血液细胞分析流水线自动审核规则制定与确认

Study on Autoverification Systems of Hematology Analysis System

目的制定血液细胞分析流水线自动审核规则,并对自动审核软件系统进行应用与确认。方法选取北京医院门诊及住院的999例乙二胺四乙酸二钾(EDTA-K_2)抗凝的静脉全血标本,在CAL 8000血液细胞分析流水线上进行检测并对所有的样本进行人工镜检,根据仪器检测结果及人工镜检结果对自动审核初版规则及镜检初版规则进行评估,另选取2014年4月~6月门诊、住院及体检的15 934例标本结果使用专家系统(labXpert)软件进行样本审核,统计自动审核通过率及没有通过自动审核的样本构成;对比1 262份标本采用自动审核软件对样本审核与全部采用人工审核的周转时间(TAT),并将镜检审核样本的异常情况进行分析,分别统计白细胞(WBC)系异常、红细胞(RBC)系异常及血小板(PLT)系异常的TAT情况。结果通过检测999份标本,通过自动审核的样本占总的样本数的78.4%,符合镜检规则及人工审核规则的样本数占总的样本数的21.6%,1.3%的自动审核假阴性低于国际血液学复检专家组要求的5%的最大允许范围。假阴性主要集中于红细胞形态及低值的中晚幼粒样本。用自动审核系统对15 934份标本结果进行分析,自动确认占总标本的84.5%,需人工审核确认及镜检确认的占15.5%,需人工审核及镜检审核确认的样本主要包括:未成熟粒细胞报警提示、红细胞平均体积(MCV)超范围、PLT超范围、WBC超范围、血小板聚集报警提示、原始细胞报警提示及血红蛋白(HGB)超范围等情况。对比1 262份样本采用自动审核系统及完全由检验师进行人工审核,非镜检样本传统人工审核平均TAT时间为28 min 40 s,自动审核样本平均TAT时间为24 min 26 s,差异具有统计学意义(P<0.05)。结论采用labXpert软件对样本进行自动审核,制定严谨的自动审核规则及镜检规则,可以保证降低假阴性前提下,实现大部分样本自动审核,缩短TAT,提高检验科的工作效率。同时采用自动审核系统可以使不同的检验医生审核报告统一化,所有的医生均采用同一套规则审核报告,减少报告出错的概率。

Objective To build anautoverification system for hematology analysis system and validate the system based on commercialized labXpert software. Methods Preliminary validation rules was established base on ＂41 Items of International Consensus Review Rules＂ and instructions for Mindray CAL8000 auto hematology analyzer,and input the rules into labXpert sample validation system. 999 clinical samples were collected from Beijing Hospital Ministry of Health to test the preliminary rules and parameters including false positive rate, false negative rate and autoverification pass rate were calculated, based on which to adjust and customize the original protocol. Then 15 934 samples were tested,respectively, for autoverifica- tion by calculating the autoverification pass rate, proportion of manual verification and microscopic verification. Autoverification were compared as well as the turnover time （TAT,timefrom receipt of sample to report of result） before and after application of autoverification system. Results Preliminary verification results showed that false negative rates in both hospitals were less than 2 %,and the false negative mainly caused by low promyelocytic cells value （blasts and promyelocytes less than 3 % ）, abnormal erythrocyte morphology, and abnormal platelet morphology. No sample with excess blasts or percentage of blasts and promyelocytes higher 30% with tested with false negative result, indicating relatively low clinical risks. Both hospitals reported with relatively high false positive rates, up to nearly 18 %, using preliminary programs, which may affect the autoverification rate of the system. Based on the analyzing result of false positive results, the program was adjusted to significantly reduce the false positive rate while remaining the false negative rate low, therefore resulted with 4 remarkable increase of autoverification pass rate. Over 10,000 samples were tested with improved program, and the autoverification pass rates for hospital was 78.40%, respectively. Primary reason causing failure of autoverification included increased IMG%, flag for immature cells and WBC exceeding set limit. Application of system reduced the TAT by 5 min （P〈0.05）. Conclusion Autoverificationsystem using Mindray CALS000 auto hematology analyzer andlabXpert has been confirmed effective in reducing TAT and enhancing working efficiency while remaining low false negative rate. The autoverification pass rate tested 75%,which suggested that laboratory workers can spare more time on reexamination of abnormal samples for better blood routine report.