Evidence map›Paper›PMID 21367982›Full record

ArticleClinical and vaccine immunology : CVI2011

Multiplex immunoassay for Lyme disease using VlsE1-IgG and pepC10-IgM antibodies: improving test performance through bioinformatics.

Richard B Porwancher, C Greg Hagerty, Jianqing Fan, Lisa Landsberg, Barbara J B Johnson, Mark Kopnitsky, Allen C Steere, Karen Kulas, Susan J Wong

Open access · diamondAbstract readComparative StudyEvaluation Study
In one paragraph

Article in Clinical and vaccine immunology : CVI, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 9% 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

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 67 citations in OpenAlex.

  1. Pooled it
  2. Borrelia surface proteins: new horizons in Lyme disease diagnosis.Applied microbiology and biotechnology · 2025
    Review
  3. Article
  4. Article
  5. Review
  6. Observational
  7. Review
  8. Review
  9. Diagnostic performance of the ZEUS Borrelia VlsE1/pepC10 assay in European LB patients: a case-control study.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2022
    Article
  10. Quantitative multiplexed strategies for human Lyme disease serological testing.Experimental biology and medicine (Maywood, N.J.) · 2021
    Review
  11. Laboratory Diagnosis of Lyme Borreliosis.Clinical microbiology reviews · 2021
    Review
  12. Article
  13. Human and Veterinary Vaccines for Lyme Disease.Current issues in molecular biology · 2021
    Article
  14. Emerging Tick-Borne Diseases.Clinical microbiology reviews · 2020
    Review
  15. Article
  16. Mechanisms of Dysregulated Antibody Response in Lyme Disease.Frontiers in cellular and infection microbiology · 2020
    Article
  17. Review
  18. Article
  19. Article
  20. 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

9 authors at 6 institutions in 1 country.

Richard B PorwancherDepartment of Medicine, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, Piscataway, NJ, USA. porwancher@aol.com
C Greg Hagerty
Jianqing Fan
Lisa Landsberg
Barbara J B Johnson
Mark Kopnitsky
Allen C Steere
Karen Kulas
Susan J Wong
Infectious Disease Consultants · USNew York State Department of Health · USCenters for Disease Control and Prevention · USHarvard University · USPrinceton University · USZeus Scientific (United States) · US

Funding

Statistical Methods for Ultrahigh-dimensional Biomedical DataR01GM072611 · NIGMS · PRINCETON UNIVERSITY · PI CATTANEO, MATIAS DAMIAN · 2006 to 2021
$4.2M
Improving Lyme disease diagnosis through bioinformaticsR43AI069564 · NIAID · INFECTIOUS DISEASE CONSULTANTS, PC · PI PORWANCHER, RICHARD B. · 2006 to 2008
$238k
NIAID NIH HHS 1R43AI069564-01NIAID NIH HHS 1R43AI069564-01S1NIAID NIH HHS R43 AI069564NIGMS NIH HHS R01 GM072611
6 · The paper itself

Abstract

The Centers for Disease Control and Prevention currently recommends a 2-tier serologic approach to Lyme disease laboratory diagnosis, comprised of an initial serum enzyme immunoassay (EIA) for antibody to Borrelia burgdorferi followed by supplementary IgG and IgM Western blotting of EIA-positive or -equivocal samples. Western blot accuracy is limited by subjective interpretation of weakly positive bands, false-positive IgM immunoblots, and low sensitivity for detection of early disease. We developed an objective alternative second-tier immunoassay using a multiplex microsphere system that measures VlsE1-IgG and pepC10-IgM antibodies simultaneously in the same sample. Our study population comprised 79 patients with early acute Lyme disease, 82 patients with early-convalescent-phase disease, 47 patients with stage II and III disease, 34 patients post-antibiotic treatment, and 794 controls. A bioinformatic technique called partial receiver-operator characteristic (ROC) regression was used to combine individual antibody levels into a single diagnostic score with a single cutoff; this technique enhances test performance when a high specificity is required (e.g., ≥ 95%). Compared to Western blotting, the multiplex assay was equally specific (95.6%) but 20.7% more sensitive for early-convalescent-phase disease (89.0% versus 68.3%, respectively; 95% confidence interval [95% CI] for difference, 12.1% to 30.9%) and 12.5% more sensitive overall (75.0% versus 62.5%, respectively; 95% CI for difference, 8.1% to 17.1%). As a second-tier test, a multiplex assay for VlsE1-IgG and pepC10-IgM antibodies performed as well as or better than Western blotting for Lyme disease diagnosis. Prospective validation studies appear to be warranted.

Indexed as

Antibodies, BacterialAntigens, BacterialBacterial ProteinsClinical Laboratory TechniquesHumansImmunoassayImmunoglobulin GImmunoglobulin MLipoproteinsLyme DiseaseMicrospheresROC CurveSensitivity and SpecificityAntibodies, BacterialAntigens, BacterialBacterial ProteinsImmunoglobulin GImmunoglobulin MLipoproteinsVlsE protein, Borrelia burgdorferi

Identifiers

PMID21367982
PMCPMC3122529
OpenAlexW2104166053

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.