tetano
Editor, Senior Moderator
J Clin Microbiol
. 2021 Jan 8;JCM.02292-20.
doi: 10.1128/JCM.02292-20. Online ahead of print.
Performance characteristics of the VIDAS? SARS-COV-2 IgM and IgG serological assays
Nathalie Renard[SUP] 1 [/SUP], Soizic Daniel[SUP] 2 [/SUP], Nad?ge Cayet[SUP] 2 [/SUP], Matthieu Pecquet[SUP] 3 [/SUP], Fr?d?rique Raymond[SUP] 2 [/SUP], Sylvie Pons[SUP] 4 [/SUP], Julien Lupo[SUP] 5 [/SUP], Carole Tourneur[SUP] 2 [/SUP], Catherine Pretis[SUP] 2 [/SUP], Guillaume Gerez[SUP] 2 [/SUP], Patrick Blasco[SUP] 2 [/SUP], Maxime Combe[SUP] 2 [/SUP], Imen Canova[SUP] 2 [/SUP], Myl?ne Les?n?chal[SUP] 1 [/SUP], Franck Berthier[SUP] 2 [/SUP]
Affiliations
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 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 detection of past acute SARS-CoV-2 infections.
. 2021 Jan 8;JCM.02292-20.
doi: 10.1128/JCM.02292-20. Online ahead of print.
Performance characteristics of the VIDAS? SARS-COV-2 IgM and IgG serological assays
Nathalie Renard[SUP] 1 [/SUP], Soizic Daniel[SUP] 2 [/SUP], Nad?ge Cayet[SUP] 2 [/SUP], Matthieu Pecquet[SUP] 3 [/SUP], Fr?d?rique Raymond[SUP] 2 [/SUP], Sylvie Pons[SUP] 4 [/SUP], Julien Lupo[SUP] 5 [/SUP], Carole Tourneur[SUP] 2 [/SUP], Catherine Pretis[SUP] 2 [/SUP], Guillaume Gerez[SUP] 2 [/SUP], Patrick Blasco[SUP] 2 [/SUP], Maxime Combe[SUP] 2 [/SUP], Imen Canova[SUP] 2 [/SUP], Myl?ne Les?n?chal[SUP] 1 [/SUP], Franck Berthier[SUP] 2 [/SUP]
Affiliations
- PMID: 33419947
- DOI: 10.1128/JCM.02292-20
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 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 detection of past acute SARS-CoV-2 infections.