Background: We assessed the sensitivity, specificity and positive and negative predictive value (PPV and NPV) of molecular and serological tests for the diagnosis of SARS-CoV-2 infection. Methods: A total of 346 patients were enrolled in the emergency room. We evaluated three Reverse Transcriptase-real time PCRs (RT-PCRs) including six different gene targets, five serologic rapid diagnostic tests (RDT) and one ELISA. The final classification of infected/non-infected patients was performed using Latent Class Analysis combined with clinical re-assessment of incongruous cases. Results: Out of these, 24.6% of patients were classified as infected. The molecular test RQ-SARS-nCoV-2 showed the highest performance with 91.8% sensitivity, 100% specificity, 100.0% PPV and 97.4% NPV respectively. Considering the single gene targets, S and RdRp of RQ-SARS-nCoV-2 had the highest sensitivity (94.1%). The in-house RdRp presented the lowest sensitivity (62.4%). The specificity ranged from 99.2% for in-house RdRp and N2 to 95.0% for E . The PPV ranged from 97.1% of N2 to 85.4% of E and the NPV from 98.1% of S to 89.0% of in-house RdRp . All serological tests had < 50% sensitivity and low PPV and NPV. VivaDiag IgM (RDT) had 98.5% specificity, with 84.0% PPV, but 24.7% sensitivity. Conclusion: Molecular tests for SARS-CoV-2 infection showed excellent specificity, but significant differences in sensitivity. Serological tests have limited utility in a clinical context.
【저자키워드】 SARS-CoV-2, serology, Diagnosis, RT-PCR, Accuracy, 【초록키워드】 serological test, IgM, SARS-COV-2 infection, Infection, ELISA, sensitivity, specificity, PCR, RDT, Rapid diagnostic test, Patient, RdRP, targets, molecular, utility, Negative predictive value, significant difference, Final, class, positive, molecular test, single gene, RT-PCRs, FIVE, lowest, enrolled, highest, evaluated, was performed, ranged, clinical re-assessment, diagnosis of SARS-CoV-2, Latent, NPV, PPV, 【제목키워드】 Test, longitudinal, Emergency, room, value,