中国医疗设备
中國醫療設備
중국의료설비
CHINA MEDICAL EQUIPMENT
2014年
11期
131-133,120
,共4页
全自动血液体液分析仪%精密度%携带污染率%线性范围%准确度
全自動血液體液分析儀%精密度%攜帶汙染率%線性範圍%準確度
전자동혈액체액분석의%정밀도%휴대오염솔%선성범위%준학도
fully-automatic blood and body lfuid analyzer%precision%contamination rate%linearity range%accuracy
目的：对Sysmex XN-9000全自动血液体液分析仪的主要性能进行初步评价。方法根据美国临床和实验室标准化协会（CLSI）指南文件EP15-A2、EP6-A2的要求，对XN-9000仪进行精密度、携带污染率、线性范围和准确度验证，以Beckman LH750全自动血液分析仪的检测结果作为评估依据，将验证结果与厂商声明的性能指标或公认的质量标准进行比较。结果 XN-9000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%~2.42%，批间CV%为0.12%~2.50%，线性相关性分析r为0.99991~0.99999，携带污染率为0.00%~0.38%。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仪的精密度、携带污染率、线性范围和准确度等主要评估指标均符合要求。
目的：對Sysmex XN-9000全自動血液體液分析儀的主要性能進行初步評價。方法根據美國臨床和實驗室標準化協會（CLSI）指南文件EP15-A2、EP6-A2的要求，對XN-9000儀進行精密度、攜帶汙染率、線性範圍和準確度驗證，以Beckman LH750全自動血液分析儀的檢測結果作為評估依據，將驗證結果與廠商聲明的性能指標或公認的質量標準進行比較。結果 XN-9000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%~2.42%，批間CV%為0.12%~2.50%，線性相關性分析r為0.99991~0.99999，攜帶汙染率為0.00%~0.38%。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儀的精密度、攜帶汙染率、線性範圍和準確度等主要評估指標均符閤要求。
목적：대Sysmex XN-9000전자동혈액체액분석의적주요성능진행초보평개。방법근거미국림상화실험실표준화협회（CLSI）지남문건EP15-A2、EP6-A2적요구，대XN-9000의진행정밀도、휴대오염솔、선성범위화준학도험증，이Beckman LH750전자동혈액분석의적검측결과작위평고의거，장험증결과여엄상성명적성능지표혹공인적질량표준진행비교。결과 XN-9000의측정백세포（WBC）、홍세포（RBC）、혈홍단백（HGB）、홍세포압적（HCT）화혈소판（PLT）주요삼수적비내변이계수（CV%）위0.11%~2.42%，비간CV%위0.12%~2.50%，선성상관성분석r위0.99991~0.99999，휴대오염솔위0.00%~0.38%。대비상관성분석，각항지표r균>0.999。준학도험증각항지표적편의위-0.67%~0.96%。결론 XN-9000의적정밀도、휴대오염솔、선성범위화준학도등주요평고지표균부합요구。
Objective To evaluate the main performance of Sysmex XN-9000 fully-automatic blood and body fluid analyzer. Methods According to the guidelines EP15-A2 and EP6-A2 of clinical and laboratory standards institute (CLSI), the precision, contamination rate, linearity range and accuracy of XN-9000 analyzer were verified based on the detection results of Beckman LH750 full-automatic blood analyzer which were choosed as assessment basis. Then the verification results of XN-9000 analyzer were compared with performance indicators declared by its manufacturer or recognized quality standards. Results The intra-assay and inter-assay coefficient variations (CV%) of major parameters including WBC, RBC, HGB, HCT and PLT measured by XN-9000 analyzer were 0.11%~2.42% and 0.12%~2.50%, respectively. The correlation coefficient (r ) of linear correlation analysis between observational values and theoretical values of the above parameters was 0.99991~0.99999 while the contamination rate of the above parameters was 0.00%~0.38%. The correlation coefficient (r ) of comparative correlation analysis between the detection indicators of XN-9000 analyzer and those of Backman LH750 analyzer was greater than 0.999. The Bias of accuracy verification of the above parameters of XN-9000 analyzer was -0.67%~0.96%. Conclusion The main parameters including precision, contamination rate, linearity range and accuracy of XN-9000 analyzer can meet the requirements of relevant standards.
