Evidence map›Paper›PMID 34612691›Full record

ArticleMicrobiology spectrum2021

Validation of Commercial SARS-CoV-2 Immunoassays in a Nigerian Population.

Fehintola Ige, Yohhei Hamada, Laura Steinhardt, Nnaemeka C Iriemenam, Mabel Uwandu, Stacie Marta Greby, Maureen Aniedobe, Babatunde Lawal Salako, Molebogeng X Rangaka, Ibrahim Abubakar and 1 more

Abstract readEvaluation StudyValidation Study
In one paragraph

Article in Microbiology spectrum, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

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

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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

11 authors.

Fehintola IgeCenter for Human Virology and Genomics, Microbiology Department, Nigerian Institute of Medical Researchgrid.416197.c, Yaba, Lagos, Nigeria.
Yohhei HamadaInstitute for Global Health, University College Londongrid.83440.3b, London, United Kingdom.ORCID 0000-0002-9845-4267
Laura SteinhardtMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.ORCID 0000-0003-0540-9940
Nnaemeka C IriemenamDivision of Global HIV and TB, Center for Global Health, Centers for Disease Control and Prevention, Abuja, Nigeria.ORCID 0000-0003-2187-8894
Mabel UwanduCenter for Human Virology and Genomics, Microbiology Department, Nigerian Institute of Medical Researchgrid.416197.c, Yaba, Lagos, Nigeria.
Stacie Marta GrebyDivision of Global HIV and TB, Center for Global Health, Centers for Disease Control and Prevention, Abuja, Nigeria.
Maureen AniedobeClinical Diagnostic Laboratory, Nigerian Institute of Medical Researchgrid.416197.c, Yaba, Lagos, Nigeria.
Babatunde Lawal SalakoNigerian Institute of Medical Researchgrid.416197.c, Yaba, Lagos, Nigeria.
Molebogeng X RangakaInstitute for Global Health, University College Londongrid.83440.3b, London, United Kingdom.
Ibrahim AbubakarInstitute for Global Health, University College Londongrid.83440.3b, London, United Kingdom.
Rosemary AuduCenter for Human Virology and Genomics, Microbiology Department, Nigerian Institute of Medical Researchgrid.416197.c, Yaba, Lagos, Nigeria.ORCID 0000-0002-0330-5219

Funding

Bill and Melinda Gates Foundation (BMGF) RP-PG-0217-20009
6 · The paper itself

Abstract

Validated assays are essential for reliable serosurveys; however, most SARS-CoV-2 immunoassays have been validated using specimens from China, Europe, or U.S. populations. We evaluated the performance of five commercial SARS-CoV-2 immunoassays to inform their use in serosurveys in Nigeria. Four semiquantitative enzyme-linked immunosorbent assays (ELISAs) (Euroimmun anti-SARS-CoV-2 nucleocapsid protein [NCP] immunoglobulin G [IgG], Euroimmun spike SARS-CoV-2 IgG, Mologic Omega COVID-19 IgG, Bio-Rad Platelia SARS-CoV-2 Total Ab) and one chemiluminescent microparticle immunoassay (Abbott Architect SARS-CoV-2 IgG) were evaluated. We estimated the analytical performance characteristics using plasma from 100 SARS-CoV-2 PCR-positive patients from varied time points post-PCR confirmation and 100 prepandemic samples (50 HIV positive and 50 hepatitis B positive). The Bio-Rad assay failed the manufacturer-specified validation steps. The Euroimmun NCP, Euroimmun spike, and Mologic assays had sensitivities of 73.7%, 74.4%, and 76.9%, respectively, on samples taken 15 to 58 days after PCR confirmation and specificities of 97%, 100%, and 83.8%, respectively. The Abbott assay had 71.3% sensitivity and 100% specificity on the same panel. Parallel or serial algorithms combining two tests did not substantially improve the sensitivity or specificity. Our results showed lower sensitivity and, for one immunoassay, lower specificity compared to the manufacturers' results and other reported validations. Seroprevalence estimates using these assays might need to be interpreted with caution in Nigeria and similar settings. These findings highlight the importance of in-country validations of SARS-CoV-2 serological assays prior to use to ensure that accurate results are available for public health decision-making to control the COVID-19 pandemic in Africa.

Indexed as

AdultAntibodies, ViralCoronavirus Nucleocapsid ProteinsCOVID-19Enzyme-Linked Immunosorbent AssayFemaleHumansImmunoglobulin GMaleNigeriaPhosphoproteinsSARS-CoV-2Sensitivity and SpecificitySeroepidemiologic StudiesSpike Glycoprotein, CoronavirusAntibodies, ViralCoronavirus Nucleocapsid ProteinsImmunoglobulin Gnucleocapsid phosphoprotein, SARS-CoV-2PhosphoproteinsSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2assayimmunoassayNigeriaSARS-CoV-2serologyvalidation

Identifiers

PMID34612691
PMCPMC8510257

What OpenQuestion holds

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Registered trials

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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.