胶体金免疫层析法检测碳青霉烯类耐药肠杆菌目细菌碳青霉烯酶的应用评价
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Application and evaluation of colloidal gold immurnochromatography in carbapenemase detection of carbapenem-resistant Enterobacterales
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    摘要:目的 评价胶体金免疫层析法快速检测碳青霉烯类耐药肠杆菌目细菌(CRE)产碳青霉烯酶类型和部分KPC亚型的性能及价值。方法 收集非重复CRE分离株共128株,分别用胶体金免疫层析法和聚合酶链反应(PCR)检测KPC、NDM、IMP、VIM、OXA-48-like这5种碳青霉烯酶。以PCR为参考方法,评价胶体金免疫层析法的准确性。结果 经PCR检测后,有10株不产这5种碳青霉烯酶,另有118株CRE产碳青霉烯酶。与PCR相比,胶体金免疫层析法的敏感性为98.3%,特异性为100%,两种方法在检出率上差异无统计学意义(P>0.05),检测一致性优秀(Kappa=0.90)。未检出产KPC-31和KPC-33亚型CRE菌株的KPC酶。结论 胶体金免疫层析法是检测CRE中5种碳青霉烯酶的快速可靠方法,但对部分KPC亚型会出现漏检,需结合其他方法进行检测。

    Abstract:

    Abstract: Objective To evaluate the performance and value of the colloidal gold immunochromatographic assay for the rapid detection of carbapenemase types and a part of KPC subtypes in carbapenem-resistant Enterobacterales (CRE). MethodsA total of 128 non-duplicate CRE isolates were collected. Five carbapenemases (KPC,NDM,IMP,VIM, and OXA-48-like)were detected by both col-loidal gold immunochromatography and polymerase chain reaction (PCR). With PCR as the reference method, the accuracy of the col-loidal gold immunochromatographic assay was evaluated. ResultsThe results of PCR showed that lO strains did not produce any of the five targeted carbapenemases,and the remaining 118 strains were carbapenemase producers. Compared with PCR results,the sensitivity of the colloidal gold immunochromatographic assay was 98.3%and the specificity was l0o%. No statistically significant difference was observed in the detection rate between the two methods(P>0.05),with excellent agreement(Kappa=0.90). Notably,the colloidal gold immunochromatographic assay failed to detect the KPC enzymes in CRE strains producing KPC-31 and KPC-33 subtypes. ConclusionColloidalgold immunochromatographic assayis arapid and reliable method for detecting the fivecarbapenemase types in CRE,but it may miss some KPC subtypes,so combination with other detection methods is recommended.

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宋媛媛,夏培雯,黄娜,司亭亭,刘颖怡,夏云.胶体金免疫层析法检测碳青霉烯类耐药肠杆菌目细菌碳青霉烯酶的应用评价[J].临床检验杂志,2026,44(06):450-454

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  • 收稿日期:2026-01-20
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  • 在线发布日期: 2026-08-11
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