文摘
Improved diagnostics are critical for optimally detecting and managing tick-borne encephalitis (TBE) infections, and therefore quality control measures are essential for both serological and molecular diagnostics. Two external quality assurance (EQA) studies were performed to assess the quality of serological and molecular diagnostics of TBE infections. For the EQA of serological diagnostics, each participating laboratory received a proficiency panel of freeze-dried human sera containing 7 TBE-positive samples, 3 negative samples, and 2 samples positive for heterologous flaviviruses. For the EQA of molecular diagnostics, panels of prepared human plasma samples comprising 8 samples spiked with RNA from different TBE virus strains of European, Siberian, and Far Eastern subtypes, 2 specificity controls with heterologous flaviviruses, and two negative control samples were distributed. A total of 46 invited expert laboratories from 28 European and non-European countries participated at least in one of these studies. Applying proficiency criteria, the number of participating laboratories who passed the minimum requirements for successful participation was 60 % for the EQA of serological (both IgM and IgG detection) and 48 % for the EQA of PCR diagnostics. The EQA studies provide information on the diagnostic quality of the participating laboratories and indicate that most of them need to improve their assays.
