[1]王玲萍,许中,陆茜莹,等.干式时间分辨荧光免疫层析法检测血清抗链球菌溶血素“O”的方法学性能验证[J].现代检验医学杂志,2020,35(05):131-133,167.[doi:10.3969/j.issn.1671-7414.2020.05.034]
　WANG Ling-ping,XU Zhong,LU Qian-ying,et al.Validation of Dry Time -Resolved Fluorescence Immunochromatography for Detection of Serum Anti Streptolysin “O”[J].Journal of Modern Laboratory Medicine,2020,35(05):131-133,167.[doi:10.3969/j.issn.1671-7414.2020.05.034]
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干式时间分辨荧光免疫层析法检测血清抗链球菌溶血素“O”的方法学性能验证()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第35卷
期数:
2020年05期
页码:
131-133,167
栏目:
研究简报·实验技术
出版日期:
2020-11-01

文章信息/Info

Title:
Validation of Dry Time -Resolved Fluorescence Immunochromatography for Detection of Serum Anti Streptolysin “O”
文章编号:
1671-7414（2020）05-131-04
作者:
王玲萍1; 许中2; 陆茜莹1; 陆仁伟1; 周伟3; 刘琴1
1. 苏州市相城区漕湖人民医院检验科，江苏苏州215144；2. 苏州市立医院东区检验科, 江苏苏州 215001； 3. 上海捷门生物技术有限公司，上海 201806
Author(s):
WANG Ling-ping 1;  XU Zhong2;  LU Qian-ying 1;  LU Ren-wei 1;  ZHOU Wei 3;  LIU Qin 1
1.Department of Clinical Laboratory,Caohu People’s Hospital of Xiangcheng District in Suzhou, Jiangsu Suzhou 215144,China;2.Department of Clinical Laboratory, Eastern Distric of Suzhou Municipal Hospital, Jiangsu Suzhou 215001,China;3.Shanghai Jiemen Biotechnology Co. Ltd, Shanghai 201806, China
关键词:
抗链球菌溶血素“O”; 精密度; 正确度; 线性试验; 参考范围
分类号:
R446.62
DOI:
10.3969/j.issn.1671-7414.2020.05.034
文献标志码:
A
摘要:
目的　验证时间分辨荧光免疫层析法抗链球菌溶血素“O”（ASO）检测试剂的方法学性能。方法　参照 CLSI 对上海捷门生物技术有限公司生产的干式时间分辨荧光分析仪（FIT-1000）ASO 荧光免疫层析法检测的精密度、 正确度、线性及参考范围进行验证。并以贝克曼IMMAGE800 免疫散射速率法作为参考系统，对临床标本进行比对实验。 结果　正确度试验，检测ASO 浓度分别为83.2 ，136 和269 IU/ml 的校准品，相对偏倚分别为-1.03％，-0.99% 和-2.70%。 检测低、高两个浓度血清标本的ASO 精密度，CV 分别为8.32％，6.39％。ASO 浓度范围46.37 ～ 868.13 IU/ml 时，线 性方程为Y=0.958 8X-3.889（r2=0.998 5）。临床标本(n=61) 比对实验，Deming 回归方程Y=1.256X-6.51,r=0.950 6。性 能评价项目结果均达到厂商声明标准。结论　应用干式时间分辨荧光分析仪（FIT-1000）及配套试剂检测ASO，其正确性、 重复性良好，可满足临床尤其是基层医疗单位的要求。
Abstract:
Objective　To verify the methodological performance of anti streptolysin “O” (ASO) detection reagent by timeresolved fluorescence immunochromatography CTRFIC. Methods　According to CLSI, the precision, accuracy, linearity and reference range of ASO fluorescence immunochromatography (FIT-1000) produced by Shanghai Jiemen Biotechnology Co. Ltd were verified. Beckman IMMAGE800 was used as the reference system to compare the clinical samples. Results　In the accuracy test, the relative bias was - 1.03%, - 0.99% and - 2.70%, when the ASO concentration was 83.2 , 136 and 269 IU / ml, respectively. The precision of ASO was 8.32% and 6.39% respectively. When the concentration of ASO ranged from 46.37 to 868.13 IU / ml, the linear equation was Y = 0.958 8X-3.889 (r2 = 0.998 5). The Deming regression equation Y = 1.256X-6.51, r = 0.950 6. The results of performance evaluation items all meet the manufacturer’s declaration standard. Conclusion　The accuracy and repeatability of dry TRFIC analyzer (FIT-1000) and related reagents for ASO detection are good, which can meet the requirements of clinical, especially primary medical units.

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备注/Memo

备注/Memo:
作者简介：王玲萍（1988-），女，大专，主管检验师，研究方向：临床检验, E-mail:540280220@qq.com。
通讯作者：刘琴, 副主任技师，主要从事实验室管理及生化检验，E-mail：2297779562@qq.com。
更新日期/Last Update: 2020-10-30