Our aim was to evaluate the analytical and clinical performance of the SARS-CoV-2 molecular detection kits used in Argentina. Nine real-time reverse-transcription polymerase chain reaction (RT-qPCR) and three reverse-transcription loop-mediated isothermal amplification (RT-LAMP) assays were evaluated using the World Health Organization (WHO) recommended test as reference method. A secondary standard calibrated for the E, N and RdRp genes against the Pan American Health Organization—World Health Organization—International Standard was used to calculate the limit of detection (LoD). A panel of artificial clinical samples, 32 positive and 30 negative for SARS-CoV-2, were analyzed to estimate the kappa concordance (κ) and the diagnostic performance. Differences among the LoD values for the target genes amplified by each kit were >1 log copies/reaction. The κ for the RT-qPCR kits was greater than 0.9, whereas that for the RT-LAMP assays ranged from 0.75 to 0.93. The clinical performance of RT-qPCR kits showed 100% specificity and high sensitivity, although with variations according to the gene analyzed. The E and N genes provided greater clinical sensitivity, whereas the RdRp gene increased the clinical specificity. The RT-LAMP assays revealed a variable diagnostic performance. The information provided can be useful to choose the most appropriate diagnostic test and may contribute to the establishment of a consensus in the diagnosis of SARS-CoV-2 in Argentina and the region.
【저자키워드】 SARS-CoV-2, RT-LAMP, RT-qPCR, 【초록키워드】 Variation, diagnostic, clinical samples, sensitivity, specificity, Concordance, limit of detection, WHO, isothermal amplification, molecular, N gene, information, RdRp gene, clinical sensitivity, Standard, target gene, World Health Organization, Consensus, clinical specificity, positive, reference method, difference, polymerase chain, log, greater, amplified, analyzed, was used, evaluate, evaluated, provided, contribute, ranged, calculate, calibrated, diagnosis of SARS-CoV-2, Pan, the SARS-CoV-2, 【제목키워드】 detection,