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Multi-laboratory evaluation of ReaScan TBE IgM rapid test, 2016 to 2017.

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.

journal_name

Euro Surveill

journal_title

Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin

authors

Albinsson B,Jääskeläinen AE,Värv K,Jelovšek M,GeurtsvanKessel C,Vene S,Järhult JD,Reusken C,Golovljova I,Avšič-Županc T,Vapalahti O,Lundkvist Å

doi

10.2807/1560-7917.ES.2020.25.12.1900427

subject

Has Abstract

pub_date

2020-03-01 00:00:00

issue

12

eissn

1025-496X

issn

1560-7917

journal_volume

25

pub_type

杂志文章

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