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
Observational Study
. 2021 Oct 1;11(10):e051707.
doi: 10.1136/bmjopen-2021-051707.

Factors associated with COVID-19 viral and antibody test positivity and assessment of test concordance: a retrospective cohort study using electronic health records from the USA

Affiliations
Observational Study

Factors associated with COVID-19 viral and antibody test positivity and assessment of test concordance: a retrospective cohort study using electronic health records from the USA

Lisa Lindsay et al. BMJ Open. .

Abstract

Objectives: To identify factors associated with COVID-19 test positivity and assess viral and antibody test concordance.

Design: Observational retrospective cohort study.

Setting: Optum de-identified electronic health records including over 700 hospitals and 7000 clinics in the USA.

Participants: There were 891 754 patients who had a COVID-19 test identified in their electronic health record between 20 February 2020 and 10 July 2020.

Primary and secondary outcome measures: Per cent of viral and antibody tests positive for COVID-19 ('positivity rate'); adjusted ORs for factors associated with COVID-19 viral and antibody test positivity; and per cent concordance between positive viral and subsequent antibody test results.

Results: Overall positivity rate was 9% (70 472 of 771 278) and 12% (11 094 of 91 741) for viral and antibody tests, respectively. Positivity rate was inversely associated with the number of individuals tested and decreased over time across regions and race/ethnicities. Antibody test concordance among patients with an initial positive viral test was 91% (71%-95% depending on time between tests). Among tests separated by at least 2 weeks, discordant results occurred in 7% of patients and 9% of immunocompromised patients. Factors associated with increased odds of viral and antibody positivity in multivariable models included: male sex, Hispanic or non-Hispanic black or Asian race/ethnicity, uninsured or Medicaid insurance and Northeast residence. We identified a negative dose effect between the number of comorbidities and viral and antibody test positivity. Paediatric patients had reduced odds (OR=0.60, 95% CI 0.57 to 0.64) of a positive viral test but increased odds (OR=1.90, 95% CI 1.62 to 2.23) of a positive antibody test compared with those aged 18-34 years old.

Conclusions: This study identified sociodemographic and clinical factors associated with COVID-19 test positivity and provided real-world evidence demonstrating high antibody test concordance among viral-positive patients.

Keywords: COVID-19; epidemiology; infectious diseases; molecular diagnostics; public health.

PubMed Disclaimer

Conflict of interest statement

Competing interests: LL, MHS, SR, DSK and LT are employed by and hold shares in Genentech. FY is employed by and holds shares in Roche Diagnostics.

Figures

Figure 1
Figure 1
Flow diagram of study population.
Figure 2
Figure 2
SARS-CoV-2 viral test positivity and days since COVID-like illness by setting. C2, cohort 2.
Figure 3
Figure 3
Frequency and co-occurrence of common conditions in patients positive for SARS-CoV-2 via viral test.
Figure 4
Figure 4
Density of agreement among patients who received an initial viral positive test and subsequent antibody positive test by weeks between tests and immunocompromised status.
Figure 5
Figure 5
ORs and 95% CIs of SARS-CoV-2-positive viral test obtained via multivariable logistic regression. BMI, body mass index; GERD, gastroesophageal reflux disease.
Figure 6
Figure 6
ORs and 95% CIs of COVID-19-positive antibody test obtained via multivariable logistic regression. BMI, body mass index.
Figure 7
Figure 7
Number of patients tested and per cent positive for initial SARS-CoV-2 viral test by age.

Similar articles

Cited by

References

    1. Centers for Disease Control and Prevention . CDC data covid tracker. Available: https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days [Accessed 22 Jun 2021].
    1. Johns Hopkins University Medicine Coronavirus Resource Center . COVID-19 data in motion: current date. Available: https://coronavirus.jhu.edu/ [Accessed 22 Jun 2021].
    1. U.S Food and Drug Administration . In vitro diagnostics EUAs. individual EUAs for molecular diagnostic tests for SARS-CoV-2. Available: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-em... [Accessed 10 Dec 2020].
    1. Ward S, Lindsley A, Courter J, et al. . Clinical testing for COVID-19. J Allergy Clin Immunol 2020;146:23–34. 10.1016/j.jaci.2020.05.012 - DOI - PMC - PubMed
    1. Scohy A, Anantharajah A, Bodéus M, et al. . Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J Clin Virol 2020;129:104455. 10.1016/j.jcv.2020.104455 - DOI - PMC - PubMed

Publication types