Article ; Online: Accréditation des cryoglobulines : retour d’expérience du CHU de Lyon.
2021 Volume 79, Issue 2, Page(s) 190–195
Abstract: Research and identification of a serum cryoglobulin is a current laboratory test. This analysis is complex to accredit due to, firstly, very strict pre-analytical requirements, secondly, lack of standardization between laboratories in carrying out the ... ...
Title translation | Accreditation of cryoglobulins: Experience of CHU of Lyon. |
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Abstract | Research and identification of a serum cryoglobulin is a current laboratory test. This analysis is complex to accredit due to, firstly, very strict pre-analytical requirements, secondly, lack of standardization between laboratories in carrying out the different phases of sampling until results validation. The method validation of this analysis, carried out to meet requirements of the NF EN ISO 15189 standard, is a complex process divided into three sub-processes: cryoglobulin research including detection and isolation of cryoprecipitate, typing by immunofixation and quantification of cryoglobulin by immunoglobulin assays. This work made it possible, thanks to the development of a risk matrix taking into account all pre-analytical, analytical and post-analytical phases, to stress the importance of technical proficiency and management of critical equipment . With this approach, the laboratory also checked homogeneity of results validation practices. |
MeSH term(s) | Accreditation ; Cryoglobulins ; Humans ; Laboratories ; Reference Standards ; Research Design |
Chemical Substances | Cryoglobulins |
Language | French |
Publishing date | 2021-03-26 |
Publishing country | France |
Document type | Journal Article |
ZDB-ID | 418098-7 |
ISSN | 1950-6112 ; 0003-3898 |
ISSN (online) | 1950-6112 |
ISSN | 0003-3898 |
DOI | 10.1684/abc.2021.1631 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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