2021
DOI: 10.1016/s0140-6736(20)32635-0
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Buyer beware: inflated claims of sensitivity for rapid COVID-19 tests

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Cited by 41 publications
(26 citation statements)
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“…This finding may have some impact on testing strategies. Austria like other countries propagates low threshold testing by test kits for lay use, which mostly lack external validation of their sensitivity and specificity(20). Sensitivity varies considerably altogether in Lateral Flow Tests (LFT) (21).…”
Section: Discussionmentioning
confidence: 99%
“…This finding may have some impact on testing strategies. Austria like other countries propagates low threshold testing by test kits for lay use, which mostly lack external validation of their sensitivity and specificity(20). Sensitivity varies considerably altogether in Lateral Flow Tests (LFT) (21).…”
Section: Discussionmentioning
confidence: 99%
“…25 This has been suggested as a driver in the White House Rose Garden COVID-19 outbreak in the fall of 2020, where negative SARS-CoV-2 test results were reported to contribute to a feeling of safety, and non-compliance with masking and physical distancing. 26 Routine asymptomatic staff screen testing also carries the risk of false positive results. While the analytical specificity of SARS-CoV-2 testing by RT-PCR is nearly 100%, there are several reasons why the real-world specificity is lower, often estimated to be around 99.9 to 99.99%.…”
Section: Potential Harms Of Screen Testingmentioning
confidence: 99%
“…Some product inserts, such as the Aptima Combo 2 Assay for Chlamydia trachomatis and Neisseria gonorrhoeae detection, 32 have switched to using this more precise terminology when validating their assay compared to another for individual testing. Fitzpatrick et al 33 advocated a move to this terminology as well for test validation in general. Therefore, rather than including sensitivity in an expected value of tests expression, it may be best to use PPA.…”
Section: Laboratory Validationmentioning
confidence: 99%