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Microorganisms
Volume 8
Issue 3
10.3390/microorganisms8030457
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Article

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

by
Silvia Zannoli
1,*,
Michela Fantini
1,
Simona Semprini
1,
Barbara Marchini
1,
Barbara Ceccarelli
1,
Monica Sparacino
1,
Pasqua Schiavone
1,
Anna Belgrano
2,
Maurizio Ruscio
2,
Martina Gobbetti
3,
Maira Nicoletti
3,
Eva Robatscher
3,
Elisabetta Pagani
3 and
Vittorio Sambri
1,4
1
Unit of Microbiology, The Great Romagna Area Hub Laboratory, 47522 Pievesestina di Cesena (FC), Italy
2
Azienda Sanitaria Universitaria Integrata - Trieste (ASUIT) Laboratory, 34149 Trieste, Italy
3
Azienda Sanitaria Alto Adige-Bolzano Microbiology Laboratory, 39100 Bolzano, Italy
4
Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna, 40138 Bologna, Italy
*
Author to whom correspondence should be addressed.
Microorganisms 2020, 8(3), 457; https://doi.org/10.3390/microorganisms8030457
Submission received: 24 December 2019 / Revised: 23 February 2020 / Accepted: 20 March 2020 / Published: 24 March 2020
(This article belongs to the Special Issue Advance in Tick-Borne Diseases Research)
Versions Notes

Abstract

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.
Keywords: lyme disease; C6; Borrelia burgdorferi lyme disease; C6; Borrelia burgdorferi

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MDPI and ACS Style

Zannoli, S.; Fantini, M.; Semprini, S.; Marchini, B.; Ceccarelli, B.; Sparacino, M.; Schiavone, P.; Belgrano, A.; Ruscio, M.; Gobbetti, M.; et al. Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease. Microorganisms 2020, 8, 457. https://doi.org/10.3390/microorganisms8030457

AMA Style

Zannoli S, Fantini M, Semprini S, Marchini B, Ceccarelli B, Sparacino M, Schiavone P, Belgrano A, Ruscio M, Gobbetti M, et al. Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease. Microorganisms. 2020; 8(3):457. https://doi.org/10.3390/microorganisms8030457

Chicago/Turabian Style

Zannoli, Silvia, Michela Fantini, Simona Semprini, Barbara Marchini, Barbara Ceccarelli, Monica Sparacino, Pasqua Schiavone, Anna Belgrano, Maurizio Ruscio, Martina Gobbetti, and et al. 2020. "Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease" Microorganisms 8, no. 3: 457. https://doi.org/10.3390/microorganisms8030457

APA Style

Zannoli, S., Fantini, M., Semprini, S., Marchini, B., Ceccarelli, B., Sparacino, M., Schiavone, P., Belgrano, A., Ruscio, M., Gobbetti, M., Nicoletti, M., Robatscher, E., Pagani, E., & Sambri, V. (2020). Multicenter Evaluation of the C6 Lyme ELISA Kit for the Diagnosis of Lyme Disease. Microorganisms, 8(3), 457. https://doi.org/10.3390/microorganisms8030457

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