Accuracy of an antigen-detecting SARS-CoV-2 assay with self- and provider-collected specimens interpreted visually and with BD Veritor™ Plus analyzer.

Background: SARS-CoV-2 rapid antigen tests (RATs) are in high demand for reducing the spread of SARS-CoV-2. Reduced involvement from health care professionals (HCPs) for collection and interpretation could significantly foster the wide-spread implementation of RATs, but data evaluating RATs, when used by lay people, is limited. Objective: To valuate agreement between BD Veritor test results for self- and HCP-collected specimens, and visually- and analyzer-interpreted results. Methods: Individuals with onset of COVID-19 symptoms within five days of enrollment had three nasal swabs collected; one self-collected and the other two HCP-collected. One HCP-collected swab was stored for future testing while the order of the other two (self and HCP) was randomized before testing. with the BD Veritor System for Rapid Detection of SARS-CoV-2. Results were first assessed visually, followed by interpretation with the analyzer. Results: When self-collection was compared to HCP collection for SARS-CoV-2 detection, interpretation by analyzer resulted in positive percent agreement (PPA) of 94.7% (95% CI 82.7, 98.5) and negative percent agreement (NPA) of 99.0% (95% CI 97.5, 99.6). When visual interpretation was compared to analyzer-read results, collection by HCPs had a PPA of 97.4% (95% CI 86.5, 99.5) and NPA of 99.8% (95% CI 98.6, 100.0) while self-collection resulted in PPA of 94.9% (95% CI 83.1, 98.6) and NPA of 99.8% (95% CI 98.6, 100). Conclusions: Similar PPA and NPA were observed for self- and HCP-collected specimens as well as visually- and analyzer-interpreted tests. The equivalence in performance supports the use of expanded collection and testing methods.

Large-Scale SARS-CoV-2 Antigen Testing With Real-World Specimens.

Real-world data are needed to establish SARS-CoV-2 rapid antigen testing (RAT) as an effective and reliable approach for SARS-CoV-2 screening. This study included 1,952,931 individuals who provided upper respiratory specimens during SARS-CoV-2 screening at CityMD urgent care locations in the New York metropolitan area from October 2020 to March 2021. Positive and negative results, as determined by the BD Veritor™ System for Rapid Detection of SARS-CoV-2 antigen (Veritor), were obtained for all individuals, with reflex reverse transcriptase-polymerase chain reaction (RT-PCR) testing performed on a case-by-case basis, per standard of care. Using verification bias adjustment, two alternative model assumptions were utilized for RAT results with missing reflex RT-PCR results. The worst antigen diagnostic performance estimates asserted that missing RT-PCR results would show a distribution similar to those RT-PCR results actually obtained, based on symptom category. The best antigen diagnostic performance estimates asserted that individuals without RT-PCR results had a clinical presentation consistent with RAT results, and, therefore, missing RT-PCR results would agree with RAT results. For patients with symptoms or high-risk exposure, 25.3% (n = 86,811/343,253) of RAT results were positive; vs. 3.4% (n = 53,046/1,559,733) positive for asymptomatic individuals without high-risk exposure. Reflex RT-PCR results were obtained from 46.3% (n = 158,836/343,253) and 13.8% (n = 215,708/1,559,733) of symptomatic and asymptomatic individuals, respectively. RT-PCR confirmed 94.4% (4,265/4,518) of positive and 90.6% (139,759/154,318) of negative RAT results in symptomatic individuals; and confirmed 83.4% (6,693/8,024) of positive and 95.3% (197,955/207,684) of negative RAT results in asymptomatic individuals. Applied assumptions for missing reflex RT-PCR results led to worst performance sensitivity estimates of 77.2 and 38.5% in the symptomatic and asymptomatic populations, respectively; assumptions for best performance estimates led to sensitivity values of 85.6 and 84.2%, respectively. Specificity values, regardless of assumptions or symptom category, ranged from 97.9-99.9%. At 10% SARS-CoV-2 prevalence, RAT positive predictive value was 86.9 and 99.0% for worst and best performance estimates across the total population, respectively; negative predictive values were >95% regardless of the applied assumption. Veritor test performance was consistent with that listed in the manufacturer instructions for use for symptomatic individuals. Real-world evidence should be gathered on RATs to support their efficacy as SARS-CoV-2 persists.

Clinical Evaluation of BD Veritor SARS-CoV-2 and Flu A+B Assay for Point-Of-Care System.

Differential diagnosis of COVID-19 and/or influenza (flu) at point of care is critical for efficient patient management and treatment of both these diseases. The study presented here characterizes the BD Veritor System for Rapid Detection of SARS-CoV-2 and Flu A+B ("Veritor SARS-CoV-2/Flu") triplex assay. The performance for SARS-CoV-2 detection was determined using 298 specimens from patients reporting COVID-19 symptoms within 7 days from symptom onset (DSO) in comparison with the Lyra SARS-CoV-2 RT-PCR (reverse transcriptase PCR) assay ("Lyra SARS-CoV-2") as the reference. The performance for flu A and flu B detection was determined using 75 influenza-positive and 40 influenza-negative retrospective specimens in comparison with the previously FDA-cleared BD Veritor System for Rapid Detection of Flu A+B assay ("Veritor Flu") as the reference. The Veritor SARS-CoV-2/Flu assay met the FDA EUA acceptance criteria (86.7%; 95% confidence interval [95% CI]: 75.8 to 93.1) for SARS-CoV-2 testing compared to Lyra SARS-CoV-2. The Veritor SARS-CoV-2/Flu assay also demonstrated 100% agreement with the Veritor Flu for Flu A+B assay. For flu A detection, the lower bound of the 95% CI was 91.2%; for flu B detection, the lower bound was 90.0%. The dual detection capability of Veritor SARS-CoV-2/Flu for the etiologic agents causing COVID-19 and flu will allow efficient differentiation between the two illnesses, inform disease management, and facilitate optimal treatment. IMPORTANCE COVID-19 and flu are two respiratory illnesses which share similar clinical symptoms. The BD Veritor SARS-CoV-2/Flu assay has high sensitivity and specificity for detecting the SARS-CoV-2 and influenza A/B, the two etiologic agents causing COVID-19 and flu, respectively. This dual detection capability is critical when overlap occurs between the COVID-19 pandemic and the flu season. This triplex assay will allow efficient differentiation between the two respiratory illnesses and support a point-of-care physician diagnosis to facilitate the proper treatment and disease management for patients exhibiting overlapping symptoms.

Performance of the BD Veritor system SARS-CoV-2 antigen test among asymptomatic collegiate athletes: A diagnostic accuracy study.

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.