Evidence map›Paper›PMID 30257899›Full record

ArticleJournal of clinical microbiology2018

A Novel Sensitive Immunoassay Targeting the 5-Methylthio-d-Xylofuranose-Lipoarabinomannan Epitope Meets the WHO's Performance Target for Tuberculosis Diagnosis.

George B Sigal, Abraham Pinter, Todd L Lowary, Masanori Kawasaki, Andra Li, Anu Mathew, Michael Tsionsky, Ruixiang Blake Zheng, Tatiana Plisova, Ke Shen and 6 more

Open access · hybridAbstract readEvaluation Study
In one paragraph

Article in Journal of clinical microbiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 81 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 5 pooled it
8.7field-weighted citation impact, top 1% 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

81 citing papers in PubMed, 5 syntheses or guidelines pooled it, 122 citations in OpenAlex.

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  18. Exploiting thioether reactivity to label mycobacterial glycans.Proceedings of the National Academy of Sciences of the United States of America · 2025
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  20. Observational

21 more citing papers are in PubMed but not listed here.

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

16 authors at 7 institutions in 4 countries.

George B SigalMeso Scale Diagnostics, LLC, Rockville, Maryland, USA.
Abraham PinterPublic Health Research Institute Center, New Jersey Medical School, Rutgers University, Newark, New Jersey, USA.
Todd L LowaryDepartment of Chemistry, Alberta Glycomics Centre, University of Alberta, Edmonton, AB, Canada.
Masanori KawasakiOtsuka Pharmaceutical Co., Ltd., Tokyo, Japan.
Andra LiImmunoprecise Antibodies Ltd., Victoria, British Columbia, Canada.
Anu MathewMeso Scale Diagnostics, LLC, Rockville, Maryland, USA.
Michael TsionskyMeso Scale Diagnostics, LLC, Rockville, Maryland, USA.
Ruixiang Blake ZhengDepartment of Chemistry, Alberta Glycomics Centre, University of Alberta, Edmonton, AB, Canada.
Tatiana PlisovaMeso Scale Diagnostics, LLC, Rockville, Maryland, USA.
Ke ShenDepartment of Chemistry, Alberta Glycomics Centre, University of Alberta, Edmonton, AB, Canada.
Kiyonori KatsuragiOtsuka Pharmaceutical Co., Ltd., Tokyo, Japan.
Alok ChoudharyPublic Health Research Institute Center, New Jersey Medical School, Rutgers University, Newark, New Jersey, USA.
William J HonnenPublic Health Research Institute Center, New Jersey Medical School, Rutgers University, Newark, New Jersey, USA.
Payam NahidDivision of Pulmonary and Critical Care Medicine, University of California, San Francisco, San Francisco, California, USA.
Claudia M DenkingerFIND, Geneva, Switzerland.
Tobias BrogerFIND, Geneva, Switzerland tobias.broger@finddx.org.ORCID 0000-0002-7959-1055
Meso Scale Discovery (United States) · USRutgers, The State University of New Jersey · USUniversity of Alberta · CAFIND · CHOtsuka (Japan) · JPImmunoPrecise (Canada) · CAUniversity of California, San Francisco · US

Funding

TB Surrogate Markers for Assessing Reponse to Treatment (TB SMART Study)R01AI104589 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI NAHID, PAYAM, SIGAL, GEORGE B · 2013 to 2017
$6.2M
NIAID NIH HHS R01 AI104589
6 · The paper itself

Abstract

The only currently commercialized point-of-care assay for tuberculosis (TB) that measures lipoarabinomannan (LAM) in urine (Alere LF-LAM) has insufficient sensitivity. We evaluated the potential of 100 novel monoclonal antibody pairs targeting a variety of LAM epitopes on a sensitive electrochemiluminescence platform to improve the diagnostic accuracy. In the screening, many antibody pairs showed high reactivity to purified LAM but performed poorly at detecting urinary LAM in clinical samples, suggesting differences in antigen structure and immunoreactivity of the different LAM sources. The 12 best antibody pairs from the screening were tested in a retrospective case-control study with urine samples from 75 adults with presumptive TB. The best antibody pair reached femtomolar analytical sensitivity for LAM detection and an overall clinical sensitivity of 93% (confidence interval [CI], 80% to 97%) and specificity of 97% (CI, 85% to 100%). Importantly, in HIV-negative subjects positive for TB by sputum smear microscopy, the test achieved a sensitivity of 80% (CI, 55% to 93%). This compares to an overall sensitivity of 33% (CI, 20% to 48%) of the Alere LF-LAM and a sensitivity of 13% (CI, 4% to 38%) in HIV-negative subjects in the same sample set. The capture antibody targets a unique 5-methylthio-d-xylofuranose (MTX)-dependent epitope in LAM that is specific to the

Indexed as

ImmunoassayAdultAIDS-Related Opportunistic InfectionsAntibodies, BacterialAntibodies, MonoclonalAntigens, BacterialCase-Control StudiesDiagnostic Tests, RoutineEpitopesFemaleHumansLipopolysaccharidesMaleMiddle AgedMycobacterium tuberculosisPoint-of-Care SystemsAntibodies, BacterialAntibodies, MonoclonalAntigens, BacterialEpitopeslipoarabinomannanLipopolysaccharidesbiomarkerdiagnosticsimmunoassayslipoarabinomannantuberculosis

Identifiers

PMID30257899
PMCPMC6258851
OpenAlexW2902078840

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.