CA-1500血凝仪免疫比浊法检测D-二聚体的实验性能评价  

Experimental performance evaluation by CA-1500 blood coagulation analyzer for D-dimer by immune turbidimetry

作　　者：张金彪[1] 代荣琴 林佳静[1] 李涓[1] 翟文燕 

机构地区：[1]河北省沧州中西医结合医院实验诊断科,河北沧州061001 [2]沧州医专微免生化检验教研室,河北沧州061001

出　　处：《医疗卫生装备》2014年第11期95-97,共3页Chinese Medical Equipment Journal

摘　　要：目的：评价CA-1500血凝仪检测D-二聚体的实验性能。方法：参照CLSI发布的系列文件,评估CA-1500血凝仪检测D-二聚体的批内精密度、批间精密度、相关性分析、分析测量范围（analytical measurement range,AMR）、临床可报范围（clinical reportable range,CRR）、最大稀释倍数、抗干扰物质实验等内容。利用低、高值校准品检测精密度;随机选择门诊及住院患者50份109 mmol/L的枸橼酸钠抗凝血,与CS-5100血凝仪进行相关性分析;选择正常水平（L1）、中间水平（L2）、高水平（L3）样本进行临床可报范围评测;临床留取血红蛋白、胆红素、甘油三酯、胆固醇4种干扰血浆进行干扰试验评价。结果：高值质控品批内和批间精密度评价均小于15%;CA-1500血凝仪与CS-5100具有良好的线性关系（P=0.103〉0.01,r=0.935）;评价CA-1500血凝仪检测D-二聚体的测量线性范围为0-5 mg/L;CRR评价最适合稀释倍数为1/8,结合线性范围确定CRR为0.03-40 mg/L;抗干扰物实验影响度均小于±10%。结论：从研究结果来看,CA-1500血凝仪实验性能符合原厂家质量要求,符合CLSI发布的系列文件,在精密度、相关性、AMR、CRR、抗干扰能力等方面能够为实验室及临床提供可靠结果及质量保证。Objective To evaluate the experimental performance of CA-1500 blood coagulation analyzer for D-dimer.Methods According to series of files issued by CLSI, CA-1500 blood coagulation analyzer was applied to D-dimer test and assessed for the within-assay precision, interassay precision, correlation analysis, analytical measurement range（AMR）, clinical reportable range（CRR）, maximal dilution rate and etc. Low- and high-value calibrators were used to detect the precision. Totally 50 sodium citrate anticoagulation blood samples were selected randomly from the outpatients and inpatients, and then the correlation with CS-1500 blood coagulation analyzer was analyzed. CRRs were measured for the samples at normal level（L1）, intermediate level（L2） and high level（L3）. Interference tests were carried out with four kinds of interference plasmas of hemoglobin, bilirubin, triglyceride and cholesterol. Results The within-assay precision and interassay precision of the high-value calibrators were both less than 15%. CA-1500 blood coagulation analyzer gained high correlation with CS-1500 analyzer, with P=0.103〉0.01 and r=0.935. The AMR of CA-1500 blood coagulation analyzer for D-dimer was between 0 and 5 mg/L. The optimal dilution rate for CRR was 1/8, and CRR was determined between 0.03 and 40 mg/L. Interference tests proved that the influence degrees were all less than ±10%. Conclusion CA-1500 blood coagulation analyzer has its experimental performance meet the requirements of the manufacturer and series files issued by CLSI, and can provide references at precision, correlation, AMR, CRR, anti interference and etc.

关 键 词：血凝仪 D-二聚体 性能评价 

分 类 号：R197.39[医药卫生—卫生事业管理]