基于迈瑞CAL8000流水线复检规则的建立与验证的单中心研究  

The Establishment and Verification of the Re-Examination Rules Based on Mindray CAL8000 Pipeline:A Single-Center Study

作　　者：刘瑞菡 刘丽[1] 梁英 刘思 王锋[1] 明亮 刘自刚[1] LIU Rui-han;LIU Li;LIANG Ying;LIU Si;WANG Feng;MING Liang;LIU Zi-gang(The Clinical Laboratory,Xiaogan Central Hospital,Hubei Xiaogan 432000)

机构地区：[1]孝感市中心医院检验科,湖北孝感432000

出　　处：《中国医疗器械信息》2022年第15期25-28,共4页China Medical Device Information

基　　金：孝感市自然科学计划项目(项目编号:XGKJ2021010060)。

摘　　要：目的:提高血细胞分析项目检测的效能,建立适用于孝感市中心医院基于迈瑞CAL8000流水线的血细胞分析复检规则。方法:依据国际41条复检标准结合CAL8000流水线上血细胞分析仪的性能及实验室样本分布特点制定初步的复检规则,并根据实验室工作需求制定复检预期目标(假阴性率<5%、复检率<20%),选取2021年5月18日~2021年5月28日门诊及住院血细胞分析静脉血标本1100例,以双盲法分别进行仪器分析和血涂片镜检,应用血涂片镜检的阳性判断标准,以镜检结果为金标准,对比仪器分析和血涂片镜检结果,评估复检规则对标本判断的真阳性率、真阴性率、假阳性率、假阴性率以及血涂片复检率。随后重新选取2021年5月30日~5月31日300例标本按上述过程进行复检规则确定后的验证。结果:建立复检规则的1100例样本的真阳性率12.0%,假阳性率7.7%,真阴性率77.4%,假阴性率2.9%,复检率19.7%。验证复检规则的300例样本的真阳性率10.3%,假阳性率9.0%,真阴性率77.3%,假阴性率3.3%,复检率19.3%。结论:复检规则建立及验证过程的假阴性率(2.9%<5%、3.3%<5%)及复检率(19.7%<20%、19.3%<20%)均达到实验室预期目标,复检规则设置适宜,能满足现阶段实验室对血细胞分析复检的要求。Objective:To improve the detection efficiency of blood cell analysis and establish a blood cell analysis re-examination rules based on Mindray CAL8000 pipeline for Xiaogan Central Hospital.Methods:According to the international 41 re-examination standards,combined with the characteristics of the CAL8000 blood cell analyzer and the distribution characteristics of laboratory samples,the preliminary re-examination rules were formulated.The expected re-examination goals were set according to the actual needs of the laboratory(false negative rate<5%,re-examination rate<20%).From May 18,2021 to May 28,2021,1100 venous blood samples of outpatients and inpatients were collected,and both instrumental analysis and blood smear microscopy were performed with double-blind method.Taking the positive results from blood smear microscopy for judgements and defining the results of microscopy as the gold standard,so that the true-positive rate,true-negative rate,false-positive rate,false negative rate and blood smear re-test rate were evaluated by comparing the results from instrument analysis and blood smear microscopy.A second group of 300 samples(collected during May 30 to 31,2021)were tested following the protocol to verify the efficiency of the re-examination rules.Results:For the 1100 samples,true-positive rate was 12.0%,false-positive rate was 7.7%,true-negative rate was 77.4%,false-negative rate was 2.9%,and re-examination rate was 19.7%for instrumental analysis.The results for the other 300 samples were true-positive rate 10.3%,false-positive rate 9.0%,true-negative rate 77.3%,false-negative rate 3.3%,and re-examination rate 19.3%for instrumental analysis.Conclusion:The false negative rate(3.6%<5%,3.3%<5%)and the re-examination rate(19.7%<20%,19.3%<20%)in both the establishment and verification groups have reached the expected goals of the laboratory.The re-examination rules are properly organized and meet the requirements for the re-examination of blood cell analysis at this stage.

关 键 词：血细胞分析 血细胞分析仪 血涂片镜检 复检规则 

分 类 号：TH776[机械工程—仪器科学与技术]