| BackgroudBiochemical analyzers were the most basic and essential diagnosis analysis instrument in hospitals. Biochemical analyzer imported were used in lots of hospital for its quality stable and reliable. However, high price of the analysis system imported limited the use of it in the small and midsize hospitals. Nowadays, more and more domestic brands Biochemical analyzer were designed and manufactured, and used in hospitals for its relatively cheap cost.The results of the analysis are deeply depended on the excellent performance of the biochemical analyzer. The analysis error in an excellent stable analysis system could be limited in the range, which is the premise of QA. Analytical performance of the domestic brands Biochemical analyzer was designed to meet the need of the clinical demand when they were used. The analysis system maybe change after used for a period of time in laboratories. The performance of the instrument must be evaluated before used or periodical evaluated during use in the clinical laboratory to ensure that the instrument could meet the requirements of some relevant inspection condition. CLSI released a series of EP files, including EP-5:Clinical evaluation of equipment precision, the approval guide; EP9-A2:Methodology comparison and Evaluation of bias using the patients’samples, the approval guide; EP6-A:Linear of evaluation of the quantitative analysis method:statistical method, the second edition of the proposed guide. These files provided a scientific method to evaluate the analysis system. Precision, anti-interference ability, analytical measurement range, carry-over ability, sensitivity of the detection and methodology comparison were usually used to verify the performances of biochemical analyzer based on these EP files.In order to understand using status of domestic biochemistry analyzer, three domestic biochemical analyzers will be evaluated in this study with the found support by the National Science-technology Support Plan Project. Sixteen items (ALT, AST, TBIL, DBIL, TP, Alb, TC, TG, LDL, HDL, Glu, Ca P, CREA, UREA and UA) with different detective wavelength and reaction types were chose in the study. Precision, analytical measurement range, anti-disturbance ability, carry-over, functional sensitivity of the analyzer system were evaluated with these sixteen common analyzing items. Accuracy of the system was compared with Roche Cobas8000.Mindray Company is the leading high-tech medical equipment manufacturer in china, meanwhile, it is one of the global innovative leaders producing medical diagnostic equipment. Since it was founded in 1991, Mindray has been committed to research and manufacture of clinical medical equipment. Mindray has brought its medical electronic products with a perfect balance of performance and price to every corner of the world. Mindray’s products have been used in more than 140 countries and regions. Mindary biochemistry analysis system also was a most popular instrument in Guangdong area in our survey results before. Three main different Mindray Automatic biochemical analyzers, BS480 BS820 and BS220 will be used to evaluate in the study.This study focuses on BS480. BS480 has a constant test speed of 400t/h and its maximum speed can reach 560T/h (with ISE selected), which is mainly used to quantitative analysis of clinical biochemical items. Compare to imported analyzers, BS480 is cheaper and more applicable to primarily hospital.The innovative points of this study are as follow. Firstly, it is the first time that domestic brands Biochemical analyzer in primarily hospital was evaluated by the top three hospital. Secondly, the domestic instrument which was evaluated in the study was currently using in the primarily hospital. Furthermore, total six performance indexes were used in this subject to guarantee to meet the demands of the evaluation.Objectives1. To evaluate the repeatability of the result tested by BS480.2. To evaluate the range of ratio between the concentration and activity got from BS480.3. To evaluate analytical measurement range of BS480.4. To evaluate whether the functional sensitivity of BS480 is in line with the requirements.5. To evaluate whether the cleaning function can reach the detective demand.6. To analysis and evaluate the accuracy of the results tested by BS480.MethodAccording to the NCCLS guidelines such as EP5-A2, EP17-A2, EP6-A and EP9-A2, sixteen routine clinical testing items with different wavelength and reaction types, including AST, ALT, TP, Alb, Urea, Crea, UA, Ca, P, TBIL, DBIL, HDL, LDL, Glu-H, TC and TG were used in this study. Precision, analytical measure range, sensitivity, carry-over and anti-interference were performed as evaluate indexes. Methodology comparison was done with Roche Cobas8000 system to evaluate the accuracy of the BS480.ResultsThe within-run and average CV of all items in BS480 were less than 1/4CLIA’88 and 1/3CLIA’88 respectively. The analytical measure ranges of ALT, AST, TBIL, DBIL, ALB, TP, Ca, P, UA, UREA, CREA, TC, TG, LDL-C, Glu were 3.83-1198.6U/L,2.57-957.86U/L,1.59-814.84umol/L,0.76-446.44umol/L, 2.17-69.37g/L,1.61-139.81g/L,0.08-3.94mmol/L,0.22-4.24mmol/L, 17.4-1757.97umol/L,0.82-41.63mmol/L,8.03-8694.07umol/L,0.07-12.98mmol/L, 0.04-20.11mmol/L,0.05-20mmol/L,0.48-37.97mmol/L respectively. The analytical measure ranges of all fifteen items reach or over the range that was claimed by the system. The range of HDL was not evaluated in this study due to high concentration serum of HDL was difficult to acquire. BS480 showed a stronger anti-interference ability with bilirubin or hemolysis, anti-interference ability results were accordance with which the kit claimed except some items were not defined in this system. Anti-interference ability with endogenous ester reached the requirement of the system except TBIL and DBIL. The sensitivity results of TP, Alb, Glu, Ca, P were 7.03g/L, 2.40g/L,0.16mmol/L,1.07mmol/L,0.12mmol/L respectively. The carry-over of sample needle was 0.03%. Compare to Roche Cobas8000,11 items’correlation coefficient (R) were over 0.95, but the deviation of UREA and Glu at medical decision levels could not meet the requirement. Correlation coefficient of five items were less than 0.95.ConclusionThe results showed that BS480’s precision, analytical measure range, carryover, sensitivity and anti-interference could meet the related requirement basicly. The fail of part items in comparative test was due to the difference of quantity traceability or detection method in these different analyzers. This also proved that comparability of consequence need to be improved through establishing the procedures of comparison and verification. In a word, these results proved that the dometic biochemistry analyzer could meet up to the criteria and the demand of the primary hospitals. Other biochemical equipment also can be evaluated through this assessment methods which had been founded in this study. |
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