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

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

Lyme disease (LD), caused by infection with , 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 simi...

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Bibliographic Details
Published in:Microorganisms (Basel) Vol. 8; no. 3; p. 457
Main Authors: 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
Format: Journal Article
Language:English
Published: Switzerland MDPI AG 24-03-2020
MDPI
Subjects:
Agreements
Algorithms
Antibodies
borrelia burgdorferi
Diagnosis
Enzyme-linked immunosorbent assay
Enzymes
Epidemiology
Immunoassay
Immunoglobulins
Infections
Laboratories
Laboratory tests
Lyme disease
Performance evaluation
Vector-borne diseases
Workflow
United States > US
Italy
Europe
lyme disease
Borrelia burgdorferi
C6
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Summary:Lyme disease (LD), caused by infection with , 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.
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ISSN:2076-2607
2076-2607
DOI:10.3390/microorganisms8030457