CAJ | 학술논문

目的：对铜陵地区三级医疗机构Sysmex公司生产的血细胞分析仪进行结果比对和偏倚评估，使检测结果可比、互通。方法参考美国临床和实验室标准化委员会EP9‐A2文件的要求，试验采用患者新鲜全血样品在参考仪器（A）和测试仪器（B、C、D、E、F）对白细胞（WBC）、红细胞（RBC）、血红蛋白（Hb）、红细胞压积（HCT）、血小板计数（PLT）5项指标进行检测，制作散点图和偏倚图，计算回归方程、相关系数（r）、相对偏倚、预期偏倚和其95％的可信区间，评估结果之间的可比性。结果参考仪器和5套测试仪器的WBC、RBC、PLT、Hb和 HCT 5项指标检测结果经F检验，差异无统计学意义（P＞0．05）；各参数测定结果之间相关性密切（r≥0．975），一致性良好；B、C、D、F仪器的相对偏倚和预期偏倚在允许范围内。测试仪器E的PL T 低值结果相对偏倚（12．61％）超出美国临床实验室改进法案修正案质量要求的1／2 EA （12．5％），但其预期偏倚可信区间的上限小于可接受偏倚，结果仍可为临床接受。结论实验室间相同品牌血细胞分析系统对新鲜抗凝全血的比对试验通过；检验人员应定期对检测结果进行比对和偏倚评估，保证同地区检测结果间的可比性和互通性。
목적：대동릉지구삼급의료궤구Sysmex공사생산적혈세포분석의진행결과비대화편의평고，사검측결과가비、호통。방법삼고미국림상화실험실표준화위원회EP9‐A2문건적요구，시험채용환자신선전혈양품재삼고의기（A）화측시의기（B、C、D、E、F）대백세포（WBC）、홍세포（RBC）、혈홍단백（Hb）、홍세포압적（HCT）、혈소판계수（PLT）5항지표진행검측，제작산점도화편의도，계산회귀방정、상관계수（r）、상대편의、예기편의화기95％적가신구간，평고결과지간적가비성。결과삼고의기화5투측시의기적WBC、RBC、PLT、Hb화 HCT 5항지표검측결과경F검험，차이무통계학의의（P＞0．05）；각삼수측정결과지간상관성밀절（r≥0．975），일치성량호；B、C、D、F의기적상대편의화예기편의재윤허범위내。측시의기E적PL T 저치결과상대편의（12．61％）초출미국림상실험실개진법안수정안질량요구적1／2 EA （12．5％），단기예기편의가신구간적상한소우가접수편의，결과잉가위림상접수。결론실험실간상동품패혈세포분석계통대신선항응전혈적비대시험통과；검험인원응정기대검측결과진행비대화편의평고，보증동지구검측결과간적가비성화호통성。
Objective To ensure the consistency of test results by comparing the results on the determination and bias evaluation obtained from Sysmex hematocyte analyzers in tertiary medical institutions of Tongling District . Methods According to NCCLS(national committee for clinical laboratory standards)EP9‐A2 ,fresh whole blood sam‐ples of patients were selected ,using the reference instrument(A) and test instruments(B ,C ,D ,E ,F) to measure the white blood cell(WBC) ,red blood cell(RBC) ,platelet(PLT) ,hematocrit(HCT) ,hemoglobin(Hb) ,scatter diagram and bias map were made ,regression equations ,the correlation coefficient(r) ,relative bias ,expected bias and 95% con‐fidence interval were calculated ,and the comparability of results were assessed .Results The five test results ,WBC , RBC ,PLT ,Hb and HCT ,by F test showed no significant differences(P>0 .05) using the reference instrument(A) and five test instruments(B ,C ,D ,E ,F) .Various parameters of the results between reference instrument and test in‐strument were closely related(r≥0 .975) .The instruments of B ,C ,D ,F relative bias and the expected bias within the permissible range .The relative bias of PLT low value in test instrument E(12 .61% ) beyond CLIA′88 quality re‐quirements of 1/2 EA (12 .5% ) ,but the expected bias upper limit of the confidence interval is less than acceptable re‐sults can bias ,for clinical acceptance .Conclusion Analysis and comparison of fresh anticoagulant blood test by the same brand of hematocyte analyzers in laboratory .Inspection personnel should be regularly carried out comparison and bias evaluation on the test results ,to ensure the detection results of the same area comparability and interopera‐bility .