两种试剂在CA-7000血凝仪上的应用评价  

Evaluation of applying two kinds of reagents on CA-7000 blood coagulation instrument

作　　者：李家明[1] 杨雯翔 杨淑君[1] 余加聪 Li Jiaming;Yang Wenxiang;Yang Shujun;Yu Jiacong(Department of Laboratory,Iron and Steel Group General Hospital,Panzhihua 617000,Sichuan,China)

机构地区：[1]攀钢集团总医院检验科

出　　处：《实用检验医师杂志》2019年第3期143-145,共3页Chinese Journal of Clinical Pathologist

摘　　要：目的了解进口试剂和国产试剂在检测血凝四项结果之间的差异性,探讨非原装试剂在临床应用中的准确性以及成本效益,为选择合适的血凝试剂提供参考依据。方法选择高、中、低浓度患者的新鲜血浆标本各25份,在Sysmex CA-7000全自动血凝仪上分别用SIEMENS试剂(A试剂)和上海太阳试剂(B试剂)检测血浆凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、血浆纤维蛋白原(FIB)和血浆凝血酶时间(TT)四项指标,计算两种试剂的检测结果、相关系数(R2)、回归方程和阳性符合率,并对B试剂进行临床可接受性评价以及成本效益分析。结果A试剂检测的PT、TT检测结果明显高于B试剂,比较差异有统计学意义〔PT(s):16.4±4.9比15.3±4.5,TT(s):18.6±3.6比13.8±3.8,均P<0.01〕,而APTT、FIB检测结果比较差异均无统计学意义(均P>0.05)。A试剂和B试剂检测FIB结果的相关性略差(R^2=0.9037),而检测PT、APTT和TT两者相关性较好(R1^2=0.9737、R2^2=0.9965、R3^2=0.9739)。以A试剂(X)为标准,B试剂(Y)PT、APTT、FIB、TT的回归方程分别为Y=0.9043X+0.2834、Y=0.9771X+1.5632、Y=0.7367X+1.0106、Y=1.0558X-5.8307。A试剂与B试剂检测APTT、FIB、TT的阳性符合率较接近(APTT:48.0%比44.0%,FIB:44.0%比40.0%,TT:8.0%比12.0%),而两者PT阳性符合率比较却存在明显差异(72.0%比28.0%,P<0.05)。B试剂临床可接受性评价显示,PT、APTT项目全部可被临床接受,FIB项目在高值水平可被临床接受。成本效益评价显示,国产B试剂有明显的价格优势。结论使用非配套血凝试剂时应对试剂进行评估,在确保质量的前提下,实验室可考虑使用成本低廉的国产试剂。Objective To realize the differences in the four types of blood coagulation results detected by an imported reagent and a domestic reagent respectively on CA-7000 blood coagulation instrument and explore the accuracy and cost-benefit of non-original(unloaded)reagent in clinical application,so as to provide a base of reference for the selection of a suitable hemagglutination reagent.Methods The fresh plasma samples with high,medium and low concentrations from each one of 25 patients were collected.The plasma prothrombin time(PT),activated partial thromboplastin time(APTT),plasma fibrinogen(FIB)and plasma thrombin time(TT)were measured by SIEMENS reagent(A reagent)and Shanghai solar reagent(B reagent)respectively on Sysmex CA-7000 automatic hemagglutination instrument.The detection results,correlation coefficients(R2),regression equations and positive coincidence rates of the two reagents were calculated,and the evaluation of clinical acceptability and cost-benefit analysis of reagent B was carried out.Results The PT and TT results of A reagent were significantly higher than those of B reagent,and the differences were statistically significant[PT(s):16.4±4.9 vs.15.3±4.5,TT(s):18.6±3.6 vs.13.8±3.8,all P<0.01],while the results of APTT and FIB were not statistically significant(all P>0.05).The correlation of FIB results detected by A reagent and B reagent were slightly worse(R^2=0.9037),but the correlations between the results of PT,APTT and TT respectively detected by the two methods were relatively good(R1^2=0.9737,R2^2=0.9965,R3^2=0.9739).Using reagent(X)assigned as the standard,the regression equations of B reagent(Y)in PT,APTT,FIB and TT were Y=0.9043X+0.2834,Y=0.9771X+1.5632,Y=0.7367X+1.0106 and Y=1.0558X-5.8307,respectively.The positive coincidence rates between A reagent and B reagent were close in APTT,FIB and TT(APTT:48.0% vs.44.0%,FIB:44.0%vs.40.0%,TT:8.0% vs.12.0%),however,there was significant difference in the positive coincidence rate of PT between the two groups(72.0% vs.28.0%,P<0.05).The evaluati

关 键 词：凝血四项 血凝试剂 相关性 成本效益 

分 类 号：R44[医药卫生—诊断学]