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 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.

Carbapenemase-producing Enterobacteriaceae during 2011-12 in the Bolzano area (Northern Italy): increasing diversity in a low-endemicity setting.

The recent (2011-2012) distribution of carbapenemase determinants in Enterobacteriaceae was studied in the Bolzano area (Northern Italy). Low proportions of carbapenemase producers were found for Escherichia coli (0.2%), Citrobacter freundii (1.1%), Klebsiella pneumoniae (1.3%), Klebsiella oxytoca (1.6%) and Enterobacter spp (1.8%). Although VIM-1 remained the most common carbapenemase, the emergence of K. pneumoniae producing KPC-3 and of E. coli producing OXA-48 was observed. Of concern is the spread of the hyperepidemic strains E. coli ST131 producing VIM-1 and K. pneumoniae ST258 producing KPC-3. Low essential and category agreements between the reference broth microdilution and commercial methods were observed for carbapenems.