2009, Number 2
<< Back Next >>
Bioquimia 2009; 34 (2)
Analytical performance evaluation of haematological equipment Medonic CA 530 Thor
Chávez-Almazán LA, López-Silva S, Barlandas-Rendón E, Armenta-Solís A
Language: Spanish
References: 21
Page: 69-76
PDF size: 100.71 Kb.
ABSTRACT
Introduction: In the clinical laboratory is necessary to evaluate every method or test before its daily utilization to guaranty reliable results.
Objective: Made an analytical performance evaluation of hematological equipment Medonic CA 530 Thor, including precision, accuracy and linearity, following protocols of Clinical and Laboratory Standards Institute.
Material and methods: To determinate precision was used control blood, this sample was analyzed 4 times during 5 days to calculate and compare the imprecision with the one provided by the manufacturer. The accuracy was analyzed by means of 60 blood samples were examined in Medonic and another reference equipment to establish their correlation; in addition was evaluated the participation in an External Quality Assessment Scheme (EQAS). Finally, linearity was probed analyzing seven levels of concentration come from the dilution of the control blood.
Results: The precision calculated shows similar results to the information given by the manufacturer in white blood cells and platelets, furthermore the analytical quality were accomplished for all parameters. The Medonic accuracy is acceptable according to correlation study with comparative equipment and samples analysis of EQAS; furthermore, linearity was demonstrated in all parameters.
Discussion: The results indicate that Medonic is suitable for use in the laboratory and satisfy the quality requirements.
REFERENCES
Clinical and Laboratory Standards Institute. Performance goals for the internal quality control of multichannel hematology analyzers; Approved Standard. Document H26-A 1996; 16(12).
Clinical and Laboratory Standards Institute. Preliminary evaluation of quantitative clinical laboratory methods; Approved Guideline-Second Edition. Document EP10-A2 2002: 22(29).
US Department of Health and Human Services. Medicare, Medicaid and CLIA programs: Regulations implementing the Clinical Laboratory Improvement Amendments of 1988. Final rule. Fed Regist. 1992; 57: 7002-7186.
Instituto Mexicano de Normalización y Certificación A.C. NMX-EC-17025-IMNC-2006. Requisitos generales para la competencia de los laboratorios de ensayo y de calibración.
Instituto Mexicano de Normalización y Certificación A.C. NMX-EC-15189-IMNC-2008, Laboratorios Clínicos. Requisitos particulares para la calidad y la competencia.
Clinical and Laboratory Standards Institute. User demonstration of performance for precision and accuracy; Approved Guideline. Document EP15-A 2001; 21(25).
Clinical and Laboratory Standards Institute. Method comparison and bias estimation using patient samples; Approved Guideline-Second Edition. Document EP9-A2 1995: 22(19).
Clinical and Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures: A Statistical Approach; Approved Guideline. Document EP6-A 2003: 23(16).
David G. Rhoads Associates, Inc. Software EP Evaluator® 6.0.0.414. Copyright 1991-2004.
Passing H, Bablok W. Application of statistical procedures in analytical instrument testing. J Automatic Chem. 1985; 7: 74-9.
Centro de Cibernética Aplicada a la Medicina. El método de Passing-Bablok como solución al problema de la comparación de métodos analíticos. Rev Cubana Inform Médica. 2003:http://www.cecam.sld.cu/pages/rcim/revista_4/articulos_html/ariel.htm. [Consulta: 27 de junio de 2008].
Altman DG, Bland JM. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986; 1: 307-10.
Dewitte K, Fierens C, Stöckl D, Thienpont LM. Application of the Bland-Altman plot for interpretation of method comparison studies: A critical investigation of its practice. Clin Chem. 2002; 48: 799-801.
Altman DG, Bland JM. Commentary on quantifying agreement between two methods of measurement. Clin Chem. 2002; 48: 801-2.
Marquis P. Software Method validator®; Metz, Francia. Manual del usuario traducido por Sarsotti S. Facultad de Bioquímica y Ciencias Biológicas. Santa Fé, Argentina; 1999.
Programa Estadístico para Microsoft Excel Analyse-it®, Clinical Laboratory, versión 1.71. Leeds, England; United Kingdom: Analyse-it Ltd.
Alva-Estrada SI, Uhthoff-Brito EC. Manual del curso teórico-práctico de control de calidad en química clínica. Programa de Aseguramiento de la Calidad, 2001; Tema 13: 112-21. México D.F.: PACAL.
Buttarello M. Quality specification in haematology: the automated blood cell count. Clin Chim Acta. 2004; 346: 45-54.
Westgard JO, Seehafer JJ, Barry PL. Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria. Clin Chem. 1994; 40: 1909-14.
Skendzel LP, Barnett RN, Platt R. Medically useful criteria for analytic performance of laboratory tests. Am J Clin Pathol. 1985; 83: 200-5.
Jhang JS, Chang CC, Fink DJ, Kroll MH. Evaluation of linearity in the clinical laboratory. Arch Pathol Lab Med. 2004; 128: 44-8.