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Table. 2.

Table. 2.

Estimated clinical sensitivity of SQ-RAT in comparison with four rRT-PCR tests

RdRp Ct stratum* Sensitivity results Specimens of newly diagnosed COVID-19 patients with upper respiratory tract infection in Korea

All rRT-PCR tests (%) (N = 33,294) Allplex (%) (N = 25,650) PowerChek (%) (N = 3,935) Standard M (%) (N = 1,942) Real-Q (%) (N = 1,762)
Proportion of each stratum ≤ 14.9 100 6.9 6.5 1.9 23.2 4.7
15.0–19.9 88.6 20.6 20.2 17.8 24.5 28.5
20.0–24.9 55.4 21.6 21.6 19.9 21.0 26.9
25.0–29.9 16.9 23.2 23.6 24.5 16.3 22.9
30.0–34.9 2.9 24.9 25.0 33.6 14.2 15.1
≥ 35.0 0 2.8 3.1 2.3 0.8 1.9
LoD of SQ-RAT ≤ 23.37 81.4 42.0 41.1 33.4 62.9 52.7
> 23.37 10.6 58.0 58.9 66.6 37.1 47.3
Estimated clinical sensitivity of SQ-RAT*,† 41.8 41.1 33.8 59.7 49.2

*based on SD biosensor Standard MnCoV results; Sum of all clinical sensitivity values in the Ct strata multiplied by the corresponding proportion in Fig. 1.

Abbreviations: Allplex, Allplex 2019-nCoV; COVID-19, coronavirus disease 2019; Ct, threshold cycle; PowerChek, PowerChek 2019 nCoV; LoD, limit of detection; Real-Q, Real-Q 2019-nCoV; RdRp, RNA-dependent RNA polymerase gene; rRT-PCR, real-time reverse-transcription PCR; SQ-RAT, SD Biosensor Q rapid antigen test; Standard M, Standard M nCoV.

Ann Lab Med 2021;41:588~592

© Ann Lab Med