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Clinical reference materials for the validation of the performance of photometric systems used for clinical analyses
Authors:M Buzoianu  H Y Aboul-Enein
Institution:(1) National Institute of Metrology, Sos. Vitan-Barzesti No.11, 75669 Bucharest, Romania Tel.: +40 1 634 40 30; Fax: +40 1 330 15 33, RO;(2) Biological and Medical Research Department (MBC-03), King Faisal Specialist Hospital & Research Centre, P.O.Box 3354, Riyadh 11211, Saudi Arabia Fax: +966-1-4427858; e-mail: enein@kfshrc.edu.sa, SA
Abstract: There are a wide variety of spectrophotometric devices nowadays used in health services with various qualities of manufacture methods of measurement and metrological characteristics for performing the necessary measurements. Therefore, to meet the accuracy and repeatability requirements needed in medical diagnosis and treatment, the validation of the performance of such systems by clinical chemistry laboratories is essential. However, the validation of a spectrophotometric system for clinical analyses requires several reference materials, according to the end use of the measurement results. This paper discusses some characteristics required of the clinical reference materials needed and used by Romanian Institute of Metrology for validation work. Types of clinical reference materials developed in the national area for this purpose are also presented. Received: 23 April 1997 · Accepted: 7 July 1997
Keywords:  Clinical spectrophotometry  Quality assurance  Validation  Reference materials  Spectrophotometric standards
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