Clinical Evaluation of BD Veritor SARS-CoV-2 Point-of-Care Test Performance Compared to PCR-Based Testing and versus the Sofia 2 SARS Antigen Point-of-Care Test

Abstract

The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (≤7 days from symptom onset [DSO], ≥18 years of age) were utilized to compare Veritor with the Lyra SARS-CoV-2 PCR assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms (≤5 DSO, ≥18 years of age) were utilized to compare performance of Veritor to that of the Sofia 2 SARS Antigen FIA test (Sofia 2). The positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes. In study 1, the PPA for Veritor, compared to Lyra, ranged from 81.8 to 87.5% across the 0 to 1 and 0 to 6 DSO ranges. In study 2, Veritor had PPA, NPA, and OPA values of 97.4, 98.1, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra. Veritor met FDA emergency use authorization (EUA) acceptance criteria for SARS-CoV-2 antigen testing for the 0 to 5 and 0 to 6 DSO ranges (PPA values of 83.9% and 82.4%, respectively). Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test allows for more rapid COVID-19 testing utilizing easy-to-collect nasal swabs but demonstrated <100% PPA compared to PCR.

Keywords: COVID-19; SARS-CoV-2; Sofia 2 test; Veritor test; point-of-care test.

FIG 1

Veritor test performance results are plotted as a receiver-operator curve with sensitivity (corresponding to positive percent agreement) on the y axis and 1-specificity (corresponding to 1-negative percent agreement) on the x axis. Five lines, representing 0 to 1 DSO, 0 to 3 DSO, 0 to 5 DSO, 0 to 6 DSO, and 0 to 7 DSO are shown. Also shown are the area under the curve (AUC) values. Abbreviations: DSO, days from symptom onset; AUC, area under the curve.

FIG 2

(a) The distribution of C_T values corresponding to the 38 specimens that were positive by the Lyra assay (from specimens collected from participants, 0 to 7 DSO) following stratification by number of symptoms. C_T score distribution for specimens matched to 1 symptom is shown in blue, while those matched to ≥2 symptoms are shown in orange; the pink color indicates blue/orange overlap. (b) The mean C_T values (and standard deviation) are shown for the ≥2-symptom specimens (n = 31; mean = 22.10, standard deviation = 5.63) and the 1-symptom specimens (n = 7; mean = 25.56, standard deviation = 3.90). A two-sample t test (two-tailed) analysis indicated nonsignificant difference between the means (P = 0.077; mean difference of 3.46; [95% CI = −0.43 to 7.36]).

FIG 3

(a) The distribution of C_T values corresponding to the 38 specimens that were positive by the Lyra assay (from specimens collected from participants, 0 to 7 DSO). Plotted along the fitted distribution line are the 29 true-positive Veritor results (orange circles) and the nine participant designations (letters superimposed onto blue circles), corresponding to those in Table 3, that represent the Veritor false-negative results matched to Lyra assay C_T value. (b) The mean C_T values (and standard deviation) are shown for the 29 true-positive (20.76 and 4.21, respectively) and the 9 false-negative (29.12 and 4.11, respectively) Veritor test results. A two-sample t test (two-tailed) analysis indicated a significantly higher mean Lyra assay C_T value for specimens matched to the 9 Veritor test false-negative results compared to those matched to the 29 true positive results (P < 0.001; mean difference of 8.36; [95% CI = 4.95 to 11.77]).