SARS-CoV-2 Seropositivity and Subsequent Infection Risk in Healthy Young Adults: A Prospective Cohort Study

Letizia, Andrew G.; Ge, Yongchao; Vangeti, Sindhu; Goforth, Carl; Weir, Dawn L.; Kuzmina, Natalia; Chen, Hua Wei; Ewing, Daniel; Soares‐Schanoski, Alessandra; George, Mary‐Catherine; Graham, William D.; Jones, Franca R.; Bharaj, Preeti; Lizewski, Rhonda A.; Lizewski, Stephen E.; Marayag, Jan; Marjanović, Nada; Miller, Clare M.; Mofsowitz, Sagie; Nair, Venugopalan D.; Nunez, Edgar; Parent, Danielle; Porter, Chad K.; Ana, Ernesto Santa; Schilling, Megan A.; Stadlbauer, Daniel; Sugiharto, Victor A.; Termini, Michael; Sun, Peifang; Tracy, Russell P.; Krammer, Florian; Bukreyev, Alexander; Ramos, Irene; Sealfon, Stuart C.

doi:10.2139/ssrn.3779907

Cited by 14 publications

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“…( 25 ) However, serologic assays have been developed and validated to accurately detect anti–SARS‐CoV‐2 nucleocapsid antibodies, which would be elicited by naturally acquired infection but not by a SARS‐CoV‐2 spike protein–based vaccination. ( 26 ) Letizia et al ( 27 ) showed that subjects with higher serum following disease S IgG titers were less likely to have a subsequent infection. In addition, Bergwerk et al ( 15 ) showed a similar phenomenon among vaccinated individuals.…”

Section: Discussionmentioning

confidence: 99%

Advanced Liver Fibrosis Correlates With Impaired Efficacy of Pfizer‐BioNTech COVID‐19 Vaccine in Medical Employees

et al. 2022

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The Pfizer‐BioNTech coronavirus disease 2019 (COVID‐19) vaccine has been offered to nonallergic ≥16‐year‐old Israeli adults since December 19, 2020. Data regarding factors associated with vaccine ineffectiveness are limited. The aim of this study is to assess the impact of hepatic fibrosis on the efficacy of the BioNTech vaccine. Serum severe acute respiratory syndrome coronavirus 2 spike immunoglobulins (S IgG) obtained at least 7 days following vaccination completion was correlated with the prevaccine calculated Fibrosis‐4 (FIB‐4) score among 719 employees in the Hadassah Medical Center, Jerusalem. Positive vaccine response (S IgG levels ≥ 19 AU/mL) was found in 708 of 719 individuals (98.5%). Vaccine failure (S IgG levels < 19) was found in 11 (1.5%); of these, 7 were immunosuppressed. Mean FIB‐4 available in 501 of 708 vaccine responders was 1.13 ± 0.66, mean age 51.4 ± 12.4 years (29.3% males), and mean S IgG titers 239.7 ± 86.1 AU/mL. Similar to the general population, 70.5% had normal FIB‐4 (<1.3), 26.8% undetermined FIB‐4 (1.3‐2.67), and 2.7% advanced FIB‐4 (>2.67). When divided into response subgroups, 158 of 501 individuals (30.1%) with IgG titers 19‐100 AU/mL had a mean FIB‐4 of 1.48 ± 0.82; 198 (39.5%) with IgG titers 101‐200 AU/mL had mean FIB‐4 of 1.22 ± 0.76; 83 (16.6%) with titers 201‐300 AU/mL had mean FIB‐4 of 1.04 ± 0.48; 38 (7.6%) individuals with IgG titers 301‐400 AU/ml had a mean FIB‐4 of 1.08 ± 0.63; and 121 (24.2%) with IgG titers >400 AU/mL had mean FIB‐4 of 1.18 ± 0.87. Increased FIB‐4, age, and male gender significantly correlated with lower postvaccine IgG titers ( P < 0.001). FIB‐4 results were confirmed using FibroScan data displaying advanced fibrosis impact on weakened COVID‐19 vaccine response. Conclusion: Immune suppression, older age, male gender, and advanced chronic liver disease are risk factors for lower vaccine response. The FIB‐4 provides a simple tool to prioritize candidates for third‐dose vaccine booster.

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Section: Discussionmentioning

confidence: 99%

Advanced Liver Fibrosis Correlates With Impaired Efficacy of Pfizer‐BioNTech COVID‐19 Vaccine in Medical Employees

et al. 2022

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“…We optimised and evaluated a suite of in-house ELISA and LIPS assays for detecting and measuring antibody responses to SARS-CoV-2 by adapting available protocols (7, 14, 20). Whilst such assays have been used widely to explore the heterogeneity of immune responses to SARS-CoV-2 infection and vaccination (11, 12, 21), few have simultaneously and rigorously evaluated two different platforms with shared standards and quality controls using the same well characterised, large sample collections. This approach facilitated accurate threshold setting to determine serological status.…”

Section: Discussionmentioning

confidence: 99%

“…Sub-optimal performance of antibody assays can lead to uncertainty around persistence of antibodies and associated immune protection. Non-commercial (‘in-house’) assays have played an essential role in characterising the antibody responses in various large cohort studies (11, 12), but many lack standardization and have been optimised/evaluated using relatively small numbers of samples making their performance unclear (13). A range of high-performance platforms such as ELISA and Luciferase Immunoprecipitation System (LIPS) assays have been reported and widely used for the measurement of SARS-CoV-2 antibodies (7, 14).…”

Section: Introductionmentioning

confidence: 99%

Development and evaluation of low-volume tests to detect and characterise antibodies to SARS-CoV-2

Halliday

Long

Baum

et al. 2022

Preprint

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Low-volume antibody assays can be used to track SARS-CoV-2 infection rates in settings where active testing for virus is limited and remote sampling is optimal. We developed 12 ELISAs detecting total or antibody isotypes to SARS-CoV-2 nucleocapsid, spike protein or its receptor binding domain (RBD), 3 anti-RBD isotype specific luciferase immunoprecipitation system (LIPS) assays and a novel Spike-RBD bridging LIPS total-antibody assay. We utilised pre-pandemic (n=984) and confirmed/suspected recent COVID-19 sera taken pre-vaccination rollout in 2020 (n=269). Assays measuring total antibody discriminated best between pre-pandemic and COVID-19 sera and were selected for diagnostic evaluation. In the blind evaluation, two of these assays (Spike Pan ELISA and Spike-RBD Bridging LIPS assay) demonstrated >97% specificity and >92% sensitivity for samples from COVID-19 patients taken >21 days post symptom onset or PCR test. These assays offered better sensitivity for the detection of COVID-19 cases than a commercial assay which requires 100-fold larger serum volumes. This study demonstrates that low-volume in-house antibody assays can provide good diagnostic performance, and highlights the importance of using well-characterised samples and controls for all stages of assay development and evaluation. These cost-effective assays may be particularly useful for seroprevalence studies in low and middle-income countries.

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“…Multiple studies following up individuals with SARS-CoV-2 infection have described protection to SARS-CoV-2 following natural infection in individuals with detectable antibody levels: protection from subsequent symptomatic infection with SARS-CoV-2 was estimated at about 85% protection in two overlapping meta-analyses of 19 studies performed in the general population, healthcare workers, college students, and residents in long term care facilities(14, 15). In some studies, quantitative antibody levels were recorded, and increased protection in individuals with higher antibody levels was observed(9, 16).…”

Section: Introductionmentioning

confidence: 99%

Association of results of four lateral flow antibody tests with subsequent SARS-CoV-2 infection

Findlater¹,

Trickey

Jones

et al. 2022

Preprint

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Background: SARS-CoV-2 vaccine coverage remains incomplete, being only 15% in low income countries. Rapid point of care tests predicting SARS-CoV-2 infection susceptibility in the unvaccinated might assist in risk management and vaccine prioritisation. Methods: We conducted a prospective cohort study in 2,826 participants working in hospitals and Fire and Police services in England, UK, during the pandemic (ISRCTN5660922). Plasma taken at recruitment in June 2020 was tested using four lateral flow immunoassay (LFIA) devices and two laboratory immunoassays detecting antibodies against SARS-CoV-2 (UK Rapid Test Consortium's AbC-19TM Rapid Test, OrientGene COVID IgG/IgM Rapid Test Cassette, SureScreen COVID-19 Rapid Test Cassette, and Biomerica COVID-19 IgG/IgM Rapid Test; Roche N and EUROIMMUN S laboratory assays). We monitored participants for microbiologically-confirmed SARS-CoV-2 infection for 200 days. We estimated associations between test results at baseline and subsequent infection, using Poisson regression models adjusted for baseline demographic risk factors for SARS-CoV-2 exposure. Findings: Positive IgG results on each of the four LFIAs were associated with lower rates of subsequent infection: adjusted incidence rate ratios (aIRRs) 0.00 (95% confidence interval 0.00-0.01), 0.03 (0.02-0.05), 0.07 (0.05-0.10), and 0.09 (0.07-0.12) respectively. The protective association was strongest for AbC-19 and SureScreen. The aIRR for the laboratory Roche N antibody assay at the manufacturer-recommended threshold was similar to those of the two best performing LFIAs at 0.03 (0.01-0.10). Interpretation: Lateral flow devices measuring SARS-CoV-2 IgG predicted disease risk in unvaccinated individuals over 200 day follow-up. The association of some LFIAs with subsequent infection was similar to laboratory immunoassays.

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SARS-CoV-2 Seropositivity and Subsequent Infection Risk in Healthy Young Adults: A Prospective Cohort Study

Cited by 14 publications

References 0 publications

Advanced Liver Fibrosis Correlates With Impaired Efficacy of Pfizer‐BioNTech COVID‐19 Vaccine in Medical Employees

Advanced Liver Fibrosis Correlates With Impaired Efficacy of Pfizer‐BioNTech COVID‐19 Vaccine in Medical Employees

Development and evaluation of low-volume tests to detect and characterise antibodies to SARS-CoV-2

Association of results of four lateral flow antibody tests with subsequent SARS-CoV-2 infection

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