Journal of Laboratory Medicine and Quality Assurance.2013;35(1):36-46.
BACKGROUND: Analyzing large numbers of specimens in a short time and generating accurate results while minimizing costs are critical to laboratory tests. The CS-6400 (Dong-A Dirui, China), an automated chemistry analyzer, has been recently developed in China in collaboration with domestic corporations. To assess the performance and usability of the analyzer, we evaluated its analytical performance and clinical usefulness including accuracy and linearity of electrolytes and chemistry tests using HiSens reagent (HBI Co., Korea) with protocols provided by the Clinical and Laboratory Standards Institute, and compared these results with those of the formerly used DXC800 (Beckman Coulter, USA), and Vista500 (Siemens, Germany). METHODS: The accuracy, linearity, recovery factor, and sample carryover of the CS-6400 using HiSens reagent were determined for 29 tests-aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (ALP), lactate dehydrogenase (LDH), gamma glutamyl transferase, glucose, total cholesterol, triglyceride (TG), amylase, lipase, creatine kinase (CK), blood urea nitrogen, creatinine, uric acid, total protein, albumin, total bilirubin (TB), direct bilirubin (DB), calcium, inorganic phosphorus, magnesium (MG), HDL cholesterol, rheumatoid factor (RF), LDL cholesterol, C-reactive protein, anti-streptolysin O, sodium, potassium, and chloride and the results were compared with the values obtained from the DXC800 and Vista500 to set reference intervals for each test. Serum samples obtained from 128 healthy adults were used for the reference intervals. and values obtained from DXC800 and Vista500 were used to make comparison on and to set reference intervals for each routine. Serum specimens obtained from a total of 128 healthy adults were used for the reference intervals. RESULTS: The coefficient of variation showed excellent values of < or =5% for all tests except ALP, DB, MG, RF, TB, and TG (> or =5%). The coefficient of determination (R2) was > or =0.993 with linearity between 0.928 and 1.078 within the useful clinical span. In addition, the recovery factor values of the tests were 84% to 108%, and correlation comparisons were 0.975 except for albumin (0.9516), RF (0.7617), and LDL cholesterol (0.9709). We evaluated whether the CS-6400 contributed to the attempt to minimize the test's cost and running time. Developed in China, the CS-6400 has been approved by the Food and Drug Administration and uses indirect ion selective electrodes for electrolytes and colorimetry and turbidimetry for general and specific chemistry items. The tests showed excellent linearity of > or =0.993 using commercial certified linearity material. The recovery factor values of the tests were 93% to 108%, except for LDL cholesterol (84%). Except for the minimum values, percentage sample carryover values for CK and LDH were < or =1% (0.00% and 0.07%, respectively), suggesting that the results of the tests were not affected by sample carryover, and reference interval was present based on sex. CONCLUSIONS: The CS-6400 with HiSens showed excellent analytical performance (precision, linearity, and accuracy). Furthermore, results from the CS-6400 were highly correlated with those obtained from similar tests performed on DXC800 and Vista500. Therefore, the CS-6400 is appropriate for tertiary care hospitals where large volumes of test samples must be processed within a short period with minimal cost.
Adult
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Alanine Transaminase
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Alkaline Phosphatase
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Amylases
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Bilirubin
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Blood Urea Nitrogen
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C-Reactive Protein
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Calcium
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China
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Cholesterol
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Cholesterol, HDL
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Cholesterol, LDL
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Colorimetry
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Cooperative Behavior
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Creatine Kinase
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Creatinine
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Electrolytes
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Glucose
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Humans
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Ion-Selective Electrodes
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L-Lactate Dehydrogenase
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Lipase
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Magnesium
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Nephelometry and Turbidimetry
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Phosphorus
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Potassium
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Rheumatoid Factor
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Running
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Sodium
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Tertiary Healthcare
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Transferases
;
United States Food and Drug Administration
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Uric Acid
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