ArticleDiagnostic microbiology and infectious disease2013
Single-tier testing with the C6 peptide ELISA kit compared with two-tier testing for Lyme disease.
Article in Diagnostic microbiology and infectious disease, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
73 citing papers in PubMed, 1 synthesis or guideline pooled it, 159 citations in OpenAlex.
- The Accuracy of Diagnostic Tests for Lyme Disease in Humans, A Systematic Review and Meta-Analysis of North American Research.PloS one · 2016Pooled it
- Lyme borreliosis.Nature reviews. Disease primers · 2026Review
- A novel single-tier serologic test to diagnose all stages of Lyme disease.Journal of clinical microbiology · 2025Article
- Comparison of the Serodiagnostic Accuracy Tests for Lyme Disease in Adults and Children: A Network Meta-Analysis.Pathogens (Basel, Switzerland) · 2025Review
- Article
- Current and emerging approaches for eliminatingFrontiers in microbiology · 2024Review
- Antibody Cross-Reactivity in Serodiagnosis of Lyme Disease.Antibodies (Basel, Switzerland) · 2023Review
- Profiling disease burden and Borrelia seroprevalence in Canadians with complex and chronic illness.PloS one · 2023Article
- Neuropsychiatric Symptoms and Tick-Borne Diseases.Current topics in behavioral neurosciences · 2023Article
- Evolution of theMicrobiology spectrum · 2022Article
- Multicenter Clinical Evaluation of Modified Two-Tiered Testing Algorithms for Lyme Disease Using Zeus Scientific Commercial Assays.Journal of clinical microbiology · 2022Article
- 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 · 2022Article
- Single-cell immunophenotyping of the skin lesion erythema migrans identifies IgM memory B cells.JCI insight · 2021Article
- Laboratory Diagnosis of Lyme Borreliosis.Clinical microbiology reviews · 2021Review
- Lyme Disease in Humans.Current issues in molecular biology · 2021Article
- Optimizing use of multi-antibody assays for Lyme disease diagnosis: A bioinformatic approach.PloS one · 2021Article
- Lessons Learned from a Rhode Island Academic Out-Patient Lyme and Tick-Borne Disease Clinic.Rhode Island medical journal (2013) · 2020Article
- Diagnostic parameters of modified two-tier testing in European patients with early Lyme disease.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2020Article
- Expanding Access to Biospecimens for Lyme Disease Test Development.Journal of clinical microbiology · 2020Article
- Measurement of Organ-Specific and Acute-Phase Blood Protein Levels in Early Lyme Disease.Journal of proteome research · 2020Article
13 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
10 authors at 7 institutions in 1 country.
Funding
Abstract
For the diagnosis of Lyme disease, the 2-tier serologic testing protocol for Lyme disease has a number of shortcomings including low sensitivity in early disease; increased cost, time, and labor; and subjectivity in the interpretation of immunoblots. In this study, the diagnostic accuracy of a single-tier commercial C6 ELISA kit was compared with 2-tier testing. The results showed that the C6 ELISA was significantly more sensitive than 2-tier testing with sensitivities of 66.5% (95% confidence interval [CI] 61.7-71.1) and 35.2% (95% CI 30.6-40.1), respectively (P < 0.001) in 403 sera from patients with erythema migrans. The C6 ELISA had sensitivity statistically comparable to 2-tier testing in sera from Lyme disease patients with early neurologic manifestations (88.6% versus 77.3%, P = 0.13) or arthritis (98.3% versus 95.6%, P = 0.38). The specificities of C6 ELISA and 2-tier testing in over 2200 blood donors, patients with other conditions, and Lyme disease vaccine recipients were found to be 98.9% and 99.5%, respectively (P < 0.05, 95% CI surrounding the 0.6 percentage point difference of 0.04 to 1.15). In conclusion, using a reference standard of 2-tier testing, the C6 ELISA as a single-step serodiagnostic test provided increased sensitivity in early Lyme disease with comparable sensitivity in later manifestations of Lyme disease. The C6 ELISA had slightly decreased specificity. Future studies should evaluate the performance of the C6 ELISA compared with 2-tier testing in routine clinical practice.
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Registered trials
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