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

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

M Döhla  1 , C Boesecke  2 , B Schulte  3 , C Diegmann  4 , E Sib  4 , E Richter  3 , M Eschbach-Bludau  3 , S Aldabbagh  3 , B Marx  3 , A-M Eis-Hübinger  3 , R M Schmithausen  4 , H Streeck  3
Affiliations

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

M Döhla et al. Public Health. 2020 May.

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.

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Figures

Fig. 1
Fig. 1
Documentation of the 49 test results and their valuation. +++: Strong positive; +: positive; neg: negative; Ctrl: control.
See this image and copyright information in PMC

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