Evidence map›Paper›PMID 33762363›Full record

ArticleJournal of clinical microbiology2021

Comparative Performance of Latest-Generation and FDA-Cleared Serology Tests for the Diagnosis of Chagas Disease.

Emily A Kelly, Christina A Bulman, Emma L Gunderson, Amanda M Irish, Rebecca L Townsend, Judy A Sakanari, Susan L Stramer, Caryn Bern, Jeffrey D Whitman

Open access · greenAbstract read
In one paragraph

Article in Journal of clinical microbiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
4.8field-weighted citation impact, top 4% 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

22 citing papers in PubMed, 39 citations in OpenAlex.

  1. Evaluation of Chagas TESA VirClia assay for chronicJournal of clinical microbiology · 2026
    Article
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  3. Article
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  7. Identification of highly conservedEmerging microbes & infections · 2024
    Article
  8. Review
  9. Article
  10. Review
  11. Frontiers in microbiology · 2024
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Laboratory diagnosis ofFrontiers in parasitology · 2023
    Review
  18. Article
  19. Article
  20. Review
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

9 authors at 2 institutions in 1 country.

Emily A KellySchool of Medicine, University of California, San Francisco, San Francisco, California, USA.
Christina A BulmanDepartment of Pharmaceutical Chemistry, University of California, San Francisco, San Francisco, California, USA.
Emma L GundersonDepartment of Pharmaceutical Chemistry, University of California, San Francisco, San Francisco, California, USA.
Amanda M IrishDepartment of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA.
Rebecca L TownsendScientific Affairs, American Red Cross, Gaithersburg, Maryland, USA.
Judy A SakanariDepartment of Pharmaceutical Chemistry, University of California, San Francisco, San Francisco, California, USA.
Susan L StramerScientific Affairs, American Red Cross, Gaithersburg, Maryland, USA.
Caryn BernDepartment of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California, USA caryn.bern2@ucsf.edu Jeffrey.whitman@ucsf.edu.
Jeffrey D WhitmanDepartment of Laboratory Medicine, University of California, San Francisco, San Francisco, California, USA caryn.bern2@ucsf.edu Jeffrey.whitman@ucsf.edu.
University of California, San Francisco · USAmerican Red Cross · US

Funding

Host-parasite lipid metabolism in Trypanosoma cruzi-infected cardiac myocytesK38HL154203 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI WHITMAN, JEFFREY DOMINICK · 2020 to 2021
$227k
NHLBI NIH HHS K38 HL154203
6 · The paper itself

Abstract

Confirmed diagnosis of chronic Chagas disease (CD) requires positive results by two different IgG serology tests. Variable sensitivity has been reported among tests and in different geographic regions. Inadequate specificity presents a particular challenge in low-prevalence settings such as the United States. This study provides a direct comparison of the latest-generation IgG serology assays with four previously assessed FDA-cleared tests. Seven hundred ten blood donor plasma specimens were evaluated by Wiener Lisado and Wiener v.4.0 enzyme-linked immunosorbent assays (ELISAs) and Abbott PRISM Chagas chemiluminescent assay (ChLIA). Sensitivity and specificity were assessed relative to infection status as determined by the original blood donation testing algorithm. All three latest-generation assays demonstrated 100% specificity (95% confidence interval [CI], 98.6 to 100.0). Wiener Lisado, Wiener v.4.0, and Abbott PRISM had sensitivities of 97.1% (95% CI, 95.1 to 98.4), 98.9% (95% CI, 97.4 to 99.6), and 95.5% (95% CI, 93.2 to 97.3), respectively. As with previously evaluated FDA-cleared tests, all three assays had the highest reactivity and sensitivity in samples from donors born in South America and lowest reactivity and sensitivity in specimens from those born in Mexico, with intermediate results in specimens from Central American donors. Wiener v.4.0 had the highest diagnostic sensitivity in all comparisons. Our findings suggest that the latest-generation CD serology tests could improve diagnostic sensitivity without affecting specificity.

Indexed as

Chagas DiseaseTrypanosoma cruziAntibodies, ProtozoanEnzyme-Linked Immunosorbent AssayHumansMexicoSensitivity and SpecificitySerologic TestsSouth AmericaAntibodies, ProtozoanChagas diseaseclinical diagnosticsdiagnosticsserologyTrypanosoma cruzi

Identifiers

PMID33762363
PMCPMC8316041
OpenAlexW3139444930

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.