海南医学
海南醫學
해남의학
HAINAN MEDICAL JOURNAL
2014年
24期
3665-3667
,共3页
XN-9000血液分析仪%精密度%携带污染率%线性范围%正确度
XN-9000血液分析儀%精密度%攜帶汙染率%線性範圍%正確度
XN-9000혈액분석의%정밀도%휴대오염솔%선성범위%정학도
XN-9000 blood analyzer%Precision%Carry-over%Linear range%Accuracy
目的：对Sysmex公司最新推出的Sysmex XN-9000多功能自动血液分析仪的主要性能进行初步评价，以证实其检测效果。方法按美国临床实验室标准化协会指南文件EP15-A2、EP6-A2的要求对Sysmex XN-9000血液分析仪进行精密度、携带污染率、线性范围和正确度进行验证，以Backman LH750比对结果作为评估依据，结果与厂商声明的性能或公认的质量标准进行比较。结果 XN-9000血液分析仪测定白细胞(WBC)、红细胞(RBC)、血红蛋白(HGB)、红细胞压积(HCT)和血小板(PLT)主要参数的批内变异系数(CV%)为0.11%~2.32%，批间CV%为0.12%~2.46%，线性相关性分析r为0.99990~0.99997，携带污染率为0~0.37%，对比相关性分析，各项指标r均>0.999，准确度验证各项指标的偏倚为-0.67~0.96。结论 XN-9000仪测定主要参数的精密度、线性、携带污染率、准确性等主要评估指标均符合要求，检测结果可用于临床。
目的：對Sysmex公司最新推齣的Sysmex XN-9000多功能自動血液分析儀的主要性能進行初步評價，以證實其檢測效果。方法按美國臨床實驗室標準化協會指南文件EP15-A2、EP6-A2的要求對Sysmex XN-9000血液分析儀進行精密度、攜帶汙染率、線性範圍和正確度進行驗證，以Backman LH750比對結果作為評估依據，結果與廠商聲明的性能或公認的質量標準進行比較。結果 XN-9000血液分析儀測定白細胞(WBC)、紅細胞(RBC)、血紅蛋白(HGB)、紅細胞壓積(HCT)和血小闆(PLT)主要參數的批內變異繫數(CV%)為0.11%~2.32%，批間CV%為0.12%~2.46%，線性相關性分析r為0.99990~0.99997，攜帶汙染率為0~0.37%，對比相關性分析，各項指標r均>0.999，準確度驗證各項指標的偏倚為-0.67~0.96。結論 XN-9000儀測定主要參數的精密度、線性、攜帶汙染率、準確性等主要評估指標均符閤要求，檢測結果可用于臨床。
목적：대Sysmex공사최신추출적Sysmex XN-9000다공능자동혈액분석의적주요성능진행초보평개，이증실기검측효과。방법안미국림상실험실표준화협회지남문건EP15-A2、EP6-A2적요구대Sysmex XN-9000혈액분석의진행정밀도、휴대오염솔、선성범위화정학도진행험증，이Backman LH750비대결과작위평고의거，결과여엄상성명적성능혹공인적질량표준진행비교。결과 XN-9000혈액분석의측정백세포(WBC)、홍세포(RBC)、혈홍단백(HGB)、홍세포압적(HCT)화혈소판(PLT)주요삼수적비내변이계수(CV%)위0.11%~2.32%，비간CV%위0.12%~2.46%，선성상관성분석r위0.99990~0.99997，휴대오염솔위0~0.37%，대비상관성분석，각항지표r균>0.999，준학도험증각항지표적편의위-0.67~0.96。결론 XN-9000의측정주요삼수적정밀도、선성、휴대오염솔、준학성등주요평고지표균부합요구，검측결과가용우림상。
Objective To carry on a preliminary performance evaluation of Sysmex XN-9000 multi-func-tion automatic blood nalyzer, to confirm its test performance. Methods According to the EP15-A2 and EP6-A2 re-quirements of American association of clinical laboratory standardization guidelines, Sysmex XN-9000 blood analyzer's precision, carry-over, linear range and accuracy were confirmed. Taking Backman LH750 as basis for evaluating, the re-sults were compared with the manufacturer's performance statement or recognized quality standards. Results The coef-ficient of variation (CV%) within-run of XN-9000 blood analyzer determination of white blood cell (WBC), red blood cell (RBC), hemoglobin (HGB), hematocrit (HCT) and platelet (PLT) was 0.11%~2.32%, the between-run CV%was 0.12%~2.46%, linear correlation r was 0.999 90~0.999 97, the carry-over was 0~0.37%, the correlation analysis of each index r>0.999, the indicators accuracy verification bias was-0.67~0.96. Conclusion XN-9000 instrument for determination of main parameters of precision, accuracy, linear, carry-over and other major evaluation indexes meet the requirements and is therefore useful for clinical application.
