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Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease
Lyme disease (LD), caused by infection with Borrelia burgdorferi, is the most common tick-borne infection in many regions of Eurasia. Antibody detection is the most frequently used laboratory test, favoring a two-step serodiagnostic algorithm; immunoenzymatic detection of antibodies to C6 has been s...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7143974/ https://www.ncbi.nlm.nih.gov/pubmed/32213811 http://dx.doi.org/10.3390/microorganisms8030457 |
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author | Zannoli, Silvia Fantini, Michela Semprini, Simona Marchini, Barbara Ceccarelli, Barbara Sparacino, Monica Schiavone, Pasqua Belgrano, Anna Ruscio, Maurizio Gobbetti, Martina Nicoletti, Maira Robatscher, Eva Pagani, Elisabetta Sambri, Vittorio |
author_facet | Zannoli, Silvia Fantini, Michela Semprini, Simona Marchini, Barbara Ceccarelli, Barbara Sparacino, Monica Schiavone, Pasqua Belgrano, Anna Ruscio, Maurizio Gobbetti, Martina Nicoletti, Maira Robatscher, Eva Pagani, Elisabetta Sambri, Vittorio |
author_sort | Zannoli, Silvia |
collection | PubMed |
description | Lyme disease (LD), caused by infection with Borrelia burgdorferi, is the most common tick-borne infection in many regions of Eurasia. Antibody detection is the most frequently used laboratory test, favoring a two-step serodiagnostic algorithm; immunoenzymatic detection of antibodies to C6 has been shown to perform similarly to a standard two-step workflow. The aim of this study was the performance evaluation of the C6 Lyme ELISA kit compared to a standard two-step algorithm in three laboratories located in the northeastern region of Italy which cater to areas with different LD epidemiology. A total of 804 samples were tested, of which 695 gave concordant results between C6 testing and routine workflow (564 negative, 131 positive). Wherever available, clinical presentation and additional laboratory tests were analyzed to solve discrepancies. The C6 based method showed a good concordance with the standard two-step algorithm (Cohen’s κ = 0.619), however, the distribution of discrepancies seems to point towards a slightly lower specificity of C6 testing, which is supported by literature and could impact on patient management. The C6 ELISA, therefore, is not an ideal stand-alone test; however, if integrated into a two-step algorithm, it might play a part in achieving a sensitive, specific laboratory diagnosis of LD. |
format | Online Article Text |
id | pubmed-7143974 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-71439742020-04-13 Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease Zannoli, Silvia Fantini, Michela Semprini, Simona Marchini, Barbara Ceccarelli, Barbara Sparacino, Monica Schiavone, Pasqua Belgrano, Anna Ruscio, Maurizio Gobbetti, Martina Nicoletti, Maira Robatscher, Eva Pagani, Elisabetta Sambri, Vittorio Microorganisms Article Lyme disease (LD), caused by infection with Borrelia burgdorferi, is the most common tick-borne infection in many regions of Eurasia. Antibody detection is the most frequently used laboratory test, favoring a two-step serodiagnostic algorithm; immunoenzymatic detection of antibodies to C6 has been shown to perform similarly to a standard two-step workflow. The aim of this study was the performance evaluation of the C6 Lyme ELISA kit compared to a standard two-step algorithm in three laboratories located in the northeastern region of Italy which cater to areas with different LD epidemiology. A total of 804 samples were tested, of which 695 gave concordant results between C6 testing and routine workflow (564 negative, 131 positive). Wherever available, clinical presentation and additional laboratory tests were analyzed to solve discrepancies. The C6 based method showed a good concordance with the standard two-step algorithm (Cohen’s κ = 0.619), however, the distribution of discrepancies seems to point towards a slightly lower specificity of C6 testing, which is supported by literature and could impact on patient management. The C6 ELISA, therefore, is not an ideal stand-alone test; however, if integrated into a two-step algorithm, it might play a part in achieving a sensitive, specific laboratory diagnosis of LD. MDPI 2020-03-24 /pmc/articles/PMC7143974/ /pubmed/32213811 http://dx.doi.org/10.3390/microorganisms8030457 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Zannoli, Silvia Fantini, Michela Semprini, Simona Marchini, Barbara Ceccarelli, Barbara Sparacino, Monica Schiavone, Pasqua Belgrano, Anna Ruscio, Maurizio Gobbetti, Martina Nicoletti, Maira Robatscher, Eva Pagani, Elisabetta Sambri, Vittorio Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease |
title | Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease |
title_full | Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease |
title_fullStr | Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease |
title_full_unstemmed | Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease |
title_short | Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease |
title_sort | multicenter evaluation of the c6 lyme elisa kit for the diagnosis of lyme disease |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7143974/ https://www.ncbi.nlm.nih.gov/pubmed/32213811 http://dx.doi.org/10.3390/microorganisms8030457 |
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