Evidence map›Paper›PMID 33442555›Full record

ReviewOpen forum infectious diseases2021

SARS-CoV-2 Serologic Assay Needs for the Next Phase of the US COVID-19 Pandemic Response.

Adi V Gundlapalli, Reynolds M Salerno, John T Brooks, Francisco Averhoff, Lyle R Petersen, L Clifford McDonald, Michael F Iademarco, CDC COVID-19 Response

Abstract readReview
In one paragraph

Review in Open forum infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed
–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

42 citing papers in PubMed.

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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

8 authors.

Adi V GundlapalliCenters for Disease Control and Prevention, Atlanta, GA, USA.
Reynolds M SalernoCenters for Disease Control and Prevention, Atlanta, GA, USA.
John T BrooksCenters for Disease Control and Prevention, Atlanta, GA, USA.
Francisco AverhoffCenters for Disease Control and Prevention, Atlanta, GA, USA.
Lyle R PetersenCenters for Disease Control and Prevention, Atlanta, GA, USA.
L Clifford McDonaldCenters for Disease Control and Prevention, Atlanta, GA, USA.
Michael F IademarcoCenters for Disease Control and Prevention, Atlanta, GA, USA.
CDC COVID-19 Response

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is a need for validated and standardized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative immunoglobulin G (IgG) and neutralization assays that can be used to understand the immunology and pathogenesis of SARS-CoV-2 infection and support the coronavirus disease 2019 (COVID-19) pandemic response.

methodsLiterature searches were conducted to identify English language publications from peer-reviewed journals and preprints from January 2020 through November 6, 2020. Relevant publications were reviewed for mention of IgG or neutralization assays for SARS-CoV-2, or both, and the methods of reporting assay results.

resultsQuantitative SARS-CoV-2 IgG results have been reported from a limited number of studies; most studies used in-house laboratory-developed tests in limited settings, and only two semiquantitative tests have received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA). As of November 6, 2020, there is only one SARS-CoV-2 neutralization assay with FDA EUA. Relatively few studies have attempted correlation of quantitative IgG titers with neutralization results to estimate surrogates of protection. The number of individuals tested is small compared with the magnitude of the pandemic, and persons tested are not representative of disproportionately affected populations. Methods of reporting quantitative results are not standardized to enable comparisons and meta-analyses.

conclusionsLack of standardized SARS-CoV-2 quantitative IgG and neutralization assays precludes comparison of results from published studies. Interassay and interlaboratory validation and standardization of assays will support efforts to better understand antibody kinetics and longevity of humoral immune responses postillness, surrogates of immune protection, and vaccine immunogenicity and efficacy. Public-private partnerships could facilitate realization of these advances in the United States and worldwide.

Indexed as

immunitypandemicquantitative assaysSARS-CoV-2serology

Identifiers

PMID33442555
PMCPMC7717402

What OpenQuestion holds

Textmetadata
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.