迈瑞UA-5800全自动干化学尿液分析仪临床性能评估  

Clinical performance evaluation of mindray UA-5800 automatic dry chemistry urine analyzer

作　　者：李秋晨 黄盛[1] 史琪 柯群 李莉[1] LI Qiuchen;HUANG Sheng;SHI Qi;KE Qun;LI Li(Department of Clinical Laboratory,Shanghai General Hospital Affiliated to ShanghaiJiao Tong University,Shanghai 200080,Chin)

机构地区：[1]上海交通大学附属第一人民医院检验科,上海200080

出　　处：《国际检验医学杂志》2018年第A01期89-92,共4页International Journal of Laboratory Medicine

摘　　要：目的 对迈瑞UA-5800全自动干化学尿液分析仪进行临床性能评估，确认产品是否满足临床应用的性能要求。 方法 依据中华人民共和国医药行业标准YY/T 0475-2011《干化学尿液分析仪行业标准》和YY/T 0478-2011《尿液分析试纸条行业标准》的要求。对迈瑞UA-5800干化学分析仪进行批内精密度、日间精密度、准确性、一致性、试纸条精密度、携带污染率、颜色结果准确性进行验证，其中批内精密度、准确性和日间精密度使用干化学分析仪配套质控作为标本进行测试；与对照仪器AX-4280结果一致性使用227例临床尿液标本进行测试，携带污染率使用稀释后的临床新鲜抗凝静脉血模拟标本进行测试。 结果 UA-5800的潜血（BLD）、白细胞酯酶（LEU）、蛋白质（PRO）、葡萄糖（GLU）、尿胆原（URO）、胆红素（BIL）、酮体（KET）、亚硝酸盐（NIT）的批内精密度和日间精密度完全一致率大于95%，上述参数的结果准确性一致率大于90%，与AX-4280的结果一般一致性和完全一致率分别为：BLD：74.89%和96.92%；LEU：76.65%和90.75%；PRO： 81.50% 和96.92%；GLU：87.22%和96.92%；KET：96.04%和100%；NIT：97.80%和97.80%；UA-5800对48 580/μL的肉眼血尿标本无携带污染，颜色检测结果与人工判断结果一致率大于95%。 结论 UA-5800具有良好的临床检测性能，能够满足尿液干化学常规检测筛查的临床要求。Objective ： To verify the clinical performance of mindray UA-5800 to verify whether it meets the performance requirements for clinical application. Methods ： According to the People′s Republic of China pharmaceutical industry standard YY/T 0475-2011 “dry chemical urine analyzer industry standard” and YY/T 0478-2011 “urine analysis test strip industry standard” requirements,the following clinical items have been tested on the instrument：within-run precision,strip result accuracy,between-run precision,result concordance rate with AX-4280,carry over,color result accuracy.Applicable quality control material is used as test sample for within-run precision,strip result accuracy and between-run precision evaluation.The sample size is 227 for clinical urine test for result concordance rate with AX-4280.Diluted hematology sample is used as test sample for carry over evaluation. Results： Within-run precision and between-run precision of all the following items：occult blood （BLD）,leucocyte esterase （LEU）,protein （PRO）,glucose （GLU）,urobilinogen（URO）,bilirubin（BIL）,ketone bodies（KET）,nitrite（NIT） are greater than 95% in results concordance rate.Strip result accuracy of all the above items are greater than 90% in result concordance rate;comparing the result concordance rate with AX-4280,the respective normal concordance rate and absolute concordance rate are as follows：BLD,74.89% and 96.92%;LEU,76.65% and 90.75%;PRO,81.50% and 96.92%;GLU,87.22% and 96.92%,KET,96.04% and 100%;absolute concordance rate of NIT is 97.80%.UA-5800 can test the high concentration macrohematuria specimen of 48 580/μL with no carry over,and the color result concordance rate is greater than 95% compared with macroscopic observation. Conclusion ： UA-5800 has the good clinical performance that meet the clinical application requirements of urine chemistry routine test.

关 键 词：全自动干化学尿液分析仪 性能评估 精密度 一致率 准确性 携带污染率 

分 类 号：R446.12[医药卫生—诊断学]