$202.34 and $183.67 million dollars for low- and high-prevalence instances. A test with low specificity will result in higher numbers of false positive results for patients, who would be hospitalized for 1-2 days, before being confirmed as COVID-19 negative and discharged. Previous research examined costs
associated with false positives in mam- mograms;13
prostate, lung, and ovarian and radiographic
interpretations in the pediatric emer- gency department.15
Costs of false
negatives have been estimated, for example, for human epidermal growth factor receptor 2 (HER2) testing in patients with breast cancer.16
studies report increased costs associ- ated with inaccurate results, but differ considerably in terms of context from the examination of COVID-19 testing. Most importantly, they examined the diagnosis of conditions with relatively stable prevalence, creating a stable positive predictive value for a diagnos- tic procedure with a given sensitivity and specificity and in conditions not involving contagious pathogen; mean- ing, there is no risk of people with false negative results then unknowingly infecting others. In contrast, COVID-19 is highly con-
tagious, with an unstable prevalence, differing geographically and over time, creating challenges as localized “hot spots” develop and are controlled through various non-pharmaceutical interventions. A test with a particular specificity and sensitivity may pro- vide adequate diagnostic accuracy to successfully identify and control an outbreak in one community without incurring excessive unnecessary costs. However, in another community with a different disease prevalence, it is woefully inadequate and results in unnecessary treatment costs associ- ated with false-positive patients — or releases so many false negatives into the population that “test and trace” containment fails.
Conclusion Test selection in the United States is based largely on the availability of tests and supplies needed to run them.17
This is likely to continue when
there are shortages or disruptions in the supply chain. Results demonstrate that failing to take local disease preva- lence into account when choosing a
The authors are executives, directors, managers, physicians, and laboratorians at Baylor Scott & White Medical Center – Temple, TX.
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6 CLR 2021-2022 • MLO • www.clr-online.co
test or interpreting results can incur substantial, unnecessary charges. Analysis shows that when disease prevalence is low (≤ 0.2%), it is reason- able to have a test with high specific- ity (≥ 99.5 %), while allowing some flexibility in sensitivity (ranging from 95.0% - 60.0%). However, when disease prevalence increases to ≥ 10%, the best option is to have tests with both sensi- tivity and specificity as close to 100% as possible. Healthcare providers and public health officials should consider strategies to mitigate the risks of inac- curate results, such as repeat testing and giving greater weight to symp- toms and epidemiologic risk factors.
8. Center for Devices and Radiological Health. Coronavirus Disease 2019 (COVID-19) EUA. U.S. Food and Drug Administration. https://www.fda. gov/medical-devices/emergency-use-authori- zations-medical-devices/coronavirus-disease- 2019-covid-19-emergency-use-authoriza- tions-medical-devices. Accessed June 17, 2021.
9. Center for Devices and Radiological Health. In Vitro Diagnostics EUAs. U.S. Food and Drug Administration. https://www.fda.gov/medical-
devices/coronavirus-disease-2019-covid- 19-emergency-use-authorizations-medical- devices/vitro-diagnostics-euas. Accessed June 17, 2021.
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