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以Vitek 2药敏试验卡系统为参考标准,评估Alere PBP2a SA培养菌落试验在凝固酶阴性菌中的性能。

Evaluating the performance of the Alere PBP2a SA Culture Colony Test with the Vitek 2 Antimicrobial Susceptibility Test Card System as reference standard in coagulase-negative species.

作者信息

Lo Tze Shien, Goto Michihiko, Hammer Kimberly D P

机构信息

Fargo VA Health Care System, 2101 Elm Street, Fargo, ND 58102, USA.

University of North Dakota School of Medicine & Health Sciences, 1919 Elm Street, Fargo, ND 58102, USA.

出版信息

Infect Med (Beijing). 2024 Aug 6;3(3):100126. doi: 10.1016/j.imj.2024.100126. eCollection 2024 Sep.

Abstract

BACKGROUND

The Alere PBP2a SA Culture Colony Test is an FDA-cleared immunochromatographic assay for rapid detection of penicillin-binding protein2a (PBP2a) in .

METHODS

We investigated the performance of the PBP2a SA Culture Colony Test with 78 coagulase-negative (CoNS) isolates from different body sites, with the Vitek 2 Antimicrobial Susceptibility Test (AST) as a reference standard.

RESULTS

The CoNS species were 62 ; 6 ; 3 ; 2 ; 2 ; and 1 each of and . Of the 78 CoNS isolates, 68 showed concordance in the PBP2a IC assay and Vitek 2 AST. Discordance was seen for 10 isolates, which showed negative in the PBP2a assay, despite oxacillin-resistance detection using the Vitek 2 AST (66.7% sensitivity and 100% specificity). All non- CoNS were identified with 100% concordance using the PBP2a IC assay and Vitek 2 AST.

CONCLUSION

We demonstrated that, while the PBP2a IC assay has low sensitivity in determining the susceptibility of to oxacillin, it highly accurately predicted the susceptibility of non- CoNS to oxacillin. The diagnostic accuracy for non- CoNS needs further assessment with more isolates to confirm our findings.

摘要

背景

Alere PBP2a SA培养菌落试验是一种经美国食品药品监督管理局(FDA)批准的免疫层析测定法,用于快速检测[具体检测对象未提及]中的青霉素结合蛋白2a(PBP2a)。

方法

我们以Vitek 2抗菌药物敏感性试验(AST)作为参考标准,对来自不同身体部位的78株凝固酶阴性葡萄球菌(CoNS)分离株进行了PBP2a SA培养菌落试验性能的研究。

结果

CoNS菌株中,[具体62种未提及]有62株;[具体6种未提及]有6株;[具体3种未提及]有3株;[具体2种未提及]有2株;[具体2种未提及]有2株;[具体1种未提及]和[具体1种未提及]各有1株。在78株CoNS分离株中,68株在PBP2a免疫层析测定法和Vitek 2 AST检测中结果一致。10株分离株结果不一致,尽管使用Vitek 2 AST检测出它们对苯唑西林耐药,但在PBP2a测定中呈阴性(敏感性为66.7%,特异性为100%)。使用PBP2a免疫层析测定法和Vitek 2 AST检测对所有非CoNS菌株的鉴定结果一致性为100%。

结论

我们证明,虽然PBP2a免疫层析测定法在确定CoNS对苯唑西林的敏感性方面敏感性较低,但它能高度准确地预测非CoNS对苯唑西林的敏感性。非CoNS的诊断准确性需要用更多分离株进一步评估以证实我们的发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c186/11405896/edb2e9232e69/ga1.jpg

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