Abstract
BackgroundTick-borne encephalitis (TBE) is a potentially severe neurological disease caused by TBE virus (TBEV). In Europe and Asia, TBEV infection has become a growing public health concern and requires fast and specific detection.AimIn this observational study, we evaluated a rapid TBE IgM test, ReaScan TBE, for usage in a clinical laboratory setting.MethodsPatient sera found negative or positive for TBEV by serological and/or molecular methods in diagnostic laboratories of five European countries endemic for TBEV (Estonia, Finland, Slovenia, the Netherlands and Sweden) were used to assess the sensitivity and specificity of the test. The patients’ diagnoses were based on other commercial or quality assured in-house assays, i.e. each laboratory’s conventional routine methods. For specificity analysis, serum samples from patients with infections known to cause problems in serology were employed. These samples tested positive for e.g. Epstein–Barr virus, cytomegalovirus and Anaplasma phagocytophilum, or for flaviviruses other than TBEV, i.e. dengue, Japanese encephalitis, West Nile and Zika viruses. Samples from individuals vaccinated against flaviviruses other than TBEV were also included. Altogether, 172 serum samples from patients with acute TBE and 306 TBE IgM negative samples were analysed.ResultsCompared with each laboratory’s conventional methods, the tested assay had similar sensitivity and specificity (99.4% and 97.7%, respectively). Samples containing potentially interfering antibodies did not cause specificity problems.ConclusionRegarding diagnosis of acute TBEV infections, ReaScan TBE offers rapid and convenient complementary IgM detection. If used as a stand-alone, it can provide preliminary results in a laboratory or point of care setting.
Highlights
Tick-borne encephalitis virus (TBEV) is the most important tick-transmitted virus causing human disease in Europe and Asia [1,2,3,4]
26 acute phase sera from Swedish patients with other flavivirus infections (22 DENV, 2 JEV, 2 WNV) and one serum sample from a YFV-vaccinated individual were analysed. These 27 samples were from individuals with no medical reason to check for TBE virus (TBEV) infection so they were not tested for TBE IgM prior to the analysis by ReaScan TBE in this study
Based on 141 locally-available samples prior testing TBEV IgM negative using the routine method for each laboratory in Finland, Slovenia and Sweden, a specificity of 97.9% (138/141) was found (Table 2 and Table 3)
Summary
Tick-borne encephalitis virus (TBEV) is the most important tick-transmitted virus causing human disease in Europe and Asia [1,2,3,4]. Several studies suggest that the case fatality rate for TBE caused by TBEV-Eur is 0–4% [1,7] by TBEV-Sib 2-3% [1,7] and by TBEV-FE 6–40% [1,3,7,8]. Tick-borne encephalitis (TBE) is a potentially severe neurological disease caused by TBE virus (TBEV). Serum samples from patients with infections known to cause problems in serology were employed. These samples tested positive for e.g. Epstein–Barr virus, cytomegalovirus and Anaplasma phagocytophilum, or for flaviviruses other than TBEV, i.e. dengue, Japanese encephalitis, West Nile and Zika viruses. If used as a stand-alone, it can provide preliminary results in a laboratory or point of care setting
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