Comparison of 2 fully automated tests detecting antibodies against nucleocapsid N and spike S1/S2 proteins in COVID-19

Flinck, Heini; Rauhio, Anne; Luukinen, Bruno; Lehtimäki, Terho; Haapala, Anna‐Maija; Seiskari, Tapio; Aittoniemi, Janne

doi:10.1016/j.diagmicrobio.2020.115197

Cited by 13 publications

(12 citation statements)

References 21 publications

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“…A high proportion of seropositives also demonstrated both S and RBD IgG responses, and there was good correlation in serostatus across the 3 antigens. Whilst the value of N protein only based platforms has generated some debate in view of the weaker correlation with viral neutralising activity compared with S and RBD binding assays (19), our data supports other reports showing that N protein based assays are most sensitive for detection of serum responses(20, 21). Within the seropositive cohort, we found no relationship between symptom score and the spectrum of binding activity to the 3 antigens tested (data not shown).…”

Section: Discussionsupporting

confidence: 86%

Critical care workers have lower seroprevalence of SARS-CoV-2 IgG compared with non-patient facing staff in first wave of COVID19

Baxendale

Wells

Gronlund

et al. 2020

Preprint

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With the first 2020 surge of the COVID-19 pandemic, many health care workers (HCW) were re-deployed to critical care environments to support intensive care teams to look after high numbers of patients with severe COVID-19. There was considerable anxiety of increased risk of COVID19 for staff working in these environments.Using a multiplex platform to assess serum IgG responses to SARS-CoV-2 N, S and RBD proteins, and detailed symptom reporting, we screened over 500 HCW (25% of the total workforce) in a quaternary level hospital to explore the relationship between workplace and evidence of exposure to SARS-CoV-2.Whilst 45% of the cohort reported symptoms that they consider may have represented COVID-19, overall seroprevalence was 14% with anosmia and fever being the most discriminating symptoms for seropositive status. There was a significant difference in seropositive status between staff working in clinical and non-clinical roles (9% patient facing critical care, 15% patient facing non-critical care, 22% nonpatient facing). In the seropositive cohort, symptom severity increased with age for men and not for women. In contrast, there was no relationship between symptom severity and age or sex in the seronegative cohort reporting possible COVID-19 symptoms. Of the 12 staff screened PCR positive (10 symptomatic), 3 showed no evidence of seroconversion in convalescence.ConclusionThe current approach to Personal Protective Equipment (PPE) appears highly effective in protecting staff from patient acquired infection in the critical care environment including protecting staff managing interhospital transfers of COVID-19 patients. The relationship between seroconversion and disease severity in different demographics warrants further investigation. Longitudinally paired virological and serological surveillance, with symptom reporting are urgently required to better understand the role of antibody in the outcome of HCW exposure during subsequent waves of COVID-19 in health care environments.

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Section: Discussionsupporting

confidence: 86%

Critical care workers have lower seroprevalence of SARS-CoV-2 IgG compared with non-patient facing staff in first wave of COVID19

Baxendale

Wells

Gronlund

et al. 2020

Preprint

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“…In the short-term range of 2 weeks after infection, there are no differences between sensitivity of assays targeting antibodies against the nucleocapsid or the spike protein [ 25 ]. In recent comparisons of nucleocapsid- and spike-protein-based assays, no unambiguous superiority of one approach or the other could be identified [ 26 , 27 , 28 , 29 ]. In early infection states, sensitivity of anti-nucleocapsid antibodies can even be higher than that of anti-spike protein antibodies [ 24 , 30 , 31 ].…”

Section: Introductionmentioning

confidence: 99%

Comparative Assessment of Sera from Individuals after S-Gene RNA-Based SARS-CoV-2 Vaccination with Spike-Protein-Based and Nucleocapsid-Based Serological Assays

et al. 2021

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Due to the beginning of vaccination against COVID-19, serological discrimination between vaccine-associated humoral response and serology-based surveillance of natural SARS-CoV-2 infections as well as breakthrough infections becomes an issue of relevance. Here, we assessed the differentiated effects of the application of an RNA vaccine using SARS-CoV-2 spike protein epitopes on the results of both anti-spike protein–based serology (EUROIMMUN) and anti-nucleocapsid-based serology (VIROTECH). A total of 80 serum samples from vaccinees acquired at different time points after vaccination was assessed. While positive or borderline serological response in the anti-spike protein assay was observed for all samples (90% both IgG and IgA, 6.3% IgA only, 3.8% borderline IgG only), only a single case of a falsely positive IgM was observed for the anti-nucleocapsid assay as expected due to this assay’s specificity. Positive anti-spike protein antibodies were already detectable in the second week after the first dose of vaccination, with higher titers after the second dose of the vaccine. In conclusion, the combined application of anti-spike protein–based serology and anti-nucleocapsid-based serology will provide a useful option for the discrimination of vaccination response and natural infection.

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“…Low sensitivity early in infection could be a result of an assay detecting only IgG antibodies, but both the Ortho and Abbott IgG-specific assays had higher 0-14 day sensitivities which were similar to the total antibody assays. Other assay validation studies have reported similarly high sensitivities for samples collected after at least 14 days 6 , 7 , 8 , 9 , 10 . In the outbreak field study, where all samples were collected >14 days and within 2 months post-onset, >95% sensitivity was observed for all assays.…”

Section: Discussionmentioning

confidence: 63%

SARS-CoV-2 serology: Validation of high-throughput chemiluminescent immunoassay (CLIA) platforms and a field study in British Columbia

Sekirov¹,

Barakauskas²,

Simons³

et al. 2021

Journal of Clinical Virology

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Background SARS-CoV-2 antibody testing is required for estimating population seroprevalence and vaccine response studies. It may also increase case identification when as an adjunct to routine molecular testing. We performed a validation study and evaluated the use of automated high-throughput assays in a field study of COVID-19-affected care facilities. Methods Six automated assays were assessed: 1) DiaSorin LIAISON TM SARS-CoV-2 S1/S2 IgG; 2) Abbott ARCHITECT TM SARS-CoV-2 IgG; 3) Ortho VITROS TM Anti-SARS-CoV-2 Total; 4) VITROS TM Anti-SARS-CoV-2 IgG; 5) Siemens SARS-CoV-2 Total Assay; and 6) Roche Elecsys TM Anti-SARS-CoV-2. The validation study included 107 samples (42 known positive; 65 presumed negative). The field study included 296 samples (92 PCR positive; 204 PCR negative or not PCR tested). All samples were tested by the six assays. Results; All assays had sensitivities >90% in the field study, while in the validation study, 5/6 assays were >90% sensitive and DiaSorin was 79% sensitive. Specificities and negative predictive values were >95% for all assays. Field study estimated positive predictive values at 1%-10% disease prevalence were 100% for Siemens, Abbott and Roche, while DiaSorin and Ortho assays had lower PPVs at 1% prevalence, but PPVs increased at 5%-10% prevalence. In the field study, addition of serology increased diagnoses by 16% compared to PCR testing alone. Conclusions All assays evaluated in this study demonstrated high sensitivity and specificity for samples collected at least 14 days post-symptom onset, while sensitivity was variable 0-14 days after infection. The addition of serology to the outbreak investigations increased case detection by 16%.

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Comparison of 2 fully automated tests detecting antibodies against nucleocapsid N and spike S1/S2 proteins in COVID-19

Cited by 13 publications

References 21 publications

Critical care workers have lower seroprevalence of SARS-CoV-2 IgG compared with non-patient facing staff in first wave of COVID19

Critical care workers have lower seroprevalence of SARS-CoV-2 IgG compared with non-patient facing staff in first wave of COVID19

Comparative Assessment of Sera from Individuals after S-Gene RNA-Based SARS-CoV-2 Vaccination with Spike-Protein-Based and Nucleocapsid-Based Serological Assays

SARS-CoV-2 serology: Validation of high-throughput chemiluminescent immunoassay (CLIA) platforms and a field study in British Columbia

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