Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Oct 3;5(10):e2236288.
doi: 10.1001/jamanetworkopen.2022.36288.

Sensitivity and Diagnostic Yield of the First SARS-CoV-2 Nucleic Acid Amplification Test Performed for Patients Presenting to the Hospital

Corinne M Hohl  1   2 , Jeffrey P Hau  1   2 , Samuel Vaillancourt  3   4 , Jennifer Grant  5   6 , Steven C Brooks  7 , Laurie J Morrison  4   8 , Jeffrey J Perry  9   10 , Rhonda J Rosychuk  11 ; CCEDRRN investigators for the Network of Canadian Emergency Researchers and the Canadian Critical Care Trials Group
Collaborators, Affiliations

Sensitivity and Diagnostic Yield of the First SARS-CoV-2 Nucleic Acid Amplification Test Performed for Patients Presenting to the Hospital

Corinne M Hohl et al. JAMA Netw Open. .

Abstract

Importance: Early and accurate diagnostic testing for SARS-CoV-2 is essential to initiate appropriate treatment and infection control and prevention measures among patients presenting to the hospital.

Objective: To evaluate the diagnostic sensitivity of the SARS-CoV-2 nucleic acid amplification test (NAAT) performed within 24 hours of arrival to the emergency department among a nationally representative sample of patients.

Design, setting, and participants: This diagnostic study was conducted at 47 hospitals across 7 provinces in Canada participating in the Canadian COVID-19 Rapid Response Emergency Department Network among consecutive eligible patients presenting to a participating emergency department who were tested for SARS-CoV-2 from March 1, 2020, to December 31, 2021. Patients not tested within 24 hours of arrival and those presenting with a positive result from a test performed in the community were excluded.

Main outcomes and measures: The primary outcome was a positive result from the SARS-CoV-2 NAAT. Outcome measures were the diagnostic sensitivity and yield of the SARS-CoV-2 NAAT.

Results: Of 132 760 eligible patients (66 433 women [50.0%]; median age, 57 years [IQR, 37-74 years]), 17 174 (12.9%) tested positive for SARS-CoV-2 within 14 days of their first NAAT. The diagnostic sensitivity of the SARS-CoV-2 NAAT was 96.2% (17 070 of 17 740 [95% CI, 95.9%-96.4%]) among all of the tests performed. Estimates ranged from a high of 97.7% (1710 of 1751 [95% CI, 96.8%-98.3%]) on day 2 of symptoms to a low of 90.4% (170 of 188 [95% CI, 85.3%-94.2%]) on day 11 of symptoms among patients presenting with COVID-19 symptoms. Among patients reporting COVID-19 symptoms, the sensitivity of the SARS-CoV-2 NAAT was 97.1% (11 870 of 12 225 [95% CI, 96.7%-97.3%]) compared with 87.6% (812 of 927 [95% CI, 85.2%-89.6%]) among patients without COVID-19 symptoms. The diagnostic yield of the SARS-CoV-2 NAAT was 12.0% (18 985 of 158 004 [95% CI, 11.8%-12.2%]) and varied from a high of 20.0% (445 of 2229 [95% CI, 18.3%-21.6%]) among patients tested on day 10 after symptom onset to a low of 8.1% (1686 of 20 719 [95% CI, 7.7%-8.5%]) among patients presenting within the first 24 hours of symptom onset.

Conclusions and relevance: This study suggests that the diagnostic sensitivity was high for the first SARS-CoV-2 NAAT performed in the hospital and did not vary significantly by symptom duration. Repeated testing of patients with negative test results should be avoided unless their pretest probability of disease is high.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Hohl reported receiving grants from the Canadian Institutes of Health Research, Genome BC, Health Research BC, the Canadian Immunity Task Force/Public Health Agency of Canada, Ontario Ministry of Colleges and Universities, the Saskatchewan Health Research Foundation, and Fondation du CHU de Québec during the conduct of the study. Dr Brooks reported receiving grants from the Canadian Institutes of Health Research, Ontario Ministry of Colleges and Universities, the Saskatchewan Health Research Foundation, Genome BC, Fondation du CHU de Québec, COVID-19 Immunity Task Force, BC Academic Health Science Network, and BioTalent Canada during the conduct of the study. Dr Perry reported receiving the Heart and Stroke Foundation Canada Mid-Career Salary Award outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patient Flow Diagram
ED indicates emergency department.
Figure 2.
Figure 2.. SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) Sensitivity by Symptom Duration
Sensitivity for the first SARS-CoV-2 NAAT performed in the hospital for 96 232 patients who reported a date of symptom onset. Vertical lines indicate 95% CIs.
Figure 3.
Figure 3.. SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) Diagnostic Yield by Symptom Duration
Diagnostic yield at the time of the first SARS-CoV-2 NAAT among 96 232 patients who reported a date of symptom onset. Vertical lines indicate 95% CIs.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Dinnes J, Deeks JJ, Berhane S, et al. ; Cochrane COVID-19 Diagnostic Test Accuracy Group . Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2021;3:CD013705. doi:10.1002/14651858.CD013705 - DOI - PMC - PubMed
    1. Infectious Diseases Society of America . IDSA guidelines on the diagnosis of COVID-19: molecular diagnostic testing. Updated December 23, 2020. Accessed March 10, 2022. https://www.idsociety.org/practice-guideline/covid-19-guideline-diagnost...
    1. Kucirka LM, Lauer SA, Laeyendecker O, Boon D, Lessler J. Variation in false-negative rate of reverse transcriptase polymerase chain reaction-based SARS-CoV-2 tests by time since exposure. Ann Intern Med. 2020;173(4):262-267. doi:10.7326/M20-1495 - DOI - PMC - PubMed
    1. Mallett S, Allen AJ, Graziadio S, et al. . At what times during infection is SARS-CoV-2 detectable and no longer detectable using RT-PCR–based tests? a systematic review of individual participant data. BMC Med. 2020;18(1):346. doi:10.1186/s12916-020-01810-8 - DOI - PMC - PubMed
    1. Miller TE, Garcia Beltran WF, Bard AZ, et al. . Clinical sensitivity and interpretation of PCR and serological COVID-19 diagnostics for patients presenting to the hospital. FASEB J. 2020;34(10):13877-13884. doi:10.1096/fj.202001700RR - DOI - PMC - PubMed

Publication types