Evidence map›Paper›PMID 34839430›Full record

ArticleJournal of clinical immunology2022

A Novel Point-of-Care Rapid Diagnostic Test for Screening Individuals for Antibody Deficiencies.

Shirli Israeli, Allison Golden, Melissa Atalig, Najla Mekki, Afef Rais, Helen Storey, Mohamed-Ridha Barbouche, Roger Peck

Open access · hybridAbstract read
In one paragraph

Article in Journal of clinical immunology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 45% of its field
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

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. 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

8 authors at 2 institutions in 2 countries.

Shirli IsraeliDiagnostics, PATH, Seattle, WA, USA.ORCID http://orcid.org/0000-0002-0258-472X
Allison GoldenDiagnostics, PATH, Seattle, WA, USA.
Melissa AtaligDiagnostics, PATH, Seattle, WA, USA.
Najla MekkiDepartment of Immunology, Pasteur Institute of Tunis, Tunis, Tunisia.
Afef RaisDepartment of Immunology, Pasteur Institute of Tunis, Tunis, Tunisia.
Helen StoreyDiagnostics, PATH, Seattle, WA, USA.
Mohamed-Ridha BarboucheDepartment of Immunology, Pasteur Institute of Tunis, Tunis, Tunisia.
Roger PeckDiagnostics, PATH, Seattle, WA, USA. rpeck@path.org.ORCID http://orcid.org/0000-0003-1085-2883
Program for Appropriate Technology in Health · USInstitut Pasteur de Tunis · TN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeNo rapid diagnostic test exists to screen individuals for primary antibody deficiencies (PAD) at or near the point of care. In settings at risk for polio where live oral polio vaccine is utilized, undiagnosed PAD patients and cases with delayed diagnosis constitute a potential reservoir for neurovirulent polioviruses, undermining polio eradication. This research aimed to develop a rapid screening test suited for use in resource-limited settings to identify individuals with low immunoglobulin G (IgG) levels, enabling early diagnosis and appropriate treatment.

methodsThree prototype tests distinguishing low and normal IgG levels were evaluated with a blinded panel of serum/plasma specimens from 32 healthy controls and 86 primary immunodeficiency-confirmed patients with agammaglobulinemia, common variable immunodeficiency, and hyper-IgM syndrome, including 57 not receiving IgG therapy. Prototype tests were compared to laboratory reference and clinical case definition.

resultsThe leading prototype correctly identified 32 of 32 healthy controls. Among primary antibody deficiency patients not receiving IgG treatment, 17 of 19 agammaglobulinemia, 7 of 24 common variable immunodeficiency, and 5 of 14 hyper-IgM were correctly identified by the prototype, with 67% agreement with the reference assay.

conclusionThe Rapid IgG Screen (RIgGS) test can differentiate between low IgG levels associated with agammaglobulinemia and normal IgG antibody levels. Differentiating CVID and hyper IgM was challenging due to the wide range in IgG levels and influence of high IgM. This test can facilitate the identification of patients with primary antibody deficiencies and support polio surveillance initiatives.

Indexed as

AgammaglobulinemiaCommon Variable ImmunodeficiencyPrimary Immunodeficiency DiseasesDiagnostic Tests, RoutineHumansPoint-of-Care SystemsPoint of carePrimary antibody deficiencyPrimary immunodeficiency diseaseRapid diagnostic testScreeningVaccine-derived poliovirus

Identifiers

PMID34839430
PMCPMC8821486
OpenAlexW3217532677

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.