Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity

M Döhla; C Boesecke; B Schulte; C Diegmann; E Sib; E Richter; M Eschbach-Bludau; S Aldabbagh; B Marx; A-M Eis-Hübinger; R M Schmithausen; H Streeck

doi:10.1016/j.puhe.2020.04.009

Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity

Public Health. 2020 May:182:170-172. doi: 10.1016/j.puhe.2020.04.009. Epub 2020 Apr 18.

Authors

M Döhla¹, C Boesecke², B Schulte³, C Diegmann⁴, E Sib⁴, E Richter³, M Eschbach-Bludau³, S Aldabbagh³, B Marx³, A-M Eis-Hübinger³, R M Schmithausen⁴, H Streeck³

Affiliations

¹ Institute for Hygiene and Public Health, One Health Department, Medical Faculty, University of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany. Electronic address: [email protected].
² Clinic for Internal Medicine, Infectious Diseases Department, Medical Faculty, University of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.
³ Institute of Virology, Medical Faculty, University of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.
⁴ Institute for Hygiene and Public Health, One Health Department, Medical Faculty, University of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.

Abstract

Objective: With the current SARS-CoV2 outbreak, countless tests need to be performed on potential symptomatic individuals, contacts and travellers. The gold standard is a quantitative polymerase chain reaction (qPCR)-based system taking several hours to confirm positivity. For effective public health containment measures, this time span is too long. We therefore evaluated a rapid test in a high-prevalence community setting.

Study design: Thirty-nine randomly selected individuals at a COVID-19 screening centre were simultaneously tested via qPCR and a rapid test. Ten previously diagnosed individuals with known SARS-CoV-2 infection were also analysed.

Methods: The evaluated rapid test is an IgG/IgM-based test for SARS-CoV-2 with a time to result of 20 min. Two drops of blood are needed for the test performance.

Results: Of 49 individuals, 22 tested positive by repeated qPCR. In contrast, the rapid test detected only eight of those positive correctly (sensitivity: 36.4%). Of the 27 qPCR-negative individuals, 24 were detected correctly (specificity: 88.9%).

Conclusion: Given the low sensitivity, we recommend not to rely on an antibody-based rapid test for public health measures such as community screenings.

Keywords: COVID-19; Coronavirus; Outbreak; Rapid test; SARS-CoV-2.

MeSH terms

Adult
Aged
Betacoronavirus / isolation & purification*
COVID-19
COVID-19 Testing
Clinical Laboratory Techniques / standards*
Community Health Services*
Coronavirus Infections / diagnosis*
Coronavirus Infections / epidemiology
Disease Outbreaks*
Female
Humans
Male
Mass Screening / methods
Mass Screening / standards*
Middle Aged
Pandemics
Pneumonia, Viral / diagnosis*
Pneumonia, Viral / epidemiology
Point-of-Care Testing*
Polymerase Chain Reaction
SARS-CoV-2
Sensitivity and Specificity
Time Factors