CAJ | 학술논문

目的对国产仪器BC-5500全自动血液分析仪进行系统评价,了解国产血液分析仪的白细胞(WBC)分类性能.方法参照国际血液学标准化委员会(ICSH)和美国临床实验室标准化委员会(NCCLS)制定的评价标准对BC-5500的各项性能进行评估.结果 BC-5500血液分析仪的总重复性、批内、批间CV值为0.27%～2.85%,天间CV值为0.57%～2.93%;BC-5500各项指标线性良好(r>0.998);携带污染率低,各参数都接近0%;相关性实验表明BC-5500与雅培CELL-DYN 3700血液分析仪测定结果密切相关;WBC分类实验表明BC-5500与手工分类结果比较,二者中性粒细胞、淋巴细胞、单核细胞、嗜酸性粒细胞及嗜碱性粒细胞的r值分别为0.968 0、0.942 6、0.646 5、0.820 7和0.287 6.在异常细胞识别方面,BC-5500能够对172例临床标本中明显的异常细胞进行提示,但提示结果出现较高假阳性,提示信息也比较简单,个别异常标本出现假阴性.与CELL-DYN 3700旗标提示相比,BC-5500漏检率稍高.结论 BC-5500各方面性能良好, 但在异常细胞提示上还需进一步改进.由于它是我国第一台拥有自主知识产权的全自动五分类血液分析仪,并有自己的配套试剂及质量溯源体系,因而具有理想的发展应用前景,是一款能够对大批量全血标本的血细胞计数与WBC分类进行快速而有效筛检的全自动血液分析仪.
목적 대국산의기BC-5500전자동혈액분석의진행계통평개,료해국산혈액분석의적백세포(WBC)분류성능.방법 삼조국제혈액학표준화위원회(ICSH)화미국림상실험실표준화위원회(NCCLS)제정적평개표준대BC-5500적각항성능진행평고.결과 BC-5500혈액분석의적총중복성、비내、비간CV치위0.27%～2.85%,천간CV치위0.57%～2.93%;BC-5500각항지표선성량호(r>0.998);휴대오염솔저,각삼수도접근0%;상관성실험표명BC-5500여아배CELL-DYN 3700혈액분석의측정결과밀절상관;WBC분류실험표명BC-5500여수공분류결과비교,이자중성립세포、림파세포、단핵세포、기산성립세포급기감성립세포적r치분별위0.968 0、0.942 6、0.646 5、0.820 7화0.287 6.재이상세포식별방면,BC-5500능구대172례림상표본중명현적이상세포진행제시,단제시결과출현교고가양성,제시신식야비교간단,개별이상표본출현가음성.여CELL-DYN 3700기표제시상비,BC-5500루검솔초고.결론 BC-5500각방면성능량호, 단재이상세포제시상환수진일보개진.유우타시아국제일태옹유자주지식산권적전자동오분류혈액분석의,병유자기적배투시제급질량소원체계,인이구유이상적발전응용전경,시일관능구대대비량전혈표본적혈세포계수여WBC분류진행쾌속이유효사검적전자동혈액분석의.
Objective To evaluate the performance of domestic automatic hematology analyzer BC-5500,in leukocyte differential analysis. Methods The BC-5500 was evaluated according to the guidelines of International Council for Standardization in Haematology(ICSH) and National Committee for Clinical Laboratory Standards(NCCLS). Results BC-5500 achieved higher precision in detecting complete blood count, its total reproducibility, within group and between group coefficient variation (CV) in each parameter was from 0.27% to 2.85%. Stability was outstanding in 20 days for which its CV was from 0.57% to 2.93% . BC-5500 had an excellent linearity for white blood cell(WBC), red blood cell(RBC), hemoglobin(Hb) and platelet(PLT)(r>0.995)and minimal carryover. Compared with CELL-DYN 3700, both results were highly related. Evaluation of WBC differential count indicated an excellent correlation with microscopic examination for Neut and Lym (r=0.968 0,0.942 6 respectively), acceptable correlation for Mon and Eso (r=0.646 5,0.820 7),but poor for Baso (r=0.287 6). In assessing the effect of the WBC warning by the BC-5500, alarm signals could indicate abnormal morphology cells in 172 cases. However its false positive rate was high and existed false negative to some extend. Compared with CELL-DYN 3700, the false negative of BC-5500 was a bit higher.Conclusions Automatic BC-5500 hematology analyzer is sensitive, accurate and rapid, but the improvement in abnormal morphology cell warnings is expected. As it is firstly made in our country and BC-5500 has its own reagent and quality control system, it can be greatly applicated in clinical detection of complete blood count and leukocyte differential.