Sensitivity of SARS-CoV-2 RNA polymerase chain reaction using a clinical and radiological reference standard - 12/05/21
, Fred Fyles a, Catriona Farrell c, Joe Lewis a, b, David Barr a, b, Kathryn Haigh a, b, Michael Abouyannis a, Beth Hankinson c, Diana Penha c, Rashika Fernando c, Rebecca Wiles c, Sheetal Sharma c, Nuria Santamaria c, Vijay Chindambaram c, Cairine Probert c, Muhammad Shamsher Ahmed a, James Cruise a, Imogen Fordham a, Rory Hicks a, Alice Maxwell a, Nick Moody a, Tamsin Paterson a, Katharine Stott a, d, Meng-San Wu a, Michael Beadsworth a, Stacy Todd a, Elizabeth Joekes c
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Highlights |
• | Compared to a clinical and radiological standard, SARS-CoV-2 PCR sensitivity was 68%. |
• | Sensitivity declined after one week from patient-reported symptom onset. |
• | Test sensitivity was lower among current smokers compared to never/former smokers. |
• | Lower test sensitivity among smokers may explain lower observed disease incidence. |
Abstract |
Objectives |
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.
Methods |
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.
Results |
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).
Conclusions |
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.
Le texte complet de cet article est disponible en PDF.Keywords : SARS-CoV-2, COVID-19, Real-time polymerase chain reaction, Radiology, Diagnostic X-Ray, Diagnostic testing, Sensitivity and specificity
Plan
Vol 82 - N° 6
P. 260-268 - juin 2021 Retour au numéro
Article précédent
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