ABSTRACT
BACKGROUND: COVID-19 testing strategies and determining the accuracy of tests is crucial for the prevention of disease in asymptomatic communities. OBJECTIVE: To determine the positive predictive value for the BD Veritor System for rapid detection of SARS-CoV-2 (BD Veritor System) among asymptomatic athletes and athletic staff in a University setting. Secondarily, a cost savings analysis was conducted to evaluate the benefits of a rapid antigen testing strategy over a universal PCR-based strategy. METHODS: Asymptomatic athletic personnel at Ferris State University tested using the BD Veritor System from November 4, 2020-February 15, 2021. Individuals whose antigen test was positive immediately had specimen collected for confirmatory PCR testing. These results were used to determine the positive predictive value (PPV) for the BD Veritor System. A cost-savings analysis was conducted from the University's perspective to determine the value of this rapid antigen testing strategy over a universal PCR-based strategy. RESULTS: A total of 3352 antigen tests were performed on 359 individuals during the study period. During this period, 21 positive antigen tests were obtained of which 5 individuals had a positive reflex PCR result. The calculated PPV of the BD Veritor System among asymptomatic individuals was 25%. According to the mandated athletics testing schedule, the University spent $67,475.76 on BD Veritor System tests and $1785 on confirmatory PCR tests. In contrast, if a solely PCR-based approach had been continued, the same testing strategy would have cost the University $284,920. By employing a 2-tiered testing strategy with the BD Veritor System with reflex PCR testing, the University realized a cost savings of $215,659.24 during the 3-month period. CONCLUSIONS: Despite sub-optimal PPV associated with the BD Veritor System among asymptomatic athletes, the University was able to effectively use an antigen-based testing program to comply with collegiate testing requirements and realize $215,659.24 cost savings per quarter over a PCR-based strategy.
ABSTRACT
BACKGROUND: Home-based rapid diagnostic testing can play an integral role in controlling the spread of coronavirus disease 2019 (COVID-19). OBJECTIVES: This review aimed to identify and compare at-home diagnostic tests that have been granted Emergency Use Authorizations (EUAs) and convey details about COVID-19 diagnostic tests, including regulatory information, pertinent to pharmacy practice. METHODS: The Food and Drug Administration (FDA) online resources pertaining to COVID-19 tests, EUAs, and medical devices were consulted, as were linked resources from FDA's webpages. Homepages of the 9 COVID-19 home tests with EUAs were comprehensively reviewed. PubMed literature searches were performed, most recently in May 2021, to locate literature about the identified home tests, as were searches of Google Scholar, medRxiv, and bioRxiv. Studies were included if they were performed at home or if subjects self-tested at study sites. Samples were collected by a parent or guardian for patients under 18 years of age. Positive percent agreement (PPA) and negative percent agreement (NPA) for the clinical diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus was evaluated. RESULTS: Limited data have been published for these home tests given that they are available through EUAs that do not require clinical trials. Fifteen studies were located from searching the literature, but only 2 met the inclusion criteria. Review of the home tests' websites yielded a single study for each test, with the 3 BinaxNOW platforms using the same study for their EUAs. The 9 COVID-19 home tests with EUAs as of May 7, 2021, include 3 molecular tests and 6 antigen tests. These tests had similar performance on the basis of PPA ranging from 83.5% to 97.4% and NPA ranging from 97% to 100%. CONCLUSION: The 9 SARS-CoV-2 home tests demonstrated satisfactory performance in comparison with laboratory real time reverse-transcription polymerase chain reaction tests. The convenience and ease of use of these tests make them well-suited for home-based rapid SARS-CoV-2 testing.