Accréditation de la mesure de l’expression des molécules HLA-DR à la surface des monocytes (mHLA-DR) par cytométrie en flux (notice n° 276397)
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| fixed length control field | 04400cam a2200373 4500500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250117193807.0 |
| 041 ## - LANGUAGE CODE | |
| Language code of text/sound track or separate title | fre |
| 042 ## - AUTHENTICATION CODE | |
| Authentication code | dc |
| 100 10 - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Frugier, Audrey |
| Relator term | author |
| 245 00 - TITLE STATEMENT | |
| Title | Accréditation de la mesure de l’expression des molécules HLA-DR à la surface des monocytes (mHLA-DR) par cytométrie en flux |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Date of publication, distribution, etc. | 2022.<br/> |
| 500 ## - GENERAL NOTE | |
| General note | 3 |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Introduction. Le niveau d’expression des molécules HLA-DR à la surface des monocytes (mHLA-DR) est un marqueur diagnostique utilisé pour évaluer l’immunité des patients en réanimation (choc septique, polytraumatisés, brulures, greffe et plus récemment Covid-19). Il est également utilisé comme un outil de stratification dans les essais cliniques utilisant des thérapies immunostimulantes chez ces patients. L’objectif de cette étude était d’évaluer les performances analytiques d’une méthode de cytométrie en flux pour mesurer mHLA-DR afin de répondre aux exigences de la norme NF EN ISO 15189 dans le cadre de l’accréditation des laboratoires de biologie médicale. Matériels et méthodes. L’évaluation (performances de la technique, étendue de la mesure, comparaison de méthode) a été menée en suivant le SH GTA 04, guide recommandé par le Comité français d’accréditation (COFRAC). En complément, certaines conditions pré analytiques ont été ré-évaluées. Résultats. L’ensemble des coefficients de variation évaluant les performances étaient inférieurs à 10 % (répétabilité, reproductibilité, variabilité interopérateur). Les limites de quantification et de linéarité étaient adaptées à l’utilisation clinique du paramètre. Les résultats étaient identiques quel que soit le type et le fournisseur de cytomètre en flux. Les contraintes de conservation pré-analytiques des échantillons ont été confirmées. Conclusion. Les résultats étaient conformes aux exigences de qualité recommandées par le COFRAC. Ils permettent l’accréditation de la mesure de mHLA-DR par cytométrie en flux et son utilisation en soins courants. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Introduction. The level of expression of HLA-DR molecules on monocyte surface (mHLA-DR) is a diagnostic marker used to assess immune functions of critically ill patients in intensive care units (septic shock, trauma, burns, transplant and more recently Covid-19). It is also used as a stratification tool in clinical trials assessing immunostimulatory therapies for these patients. The objective of this study was to verify the analytical performances of a flow cytometry method to assess mHLA-DR in order to ensure it can reach requirements for NF EN ISO 15189 accreditation which are mandatory for its use, as a clinical parameter, in immunology or hematology laboratories in France. Materials and methods. The analytical performances (precision, range limits, method comparison) were assessed according to SH GTA 04 from French Accreditation Committee (COFRAC). At the same time, the importance of storage conditions before and after cell labelling was studied. Results. Regarding precision, coefficients of variation were < 10% (repeatability, reproducibility, inter-operator variability). Range limits were found to be suitable for clinical decision making thresholds. In method comparison, there was no difference regarding results obtained from different flow cytometers coming from different companies. Pre-analytical constraints were confirmed with regard to previous literature. Conclusion. The mHLA-DR results, obtained by flow cytometry, fulfilled requirements of NF EN ISO 15189 accreditation. |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | accréditation |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | HLA-DR |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | sepsis |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | monocyte |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | cytométrie en flux |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | HLA-DR |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | sepsis |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | monocyte |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | flow cytometry |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | accreditation |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Malcus, Christophe |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Baume, Maud |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Poitevin-Later, Françoise |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Lukaszewicz, Anne-Claire |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Venet, Fabienne |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Monneret, Guillaume |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Gossez, Morgane |
| Relator term | author |
| 786 0# - DATA SOURCE ENTRY | |
| Note | Annales de Biologie Clinique | 80 | 2 | 2022-03-01 | p. 190-198 | 0003-3898 |
| 856 41 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://shs.cairn.info/revue-annales-de-biologie-clinique-2022-2-page-190?lang=fr&redirect-ssocas=7080">https://shs.cairn.info/revue-annales-de-biologie-clinique-2022-2-page-190?lang=fr&redirect-ssocas=7080</a> |
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