Spotlights on the trends in performance assessment of qualitative in vitro diagnostic medical devices in transfusion medicine.
Transfus Apher Sci
; 63(2): 103887, 2024 Apr.
Article
in En
| MEDLINE
| ID: mdl-38310031
ABSTRACT
For reliable clinical decisions in transfusion medicine, assessing the performance of qualitative tests performed in medical laboratories is critical. When false results are reported, these can lead to an adverse reaction to blood components. Good performance assessment practices are essential for this kind of scenario, and they still remain as one of the many unmet high-priority challenges in this area. This paper aims to provide an overview of the current trends in this field. A review of the IFCC-IUPC. qualitative vocabulary was carried out, and a particular focus was given to the evaluation protocols CLSI EP12-A3 and Eurachem AQA, such as the European Union Regulation for class D in vitro diagnostic medical devices. There is a consistency between the current protocols and recognized performance assessment principles, which are mandatory in transfusion service labs. We believe that a revised imprecision interval approach and models based on emerging qualitative test types may prove beneficial in the long run. It is also important to emphasize the uncertainty of proportions to mitigate the risk of misclassification.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Reagent Kits, Diagnostic
/
Transfusion Medicine
Type of study:
Diagnostic_studies
/
Guideline
/
Prognostic_studies
/
Qualitative_research
Limits:
Humans
Language:
En
Journal:
Transfus Apher Sci
Journal subject:
HEMATOLOGIA
Year:
2024
Type:
Article