Evidence map›Paper›PMID 36560415›Full record

ArticleVaccines2022

Serology Assays Used in SARS-CoV-2 Seroprevalence Surveys Worldwide: A Systematic Review and Meta-Analysis of Assay Features, Testing Algorithms, and Performance.

Xiaomeng Ma, Zihan Li, Mairead G Whelan, Dayoung Kim, Christian Cao, Mercedes Yanes-Lane, Tingting Yan, Thomas Jaenisch, May Chu, David A Clifton and 3 more

Abstract read
In one paragraph

Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Xiaomeng MaCumming School of Medicine, University of Calgary, Calgary, AB T2N 4N1, Canada.
Zihan LiCumming School of Medicine, University of Calgary, Calgary, AB T2N 4N1, Canada.
Mairead G WhelanCumming School of Medicine, University of Calgary, Calgary, AB T2N 4N1, Canada.ORCID 0000-0002-4895-9304
Dayoung KimFaculty of Science, University of Calgary, Calgary, AB T2N 1N4, Canada.
Christian CaoCumming School of Medicine, University of Calgary, Calgary, AB T2N 4N1, Canada.ORCID 0000-0002-0395-0381
Mercedes Yanes-LaneCOVID-19 Immunity Task Force, McGill University, Montreal, QC H3A 0G4, Canada.
Tingting YanCumming School of Medicine, University of Calgary, Calgary, AB T2N 4N1, Canada.
Thomas JaenischDepartment of Epidemiology & Center for Global Health, Colorado School of Public Health, Aurora, CO 80045, USA.
May ChuDepartment of Epidemiology & Center for Global Health, Colorado School of Public Health, Aurora, CO 80045, USA.
David A CliftonInstitute of Biomedical Engineering, University of Oxford, Oxford OX3 7DQ, UK.
Lorenzo SubissiWorld Health Organization, 1211 Geneva, Switzerland.ORCID 0000-0001-5147-575X
Niklas BobrovitzTemerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada.
Rahul K AroraCumming School of Medicine, University of Calgary, Calgary, AB T2N 4N1, Canada.ORCID 0000-0003-3526-6338

Funding

World Health Organization 001
6 · The paper itself

Abstract

Background: Many serological assays to detect SARS-CoV-2 antibodies were developed during the COVID-19 pandemic. Differences in the detection mechanism of SARS-CoV-2 serological assays limited the comparability of seroprevalence estimates for populations being tested. Methods: We conducted a systematic review and meta-analysis of serological assays used in SARS-CoV-2 population seroprevalence surveys, searching for published articles, preprints, institutional sources, and grey literature between 1 January 2020, and 19 November 2021. We described features of all identified assays and mapped performance metrics by the manufacturers, third-party head-to-head, and independent group evaluations. We compared the reported assay performance by evaluation source with a mixed-effect beta regression model. A simulation was run to quantify how biased assay performance affects population seroprevalence estimates with test adjustment. Results: Among 1807 included 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%). However, manufacturers overstated the absolute values of Sn. of commercial assays by 1.0% [0.1, 1.4%] and 3.3% [2.7, 3.4%], and Sp. by 0.9% [0.9, 0.9%] and 0.2% [−0.1, 0.4%] compared to third-party and independent evaluations, respectively. Reported performance data was not sufficient to support a similar analysis for self-developed assays. Simulations indicate that inaccurate Sn. and Sp. can bias seroprevalence estimates adjusted for assay performance; the error level changes with the background seroprevalence. Conclusions: The Sn. and Sp. of the serological assay are not fixed properties, but varying features depending on the testing population. To achieve precise population estimates and to ensure the comparability of seroprevalence, serosurveys should select assays with high performance validated not only by their manufacturers and adjust seroprevalence estimates based on assured performance data. More investigation should be directed to consolidating the performance of self-developed assays.

Indexed as

evaluationperformancesensitivityserological assayseroprevalencespecificityvalidation

Identifiers

PMID36560415
PMCPMC9783516

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.