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Table. 2.

Performance of the STANDARD Q COVID-19 Ag test for the detection of SARS-CoV-2

Groups Allplex 2019-nCoV Assay

rRT-PCR (+) (N = 65) rRT-PCR (–) (N = 100) 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* ≤ 30 51 (78.4) 3 (4.6) - - 94.4 (84.6–98.8) - - -
Ct* > 30 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.

Ann Lab Med 2022;42:100~104 https://doi.org/10.3343/alm.2022.42.1.100

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