Evidence map›Paper›PMID 26275445›Full record

ArticleJournal of clinical immunology2015

A Novel Targeted Screening Tool for Hypogammaglobulinemia: Measurement of Serum Immunoglobulin (IgG, IgM, IgA) Levels from Dried Blood Spots (Ig-DBS Assay).

Leman Yel, Christopher J Rabbat, Charlotte Cunningham-Rundles, Jordan S Orange, Troy R Torgerson, James W Verbsky, Yeong Wang, Maoyong Fu, Terry S Robins, Marc S Edwards and 1 more

Open access · hybridAbstract readComparative Study
In one paragraph

Article in Journal of clinical immunology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 38% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. 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 at 6 institutions in 1 country.

Leman YelBaxalta US, Inc., Global Clinical Research, One Baxter Way, Westlake Village, CA, 91362, USA. leman.yel@baxalta.com.
Christopher J RabbatBaxalta US, Inc., North American Medical Affairs, Bannockburn, IL, USA.
Charlotte Cunningham-RundlesMount Sinai School of Medicine, New York, NY, USA.
Jordan S OrangeTexas Children's Hospital, Baylor College of Medicine, Houston, TX, USA.
Troy R TorgersonUniversity of Washington and Seattle Children's Hospital, Seattle Children's Research Institute, Seattle, WA, USA.
James W VerbskyMedical College of Wisconsin, Milwaukee, WI, USA.
Yeong WangBaxalta US, Inc., Global Quality, Westlake Village, CA, USA.
Maoyong FuQuest Diagnostics, Valencia, CA, USA.
Terry S RobinsQuest Diagnostics, Valencia, CA, USA.
Marc S EdwardsQuest Diagnostics, Valencia, CA, USA.
Jesper Nymann-AndersenQuest Diagnostics, Valencia, CA, USA.
Quest Diagnostics (United States) · USBaxalta (United States) · USBaylor College of Medicine · USIcahn School of Medicine at Mount Sinai · USMedical College of Wisconsin · USSeattle Children's Hospital · US

Funding

Regulation of IgA class switching in the intestinal mucosaP01AI061093 · NIAID · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI CUNNINGHAM-RUNDLES, CHARLOTTE · 2004 to 2021
$29.8M
Resources to Assist Investigations in Primary Immunodeficiency Diseases (U24)U24AI086037 · NIAID · IMMUNE DEFICIENCY FOUNDATION · PI CUNNINGHAM-RUNDLES, CHARLOTTE · 2010 to 2019
$6.5M
TARGETING PRIMARY IMMUNODEFICIENCY AMONG MINORITIESR18AI048693 · NIAID · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI CUNNINGHAM-RUNDLES, CHARLOTTE · 2000 to 2016
$6.2M
NIAID NIH HHS P01 AI061093NIAID NIH HHS R18 AI048693NIAID NIH HHS U24 AI086037
6 · The paper itself

Abstract

purposeTo develop an assay to quantify serum immunoglobulin (IgG, IgM, IgA) levels using dried blood spots (DBS) obtained on collection cards to be used as a tool for targeted screening for hypogammaglobulinemia.

methodsDBS samples, along with simultaneous serum samples, were collected from 107 healthy individuals (11 months to 57 years of age). After eluting proteins from DBS, IgG, IgM, and IgA were quantified by an enzyme-linked immunosorbent assay (ELISA). The Ig-DBS assay was validated through calibration curve performance, intra- and inter-assay precision, accuracy, specificity, selectivity, and linearity. The ELISA measurements were compared with serum Ig levels obtained using a standard nephelometry assay on serum samples collected simultaneously with the DBS samples and the results of the two assays were correlated. The stability of IgG, IgM, and IgA in the DBS was tested at room temperature, 36° to 38 °C, 2 to 8 °C, and -25 to -40 °C, from 4 to 14 days.

resultsThe Ig-DBS assay demonstrated precision, accuracy, specificity, selectivity, and linearity. Using the identified correlation coefficients of 0.834 for IgG, 0.789 for IgM, and 0.918 for IgA, the standard nephelometry-based normal reference ranges for all 3 serum Ig isotypes could be used with the Ig-DBS assay in individuals ≥16 years of age. The DBS samples were stable for 14 days at room temperature in a closed polyethylene bag.

conclusionsThe Ig-DBS assay is both sensitive and accurate for quantification of serum immunoglobulins. Samples are sufficiently stable at ambient temperature to allow for convenient shipping and analysis at a centralized laboratory. This assay therefore presents a new option for screening patients ≥16 years of age for hypogammaglobulinemia in any setting.

Indexed as

AdolescentAdultAgammaglobulinemiaChildChild, PreschoolDried Blood Spot TestingEnzyme-Linked Immunosorbent AssayHumansImmunoglobulin AImmunoglobulin GImmunoglobulin MInfantMass ScreeningMiddle AgedReproducibility of ResultsSensitivity and SpecificityImmunoglobulin AImmunoglobulin GImmunoglobulin MDBSdried blood spotsELISAIg-DBS assayimmunoglobulinnephelometryprimary immunodeficiencyvalidation

Identifiers

PMID26275445
PMCPMC4572045
OpenAlexW1760328227

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.