Seroconversion Rate and Diagnostic Accuracy of Serological Tests for Coronavirus 2019

Nagappa, Bharathnag; Marimuthu, Yamini

doi:10.1093/cid/ciaa676

Cited by 5 publications

(5 citation statements)

References 2 publications

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“…Currently, the available SARS-CoV-2 antibody tests lack sufficient sensitivity to allow for accurate estimation of the antibody response [33], although the used diagnostic assay (VIDAS) was shown to have a sensitivity of 88.3% and specificity of 98.4% in a recent study investigating the diagnostic efficiency of fully automated serology assays for SARS-CoV-2 IgG [34]. Furthermore, some cross-reactivity between SARS-CoV-2-specific antibodies and other endemic coronaviruses has been found and can reduce the test reliability [35].…”

Section: Discussionmentioning

confidence: 99%

Pfizer-BioNTech and Sinopharm: A Comparative Study on Post-Vaccination Antibody Titers

et al. 2021

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COVID-19 (coronavirus disease 2019) vaccines induce immunity through different mechanisms. The aim of this study is to compare the titers of specific antibodies in subjects vaccinated with either the Pfizer-BioNTech COVID-19 vaccine or the Sinopharm vaccine. This prospective observational cohort included Jordanian adults vaccinated with two doses, 21 days apart, of either of the two aforementioned vaccines. Titers were collected 6 weeks after the administration of the second dose. Overall, 288 participants were included, of which 141 were administered the Pfizer-BioNTech vaccine, while 147 were administered the Sinopharm vaccine. Remarkably, 140 (99.3%) of the Pfizer-BioNTech vaccine recipients had positive IgG titers, while 126 (85.7%) of Sinopharm recipients had positive IgG (p < 0.001). The mean titer for IgG among Pfizer-BioNTech recipients was 515.5 ± 1143.5 BAU/mL, compared to 170.0 ± 230.0 BAU/mL among Sinopharm subjects (p < 0.001). Multivariable regression analysis showed that the Pfizer-BioNTech vaccine positively correlated with positive IgG titers (OR: 25.25; 95% CI: 3.25–196.15; p = 0.002), compared with a negative effect of cardiovascular diseases (OR: 0.33; 95% CI: 0.11–0.99; p = 0.48) on IgG titers. In conclusion, fully vaccinated recipients of the Pfizer-BioNTech vaccine had superior quantitative efficiency compared to Sinopharm recipients. A booster dose is supported for Sinopharm recipients, or those with chronic immunosuppressive diseases.

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Section: Discussionmentioning

confidence: 99%

Pfizer-BioNTech and Sinopharm: A Comparative Study on Post-Vaccination Antibody Titers

et al. 2021

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“…To our knowledge, serum IgM may decrease rapidly, potentially accounting for apparently poor assay sensitivity. Previous studies reported slightly better sensitivity results, 66.7-98% for IgG and 60-95% for IgM (Beavis et al, 2020;Guo et al, 2020;Hou et al, 2020;Kohmer et al, 2020;Li Z. et al, 2020;Ma et al, 2020;Nagappa and Marimuthu, 2020;Qu et al, 2020;Traugott et al, 2020;Tuaillon et al, 2020;Van Elslande et al, 2020;Zhao et al, 2020). It is difficult to accurately determine the clinical performance without a gold standard method, therefore we calculated an "estimated" sensitivity: we assumed that antibodies were present at least 10 days after the onset of the symptoms.…”

Section: Discussionmentioning

confidence: 99%

Evaluating ELISA, Immunofluorescence, and Lateral Flow Assay for SARS-CoV-2 Serologic Assays

et al. 2020

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BackgroundThe SARS-CoV-2 outbreak has emerged at the end of 2019. Aside from the detection of viral genome with specific RT-PCR, there is a growing need for reliable determination of the serological status. We aimed at evaluating five SARS-CoV-2 serology assays.MethodsAn in-house immunofluorescence assay (IFA), two ELISA kits (EUROIMMUN® ELISA SARS-CoV-2 IgG and NovaLisa® SARS-CoV-2 IgG and IgM) and two lateral flow assays (T-Tek® SARS-CoV-2 IgG/IgM Antibody Test Kit and Sure Bio-tech® SARS-CoV-2 IgM/IgG Antibody Rapid Test) were compared on 40 serums from RT-PCR-confirmed SARS-CoV-2 infected patients and 10 SARS-CoV-2 RT-PCR negative subjects as controls.ResultsControl subjects tested negative for SARS-CoV-2 antibodies with all five systems. Estimated sensitivities varied from 35.5 to 71.0% for IgG detection and from 19.4 to 64.5% for IgM detection. For IgG, in-house IFA, EuroImmun, T-Tek and NovaLisa displayed 50–72.5% agreement with other systems except IFA vs EuroImmun and T-Tek vs NovaLisa. Intermethod agreement for IgM determination was between 30 and 72.5%.DiscussionThe overall intermethod agreement was moderate. This inconsistency could be explained by the diversity of assay methods, antigens used and immunoglobulin isotype tested. Estimated sensitivities were low, highlighting the limited value of antibody detection in CoVID-19.ConclusionComparison of five systems for SARS-CoV-2 IgG and IgM antibodies showed limited sensitivity and overall concordance. The place and indications of serological status assessment with currently available tools in the CoVID-19 pandemic need further evaluations.

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“…In this regard, assessing the level of neutralizing antibodies (NAbs) that block viral entry into cells could be a critical parameter in determining protection from SARS-CoV-2 and management of convalescent plasma therapies, which are being tested as a COVID-19 treatment option [12][13][14][15] . Defining the relationship between disease severity, other individual-specific comorbidities and the neutralizing antibody responses will be critical in our understanding of COVID- 19 and in tailoring effective therapies.…”

Section: Introductionmentioning

confidence: 99%

“…Currently available SARS-CoV-2 antibody tests mostly lack sufficient dynamic range and sensitivity to allow for accurate detection or determination of the magnitude of the antibody response 16 . Furthermore, potential cross-reactivity among SARS-CoV-2 specific antibodies to other endemic coronaviruses could also be confounders in these tests [17][18][19][20] , thus making them less reliable. Determining neutralization activity in patient plasma also has challenges, as these assays generally rely on live virus replication, requiring a high-level biohazard security BSL-3 level laboratory.…”

Section: Introductionmentioning

confidence: 99%

Novel SARS-CoV-2 specific antibody and neutralization assays reveal wide range of humoral immune response during COVID-19

Gupta

2020

Preprint

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Development of antibody protection during SARS-CoV-2 (CoV-2) infection is a pressing question for public health and for vaccine development. We developed highly sensitive CoV-2-specific antibody and neutralization assays. CoV-2 Spike protein or Nucleocapsid protein specific IgG antibodies at titers more than 1:100,000 were detectable in all PCR+ subjects (n=87) and were absent in the negative controls. Other isotype antibodies (IgA, IgG1-4) were also detected. CoV-2 neutralization was determined in COVID-19 and convalescent plasma up to 10,000-fold dilution, using Spike protein pseudotyped lentiviruses, which was also blocked by neutralizing antibodies (NAbs). Hospitalized patients had up to 3000-fold higher antibody and neutralization titers compared to outpatients or convalescent plasma donors. Further, subjects who donated plasma further out from the diagnosis of COVID-19 appeared to have lower titers. Interestingly, some COVID-19 patients also contained NAbs against SARS Spike protein pseudovirus. Together these results demonstrate the high specificity and sensitivity of our assays, which may impact understanding the quality or duration of the antibody response during COVID-19 and in determining the effectiveness of potential vaccines.

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Seroconversion Rate and Diagnostic Accuracy of Serological Tests for Coronavirus 2019

Cited by 5 publications

References 2 publications

Pfizer-BioNTech and Sinopharm: A Comparative Study on Post-Vaccination Antibody Titers

Pfizer-BioNTech and Sinopharm: A Comparative Study on Post-Vaccination Antibody Titers

Evaluating ELISA, Immunofluorescence, and Lateral Flow Assay for SARS-CoV-2 Serologic Assays

Novel SARS-CoV-2 specific antibody and neutralization assays reveal wide range of humoral immune response during COVID-19

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