Study of the analytical performance at different concentrations of hematological parameters using Spanish EQAS data
-
Angel Molina
, José Alcaraz
, Leonor Guiñón , Aránzazu Pérez , Anna Segurana , Joan Carles Reverter , Josep Lluís Bedini und Anna Merino
Abstract
Background
External quality assessment programs are one of the currently available tools to evaluate the analytical performance of clinical laboratories, where the measurement error (ME) obtained can be compared with quality specifications to evaluate possible deviations. The objective of this work was to analyze the ME behavior over the analytical range to assess the need to establish concentration-dependent specifications.
Methods
A total of 389,000 results from 585 laboratories and 2628 analyzers were collected from the Spanish external quality assessment schemes (EQAS) in hematology during the years 2015–2016. The parameters evaluated included white blood cells, red blood cells, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, prothrombin time, activated partial thromboplastin time, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocytes, hemoglobin A2, antithrombin, factor VIII, protein C and von Willebrand factor. The 90th percentile of ME was calculated for every concentration evaluated of each parameter.
Results
We found a significant variation in the analytical performance of leukocytes, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, prothrombin time, reticulocytes, hemoglobin A2, antithrombin and protein C. Furthermore, this ME variation may not allow complying with the same biological variability requirements within the whole analytical range studied.
Conclusions
Our work shows the importance of implementing concentration-dependent specifications which can help laboratories to use proper criteria for quality specifications selection and for a better external quality control results evaluation.
Acknowledgments
This research was partially supported by FPCQLC (Fundació pel Control de Qualitat dels Laboratoris Clinics).
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: This work is part of a research project funded by the Directory of Science, Technology and Innovation of the Ministry of Economy and Competitiveness of Spain, with reference DPI2015-64493-R.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
1. Laboratorio Clínico Central. Estándares y recomendaciones de calidad y seguridad. Ministerio de Sanidad, Servicios Sociales e Igualdad. Gobierno de España. 2013. https://www.mscbs.gob.es/organizacion/sns/planCalidadSNS/docs/Laboratorio_Clinico_EyR.pdf. Accessed: January 2019.Suche in Google Scholar
2. Krouwer JS. Setting performance goals and evaluating total analytical error for diagnostic assays. Clin Chem 2002;48:919–27.10.1093/clinchem/48.6.919Suche in Google Scholar
3. Libeer JC. Role of external quality assurance schemes in assessing and improving quality in medical laboratories. Clin Chim Acta 2001;309:173–7.10.1016/S0009-8981(01)00518-6Suche in Google Scholar
4. Miller WG, Jones GR, Horowitz GL, Weykamp C. Proficiency testing/external quality assessment: current challenges and future directions. Clin Chem 2011;57:1670–80.10.1373/clinchem.2011.168641Suche in Google Scholar PubMed
5. EN ISO 15189:2012. Medical laboratories – Particular requirements for quality and competence, Geneva: ISO, 2012.Suche in Google Scholar
6. Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, et al. Defining analytical performance specifications: consensus statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med 2015;53:833–5.10.1515/cclm-2015-0067Suche in Google Scholar PubMed
7. Clinical Laboratory Improvement Act 2004. Part 493 laboratory requirements. Subpart I – proficiency testing programs for nonwaived testing. https://www.ecfr.gov/cgi-bin/text-idx?SID=bed215d568a567e7f0c2f8710d44331c&mc=true&node=sg42.5.493_1905.sg1&rgn=div7 Accessed: January 2019.Suche in Google Scholar
8. German Medical Association. Revision of the “Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations–RiliBAEK”. J Lab Med 2015;39:26–69.10.1515/labmed-2014-0046Suche in Google Scholar
9. Jones GR, Sikaris K, Gill J. ‘Allowable limits of performance’ for external quality assurance programs – an approach to application of the Stockholm Criteria by the RCPA Quality Assurance Programs. Clin Biochem Rev 2012;33:133–9.Suche in Google Scholar
10. Ricós C, Álvarez V, Cava F, García-Lario JV, Hernández A, Jiménez CV, et al. Current Database on biologic variation: prons, cons and progress. Scand J Clin Lab Invest 1999;59: 491–500.10.1080/00365519950185229Suche in Google Scholar PubMed
11. Salas A, Ricós C, Prada E, Ramón F, Morancho J, Jou JM, et al. State of the art approach to goal setting. Clin Lab Med 2017;37:73–84.10.1016/j.cll.2016.09.007Suche in Google Scholar PubMed
12. Ricós C, Baadenhuijsen H, Libeer JC, Hyltoft Petersen P, Stockl D, Thienpont L, et al. External quality assesment: currently used criteria for evaluating performance in European countries, and criteria for future harmonization. Eur J Clin Chem Clin Biochem 1996;34:159–65.Suche in Google Scholar
13. Hübl W, Tlustos L, Bayer PM. Use of precision profiles to evaluate precision of the automated leukocyte differential. Clin Chem 1996;42:1068–73.10.1093/clinchem/42.7.1068Suche in Google Scholar
14. Buttarello M, Bulian P, Farina G, Temporin V, Toffolo L, Trabuio E, et al. Flow cytometric reticulocyte counting: parallel evaluation of five fully automated analyzers: an NCCLS-ICSH approach. Am J Clin Pathol 2001;115:100–11.10.1309/M26B-1YNQ-VNU8-M1CESuche in Google Scholar PubMed
15. Buttarello M. Quality specification in haematology: the automated blood cell count. Clin Chim Acta 2004;346:45–54.10.1016/j.cccn.2004.02.038Suche in Google Scholar PubMed
16. Vives-Corrons JL, Gutiérrez G, Jou JM, Reverter JC, Martínez-Brotons F, Domingo A, et al. Characteristics and performance of the external quality assessment scheme (EQAS) for hematology in Spain. Ten years of experience. Ann Ist Super Sanita 1995;31:95–101.Suche in Google Scholar
17. EN ISO 13528:2015. Stastistical methods for use in proficiency testing by interlaboratory comparisons. ISO 13528. Geneva: ISO, 2015.Suche in Google Scholar
18. Fraser CG, Petersen PH, Libeer JC, Ricós C. Proposals for setting generally applicable quality goals solely based on biology. Ann Clin Biochem 1997;34:8–12.10.1177/000456329703400103Suche in Google Scholar PubMed
19. Ricós C, Álvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, et al. Desirable specifications for total error, imprecision, and bias, derived from intra- and inter-individual biologic variation. The 2014 update. Original publication available from (Spanish only). http://www.seqc.es/es/comisiones/comision-de-calidad-analitica/_id:4/. Accessed: January 2019. Also available on (English): http://www.westgard.com/biodatabase1.htm. Accessed: January 2019.Suche in Google Scholar
20. Coşkun A, Carobene A, Kilercik M, Serteser M, Sandberg S, Aarsand AK, et al. Within-subject and between-subject biological variation estimates of 21 hematological parameters in 30 healthy subjects. Clin Chem Lab Med 2018;56:1309–18.10.1515/cclm-2017-1155Suche in Google Scholar PubMed
21. Soumali MR, Van Blerk M, Akharif A, Albarède S, Kesseler D, Gutierrez G, et al. A new approach to define acceptance limits for hematology in external quality assessment schemes. Clin Chem Lab Med 2017;55:1936–42.10.1515/cclm-2016-1048Suche in Google Scholar PubMed
22. Horsti J, Uppa H, Vilpo JA. Poor agreement among prothrombin time international normalized ratio methods: comparison of seven commercial reagents. Clin Chem 2005;51:553–60.10.1373/clinchem.2004.043836Suche in Google Scholar PubMed
23. Bowyer A, Kitchen S, Makris M. The responsiveness of different APTT reagents to mild factor VIII, IX and XI deficiencies. Int J Lab Hematol 2011;33:154–8.10.1111/j.1751-553X.2010.01261.xSuche in Google Scholar PubMed
24. Ricós C, Álvarez V, Minchinela J, Fernández-Calle P, Perich C, Boned B, et al. Biologic variation approach to daily laboratory. Clin Lab Med 2017;37:47–56.10.1016/j.cll.2016.09.005Suche in Google Scholar PubMed
25. Ricós C, Iglesias N, García-Lario JV, Simón M, Cava F, Hernández A, et al. Within-subject biological variation in disease: collated data and clinical consequences. Ann Clin Biochem 2007;44:343–52.10.1258/000456307780945633Suche in Google Scholar PubMed
26. Molina A, Guiñón L, Pérez A, Segurana A, Bedini JL, Reverter JC, et al. (2018). State of the art vs. biological variability: Comparison on hematology parameters using Spanish EQAS data. Int J Lab Hematol 2011;40:284–91.10.1111/ijlh.12783Suche in Google Scholar PubMed
27. Westgard MolinaJ. 2016 State of the Art Hematology Performance Specifications. https://www.westgard.com/rcpa.htm. Accessed: January 2019.Suche in Google Scholar
© 2019 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
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Artikel in diesem Heft
- Frontmatter
- Editorial
- The re-emergence of dried blood spot sampling – are we ready?
- Review
- The role of platelets in bleeding in patients with thrombocytopenia and hematological disease
- Opinion Paper
- Exertional hematuria: definition, epidemiology, diagnostic and clinical considerations
- Guidelines and Recommendations from Scientific Societies
- A protocol for testing the stability of biochemical analytes. Technical document
- Genetics and Molecular Diagnostics
- Hereditary hyperferritinaemia-cataract syndrome (HHCS) – an underestimated condition: ferritin light chain variant spectrum in German families
- General Clinical Chemistry and Laboratory Medicine
- Performance of a web-based application measuring spot quality in dried blood spot sampling
- Clinical application of a dried blood spot assay for sirolimus and everolimus in transplant patients
- Plasma and dried blood spot lysosphingolipids for the diagnosis of different sphingolipidoses: a comparative study
- Liquid biopsy of cerebrospinal fluid identifies neuronal pentraxin receptor (NPTXR) as a biomarker of progression of Alzheimer’s disease
- Integrity of serum samples is changed by modified centrifugation conditions
- Heparin and citrate additive carryover during blood collection
- Copeptin – a biomarker of short-term mortality risk (7 days) in patients with end-stage liver disease
- Comparison of a new rapid method for the determination of adalimumab serum levels with two established ELISA kits
- Measurement of α-dicarbonyl compounds in human saliva by pre-column derivatization HPLC
- Establishment of the intelligent verification criteria for a routine urinalysis analyzer in a multi-center study
- Reference Values and Biological Variations
- A new indirect estimation of reference intervals: truncated minimum chi-square (TMC) approach
- EGFR and EGFR ligands in serum in healthy women; reference intervals and age dependency
- Early pregnancy reference intervals; 29 serum analytes from 4 to 12 weeks’ gestation in naturally conceived and uncomplicated pregnancies resulting in live births
- Paediatric reference intervals for 17 Roche cobas 8000 e602 immunoassays in the CALIPER cohort of healthy children and adolescents
- Hematology and Coagulation
- Study of the analytical performance at different concentrations of hematological parameters using Spanish EQAS data
- Multicenter performance evaluation of the Abbott Alinity hq hematology analyzer
- Cardiovascular Diseases
- Fast 0/1-h algorithm for detection of NSTEMI: are current high-sensitivity cardiac troponin assays fit for purpose? An EQA-based evaluation
- Infectious Diseases
- Diagnostic performance of cerebrospinal fluid free light chains in Lyme neuroborreliosis – a pilot study
- Letters to the Editor
- Quality management at the national biobanking level – establishing a culture of mutual trust and support: the BBMRI.at example
- Molecular diagnosis of MODY3 permitted to reveal a de novo 12q24.31 deletion and to explain a complex phenotype in a young diabetic patient
- Increased C-reactive protein values in the absence of inflammation: monoclonal immunoglobulin interference in immunonephelometry
- An approach based on simulated hemolysis for establishing the hemolysis index threshold for high-sensitivity cardiac troponin T assay
- Utility of the icteric index for the management of bilirubin test requesting
- Quality control of monocyte volume and distribution width parameters of the Beckman Coulter DxH series
- Mozhaisk haemoglobin variant effects on leukocyte differential channel using the Sysmex XN series
- Detection of a novel hemoglobin variant Hb Liaoning by matrix assisted laser desorption/ionization-time of flight mass spectrometry
- Appropriateness of repetitive therapeutic drug monitoring and laboratory turnaround time
- Congress Abstracts
- 51th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)