$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

cancer screenings;14

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.


1. Carmody S. Gov. Whitmer asks for federal funding for National Guard COVID-19 opera- tions. Michigan Radio. https://www.michiganra- national-guard-covid-19-operations. Published March 19, 2020. Accessed June 17, 2021.

2. Scott D. Coronavirus is exposing all of the weak- nesses in the US health system. Vox. https://www. coronavirus-covid-19-us-cases-health-care- system. Published March 16, 2020. Accessed June 17, 2021.

3. Cohn J. The next big coronavirus worry: Can hospitals handle the influx? HuffPost. outbreakhospital-icu-masks-shortages_n_5e 6521f9c5b6670e72f9b902. Published March 10, 2020. Accessed June 17, 2021.

4. Bartsch SM, Ferguson MC, McKinnell JA, O’Shea KJ, Wedlock PT, Siegmund SS, et al. The potential health care costs and resource use associated with COVID-19 in The United States. Health Aff (Millwood). 2020;39(6):927-35. doi:10.1377/hlthaff.2020.00426.

5. Rae M. Potential costs of COVID-19 treat- ment for people with employer coverage. Peterson-KFF Health System Tracker. https:// costs-of-coronavirus-treatment-for-people- with-employer-coverage/. Published April 14, 2020. Accessed June 17, 2021.

6. To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infec- tion by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020;20(5):565-74. doi:10.1016/S1473-3099(20)30196-1.

7. Akobeng AK. Understanding diagnostic tests 1: sensitivity, specificity and predic- tive values. Acta Paediatr. 2007;96(3):338-41. doi:10.1111/j.1651-2227.2006.00180.x.

6 CLR 2021-2022 • MLO •

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. devices/coronavirus-disease-2019-covid- 19-emergency-use-authorizations-medical- devices/vitro-diagnostics-euas. Accessed June 17, 2021.

10. Quan-Xin Long, Bai-Zhong Liu, Hai-Jun Deng, Gui-Cheng Wu. Antibody responses to SARS-Cov-2 in patients with COVID-19. Nature Medicine. Available from https://doi. org/10.1038/s41591-020-0897-1.

11. Mei San Tang, Karl G. Hock, Nicole M. Longsdon, Jennifer E. Hayes, Ann M. Gronowski, Neil W. Anderson, Christopher W. Farnsworth. Clinical

Performance of Two SARS-CoV-2

Serologic Assays. Clin Chem 2020;66(8):1055-62. doi:10.1093/clinchem/hvaa120.

12. David Jacofsky, Emilia M Jacofsky and Marc Jacofsky. Understanding Antibody Test- ing for COVID-19. The Journal of Arthroplasty. Available from: arth.2020.04.055. doi:10.1016/j.arth.2020.04.055.

13. Ong MS, Mandl KD. National expenditure for false-positive mammograms and breast cancer overdiagnoses estimated at $4 billion a year. Health Aff (Millwood). 2015;34(4):576-83. doi:10.1377/hlthaff.2014.1087.

14. Lafata JE, Simpkins J, Lamerato L, Poisson L, Divine G, Johnson CC. The economic impact of false-positive cancer screens. Cancer Epi- demiol Biomarkers Prev. 2004;13(12):2126-32.

15. Walsh-Kelly CM, Hennes HM, Melzer-Lange MD. False-positive preliminary radiograph interpretations in a pediatric emergency department: clinical and economic impact. Am J Emerg Med. 1997;15(4):354-6. doi:10.1016/ s0735-6757(97)90123-6.

16. Garrison LP, Jr., Babigumira JB, Masaquel A, Wang BC, Lalla D, Brammer M. The Lifetime Economic Burden of Inaccurate HER2 Test- ing: Estimating the Costs of False-Positive and False-Negative HER2 Test Results in US Patients with Early-Stage Value

Health. jval.2015.01.012.

17. Behnam M, Dey A, Gambell T, Talwar V. COVID-19: Overcoming supply shortages for diagnostic testing.

McKinsey & Company. ceuticals-and-medical-products/our-insights/ covid-19-overcoming-supply-shortages-for- diagnostic-testing#. Published July 15, 2020. Accessed June 17, 2021.

18. Who’s going to pay for Covid-19 treat- ment? Advisory Board. https://www.advisory. com/research/health-plan-advisory-council/ members/expert-insights/2020/whos-going-to- pay-for-covid-19-treatment. Published April 20, 2020. Accessed June 17, 2021.


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