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Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity
M Döhla1, C Boesecke2, B Schulte3
1Institute for Hygiene and Public Health, One Health Department, Medical Faculty, University of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.
Public Health
|April 26, 2020
Summary
This study found that a rapid antibody test for SARS-CoV-2 had low sensitivity (36.4%), failing to detect most positive cases. Researchers do not recommend this rapid test for public health screenings due to its poor performance in identifying COVID-19 infections.
Area of Science:
- Infectious Diseases
- Public Health
- Diagnostic Testing
Background:
- The SARS-CoV-2 pandemic necessitates rapid diagnostic tools for effective containment.
- Quantitative polymerase chain reaction (qPCR) is the gold standard but has a lengthy turnaround time.
- There is a need for faster testing methods in community settings.
Purpose of the Study:
- To evaluate the performance of a rapid IgG/IgM antibody test for SARS-CoV-2 in a high-prevalence community setting.
- To compare the rapid test results against qPCR, the established gold standard for COVID-19 detection.
Main Methods:
- A comparative study involving 49 individuals tested simultaneously with qPCR and a rapid antibody test.
- The rapid test utilized two drops of blood and provided results within 20 minutes.
- Included 39 individuals from a screening center and 10 previously diagnosed positive cases.
Main Results:
- The rapid test correctly identified only 8 out of 22 qPCR-positive individuals, yielding a sensitivity of 36.4%.
- The rapid test correctly identified 24 out of 27 qPCR-negative individuals, resulting in a specificity of 88.9%.
- Overall diagnostic accuracy was significantly limited by the low sensitivity.
Conclusions:
- The evaluated rapid antibody test demonstrates insufficient sensitivity for reliable detection of SARS-CoV-2 infections.
- The low sensitivity makes this rapid test unsuitable for public health measures like community-wide COVID-19 screenings.
- Relying on this test could lead to missed diagnoses and hinder effective disease control efforts.
