Analytical performance evaluation of a new integrated clinical chemistry and immunoassay analyzer.
Analytical performance evaluation
Atellica CI analyzer
Chemistry
Immunochemistry
Method comparison
Precision
Journal
Practical laboratory medicine
ISSN: 2352-5517
Titre abrégé: Pract Lab Med
Pays: Netherlands
ID NLM: 101690848
Informations de publication
Date de publication:
Aug 2024
Aug 2024
Historique:
received:
28
05
2024
revised:
16
08
2024
accepted:
31
08
2024
medline:
23
9
2024
pubmed:
23
9
2024
entrez:
23
9
2024
Statut:
epublish
Résumé
Clinical laboratories perform a wide range of tests that are used by healthcare professionals to guide medical decision making. Use of automated analyzers in the clinical laboratory can improve patient care by not only reducing the turn-around-time (TAT) of results but also improving accuracy of the reported results by reducing human error. The aim of this study was to evaluate the performance characteristics of a new automated laboratory instrument, the Atellica® CI Analyzer, Model 1900, over a 3-month period in a European laboratory setting. Analytical performance of 17 analytes (13 chemistry and four immunochemistry) was assessed by evaluating repeatability and within-laboratory precision using anonymized remnant serum samples. Method comparison studies were performed on the Atellica CI Analyzer and the Roche cobas® 6000. Excellent precision was observed with coefficients of variation (CVs) less than 2 % for repeatability and less than 3 % within-laboratory imprecision for most analytes. Comparison of select assays with the cobas 6000 system resulted in correlation coefficients ranging from 0.980 to 1.000. This is the first reported evaluation of the Atellica CI Analyzer in a clinical laboratory setting. The strong analytical performance of the Atellica CI Analyzer demonstrates that this instrument is suitable for routine clinical use.
Sections du résumé
Background
UNASSIGNED
Clinical laboratories perform a wide range of tests that are used by healthcare professionals to guide medical decision making. Use of automated analyzers in the clinical laboratory can improve patient care by not only reducing the turn-around-time (TAT) of results but also improving accuracy of the reported results by reducing human error. The aim of this study was to evaluate the performance characteristics of a new automated laboratory instrument, the Atellica® CI Analyzer, Model 1900, over a 3-month period in a European laboratory setting.
Methods
UNASSIGNED
Analytical performance of 17 analytes (13 chemistry and four immunochemistry) was assessed by evaluating repeatability and within-laboratory precision using anonymized remnant serum samples. Method comparison studies were performed on the Atellica CI Analyzer and the Roche cobas® 6000.
Results
UNASSIGNED
Excellent precision was observed with coefficients of variation (CVs) less than 2 % for repeatability and less than 3 % within-laboratory imprecision for most analytes. Comparison of select assays with the cobas 6000 system resulted in correlation coefficients ranging from 0.980 to 1.000.
Conclusion
UNASSIGNED
This is the first reported evaluation of the Atellica CI Analyzer in a clinical laboratory setting. The strong analytical performance of the Atellica CI Analyzer demonstrates that this instrument is suitable for routine clinical use.
Identifiants
pubmed: 39310744
doi: 10.1016/j.plabm.2024.e00427
pii: S2352-5517(24)00073-8
pmc: PMC11415768
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e00427Informations de copyright
© 2024 The Authors.
Déclaration de conflit d'intérêts
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Peter Findeisen reports article publishing charges, equipment, drugs, or supplies, and writing assistance were provided by Siemens Healthineers AG. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.