Specification of analytical requirements in programmes of external data evaluation.
Authors:
B. Friedecký; J. Kratochvíla
Authors place of work:
SEKK s. r. o., Pardubice
Published in the journal:
Klin. Biochem. Metab., 26, 2018, No. 2, p. 87-91
Summary
Objective: Review on the determination of harmonized analytical performance specification. Methods: Based on the studies of EFLM Working Group for specification of analytical performance and the elucidation of their sense. Results: Clinical outcomes, biological variation and state-of-art are three possible methods for derivation of analytical performance criteria-APS. Standardization methods, commutability of control materials and suitable target. Values (means, reference method values) are necessary conditions for this specification. Discussion: Current state of analytical performance shows large differences in individual EQA programs. This fact means impossibility for objective analytical quality assessment and should be immediately improved. Keywords: analytical performance specification, clinical outcomes, biological variation, State of the art, harmonization.
Zdroje
1. Jones, G. R. Analytical performance specifications for EQA schemes-need for harmonization. Clin. Chem. Lab. Med., 2015, 53, p. 919-924.
2. Kenny, D., Fraser, C. G., Petersen, P. H., Kallner, A. Consensus Agreement. Strategies to set global analytical quality specifications in laboratory medicine Scand J Clin. Lab. Invest, 1999, 59, p. 585.
3. Panteghini, M., Sandberg, S. Defining analytical performance specifications 15 years after the Stockholm conference. Clin. Chem. Lab. Med., 2015, 53, p. 829-833.
4. Sandberg, S., Fraser, C. G., Horvath, A. R., Jansen, R., Jones, G., Oosterhuis, W. et al. Defining analytical performance specification: Consensus statement from the 1st strategic conference of the European Federation of Clinical Chemistry and Laboratory Medicin. Clin. Chem. Lab. Med., 2015, 53, p. 833-836.
5. Jones, G. R. D., Albarede, S., Kesseler, D., McKenzie, F., Mammen, J., Petersen, M. et al. Analytical performance specifications for external quality assessment-definitions and descriptions. Clin. Chem. Lab. Med., 2017, 55, p. 945-955.
6. Jones, G. R. Common performance specification in EQA-is it possible? EQALM Symposium, Bergen, Norway 2015. http://www.eqalm.org
7. Lippi, G., Banfi, G., Church, S., Cornes, M., De Carli, G., Grankvist, K. et al. Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for preanalytical phase (WG-PRE). Clin. Chem. Lab. Med., 2015, 53, p. 357-370.
8. Plebani, M., Astion, M. L., Barth, J. H., Chen, W., de Oliveira Caloro, C. A., Ibarz Escuer, M. et al. Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin. Chem. Lab. Med., 2014, 52, p. 951-958
9. Ceriotti, F., Fernandez-Cale, P., Klee, G. G., Nordin, G., Sandberg, S., Streichert, T. et al. Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM strategic conferences. Clin. Chem. Lab. Med., 2017, 55, p. 189-194.
10. Carobene, A. Reliability of biological variation data available in an online database: need for improvement. Clin. Chem. Lab. Med., 2015, 53, p. 871-877.
11. Carobene, A., Marino, I., Guerra, E., Jonker, N., Barla, G., Barlett, W. A. et al. Biological variation estimates obtained from 91 healthy subjects for six electrolytes in serum. Ebiovar study of the EFLM working group on biological variation. Clin. Chem. Lab. Med., 2017, 55/Suppl1, S170.
12. Carobene, A., Roraas, T., Solvik, U., Sylte, M. S., Sandberg, S., Guerra, E. et al. Biological variation estimates obtained from 91 healthy study participants for 9 enzymes in serum. Clin. Chem., 2017, 63, p. 1141-1150.
13. Carobene, A., Marino, I., Coskum, A., Serteser, M., Unsal, I., Guerra, E. et al. The EuBivas project within- and between- subject biological variation data for serum creatinine using enzymatic and alkaline picrate methods and implications for monitoring. Clin. Chem., 2017, 63/9, p. 1527-1536.
14. Friedecký, B., Kratochvíla, J. Harmonizace programů externího hodnocení kvality v čase harmonizace výsledků laboratorních vyšetření. Klin. Biochem. Metab., 2017, 25(46)/2, p. 64-71.
15. Weykamp, C., Secchiero, S., Plebani, M., Thelen, M., Cobbaert, C., Thomas, A. et al. Analytical performance of 17 general chemistry analytes across countries and across manufacturers with INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain. Clin. Chem. Lab. Med., 2016, 55, p. 203-211
16. Friedecký, B., Kratochvíla, J. Soudobá úroveň analytické kvality měření HbA1c v Evropě. Fons 2017,4:29-31.
17. Panteghini, M., Ceriotti, F., Jones, G., Oosterhuis, W., Plebani, M., Sandberg, S. et al. Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference. Clin. Chem. Lab. Med., 2017, DOI:org/10.1515/cclm-2017-0772.
18. Ioannidis, J. P. Why most published research findings are false? PLoS Med 2005,2/8:e124.
Štítky
Clinical biochemistry Nuclear medicine Nutritive therapistČlánok vyšiel v časopise
Clinical Biochemistry and Metabolism
2018 Číslo 2
Najčítanejšie v tomto čísle
- Definition of sepsis and septic shock
- Glycated albumin in blood serum/plasma. Brief overview of the current state.
- Neurofilaments in traumatic brain injury – current knowledge
- Comparison of different electrophoretic systems in the laboratory diagnosis of monoclonal gammopathy