卡他莫拉菌胶体金免疫层析试纸的性能评估

程雨洁，侯昊，王毅，杨波，胡征

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主办：上海医药工业研究院
　　　中国药学会
　　　中国化学制药工业协会
ISSN 1001-8255   CN 31-1243/R   ZYGZEA
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中国医药工业杂志
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中国医药工业杂志 ›› 2021, Vol. 52 ›› Issue (10) : 1356-1360. DOI: 10.16522/j.cnki.cjph.2021.10.012
研究论文 Paper

卡他莫拉菌胶体金免疫层析试纸的性能评估

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Performance Evaluation of Immunochromatographic Colloidal Gold Test Strips for Detecting Moraxella catarrhalis

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摘要

对自研的卡他莫拉菌胶体金试纸的性能进行检测。随机抽取试纸，与呼吸道常见病原菌进行交叉反应检测其灵敏度，考察内源外源干扰物对试纸的干扰作用，以及检测试纸是否存在钩状效应和批次间试纸的贮存稳定性。结果显示，制备的卡他莫拉菌胶体金免疫层析试纸检测灵敏度为3.25×104 CFU/ml ；对呼吸道其他常见22 种病原体均无交叉反应；可稳定保存一年半以上；在菌浓度为1.0×107 ～ 1.0×109 CFU/ml 时，不存在钩状效应；内源和外源干扰物均没有对检测结果产生干扰反应。试纸的准确性、灵敏度及稳定性满足批量生产要求，符合体外诊断试剂产品的注册要求。

Abstract

The performance of self-developed immunochromatographic colloidal gold test strips for detecting Moraxella catarrhalis was tested. Test strips were selected randomly and cross-reacted with common respiratory pathogens to detect their sensitivity. In addition, the interference effects of internal and external interferences, hook effect of the test strips and storage stability of the test strips between batches were also tested. The results showed that the immunochromatographic colloidal gold test strips for detecting Moraxella catarrhalis had a detection sensitivity of 3.25×104 CFU/ml. The test strips had no cross-reactivity to other 22 common respiratory pathogens and could keep stable for more than one and a half years. No hook effect was observed when the bacterial concentration was 1.0×107 - 1.0× 109 CFU/ml, and neither endogenous nor exogenous interfering substances could interfere with the detection results. The accuracy, sensitivity and stability of the test strips met the requirements of mass production, as well as the registration requirements of in vitro diagnostic reagent products.

关键词

卡他莫拉菌 / 胶体金免疫层析试纸 / 特异性 / 灵敏度 / 钩状效应 / 稳定性

Key words

Moraxella catarrhalis / immunochromatographic colloidal gold test strip / specificity / sensitivity / hook effect / stability

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程雨洁，侯昊，王毅，杨波，胡征. 卡他莫拉菌胶体金免疫层析试纸的性能评估. 中国医药工业杂志. 2021, 52(10): 1356-1360 https://doi.org/10.16522/j.cnki.cjph.2021.10.012
CHENG Yujie, HOU Hao, WANG Yi, YANG Bo, HU Zheng. Performance Evaluation of Immunochromatographic Colloidal Gold Test Strips for Detecting Moraxella catarrhalis. Chinese Journal of Pharmaceuticals. 2021, 52(10): 1356-1360 https://doi.org/10.16522/j.cnki.cjph.2021.10.012

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基金

湖北省科技厅自然科学青年基金(2017CFB226)

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