CAJ | 학술논문

目的：评估7种半胱氨酸蛋白酶抑制剂C（Cys C）检测系统的分析性能。方法应用美国临床实验室标准化协会（CLSI）系列文件评估5个颗粒增强免疫透射比浊（PETIA）检测系统和1个均相溶胶颗粒免疫法（SPIA）检测系统的精密度、正确度、空白限（LoB）、抗干扰性以及与SIEMENS BNⅡ颗粒增强免疫散射比浊（PE-NIA）检测系统（简称BNⅡ系统）的相关性和偏差。结果6个检测系统（以A～F表示）和BNⅡ系统在Cys C浓度为0．8～5．0 mg/L时的总批内变异系数（CV）均＜3．75％，总批间CV除E系统外均＜5％；正确度验证显示A～E系统和BNⅡ系统测定ERM-DA471的绝对偏倚分别为0．00、0．00、1．01、-0．01、-0．50和-0．35 mg/L，相对偏倚分别为0％、0％、18．43％、-0．18％、-9．12％和-6．39％；测定CAP室间质评物显示仅D系统和BNⅡ系统较为理想。A～F系统及BNⅡ系统的LoB分别为0．00、0．00、0．31、0．01、0．10、0．06和＜0．05 mg/L。干扰分析显示Hb≤13 g/L、TG≤28 mmol/L时，对A、B系统及BNⅡ系统无明显影响（干扰＜±10％），其他系统均有不同程度干扰。相关分析显示A～F系统与BNⅡ系统相关性较好[相关系数（r）均＞0．975，P＜0．01]。偏差分析显示，A～F系统与BNⅡ系统的平均偏差分别为-0．02、-0．10、-0．31、0．05、0．04、0．36 mg/L。结论 Cys C各检测系统测定有证参考物质ERM-DA471的最大偏倚可达到1 mg/L，最大相对偏倚为18．43％；其中PENIA在测定ERM-DA471和CAP室间质评物时结果低于PETIA；部分检测系统分析性能存在不足。
목적：평고7충반광안산단백매억제제C（Cys C）검측계통적분석성능。방법응용미국림상실험실표준화협회（CLSI）계렬문건평고5개과립증강면역투사비탁（PETIA）검측계통화1개균상용효과립면역법（SPIA）검측계통적정밀도、정학도、공백한（LoB）、항간우성이급여SIEMENS BNⅡ과립증강면역산사비탁（PE-NIA）검측계통（간칭BNⅡ계통）적상관성화편차。결과6개검측계통（이A～F표시）화BNⅡ계통재Cys C농도위0．8～5．0 mg/L시적총비내변이계수（CV）균＜3．75％，총비간CV제E계통외균＜5％；정학도험증현시A～E계통화BNⅡ계통측정ERM-DA471적절대편의분별위0．00、0．00、1．01、-0．01、-0．50화-0．35 mg/L，상대편의분별위0％、0％、18．43％、-0．18％、-9．12％화-6．39％；측정CAP실간질평물현시부D계통화BNⅡ계통교위이상。A～F계통급BNⅡ계통적LoB분별위0．00、0．00、0．31、0．01、0．10、0．06화＜0．05 mg/L。간우분석현시Hb≤13 g/L、TG≤28 mmol/L시，대A、B계통급BNⅡ계통무명현영향（간우＜±10％），기타계통균유불동정도간우。상관분석현시A～F계통여BNⅡ계통상관성교호[상관계수（r）균＞0．975，P＜0．01]。편차분석현시，A～F계통여BNⅡ계통적평균편차분별위-0．02、-0．10、-0．31、0．05、0．04、0．36 mg/L。결론 Cys C각검측계통측정유증삼고물질ERM-DA471적최대편의가체도1 mg/L，최대상대편의위18．43％；기중PENIA재측정ERM-DA471화CAP실간질평물시결과저우PETIA；부분검측계통분석성능존재불족。
Objective To evaluate the analysis performance for 7 cystatin C (Cys C )analysis systems.Methods A total of 5 particle-enhanced turbidimetric immunoassay (PETIA)systems and 1 sol particle immunoassay (SPIA) system were evaluated according to the documents of the Clinical and Laboratory Standards Institute (CLSI),and their correlation with particle-enhanced nephelometric immunoassay (PENIA)system from the SIEMENS BNⅡ system (BNⅡ system),precision,accuracy,limit of blank (LoB)and anti-interference ability were evaluated.Results For 6 systems (A-F)and BNⅡsystem,the total within-run coefficients of variation (CV)were all<3.75%,and except E, the total between-run CV were all<5%,when Cys C concentration was 0.8-5.0 mg/L.For A-E and BNⅡ systems, accuracy verification showed that the absolute biases for measuring ERM-DA471 were 0.00,0.00,1.01,-0.01,-0.50 and -0.35 mg/L respectively,and the relative biases were 0%,0%,18.43%,-0.18%,-9.12% and -6.39%respectively.The measurement of CAP external quality assessment materials showed that D and BNⅡ systems had desirable results.The LoB were 0.00,0.00,0.31,0.01,0.10,0.06 and <0.05 mg/L for A-F and BNⅡ systems, respectively.When Hb≤13 g/L and TG ≤28 mmol/L,A,B and BNⅡ systems were not significantly influenced (interference<± 10% ).Other systems were influenced with different levels.The A-F systems correlated well with BNⅡ system,and the correlation coefficients (r)were all>0.975 (P<0.01 ).Compared with BN Ⅱ system,the average deviations were -0.02,-0.10,-0.31,0.05,0.04 and 0.36 mg/L for A-F systems,respectively. Conclusions The maximum bias can reach 1 mg/L when measuring the reference materials for Cys C analysis systems, and the maximum relative bias is 18.43%.The results of PENIA system are lower than those of PETIA system when measuring ERM-DA47 1 and CAP external quality assessment materials. In a part of analysis systems, analysis performance is not good.