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Multiplex Immunoassay for Lyme Disease Using VlsE1-IgG and pepC10-IgM Antibodies: Improving Test Performance through Bioinformatics ▿
- Publication Year :
- 2011
- Publisher :
- American Society for Microbiology, 2011.
-
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. Lyme disease (LD) is the most common vector-borne disease in the United States, with a reported incidence of nearly 35,000 new cases annually (10, 21). There are three disease stages: stage I is the early acute phase, characterized by a rash (erythema migrans [EM]) that occurs in at least 70% of patients; stage II represents early disseminated infection, including lymphocytic meningitis, cranial neuropathy, radiculopathy, and Lyme carditis; and stage III represents late disseminated
- Subjects :
- Microbiology (medical)
medicine.medical_specialty
Lipoproteins
Clinical Biochemistry
Immunology
Gastroenterology
Sensitivity and Specificity
Serology
Lyme disease
Bacterial Proteins
Internal medicine
medicine
Immunology and Allergy
Clinical Laboratory Immunology
Humans
Multiplex
Borrelia burgdorferi
Immunoassay
Antigens, Bacterial
Lyme Disease
biology
medicine.diagnostic_test
business.industry
Clinical Laboratory Techniques
biology.organism_classification
medicine.disease
Antibodies, Bacterial
Microspheres
Immunoglobulin M
ROC Curve
Immunoglobulin G
biology.protein
Population study
Antibody
business
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....ff8f018c82a6300612ea831a112175bb