ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016
Evaluation of the C6 Lyme Enzyme Immunoassay for the Diagnosis of Lyme Disease in Children and Adolescents.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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.
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.
Who cites it
17 citing papers in PubMed, 38 citations in OpenAlex.
- 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
- Direct Detection of Lyme Borrelia: Recent Advancement and Use of Aptamer Technology.Biomedicines · 2023Review
- Seroprevalence and Risk Factors of Lyme Borreliosis in The Netherlands: A Population-Based Cross-Sectional Study.Microorganisms · 2023Article
- Circulating antibody-secreting cells are a biomarker for early diagnosis in patients with Lyme disease.PloS one · 2023Observational
- Evaluation of 2 ELISAs to determineJournal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, Inc · 2021Article
- Performance of a Modified Two-Tiered Testing Enzyme Immunoassay Algorithm for Serologic Diagnosis of Lyme Disease in Nova Scotia.Journal of clinical microbiology · 2020Article
- Modified two-tiered testing algorithm for Lyme disease serology: the Canadian context.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2020Review
- Evaluation of the Modified Two-Tiered Testing Method for Diagnosis of Lyme Disease in Children.Journal of clinical microbiology · 2019Article
- Positive 2-Tiered Lyme Disease Serology is Uncommon in Asymptomatic Children Living in Endemic Areas of the United States.The Pediatric infectious disease journal · 2019Article
- Revisiting the Lyme Disease Serodiagnostic Algorithm: the Momentum Gathers.Journal of clinical microbiology · 2018Article
- Evaluation of a sequential enzyme immunoassay testing algorithm for Lyme disease demonstrates lack of test independence but high diagnostic specificity.Diagnostic microbiology and infectious disease · 2018Article
- A Community Study ofHealthcare (Basel, Switzerland) · 2018Article
- Article
- Article
- When a patient suspected with juvenile idiopathic arthritis turns out to be diagnosed with an infectious disease - a review of Lyme arthritis in children.Pediatric rheumatology online journal · 2017Review
- Evaluation of Modified 2-Tiered Serodiagnostic Testing Algorithms for Early Lyme Disease.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundThe commercially-available C6 Lyme enzyme immunoassay (EIA) has been approved to replace the standard whole-cell sonicate EIA as a first-tier test for the diagnosis of Lyme disease and has been suggested as a stand-alone diagnostic. However, the C6 EIA has not been extensively studied in pediatric patients undergoing evaluation for Lyme disease.
methodsWe collected discarded serum samples from children and adolescents (aged ≤21 years) undergoing conventional 2-tiered testing for Lyme disease at a single hospital-based clinical laboratory located in an area endemic for Lyme disease. We performed a C6 EIA on all collected specimens, followed by a supplemental immunoblot if the C6 EIA result was positive but the whole-cell sonicate EIA result was negative. We defined a case of Lyme disease as either a clinician-diagnosed erythema migrans lesion or a positive standard 2-tiered serologic result in a patient with symptoms compatible with Lyme disease. We then compared the performance of the C6 EIA alone and as a first-tier test followed by immunoblot, with that of standard 2-tiered serology for the diagnosis of Lyme disease.
resultsOf the 944 specimens collected, 114 (12%) were from patients with Lyme disease. The C6 EIA alone had sensitivity similar to that of standard 2-tiered testing (79.8% vs 81.6% for standard 2-tiered testing; P = .71) with slightly lower specificity (94.2% vs 98.8% 2; P < .002). Addition of a supplemental immunoblot improved the specificity of the C6 EIA to 98.6%.
conclusionsFor children and adolescents undergoing evaluation for Lyme disease, the C6 EIA could guide initial clinical decision making, although a supplemental immunoblot should still be performed.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.