Age significantly influences the sensitivity of SARS-CoV-2 rapid antibody assays

Irwin, Natalie; Murray, Lyle; Ozynski, Benjamin; Richards, Guy A.; Paget, Graham; Venturas, Jacqueline; Kalla, Ismail; Diana, Nina; Mahomed, Adam; Zamparini, Jarrod

doi:10.1016/j.ijid.2021.07.027

Cited by 7 publications

(9 citation statements)

References 13 publications

(13 reference statements)

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“…In order to exclude the effect of disease course, we analyzed and confirmed no correlation between age and disease course (p = 0.12). A previous study using five rapid antibody tests on 102 clinically confirmed cases also found significantly lower IgM sensitivity in younger (under 40 years old) COVID-19 patients (Irwin et al, 2021). However, within all five tests, the only one with a non-significant result was the ALLtest.…”

Section: Discussionmentioning

confidence: 68%

“…Several studies have tried to find clinical factors correlated with antibody test results and several factors have been identified such as clinical severity (Zhao et al, 2020), and age (Irwin et al, 2021). With a large number of samples, even only based on 0/1 result, we still could identify factors correlated with our ALLtest results and compare factors among centers.…”

Section: Discussionmentioning

confidence: 99%

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Antibody Response to SARS-CoV-2 in the First Batch of COVID-19 Patients in China by a Self-Developed Rapid IgM-IgG Test

Weng

et al. 2022

Front. Cell. Infect. Microbiol.

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It has been over two years since the COVID-19 pandemic began and it is still an unprecedented global challenge. Here, we aim to characterize the antibody profile from a large batch of early COVID-19 cases in China, from January – March 2020. More than 1,000 serum samples from participants in Hubei and Zhejiang province were collected. A series of serum samples were also collected along the disease course from 70 patients in Shanghai and Chongqing for longitudinal analysis. The serologic assay (ALLtest) we developed was confirmed to have high sensitivity (92.58% - 97.55%) and high specificity (92.14% - 96.28%) for the detection of SARS-CoV-2 nucleocapsid-specific antibodies. Confirmed cases found in the Hubei Provincial Center for Disease Control and Prevention (HBCDC), showed a significantly (p = 0.0018) higher positive rate from the ALLtest than RNA test. Then, we further identified the disease course, age, sex, and symptoms that were correlating factors with our ALLtest results. In summary, we confirmed the high reliability of our ALLtest and its important role in COVID-19 diagnosis. The correlating factors we identified will require special attention during future clinical application.

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Section: Discussionmentioning

confidence: 68%

Section: Discussionmentioning

confidence: 99%

Antibody Response to SARS-CoV-2 in the First Batch of COVID-19 Patients in China by a Self-Developed Rapid IgM-IgG Test

Weng

et al. 2022

Front. Cell. Infect. Microbiol.

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“…and sequential testing (one test followed by a second or more other tests for con rmation), which are plausibly effective in ruling out false positive results (49). Moreover, it was found that viral mutation and differences in antibody dynamics in particular populations speci cally in sub-Saharan Africa and in young people can affect the assay performance (49,(51)(52)(53)(54).…”

Section: Discussionmentioning

confidence: 99%

Seroprevalence of SARS-CoV-2 antibodies among healthy blood donors: a systematic review and meta-analysis

Ukwishaka,

Fotabong,

Aseneh

et al. 2023

Preprint

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Introduction: The development of a potent immune response and antibodies against SARS-CoV-2 is important for attaining herd immunity. This serological response could be due to past infection or vaccines. Healthy blood donors could represent and provide information on the immune status of the general population. Hence, we estimated the global and regional prevalence of SARS-CoV-2 antibodies among healthy asymptomatic blood donors. Methods: We systematically searched PubMed, Scopus, and ProQuest for eligible articles published between December 1, 2019, and January 12, 2023, without language restrictions. After critical appraisal and quality assessment, a qualitative synthesis of the identified pertinent articles was performed. The random-effect model was used to estimate the pooled prevalence of SARS-CoV-2 antibodies. Funnel plots and Egger’s test were used to assess publication bias. Sensitivity analysis was performed, and heterogeneity was quantified using I2 statistics. Results: A total of 70 peer-reviewed articles were selected and included 2,453,937 blood donors. The global estimated pooled prevalence of SARS-CoV-2 antibodies among healthy blood donors was 10.9% (95% CI: 5.0 – 18.8%, n=68). A high seroprevalence of SARS-CoV-2 was observed in Asia (20.4%, 95% CI: 10.1 – 33.1%, n=24), followed by Africa (16.1%, 95% CI: 6.8 – 28.3%, n=7). The seroprevalence of SARS-CoV-2 in studies conducted before the introduction of the vaccine was 6.5% (95% CI: 4.9 – 8.3%, n=50), while that of studies conducted after the vaccine was 27.6% (95% CI: 12.4 – 46.2% n=18). High seroprevalence was observed in studies that measured antibodies against the S protein of the virus (16.2%, 95% CI: 11.4 – 21.8%, n=27), while it was 12.5% (95% CI: 5.3 – 22.1%, n=16) in those that measured antibodies against the N protein. A high seroprevalence of SARS-CoV-2 was observed in studies that only measured IgG antibodies (17.2%, 95% CI: 10.5 – 25.1%, n=33) and in studies that measured total antibodies to SARS-CoV-2 (6.2%, 95% CI: 0.7 – 16.5%, n=33). Conclusion: In view of all evidence, there is variation in the prevalence of SARS-CoV-2 antibodies among healthy blood donors globally. Noticeably, there is a regional difference that could depict differences in transmission and vaccination rates. Based on the results of our analysis, we recommend evidence-based booster vaccination strategies informed by seroprevalence trends and waning immunity and reinforcing seroprevalence surveillance for outbreak management. It is advisable to mitigate socioeconomic disparities through inclusive health policies coupled with adaptable public health measures given local seroprevalence rates. These will contribute to informed policy decisions to build community resilience during the post-PHEIC phase of the COVID-19 pandemic.

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“…Additionally, studies have shown differences in antibody dynamics in specific populations such as those from sub-Saharan Africa, young adults, and pregnant women that may impact test performance [31][32][33][34] . Independent evaluations targeted toward the intended study population using representative panels are strongly supported by our findings which reach an updated understanding of serological assay performance, and conversely, accurate seroprevalence estimates.…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, viral mutations may result in decreased assay performance [30] . Additionally, studies have shown differences in antibody dynamics in specific populations such as those from sub-Saharan Africa, young adults, and pregnant women that may impact test performance [31][32][33][34] . This step is not always feasible for all research settings, as we found only a small proportion (6.9%) of independent author groups conducted their own assay pre-study validation before rolling out their serosurvey.…”

Section: Independent Evaluation Reflects Regional Population Characte...mentioning

confidence: 99%

Serology assays used in SARS-CoV-2 seroprevalence surveys worldwide: a systematic review and meta-analysis of assay features, testing algorithms, and performance

Whelan

et al. 2022

Preprint

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Background: Many SARS-CoV-2 serological assays were rapidly developed during the COVID-19 pandemic. However, differences in detection mechanism limit the comparability of assay outputs. Methods: As part of the SeroTracker global living systematic review of SARS-CoV-2 seroprevalence studies, we collated serological assays used in serosurveys between January 1, 2020 and November 19, 2021. We mapped performance metrics to the manufacturer, third-party head-to-head, and independent group evaluations, comparing the assay performance data using a mixed-effect beta regression model. Results: Among 1807 serosurveys, 192 distinctive commercial assays and 380 self-developed assays were identified. According to manufacturers, 28.6% of all commercial assays met WHO criteria for emergency use (sensitivity [Sn.] >= 90.0%, specificity [Sp.] >= 97.0%). Third-party and independent evaluations indicated that manufacturers overstated the Sn. of their assays by 5.4% and 2.8%, and Sp. by 6.3% and 1.2%. We found in simulations that inaccurate Sn. and Sp. can substantially bias seroprevalence estimates corrected for assay performance. Conclusions: The Sn. and Sp. of the serological assay are not fixed properties, but varying features depending on testing population. To achieve precise population estimates and to ensure comparability, serosurveys should select assays with strong, independently validated performance and adjust seroprevalence estimates based on assured performance data.

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Age significantly influences the sensitivity of SARS-CoV-2 rapid antibody assays

Cited by 7 publications

References 13 publications

Antibody Response to SARS-CoV-2 in the First Batch of COVID-19 Patients in China by a Self-Developed Rapid IgM-IgG Test

Antibody Response to SARS-CoV-2 in the First Batch of COVID-19 Patients in China by a Self-Developed Rapid IgM-IgG Test

Seroprevalence of SARS-CoV-2 antibodies among healthy blood donors: a systematic review and meta-analysis

Serology assays used in SARS-CoV-2 seroprevalence surveys worldwide: a systematic review and meta-analysis of assay features, testing algorithms, and performance

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