Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease

Autor: Silvia Zannoli, Michela Fantini, Simona Semprini, Barbara Marchini, Barbara Ceccarelli, Monica Sparacino, Pasqua Schiavone, Anna Belgrano, Maurizio Ruscio, Martina Gobbetti, Maira Nicoletti, Eva Robatscher, Elisabetta Pagani, Vittorio Sambri
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Microorganisms, Vol 8, Iss 3, p 457 (2020)
Druh dokumentu: article
ISSN: 2076-2607
DOI: 10.3390/microorganisms8030457
Popis: 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.
Databáze: Directory of Open Access Journals