Article Figures & Data
Figures
- 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 CT 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. CT 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 CT 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 CT 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 CT value. (b) The mean CT 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 CT 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]).
Tables
- TABLE 1
Veritor test performance at 1 through 7 DSOa
↵a Abbreviations: DSO, days from symptom onset; PPA, positive percent agreement; NPA, negative percent agreement; OPA, overall percent agreement; AUC, area under the curve. CI, confidence interval; n, number of results.
↵b Performance of Veritor test compared to the Lyra assay as a reference.
↵c The Veritor test is FDA authorized for detection of SARS-CoV-2 only in individuals that are 0 to 5 DSO.
- TABLE 2
Veritor test performance by number of symptoms at 0 to 5 and 0 to 6 DSOa
- TABLE 3
Discordant analysis for specimens associated with disagreement between the Veritor test and the Lyra assaya
↵a Abbreviations: DSO, days from symptom onset; FN, false negative; FP, false positive; POS, positive; NEG, negative; NA, not available; n, number of findings.
↵b *, Agreement of Veritor test with the MAX assay for a negative result for SARS-CoV-2.
↵c Serology testing was done as part of the standard of care prior to study-related activities.
↵d UNR, unresolved. The RNase P result (internal control) in the MAX assay was negative, suggesting no presence of human material on the nasal swab.
- TABLE 4
Agreement between Veritor and Sofia 2 for detection of SARS-CoV-2a
↵a Abbreviations: PPA, positive percent agreement; NPA, negative percent agreement; OPA, overall percent agreement; CI, confidence interval.
↵b The one negative Veritor test/positive Sofia 2 test result was positive by Lyra assay discordant testing.
↵c Of the six positive Veritor test/negative Sofia 2 test results, five were positive and one was negative by Lyra assay discordant testing.
Supplemental material
- Supplemental file 1 -
Tables S1 to S5 and Fig. S1 and S2
PDF, 574K
- Supplemental file 1 -
