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The verification of accredited analytical method for the determination of second-generation triglycerides using the biochemical analyzer Advia 1800
JANDOVÁ, Helena
Triglycerides belong to a large group of lipids. They are biologically very important substances for the human body. Chemically they are glycerols which are bound by ester bonds to fatty acids. Triglycerides are feeding, and that our organism has spend triglycerides must be broken down into glycerol and fatty acids, and then they are absorbed and transported to tissues. Determination of triglycerides in serum, respectively plasma, is particularly important for the prevention of atherosclerosis which is the leading cause of cardiovascular diseases, but also to diagnose and prevent such diseases as obesity or diabetes mellitus. To introduce method for the determination of the second-generation triglycerides via the biochemical analyzers Advia 1800 to be used in the ward of clinical biochemistry of Central Laboratories of Hospital Strakonice, a. s. there was need to carry out a verification of the method. This verification is subject ot the requiremets of ČSN EN ISO 15189 Medical laboratories Special requirements for quality and eligibility, according to which the Central Laboratory of Strakonice Hospital, a s. is accredited. It is further governed by the procedures for the validation/verfication methods, SOPO-C-06, drawn up by our laboratory. The results of the verification/validation are used for the evaluation of measurement uncertainties and to establish continuity and comparability of measurement results. On the basis of document mentioned above, the measurement of triglycerides in serum was conducted in two biochemical analyzers Advia 1800. These measurement led to the evaluation of the precision under repeatability conditions, precisions under conditions of reproductibility and accuracy. Precision under repetability condition was measured at twenty patients' samples in two concentration ranges. For evaluation of precisions under reproducibility conditions we used control materials validated in the EHK processes, exactly Liquid Assayed Multiqual 1 Lot 45651, the second check was with the help of Liquid Assayed Multiqual 2 Lot 45662 from the manufacturer BIO-RAD. These reference materials were measured every day in a singlet for twenty days. From the measured values the basic statistical parameters and analytical coefficient of variation were calculated. To evaluate the truthfulness they were also measured with the help of control materials from the manufacturer SEKK, s. r. o. Based on these measurements the basic characteristics were again calculated together with bias and total laboratory analytical error. Comparison of this error with a maximum mistake reccommended by the company SEKK, s. r. o. led to the evaluation of the method for the present purposes.
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