Multiple-centre clinical evaluation of an ultrafast single-tube assay for SARS-CoV-2 RNA-CDC

Objective: To evaluate the performance of an ultralast single-tube nucleic acid isothermal amplificationde tection assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA using clinicalsamples fromn multiple centres.Methods: A reverse transcription recombinase-aided amplification (RT-RAA) assay for SARS-CoV-2 wasconducted within 15 minutes at 39°c with portable instruments after addition of extracted RNA. Thecinical performance of RT-RAA assay was evaluated using 947 clinical samples from five institutions infour regions of'China, approved commercial fluore scence quantitative real-time PCR (gRT-PCR) kits wereused for para llel detection, The sensitivity and specificity of RT-RAA were compared and analysed.Results, The RT-RAA test results of 926 samples were consistent with those of gRT-PCR (330 werepositive, 596 negative): 2l results were inconsistent. The sensitivity and specifcity of RT-RAAwas 97.63%(330/338,95% confdence interval (cl)95 21 to 98.90)and 97.87%(596/609, 95% C1 96.28 to 98.81respectively, The positive and negative predictive values were 96.21%(3301343. 95% C1 93.45 to 97.88and 98.68% (596/604, 95% C1 97.30 to 99.38) respectively,The total coincidence rate was 97.78%(926/94795%Cl 96.80 to 98.70) and the kappa was 0.952 (p< 0.05)

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