中国医疗器械信息
中國醫療器械信息
중국의료기계신식
CHINA MEDICAL DEVICES INFORMATION
2013年
5期
13-16
,共4页
胱抑素C%性能验证%定量测定
胱抑素C%性能驗證%定量測定
광억소C%성능험증%정량측정
cystatin C%performance verification%quantitative detection system
目的:验证由豪迈胱抑素C检测试剂盒和贝克曼库尔特UniCel DxC800全自动生化分析仪组成的检测系统的性能特征.方法:对该检测系统的精密度、正确度、可报告范围和参考区间进行验证.结果:2个不同浓度水平样本的批内、批间变异系数均小于2%,均小于厂家声明;对厂家的定值参考物质进行检测,低浓度参考物质的绝对偏差为0.03~0.06mg/L,高浓度参考物质的回收率为94%~102%.使用厂家的定值物质进行回收试验,回收率为104.5%~108.4%.绝对偏差和回收率均与厂家声明一致;验证的分析测量范围为0.10~8.0mg/L,临床可报告范围为0.10~16.0mg/L;验证的参考区间与厂家声明的(0.57~1.01mg/L)一致.结论:由豪迈胱抑素C检测试剂盒和贝克曼库尔特UniCel DxC800全自动生化分析仪组成的检测系统的性能特征与豪迈公司声明一致,本研究所用性能验证的方案和方法简便、可行.
目的:驗證由豪邁胱抑素C檢測試劑盒和貝剋曼庫爾特UniCel DxC800全自動生化分析儀組成的檢測繫統的性能特徵.方法:對該檢測繫統的精密度、正確度、可報告範圍和參攷區間進行驗證.結果:2箇不同濃度水平樣本的批內、批間變異繫數均小于2%,均小于廠傢聲明;對廠傢的定值參攷物質進行檢測,低濃度參攷物質的絕對偏差為0.03~0.06mg/L,高濃度參攷物質的迴收率為94%~102%.使用廠傢的定值物質進行迴收試驗,迴收率為104.5%~108.4%.絕對偏差和迴收率均與廠傢聲明一緻;驗證的分析測量範圍為0.10~8.0mg/L,臨床可報告範圍為0.10~16.0mg/L;驗證的參攷區間與廠傢聲明的(0.57~1.01mg/L)一緻.結論:由豪邁胱抑素C檢測試劑盒和貝剋曼庫爾特UniCel DxC800全自動生化分析儀組成的檢測繫統的性能特徵與豪邁公司聲明一緻,本研究所用性能驗證的方案和方法簡便、可行.
목적:험증유호매광억소C검측시제합화패극만고이특UniCel DxC800전자동생화분석의조성적검측계통적성능특정.방법:대해검측계통적정밀도、정학도、가보고범위화삼고구간진행험증.결과:2개불동농도수평양본적비내、비간변이계수균소우2%,균소우엄가성명;대엄가적정치삼고물질진행검측,저농도삼고물질적절대편차위0.03~0.06mg/L,고농도삼고물질적회수솔위94%~102%.사용엄가적정치물질진행회수시험,회수솔위104.5%~108.4%.절대편차화회수솔균여엄가성명일치;험증적분석측량범위위0.10~8.0mg/L,림상가보고범위위0.10~16.0mg/L;험증적삼고구간여엄가성명적(0.57~1.01mg/L)일치.결론:유호매광억소C검측시제합화패극만고이특UniCel DxC800전자동생화분석의조성적검측계통적성능특정여호매공사성명일치,본연구소용성능험증적방안화방법간편、가행.
Objective: To verify the main performance characteristics of the detection system composed of HOMA cystatin C assay kit and Beckman-Coulter UniCel DxC800 Synchron Clinical System. Methods The precision, trueness, reportable range and reference interval of the quantitative detection system were analyzed according to the guidelines of CLSI. Results: For the two different levels samples, the coefficients of variation of intra-assay and inter-assay were less than 2%, less than manufacturers statement. The absolute deviations of the low concentration reference materials were 0.03~0.06mg/L, the recoveries of the high concentration reference materials were 94%~102%. The recovery tests were applied by using HOMA reference materials.The recoveries were 104.5%~108.4%. The absolute deviations and the recoveries were consistent with manufacturers statement. The verified measurement range was 0.10~8.0mg/L, the clinical reportable range was 0.10~16.0mg/L. The verified reference intervals were 0.57~1.01mg/L, and consistent with with manufacturers statement. Conclusion: The main performance characteristics of the quantitative detection system in the detection of cystatin C were consistent with manufacturers statement.The performance verification procedures and methods were simple and practicable.
