[1]陆学军,李传保,刘梦欣,等.血液细胞分析流水线自动审核规则制定与确认[J].现代检验医学杂志,2017,32(03):157-161.[doi:10.3969/j.issn.1671-7414.2017.03.044]
LU Xue-jun,LI Chuan-bao,LIU Meng-xin,et al.Study on Autoverification Systems of Hematology Analysis System[J].Journal of Modern Laboratory Medicine,2017,32(03):157-161.[doi:10.3969/j.issn.1671-7414.2017.03.044]
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血液细胞分析流水线自动审核规则制定与确认(
)
《现代检验医学杂志》[ISSN:/CN:]
- 卷:
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第32卷
- 期数:
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2017年03期
- 页码:
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157-161
- 栏目:
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质量控制·实验室管理
- 出版日期:
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2017-05-25
文章信息/Info
- Title:
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Study on Autoverification Systems of Hematology Analysis System
- 文章编号:
-
1671-7414(2017)03-
157-05
- 作者:
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陆学军; 李传保; 刘梦欣; 赵 昕
-
北京医院检验科 国
家老年医学研究中心，北京 100730
- Author(s):
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LU Xue-jun; LI Chuan-bao; LIU Meng-xin; ZHAO Xin
-
Department of Labortory Medicine，
Beijing Hospital，National Geriatric Research Centre，Beijing 100730，Chin
a
-
- 关键词:
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血液分析仪; 自动审核规则
- 分类号:
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R446
- DOI:
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10.3969/j.issn.1671-7414.2017.03.044
- 文献标志码:
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A
- 摘要:
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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-K2)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(R
BC)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 93
4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。
- Abstract:
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Objective To build anautoverification system fo
r hematology analysis system and validate the system based on commercialized la
bXpert software．Methods Preliminary validation rules was
established base on “41 Items of International Consensus Review Rules” and in
structions for Mindray CAL8000 auto hematology analyzer，and input the rules int
o labXpert sample validation system．999 clinical samples were collected from Be
ijing Hospital Ministry of Health to test the preliminary rules and parameters i
ncluding 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 autoverification by calculati
ng the autoverification pass rate，proportion of manual verification and microsc
opic verification．Autoverification were compared as well as the turnover time (
TAT，timefrom receipt of sample to report of result) before and after applicatio
n of autoverificatio
n system．Results Preliminary verification results showed
that false negative rates in both hospitals were less than 2%，and the false ne
gative 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
3% with tested with false negative result，indicating relatively low clinical ri
sks．Both hospitals reported with relatively high false positive rates，up to ne
arly 18%，using preliminary programs，which may affect the autoverification rate
of the system．Based on the analyzing result of false positive results，the pro
gram was adjusted to significantly reduce the false positive rate while remainin
g the false negative rate low，therefore resulted with 4 remarkable increase of
autoverification pass rate．Over 10，000 samples were tested with improved progr
am，and the autoverification pass rates for hospital was 78.4%，respectively．P
rimary reason causing failure of autoverification included increased IMG%，flag
for immature cells and WBC exceeding set limit．Application of system reduced th
e TAT by 5 min (P<0.05)．Conclusion Autoverification
system using Mindray CAL8000 auto hematology analyzer andlabXpert has been confi
rmed effective in reducing TAT and enhancing working efficiency while remaining
low false negative rate．The autoverification pass rate tested 75%，which sugges
ted that laboratory workers can spare more time on reexamination of abnormal sam
ples for better blood routine report．
参考文献/References:
［1］ 陆怡德，施新明，杨 帆，等．临床化学审核规则的制定及计算机自动确
认的应用［J］．检验医学，2011，26(4)：277-280．
Lu YD，Shi XM，Yang F，et al．The formulation of clinical chemistry
audit rules and the application of computer automatic verification［J］．Lab Med
，2011，26(4)：277-280．
［2］ Zhao Y，Yang L，Zheng G，et al．Building and evaluating the autoverificat
ion of coagulation items in the laboratory information system［J］．Clin Lab，20
14，60(1)：143-150．
［3］ National Committee for Clinical Laboratory Standar-ds．Autoverification of
clinical laboratory test results；Approved Guideline［S］．Wayne：PA，CLSI Auto
10-A，2006．
［4］ National Committee for Clinical Laboratory Standar-ds．Reference leukocyte
differential (proportional) and evaluation of instrumental methods，approved st
andard-Second Edition［S］．Wayne：PA，CLSI H20-A2，1992．
［5］ Barnes PW，McFadden SL，Machin SJ，et al．The inte-rnational consensus gro
up for hematology review：suggested criteria for action following automated CBC
and WBC differential analysis［J］．Lab Hemato，2005，11(2)：83-90．
［6］ Torke N，Boral L，Nguyen T，et al．Process improvement and operational ef
ficiency through test result autoverification［J］．Clin Chem，2005，51(12)：240
6-2408．
备注/Memo
- 备注/Memo:
-
作者简介：陆学军(1970-)，男，硕士学位，副主任技师，研究方向：凝血与血液检验
，Tel：13501346643，E-mail：luxuejun123@sina.com。
更新日期/Last Update:
2017-06-25