Antibody profiling and prevalence in US patients during the SARS-CoV2 pandemic

Krishnamurthy, Hari Krishnan; Jayaraman, Vasanth; Krishna, Karthik; Rajasekaran, Karenah E.; Wang, Tianhao; Bei, Kang; Rajasekaran, John J.; Yaskin, Inna; Alex, J.; Choung, Rok Seon; Murray, Joseph A.

doi:10.1371/journal.pone.0242655

Cited by 16 publications

(26 citation statements)

References 11 publications

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“…Data are presented as % (95% confidence levels). A more comprehensive analysis of the sensitivity and specificity of the Vibrant chemiluminescent immunoassay for SARS-CoV-2 has recently been published 26 .…”

Section: Resultsmentioning

confidence: 99%

“…In the current study, we utilized a multiplex serology test for COVID-19 in an otherwise healthy cohort of adults and children in Colorado. Recent results using the same test kit have shown that IgM antibodies against SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over time are not well characterized 26 . Our results show that IgM levels and IgG levels were both elevated early (0–30 days following symptom onset).…”

Section: Discussionmentioning

confidence: 99%

“…Serological testing was performed by Vibrant America using a SARS-CoV-2 IgM, IgG, and IgA chemiluminescent assay (Vibrant COVID-19 Ab Assay; Vibrant America Clinical Labs). 26 This assay was approved by the FDA for Emergency Use Authorization ( https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance ; https://www.fda.gov/media/138629/download ). Microbial contaminated or specimens containing visible particulate were excluded.…”

Section: Methodsmentioning

confidence: 99%

“…In the current manuscript, we describe a chemiluminescent immunoassay, developed by Vibrant America Clinical Labs, that is approved by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization and can sensitively detect antibody titers in SARS-CoV-2 infected patients. This serological protein microarray technology has been tested in more than 7,700 patient serum samples, and shown to detect a plurality of antibody responses including 12 antibody/antigen combinations: IgM, IgA, and IgG, against the spike 1 SP (S1 SP), receptor-binding domain (RBD), spike 2 SP (S2 SP), and NP of SARS-CoV-2 26 . Here, we present the overall clinical sensitivity and specificity for the Vibrant serology chemiluminescent immunoassay relative to PCR-confirmed COVID-19-positive and COVID-19-negative cases.…”

Section: Introductionmentioning

confidence: 99%

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A multiplex chemiluminescent immunoassay for serological profiling of COVID-19-positive symptomatic and asymptomatic patients

et al. 2021

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The COVID-19 pandemic affects more than 81 million people worldwide with over 1.7 million deaths. As the population returns to work, it is critical to develop tests that reliably detect SARS-CoV-2-specific antibodies. Here we present results from a multiplex serology test for assessing the antibody responses to COVID-19. In an initial large cohort, this test shows greater than 99% agreement with COVID-19 PCR test. In a second outpatient cohort consisting of adults and children in Colorado, the IgG responses are more robust in positive/symptomatic participants than in positive/asymptomatic participants, the IgM responses in symptomatic participants are transient and largely fall below the detection limit 30 days after symptom onset, and the levels of IgA against SARS-CoV-2 receptor binding domain are significantly increased in participants with moderate-to-severe symptoms compared to those with mild-to-moderate symptoms or asymptomatic individuals. Our results thus provide insight into serology profiling and the immune response to COVID-19.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A multiplex chemiluminescent immunoassay for serological profiling of COVID-19-positive symptomatic and asymptomatic patients

et al. 2021

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“…It is possible that some participants shielded their answer and submitted samples for analysis without meeting the eligibility criteria; this would have inflated our estimation of seroprevalence in asymptomatic groups, Thirdly, the limited number of non-White, and gender-diverse participants also limited some analyses. Fourthly, while multiple studies have validated DBS sampling for SARS-CoV-2, 46 waning antibodies in asymptomatic individuals could be below the limited of detection of the ELISA assay. Finally, generalizability is limited due to the recruitment of a university-affiliated population in a relatively restricted geographic area.…”

Section: Discussionmentioning

confidence: 99%

Serological surveys to estimate cumulative incidence of SARS-CoV-2 infection in adults (Sero-MAss study), Massachusetts, July-August 2020: a mail-based cross-sectional study

Snyder

Ravenhurst

Cramer

et al. 2021

Preprint

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Background The SARS-CoV-2 pandemic is an unprecedented global health crisis. The state of Massachusetts was especially impacted during the initial stages; however, the extent of asymptomatic transmission remains poorly understood due to limited asymptomatic testing in the "first wave." To address this gap, a geographically representative and contact-free seroprevalence survey was conducted in July-August 2020, to estimate prior undetected SARS-CoV-2 infections. Methods Students, faculty, librarians and staff members at the University of Massachusetts, Amherst without a previous COVID-19 diagnosis were invited to participate in this study along with one member of their household in June 2020. Two separate sampling frames were generated from administrative lists: all undergraduates and their household members (primary sampling group) were randomly selected with probability proportional to population size. All staff, faculty, graduate students and librarians (secondary sampling group) were selected as a simple random sample. After informed consent and a socio-behavioral survey, participants were mailed test kits and asked to return self-collected dried blood spot (DBS) samples. Samples were analyzed via ELISA for anti-SARS-CoV-2 IgG antibodies, and then IgM antibodies if IgG-positive. Seroprevalence estimates were adjusted for survey non-response. Binomial models were used to assess factors associated with seropositivity in both sample groups separately. Results Approximately 27,000 persons were invited via email to assess eligibility. Of the 1,001 individuals invited to participate in the study, 762 (76%) returned blood samples for analysis. In the primary sampling group 548 returned samples, of which 230 enrolled a household member. Within the secondary sampling group of 214 individuals, 79 enrolled a household member. In the primary sample group, 36 (4.6%) had IgG antibodies detected for an estimated weighed prevalence for this population of 5.3% (95% CI: 3.5 to 8.0). In the secondary sampling group, 10 (3.4%) of 292 individuals had IgG antibodies detected for an estimated adjusted prevalence of 4.0% (95% CI: 2.2 to 7.4). No samples were IgM positive. No association was found in either sample group between seropositivity and self-reported work duties or customer-facing hours. In the primary sampling group, self-reported febrile illness since Feb 2020, male sex, and minority race (Black or American Indian/Alaskan Native) were associated with seropositivity. No factors except geographic regions within the state were associated with evidence of prior SARS-CoV-2 infection in the secondary sampling group. Interpretation This study provides insight into the seroprevalence of university-related populations and their household members across the state of Massachusetts during the summer of 2020 of the pandemic and helps to fill a critical gap in estimating the levels of sub-clinical and asymptomatic infection. Estimates like these can be used to calibrate models that estimate levels of population immunity over time to inform public health interventions and policy.

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Antibody tests for identification of current and past infection with SARS-CoV-2

Fox

Geppert

Dinnes

et al. 2022

Cochrane Database of Systematic Reviews

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Background The diagnostic challenges associated with the COVID‐19 pandemic resulted in rapid development of diagnostic test methods for detecting SARS‐CoV‐2 infection. Serology tests to detect the presence of antibodies to SARS‐CoV‐2 enable detection of past infection and may detect cases of SARS‐CoV‐2 infection that were missed by earlier diagnostic tests. Understanding the diagnostic accuracy of serology tests for SARS‐CoV‐2 infection may enable development of effective diagnostic and management pathways, inform public health management decisions and understanding of SARS‐CoV‐2 epidemiology. Objectives To assess the accuracy of antibody tests, firstly, to determine if a person presenting in the community, or in primary or secondary care has current SARS‐CoV‐2 infection according to time after onset of infection and, secondly, to determine if a person has previously been infected with SARS‐CoV‐2. Sources of heterogeneity investigated included: timing of test, test method, SARS‐CoV‐2 antigen used, test brand, and reference standard for non‐SARS‐CoV‐2 cases. Search methods The COVID‐19 Open Access Project living evidence database from the University of Bern (which includes daily updates from PubMed and Embase and preprints from medRxiv and bioRxiv) was searched on 30 September 2020. We included additional publications from the Evidence for Policy and Practice Information and Co‐ordinating Centre (EPPI‐Centre) ‘COVID‐19: Living map of the evidence’ and the Norwegian Institute of Public Health ’NIPH systematic and living map on COVID‐19 evidence’. We did not apply language restrictions. Selection criteria We included test accuracy studies of any design that evaluated commercially produced serology tests, targeting IgG, IgM, IgA alone, or in combination. Studies must have provided data for sensitivity, that could be allocated to a predefined time period after onset of symptoms, or after a positive RT‐PCR test. Small studies with fewer than 25 SARS‐CoV‐2 infection cases were excluded. We included any reference standard to define the presence or absence of SARS‐CoV‐2 (including reverse transcription polymerase chain reaction tests (RT‐PCR), clinical diagnostic criteria, and pre‐pandemic samples). Data collection and analysis We use standard screening procedures with three reviewers. Quality assessment (using the QUADAS‐2 tool) and numeric study results were extracted independently by two people. Other study characteristics were extracted by one reviewer and checked by a second. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test and, for meta‐analysis, we fitted univariate random‐effects logistic regression models for sensitivity by eligible time period and for specificity by reference standard group. Heterogeneity was investigated by including indicator variables in the random‐effects logistic regression models. We tabulated result...

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Antibody profiling and prevalence in US patients during the SARS-CoV2 pandemic

Cited by 16 publications

References 11 publications

A multiplex chemiluminescent immunoassay for serological profiling of COVID-19-positive symptomatic and asymptomatic patients

A multiplex chemiluminescent immunoassay for serological profiling of COVID-19-positive symptomatic and asymptomatic patients

Serological surveys to estimate cumulative incidence of SARS-CoV-2 infection in adults (Sero-MAss study), Massachusetts, July-August 2020: a mail-based cross-sectional study

Antibody tests for identification of current and past infection with SARS-CoV-2

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