TY - JOUR
T1 - Diagnostic accuracy of SARS-CoV-2 rapid antigen self-tests in asymptomatic individuals in the Omicron period
T2 - a cross-sectional study
AU - Venekamp, Roderick P
AU - Schuit, Ewoud
AU - Hooft, Lotty
AU - Veldhuijzen, Irene K
AU - van den Bijllaardt, Wouter
AU - Pas, Suzan D
AU - Zwart, Vivian F
AU - Lodder, Esther B
AU - Hellwich, Marloes
AU - Koppelman, Marco
AU - Molenkamp, Richard
AU - Wijers, Constantijn Jh
AU - Vroom, Irene H
AU - Smeets, Leonard C
AU - Nagel-Imming, Carla R S
AU - Han, Wanda G H
AU - van den Hof, Susan
AU - Kluytmans, Jan AJW
AU - van de Wijgert, Janneke H M
AU - Moons, Karel G M
N1 - Funding Information:
This research was supported from the Dutch Ministry of Health , Welfare, and Sport. The funder had no role in the design; collection, analysis, and interpretation of data; writing and decision to submit the paper for publication.
Publisher Copyright:
© 2022 The Author(s)
PY - 2023/3
Y1 - 2023/3
N2 - Objectives: To assess the performances of three commonly used antigen rapid diagnostic tests used as self-tests in asymptomatic individuals in the Omicron period. Methods: We performed a cross-sectional diagnostic test accuracy study in the Omicron period in three public health service COVID-19 test sites in the Netherlands, including 3600 asymptomatic individuals aged ≥ 16 years presenting for SARS-CoV-2 testing for any reason except confirmatory testing after a positive self-test. Participants were sampled for RT-PCR (reference test) and received one self-test (either Acon Flowflex [Flowflex], MP Biomedicals (MPBio), or Siemens-Healthineers CLINITEST [CLINITEST]) to perform unsupervised at home. Diagnostic accuracies of each self-test were calculated. Results: Overall sensitivities were 27.5% (95% CI, 21.3–34.3%) for Flowflex, 20.9% (13.9–29.4%) for MPBio, and 25.6% (19.1–33.1%) for CLINITEST. After applying a viral load cut-off (≥5.2 log10 SARS-CoV-2 E-gene copies/mL), sensitivities increased to 48.3% (37.6–59.2%), 37.8% (22.5–55.2%), and 40.0% (29.5–51.2%), respectively. Specificities were >99% for all tests in most analyses. Discussion: The sensitivities of three commonly used SARS-CoV-2 antigen rapid diagnostic tests when used as self-tests in asymptomatic individuals in the Omicron period were very low. Antigen rapid diagnostic test self-testing in asymptomatic individuals may only detect a minority of infections at that point in time. Repeated self-testing in case of a negative self-test is advocated to improve the diagnostic yield, and individuals should be advised to re-test when symptoms develop.
AB - Objectives: To assess the performances of three commonly used antigen rapid diagnostic tests used as self-tests in asymptomatic individuals in the Omicron period. Methods: We performed a cross-sectional diagnostic test accuracy study in the Omicron period in three public health service COVID-19 test sites in the Netherlands, including 3600 asymptomatic individuals aged ≥ 16 years presenting for SARS-CoV-2 testing for any reason except confirmatory testing after a positive self-test. Participants were sampled for RT-PCR (reference test) and received one self-test (either Acon Flowflex [Flowflex], MP Biomedicals (MPBio), or Siemens-Healthineers CLINITEST [CLINITEST]) to perform unsupervised at home. Diagnostic accuracies of each self-test were calculated. Results: Overall sensitivities were 27.5% (95% CI, 21.3–34.3%) for Flowflex, 20.9% (13.9–29.4%) for MPBio, and 25.6% (19.1–33.1%) for CLINITEST. After applying a viral load cut-off (≥5.2 log10 SARS-CoV-2 E-gene copies/mL), sensitivities increased to 48.3% (37.6–59.2%), 37.8% (22.5–55.2%), and 40.0% (29.5–51.2%), respectively. Specificities were >99% for all tests in most analyses. Discussion: The sensitivities of three commonly used SARS-CoV-2 antigen rapid diagnostic tests when used as self-tests in asymptomatic individuals in the Omicron period were very low. Antigen rapid diagnostic test self-testing in asymptomatic individuals may only detect a minority of infections at that point in time. Repeated self-testing in case of a negative self-test is advocated to improve the diagnostic yield, and individuals should be advised to re-test when symptoms develop.
KW - Asymptomatic individuals
KW - Diagnostic accuracy
KW - Rapid antigen tests
KW - SARS-CoV-2
UR - http://www.scopus.com/inward/record.url?scp=85143139257&partnerID=8YFLogxK
U2 - 10.1016/j.cmi.2022.11.004
DO - 10.1016/j.cmi.2022.11.004
M3 - Article
C2 - 36379401
SN - 1198-743X
VL - 29
SP - 391.e1-391.e7
JO - Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
JF - Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
IS - 3
ER -