ArticleClinical and vaccine immunology : CVI2009
Development and analytical validation of an immunoassay for quantifying serum anti-pertussis toxin antibodies resulting from Bordetella pertussis infection.
Article in Clinical and vaccine immunology : CVI, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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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
19 citing papers in PubMed, 39 citations in OpenAlex.
- A pangenome approach-based loop-mediated isothermal amplification assay for the specific and early detection of Bordetella pertussis.Scientific reports · 2023Article
- Article
- Association between the timing of maternal vaccination and newborns' anti-pertussis toxin antibody levels.Vaccine · 2019Article
- Multicenter Clinical Evaluation of the Automated AriesJournal of clinical microbiology · 2019Article
- Enzyme-linked immunosorbent assay for detecting anti-pertussis toxin antibody in mouse.Clinical and experimental vaccine research · 2019Article
- Association Between Third-Trimester Tdap Immunization and Neonatal Pertussis Antibody Concentration.JAMA · 2018Observational
- Pertussis and the Minnesota State Fair: Demonstrating a Novel Setting for Efficiently Conducting Seroepidemiologic Studies.Journal of community health · 2018Article
- Article
- Expanding Pertussis Epidemiology in 6 Latin America Countries through the Latin American Pertussis Project.Emerging infectious diseases · 2017Article
- Evaluation of Commercial Assays for Single-Point Diagnosis of Pertussis in the US.Journal of the Pediatric Infectious Diseases Society · 2017Article
- Risk Factors Associated With Bordetella pertussis Among Infants ≤4 Months of Age in the Pre-Tdap Era: United States, 2002-2005.The Pediatric infectious disease journal · 2017Article
- Laboratory Diagnosis of Pertussis.Clinical microbiology reviews · 2015Review
- Humoral responses to HIVconsv induced by heterologous vaccine modalities in rhesus macaques.Immunity, inflammation and disease · 2015Article
- Serodiagnosis as adjunct assay for pertussis infection in São Paulo, Brazil.Clinical and vaccine immunology : CVI · 2014Article
- Does tetanus-diphtheria-acellular pertussis vaccination interfere with serodiagnosis of pertussis infection?Clinical and vaccine immunology : CVI · 2012Article
- Prospective evaluation of an Australian pertussis toxin IgG and IgA enzyme immunoassay.Clinical and vaccine immunology : CVI · 2012Article
- Comparative study of different sources of pertussis toxin (PT) as coating antigens in IgG anti-PT enzyme-linked immunosorbent assays.Clinical and vaccine immunology : CVI · 2012Article
- Pertussis serodiagnosis in Belgium from 1990 to 2009.Clinical and vaccine immunology : CVI · 2011Article
- Performance of commercial enzyme-linked immunosorbent assays for detection of antibodies to Bordetella pertussis.Journal of clinical microbiology · 2010Article
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Adequately sensitive and specific methods to diagnose pertussis in adolescents and adults are not widely available. Currently, no Food and Drug Administration-approved diagnostic assays are available for the serodiagnosis of Bordetella pertussis. Since concentrations of B. pertussis-specific antibodies tend to be high during the later phases of disease, a simple, rapid, easily transferable serodiagnostic test was developed. This article describes test development, initial evaluation of a prototype kit enzyme-linked immunosorbent assay (ELISA) in an interlaboratory collaborative study, and analytical validation. The data presented here demonstrate that the kit met all prespecified criteria for precision, linearity, and accuracy for samples with anti-pertussis toxin (PT) immunoglobulin G (IgG) antibody concentrations in the range of 50 to 150 ELISA units (EU)/ml, the range believed to be most relevant for serodiagnosis. The assay met the precision and linearity criteria for a wider range, namely, from 50 to 200 EU/ml; however, the accuracy criterion was not met at 200 EU/ml. When the newly adopted World Health Organization International Standard for pertussis antiserum (human) reference reagent was used to evaluate accuracy, the accuracy criteria were met from 50 to 200 international units/ml. In conclusion, the IgG anti-PT ELISA met all assay validation parameters within the range considered most relevant for serodiagnosis. This ELISA was developed and analytically validated as a user-friendly kit that can be used in both qualitative and quantitative formats. The technology for producing the kit is transferable to public health laboratories.
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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.