Clin. Lab.11+12/2012 1313 Clin. Lab. 2012;58:1313-1318 ©Copyright SHORT COMMUNICATION Analytical Performance of Centrifuge-Based Device for Clinical Chemistry Testing JAMIKORN SUK-ANAKE 1 AND CHAMRAS PROMPTMAS 1, 2 1 Department of Clinical Chemistry, Faculty of Medical Technology, Mahidol University, Salaya, Nakhon Pathom 73170, Thailand 2 National Doping Control Center, Mahidol University, Rajathevi, Bangkok 10400, Thailand SUMMARY Background: A centrifuge-based device has been introduced to the Samsung Blood Analyzer (SBA). The verifica- tion of this analyzer is essential to meet the ISO15189 standard. Methods: Analytical performance was evaluated according to the NCCLS EP05-A method. The results of plasma samples were compared between the SBA and a Hitachi 917 analyzer according to the NCCLS EP09-A2-IR meth- od. Percent recovery was determined via analysis of original control serum and spiked serum. Results: Within-run precision was found to be 0.00 - 6.61% and 0.96 - 5.99% in normal- and abnormal-level as- says, respectively, while between-run precision was 1.31 - 9.09% and 0.89 - 6.92%, respectively. The correlation coefficients (r) were > 0.990. The SBA presented analytical accuracy at 96.64 ± 3.39% to 102.82 ± 2.75% and 98.31 ± 4.04% to 103.61 ± 8.28% recovery, respectively. Conclusions: The results obtained verify that all of the 13 tests performed using the SBA demonstrates good and reliable precision suitable for use in qualified clinical chemistry laboratory service. (Clin. Lab. 2012;58:1313-1318. DOI: 10.7754/Clin.Lab.2012.120705) KEY WORDS Blood analyzer, analytical performance, clinical chem- istry INITRODUCTION The integrated centrifugal device for the clinical chem- istry analyzer has been developed over the last few dec- ades for simple analytical processes [1]. The analysis of whole blood generally requires sample preparation to be performed in combination with several analytical steps [2-4]. Various liquid handling systems have been intro- duced, including a centrifugal system, to create a com- plete total analytical system [5-9]. The first embedded centrifugal platform with a plastic disposable rotating cartridge was applied to the portable clinical chemistry analyzer at the beginning of the 1990s [10]. This complete analytical system was addi- tionally implemented in toxicology, immunology and hematology applications [11]. Blood-plasma separation has been successfully integrated into several Lab-on-a- disc systems such as the Piccolo clinical blood analyzer system from Abaxis [10], the Imtek system [12] and also the Samsung Blood Analyzer [13-15]. The excellent performance of the Samsung Blood Ana- lyzer (SBA) has been confirmed in terms of its reliabil- ity [15]. Verification of its analytical performance in different laboratory environments is required to meet the ISO 15189 standard. This study aims to determine essential performance parameters of this centrifugal- based analyzer when operating in a different laboratory environment from that of its country of origin. The analytical performance of this clinical chemistry analyzer was evaluated for a total of 13 blood chemistry tests (Clinical Chemistry Plus13); albumin, aspartate transaminase (AST), alanine transaminase (ALT), blood urea nitrogen (BUN), total cholesterol, creatinine, gamma glutamyl transferase (GGT), glucose, total bili- rubin, total protein, triglyceride, HDL-cholesterol and LDL-cholesterol (calculation). Essential analytical reli- ability parameters were tested according to the CLSI Clinical and Laboratory Standard Institute, formerly _____________________________________________ Short Communication accepted August 1, 2012