21 Apr COVID-19: Low Sensitivity of Rapid Point-of-Care Testing in a Community Setting
MedicalResearch.com Interview with:
Dr. med. Manuel Döhla
Associate Researcher, AG “One Health”
Institute for Hygiene and Public Health
Medical Faculty, University of Bonn
MedicalResearch.com: What is the background for this study?
Response: Rapid and reliable testing of suspected cases is an important measure in the fight against the corona pandemic. In PCR diagnostics, 24 hours and sometimes more elapse between testing and notification of the test result. During this period, suspect cases must be isolated pre-emptively so that they do not cause further transmission. This is logistically and personnel-intensive and highly error-prone.
The shorter the time between test and result, the more effective containment measures can be. This is why the test we have evaluated, which shows a result within 20 minutes, has aroused our interest. The manufacturer’s specifications (sensitivity 70 % in early stage disease (day 4-10), 100 % in late stage disease (day 11-24), specificity 100 %) were promising.
MedicalResearch.com: What are the main findings?
Response: However, our small study group of 49 people already showed that the performance of the test was significantly below the manufacturer’s specifications. In particular, the sensitivity turned out to be very low at only about 36 %; we calculated the specificity as 89 %. To what extent this was due to the test itself, i.e. whether a, or to the immunological course of the disease, cannot be concluded from our data.
MedicalResearch.com: What should readers take away from your report?
Response: A two-step screening strategy should at best consist of a rapid and easy-to-use screening test with a very high sensitivity (close to 100%); specificity is of secondary importance.
This produces some false-positive test results, but no false-negative ones. A slow procedure with a high specificity (close to 100%) is then suitable as a confirmatory test in order to differentiate between those who are true ill and those who have tested false positive.
PCR is an ideal confirmatory test, but the rapid test under investigation is unsuitable as a screening test.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Different manufacturers are currently developing, approving and evaluating various rapid test systems. If we could identify a rapid, easy-to-use test with a high sensitivity, we could significantly increase the effectiveness of public health measures for containment.
Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity
Available online 18 April 2020.. M. Döhla et al
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