Performance characteristics of the VIDAS® SARS-COV-2 IgM and IgG serological assays
| Autor: | Julien Lupo, Imen Canova, Nadege Cayet, Patrick Blasco, Maxime Combe, Nathalie Renard, Carole Tourneur, Sylvie Pons, Guillaume Gerez, Frédérique Raymond, Franck Berthier, Catherine Pretis, Soizic Daniel, Mylene Lesenechal, Matthieu Pecquet |
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| Rok vydání: | 2020 |
| Předmět: |
Coronavirus disease 2019 (COVID-19)
biology business.industry viruses Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) fungi Clinical performance virus diseases Virology Serology body regions Pandemic Epidemiological surveillance biology.protein Medicine Antibody skin and connective tissue diseases business |
| Popis: | 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 pandemics, 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, 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 towards sera of patients with a past common coronavirus or respiratory virus infection. Clinical specificity determined on up to 989 pre-pandemic 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 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 vs. non-hospitalized patients. Altogether, the VIDAS® SARS-CoV-2 IgM and IgG assays are highly specific and sensitive serological tests suitable for the reliable monitoring of past SARS-CoV-2 infections and for seroepidemiology investigations. |
| Databáze: | OpenAIRE |
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