Comparative study of six SARS-CoV-2 serology assays: Diagnostic performance and antibody dynamics in a cohort of hospitalized patients for moderate to critical COVID-19

Abstract

Background To overcome the COVID-19 pandemic, serology assays are needed to identify past and ongoing infections. In this context, we evaluated the diagnostic performance of 6 immunoassays on samples from hospitalized patients for moderate to critical COVID-19. Methods 701 serum samples obtained from 443 COVID-19 patients (G1: 356 positive RT-PCR patients and G2: 87 negative RT-PCR cases) and 108 pre-pandemic sera from blood donors were tested with 6 commercial immunoassays: (1) Elecsys Anti-SARS-CoV-2, Roche (Nucleocapsid, N), (2) Elecsys Anti-SARS-CoV-2 S, Roche (Spike, S), (3) Vidas SARS-COV-2 IgM/IgG, BioMérieux (S), (4) SARS-CoV-2 IgG, Abbott (N), (5) Access SARS-CoV-2 IgG, Beckman Coulter (Receptor Binding Domain), and (6) Standard F COVID-19 IgM/IgG Combo FIA, SD Biosensor (N). Results Global sensitivities of the evaluated assays were as follows: (1) Roche anti-N = 74.5% [69.6–79.3], (2) Roche anti-S = 92.7% [84.7–100], (3) Vidas IgM = 74.9% [68.6–81.2], (4) Vidas IgG = 73.9% [67.6–80.1], (5) Abbott = 78.6% [63.4–93.8], (6) Beckman Coulter = 74.5% [62–86.9], (7) SD Biosensor IgM = 73.1% [61–85.1], and (8) SD Biosensor IgG = 76.9% [65.4–88.4]. Sensitivities increased gradually from week 1 to week 3 as follow: (1) Roche anti-N: 63.3%, 81% and 82.1%; (2) Vidas IgM: 68.2%, 83.2% and 85.9%; and (3) Vidas IgG: 66.7%, 79.1% and 86.6%. All immunoassays showed a specificity of 100%. Seropositivity was significantly associated with a higher frequency of critical COVID-19 (50.8% vs. 38.2%), p = 0.018, OR [95% CI] = 1.668 [1.09–2.553]. Inversely, death occurred more frequently in seronegative patients (28.7% vs. 13.6%), p=3.02 E-4, OR [95% CI] = 0.392 [0.233–0.658]. Conclusion Evaluated serology assays exhibited good sensitivities and excellent specificities. Sensitivities increased gradually after symptoms onset. Even if seropositivity is more frequent in patients with critical COVID-19, it may predict a recovery outcome.

Utilization of the Abbott SARS-CoV-2 IgG II Quant Assay To Identify High-Titer Anti-SARS-CoV-2 Neutralizing Plasma against Wild-Type and Variant SARS-CoV-2 Viruses

“…The Abbott SARS-CoV-2 IgG II Quant assay [Abbott anti-Spike (S), Abbott, Chicago, IL, USA; here referred to as the Abbott Quant assay] was developed for the qualitative and quantitative determination of IgG against the SARS-CoV-2 S ( 12 ). This assay has been used in multiple seroprevalence surveys ( 13 – 16 ). Here, we characterized the ability of the Abbott Quant assay to identify high- and low-titer plasma for wild-type and variant (Alpha, Beta, Gamma, and Delta) SARS-CoV-2, as analyzed by a virus-like particle assay and PRNT 50 .…”

Utility of Roche Elecsys anti-SARS-CoV-2 S in ascertaining post-vaccine neutralizing antibodies

“…Several other studies [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] have also ascertained clinical sensitivity of the assay after exposure to the SARS-CoV-2 virus or vaccine or both, and specificity through evaluation of pre-pandemic specimens. Sensitivities have been reported at time intervals varying from 14 days to 240 days post-exposure.…”

Monitoring algorithm of hospitalized patients in a medical center with SARS-CoV-2 (Omicron variant) infection: clinical epidemiological surveillance and immunological assessment

“…The humoral response against SARS-CoV-2 mainly targets the S and N viral proteins ( Chamkhi et al, 2022 ). Here, we screened for anti-N IgM as an epidemic investigation of patients with COVID-19 based on local infection or imported cases.…”