CAJ | 학술논문

目的：评价 ACL TOP 血凝仪在儿科实验室的性能及应用。方法：参照 CLSI 的要求，评价 ACL TOP血凝仪的精密度、正确度、线性、抗生物干扰能力、样本携带污染率；建立 ACL TOP 血凝仪在本地区儿童的凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、凝血酶时间（TT）、纤维蛋白原（FIB）的参考区间。结果：凝固法及免疫比浊法两种方法的精密度均符合厂家规定的要求；正确度实验PT、APTT、FIB的偏倚均未超出二分之一 CLIA′88规定的允许误差范围；FIB 线性测定的直线回归方程为 Y ＝1．0021X-0．122，R2为0．9982，符合厂家要求（r≥0．975）；胆红素20 mg/dL、甘油三脂900 mg/dL、血红蛋白5 g/L 时，对 PT、APTT、TT 和 FIB 测定的影响度均小于二分之一 CLIA′88规定的允许误差范围；样本携带污染率最高为1．81％，符合厂家性能要求；本地区儿童生物参考区间：PT（9．1～13．1 s）、APTT（24．9～42．1 s）、TT（12．6～21．1 s）、FIB（1．924～4．011 g/L）。结论：ACL TOP血凝仪具有良好的精密度、正确度、线性和较低的样本携带污染率，并具较强的抗生物干扰能力，适合本实验室使用。
목적：평개 ACL TOP 혈응의재인과실험실적성능급응용。방법：삼조 CLSI 적요구，평개 ACL TOP혈응의적정밀도、정학도、선성、항생물간우능력、양본휴대오염솔；건립 ACL TOP 혈응의재본지구인동적응혈매원시간（PT）、활화부분응혈활매시간（APTT）、응혈매시간（TT）、섬유단백원（FIB）적삼고구간。결과：응고법급면역비탁법량충방법적정밀도균부합엄가규정적요구；정학도실험PT、APTT、FIB적편의균미초출이분지일 CLIA′88규정적윤허오차범위；FIB 선성측정적직선회귀방정위 Y ＝1．0021X-0．122，R2위0．9982，부합엄가요구（r≥0．975）；담홍소20 mg/dL、감유삼지900 mg/dL、혈홍단백5 g/L 시，대 PT、APTT、TT 화 FIB 측정적영향도균소우이분지일 CLIA′88규정적윤허오차범위；양본휴대오염솔최고위1．81％，부합엄가성능요구；본지구인동생물삼고구간：PT（9．1～13．1 s）、APTT（24．9～42．1 s）、TT（12．6～21．1 s）、FIB（1．924～4．011 g/L）。결론：ACL TOP혈응의구유량호적정밀도、정학도、선성화교저적양본휴대오염솔，병구교강적항생물간우능력，괄합본실험실사용。
Objective To evaluate the performance of ACL TOP coagulation analyzer system in the laboratory of children′s hospital. Methods According to the documents of CLSI, the analytic characteristics including precision, accuracy, linearity, interference and carryover rate were examined; specimens from healthy children were collected and assayed to determine the reference range of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Thrombin Time (TT), Fibrinogen (FIB) and D-Dimer (D-D) from children on ACL TOP. Results The within-run and between-day coefficient of variability (CV) were within an acceptable range; The accuracy deviation of PT , APTT and FIB were less than 1/2 allowed total errors; The results of determination of FIB linearity test were correlated with the results of calculation: Y = 1.002 1X-0.122, R2 =0.998 2; The extent of influence of low to middle grade of jaundice , fat and hemolysis on each test were all less than 1/2 allowed total error; The carryover rates were lower than 1.81% and within an acceptable range; The reference range of PT, APTT, TT and FIB were PT (9.1-13.1 s), APTT (24.9-42.1 s), TT (12.6-21.1 s), FIB (1.924-4.011 g/L). Conclusion The ACL TOP coagulation analyzer has good repeatability, stability, linearity and capability of anti-interference and anti-carryover.