Vitros-350干化学检测系统测定血清尿素氮、肌酐和尿酸的性能评价

Performance Evaluation of Vitros-350 Dry-Chemistry Analyzer System in Detection of Serum Urea Nitrogen,Creatinine and Uric Acid

目的 对Vitros-350全自动干式生化分析仪测定血清尿素氮 （BUN）、肌酐（CREA）和尿酸（UA）的分析性能进行评价.方法 采用Vitros-350全自动生化仪检测血清BUN,CREA和UA,验证其各项目检测的精密度、准确度、分析测量范围,临床可报告范围以及生物参考区间.结果 Vitros-350全自动干式生化仪测定BUN,CREA和UA的批内不精密度和总不精密度均达到厂家规定的不精密度且小于该科设定的质量要求.准确度方面,检测5个不同批号的室间质控品,均值与靶值的偏倚均小于允许偏倚.分析测量范围验证结果表明除CREA实测为3～1 226 μmol/L,稍低于厂家给定的4～1 238 μmol/L外,BUN（0.32～43.6 mmol/L）及UA（18～1 032 μmol/L）分析测量范围均宽于厂家给定的范围.BUN,CREA和UA的临床可报告范围分别为0.95～436 mmol/L,7～12 260 μmol/L和35～10 320 μmol/L.参考区间验证结果表明现用参考区间适用该实验室,可以继续使用.结论 Vitros-350全自动干式生化仪测定BUN,CREA和UA的主要验证试验结果均达到厂家给定的分析性能,能满足临床实验诊断的检测需求.

Objective To evaluate the analytical performance of Vitros-350 automatic dry-chemistry analyzer in detection of serum urea nitrogen（BUN）, creatinine（CREA） and uric aeid（UA）. Methods The precision,accuracy,analytical measurement range,clinical reportable range and biological reference interval of serum BUN,CREA and UA were demonstrated by using Vitros-350 automatic dry-chemistry analyzer. Results The within-run precision and total precision of serum BUN, CREA and UA detected by the Vitros-350 automatic dry-chemistry analyzer were all consistent with the claim of manufacturer and were all lower than the quality requirement of the clinical laboratory of the Rudong county people＇s hospital. In the hand of accuracy,the biases of mean and target value that detected in five quality control specimens were in the range of per- mission. Although the analytical measurement range of CREA （3-1 226 μmol/L） was lower than the manufacturer＇s claim （4-1 238 μmol/L） slightly,but analytical measurement ranges of BUN （0.32-43.6 mmol/L） and UA （18-1 032μmol/ L） were widely than the claim of manufacturer in the verification experiment of analytical measurement range. The verification tests of clinical reportable range and biological reference interval of BUN,CREA and UA showed the clinical reportable range were 0. 95-436 mmol/L,7-12 260 μmol/L and 35-10 320μmol/L respectively, and the biological reference interval present used in the laboratory was suitable. Conclusion The main analytical performances of Vitros-350 in detection of serum BUN, CREA and UA were all consistent with the claim defined by manufacturer, and could be satisfied with the clinical determination.