Performance of the STANDARD Q COVID-19 Ag test for the detection of SARS-CoV-2
Groups | Allplex 2019-nCoV Assay | |||||||
---|---|---|---|---|---|---|---|---|
rRT-PCR |
rRT-PCR |
Sensitivity % (95% CI) | Specificity % (95% CI) | Positive predictive value % (95% CI) | Negative predictive value % (95% CI) | |||
Ag (+), N (%) | Ag (–), N (%) | Ag (+), N (%) | Ag (–), N (%) | |||||
Overall | 58 (89.2) | 7 (10.8) | 4 (4.0) | 96 (96.0) | 89.2 (79.1–95.6) | 96.0 (90.1–98.9) | 93.6 (84.7–97.4) | 93.2 (87.2–96.5) |
Ct |
51 (78.4) | 3 (4.6) | - | - | 94.4 (84.6–98.8) | - | - | - |
Ct |
7 (10.8) | 4 (6.2) | - | - | 63.6 (30.8–89.0) | - | - | - |
Asymptomatic | 4 (6.9) | 0 (0.0) | - | - | 100 (39.8–100.0) | - | - | - |
1–5 days | 39 (67.2) | 2 (28.6) | - | - | 95.1 (83.5–99.4) | - | - | - |
6–10 days | 11 (19.0) | 4 (57.1) | - | - | 73.3 (44.9–92.2) | - | - | - |
11–21 days | 4 (6.9) | 1 (14.3) | - | - | 80.0 (28.4–99.5) | - | - | - |
*Ct value for the envelope gene in Allplex 2019-nCoV Assay; †Interpreted as described in the instruction of Allplex 2019-nCoV Assay.
Abbreviations: Ag, antigen; COVID-19, coronavirus disease 2019; CI, confidence interval; Ct, cycle threshold; rRT-PCR, real-time reverse transcription PCR; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
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