CAJ | 학술논문

目的：探讨D-二聚体(DD)试剂在不同全自动血凝仪上的性能以及检测结果的一致性。方法按照临床和实验室标准协会(CLSI)相关文件，进行精密度试验、回收实验及线性实验，对日本积水DD试剂在ACL-TOP和CA-7000血凝分析仪的性能进行评价；根据EP9-A2文件，对积水DD试剂在两台血凝仪上的结果进行可比性分析，同时对ACL-TOP血凝仪使用积水试剂和配套试剂检测DD结果进行比较。结果积水DD试剂在CA-7000血凝仪和ACL-TOP血凝仪上日内和日间精密度均<10%，平均回收率分别为105.42%和92.44%，线性范围分别为0-58.9μg/ml和0-57.4μg/ml。线性回归方程为Y=0.9528X-0.0158，R2=0.9766，相对偏差均<10%，ACL-TOP血凝仪使用积水试剂和配套试剂的结果差异无统计学意义。结论积水DD试剂在ACL-TOP和CA-7000上的性能达到临床应用要求，且在两台血凝仪上的检测结果具有一致性和可比性。
목적：탐토D-이취체(DD)시제재불동전자동혈응의상적성능이급검측결과적일치성。방법안조림상화실험실표준협회(CLSI)상관문건，진행정밀도시험、회수실험급선성실험，대일본적수DD시제재ACL-TOP화CA-7000혈응분석의적성능진행평개；근거EP9-A2문건，대적수DD시제재량태혈응의상적결과진행가비성분석，동시대ACL-TOP혈응의사용적수시제화배투시제검측DD결과진행비교。결과적수DD시제재CA-7000혈응의화ACL-TOP혈응의상일내화일간정밀도균<10%，평균회수솔분별위105.42%화92.44%，선성범위분별위0-58.9μg/ml화0-57.4μg/ml。선성회귀방정위Y=0.9528X-0.0158，R2=0.9766，상대편차균<10%，ACL-TOP혈응의사용적수시제화배투시제적결과차이무통계학의의。결론적수DD시제재ACL-TOP화CA-7000상적성능체도림상응용요구，차재량태혈응의상적검측결과구유일치성화가비성。
Objective To survey the consistency of D-dimer(DD) detection in different automatic coagulation analyzer. Methods Do precision test recover test and linear test to evaluate DD reagent performance in ACL-TOP and CA-700 coagulation analyzer according to CLSI document, do cooperation analysis with the detected data in two coagulation analyzer according to EP9-24 document. Results Intraday and interday precision of the two instrument were all <10%, mean recovery were 105.42% and 92.44% respectively, linear range were 0-55.9μg/ml and 0-57.4μg/ml respectively, the linear regression equation was Y=0.9528X-0.0158, R2=0.9766, relative deviation were all <10%, character of DD reagent in ACL-TOP and CA-700 reached the clinical requirement. The detection results in the two instruments were consistent and comparable.