 2020, 2060 patients underwent thoracic imaging and SARS-CoV-2 PCR testing. Imaging was independently double- or triple-reported (if discordance) by blinded radiologists according to radiological criteria for COVID-19. We excluded asymptomatic patients and those with alternative diagnoses that could explain imaging findings. Associations with PCR-positivity were assessed with binomial logistic regression.<h4>Results</h4>901 patients had possible/probable imaging features and clinical symptoms of COVID-19 and 429 patients met the clinical and radiological reference case definition. SARS-CoV-2 PCR sensitivity was 68% (95% confidence interval 64-73), was highest 7-8 days after symptom onset (78% (68-88)) and was lower among current smokers (adjusted odds ratio 0.23 (0.12-0.42) p<0.001).<h4>Conclusions</h4>In patients with clinical and imaging features of COVID-19, PCR test sensitivity was 68%, and was lower among smokers; a finding that could explain observations of lower disease incidence and that warrants further validation. PCR tests should be interpreted considering imaging, symptom duration and smoking status.

Item Type: Article
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Infection, Veterinary and Ecological Sciences
Depositing User: Symplectic Admin
Date Deposited: 28 Apr 2021 10:27
Last Modified: 12 Oct 2021 13:10
DOI: 10.1016/j.jinf.2021.04.012
URI: https://livrepository.liverpool.ac.uk/id/eprint/3120856