In:
LaboratoriumsMedizin, Walter de Gruyter GmbH, Vol. 31, No. 2 ( 2007-04-01), p. 41-47
Abstract:
During the last two decades the laboratory diagnostics of virus infections has achieved essential importance. In addition to low-cost examinations, it is important for the doctor and patient to obtain fast and correct laboratory results. The correctness of the results depends on different factors. The suitability and efficiency of the test and/or examination procedure under consideration are of particular importance. According to the ISO 15189 “Medical laboratories – special requirements for quality and competence” and the guideline for in vitro diagnostic medical devices (IvD Directive) only tests and/or examination procedures may be used for which suitability and capability could be demonstrated. Requirements for suitability and efficiency or the so-called validation is only generally addressed in both documents. Therefore, a guideline for virus diagnostics has been developed where the requirements for validation are described in detail. The guideline distinguishes between the validation of commercial tests, in-house tests, and the different examination methods used in virus diagnostics.
Type of Medium:
Online Resource
ISSN:
1439-0477
,
0342-3026
DOI:
10.1515/JLM.2007.009
Language:
English
Publisher:
Walter de Gruyter GmbH
Publication Date:
2007
detail.hit.zdb_id:
2081704-6
detail.hit.zdb_id:
2909042-8
SSG:
15,3
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