[1]李文东,白海燕,李淑莲,等.六种国产粪便隐血检测试剂的诊断性能评价[J].现代检验医学杂志,2019,34(01):111-114,119.[doi:10.3969/j.issn.1671-7414.2019.01.029]
LI Wen-dong,BAI Hai-yan,LI Shu-lian,et al.Diagnostic Performance Evaluation of Six Kinds
of Domestic Fecal Occult Blood Reagents[J].Journal of Modern Laboratory Medicine,2019,34(01):111-114,119.[doi:10.3969/j.issn.1671-7414.2019.01.029]
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六种国产粪便隐血检测试剂的诊断性能评价(
)
《现代检验医学杂志》[ISSN:/CN:]
- 卷:
-
第34卷
- 期数:
-
2019年01期
- 页码:
-
111-114,119
- 栏目:
-
研究简报·实验技术
- 出版日期:
-
2019-02-28
文章信息/Info
- Title:
-
Diagnostic Performance Evaluation of Six Kinds
of Domestic Fecal Occult Blood Reagents
- 文章编号:
-
1671-7414(2019
)01-111-05
- 作者:
-
李文东1; 白海燕2; 李淑莲1; 林惠玲1; 谌泰春1;
徐士兰2; 张惠林2
-
(1.厦门市湖里区妇幼保健院，福建厦门361006；2.厦门大学附属中山
医院，福建厦门361004)
- Author(s):
-
LI Wen-dong1; BAI Hai-yan2; LI Shu-lian1; LIN
Hui-ling1; CHEN Tai-chun1; XU Shi-lan2;
ZHANG Hui-lin2
-
(1.Maternity and Child Care Hospital of Huli
District in Xiamen，Fujian
Xiamen 361006，China；2.Zhongshan Hospital of Xiamen University，Fujian X
iamen 361004，China)
-
- 关键词:
-
粪便隐血试剂; 最低检测限; 干扰因素; 性能评价
- 分类号:
-
R446.133
- DOI:
-
10.3969/j.issn.1671-7414.2019.01.029
- 文献标志码:
-
A
- 摘要:
-
目的综合评价六种国产粪便隐血试剂的诊断性能。
5方法采用高值人血红蛋白稀释法对六种粪便隐血试剂的最低检测限和高
浓度人血红蛋白检测能力进行评价，采用动物血红蛋白、维生素C和辣根过氧化物酶对六种
粪便隐血试剂的抗干扰性进行评价。检测120例消化内科就诊患者和80例健康体检者来源的
新鲜粪便样本，比较六种粪便隐血试剂对临床标本的检测结果。结果”六种国产粪便检测试剂(贝索、艾博、波生、新创、万华和万孚)的最低检测限分别为25，
50，100，150，200和200 ng/ml，检测人血红蛋白高值分别为7，10，10，7，3和3 mg/ml。
500 μg/ml的动物血红蛋白和高于0.1 mg/ml的维生素C对部分检测试剂有干扰。六种粪便
检测试剂检测消化内科就诊患者来源的新鲜粪便的阳性率在23.3%～60.0%之间，六种粪便
检测试剂的检出阳性率不同( P <0.05)。结论六种国产粪便隐
血试剂最低检测限、高浓度血红蛋白检测能力、抗干扰性和临床样本的检出阳性率不全一致
。在选用诊断试剂产品前应做好性能评价，了解试剂的真实诊断性能。
- Abstract:
-
Objecti
ve To gain a comprehensive evaluation on the performance of six kind
s of domestic fecal occult blood (FOB) reagents．Methods
Human hemoglobin was used to determine the lower and upper detection limits of t
ested reagent．Animal hemoglobin，vitamin C，and horseradish peroxidase were emp
loyed to evaluate the anti-interference capacity of tested FOB reagent．Fresh f
ecal sample collected from 120 patients in the outpatient department of gastroen
terology and 80 healthy subjects who attended in regular examination were used t
o conduct the performance evaluation．Results The lower d
etection of six kinds of FOB reagent (Baso，Aibo，Boson，Xinchuang，Wanhua and W
anfu) were 25，50，100，150，200，and 200 ng/ml，respectively．As for the upper
limits for detecting human hemoglobin，the results were 7，10，10，7，3 and 3 mg
/ml，respectively．Animal hemoglobin of 500μg/ml or vitamin C higher than 0.1
mg/ml could impose interference in some kinds of FOB reagent．The positive rate
of testing samples collected from patients in the department of gastroenterology
for six tested FOB reagent was ranging from 23.3%~60.0%，and significant diff
erence was observed in comparing the positive rate( P <0.05)．Conc
lusion There were difference in lower detection limit，capacity of d
etecting high concentration of human hemoglobin，anti-interference capacity，an
d positive rate between six kinds of FOB reagent．Therefore，recommend that the
clinical evaluation should be conducted to understand the diagnostic performance
prior to reagent application．
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备注/Memo
- 备注/Memo:
-
基金项目：
国家自然科学基金青年科学基金项目(81401749，81301501)；厦门市湖里区科技局社会发展
项目(17社03)。
作者简介：李文东(1966-)，男，大学本科，副主任检验技师，主
要从事免疫检验研究，E-mail：99LWD@163.com。
通讯作者：张惠林(1982-)，男，硕士，主管检验技师，E-mail
：zhanghuilin@xmu.edu.cn。
更新日期/Last Update:
2019-02-28