The COVID-19 pandemic, caused by the new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread worldwide. Serological testing for SARS-CoV-2-specific antibodies plays an important role in understanding and controlling the pandemic, notably through epidemiological surveillance. ABSTRACT The COVID-19 pandemic, caused by the new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread worldwide. Serological testing for SARS-CoV-2-specific antibodies plays an important role in understanding and controlling the pandemic, notably through epidemiological surveillance. Well-validated and highly specific SARS-CoV-2 serological assays are urgently needed. We describe here the analytical and clinical performance of Vidas SARS-CoV-2 IgM and Vidas SARS-CoV-2 IgG, two CE-marked, emergency use authorization (EUA)-authorized, automated, qualitative assays for the detection of SARS-CoV-2-specific IgM and IgG, respectively. Both assays showed high within-run and within-laboratory precision (coefficients of variation < 11.0%) and very low cross-reactivity toward sera of patients with a past common coronavirus or respiratory virus infection. Clinical specificity determined on up to 989 prepandemic healthy donors was ≥99% with a narrow 95% confidence interval for both IgM and IgG assays. Clinical sensitivity was determined on up to 232 samples from 130 reverse transcriptase PCR (RT-PCR)-confirmed SARS-CoV-2 patients. The positive percent agreement (PPA) with SARS-CoV-2 PCR reached 100% at ≥16 days (Vidas SARS-CoV-2 IgM) and ≥32 days (Vidas SARS-CoV-2 IgG) of symptom onset. Combined IgM/IgG test results improved the PPA compared to each test alone. SARS-CoV-2 IgG seroconversion followed closely that of SARS-CoV-2 IgM and remained stable over time, while SARS-CoV-2 IgM levels rapidly declined. Interestingly, SARS-CoV-2-specific IgM and IgG responses were significantly higher in COVID-19 hospitalized versus nonhospitalized patients. Altogether, the Vidas SARS-CoV-2 IgM and IgG assays are highly specific and sensitive serological tests suitable for the reliable detection of past acute SARS-CoV-2 infections.
【저자키워드】 COVID-19, SARS-CoV-2, Diagnosis, Vidas, immunoserology, 【초록키워드】 serological test, IgG, coronavirus, pandemic, Hospitalized, COVID-19 pandemic, Variation, Infection, RT-PCR, Emergency use authorization, cross-reactivity, Spread, sensitivity, specificity, Seroconversion, Serological tests, Serological assay, Surveillance, Serological testing, respiratory virus, serological assays, IgM/IgG, clinical, sera, response, Patient, automated, epidemiological, epidemiological surveillance, virus infection, respiratory, reverse transcriptase PCR, SARS-CoV-2-specific antibodies, SARS-CoV-2 infections, patients, SARS-CoV-2 IgG, SARS-CoV-2 IgM, SARS-CoV-2 patients, SARS-CoV-2 PCR, clinical sensitivity, IgM and IgG, reverse transcriptase, test results, IgG responses, symptom onset, acute respiratory syndrome, Precision, SARS-CoV-2-specific antibody, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, 95% confidence interval, clinical specificity, positive, specific IgM, coefficients, Combined, healthy donor, caused, assays, remained, was determined, significantly higher, reached, declined, 【제목키워드】 IgG, performance,