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艰难梭菌实验室诊断技术:快速与分子方法的比较研究。

Clostridioides difficile laboratory diagnostic techniques: a comparative approach of rapid and molecular methods.

机构信息

Laboratório Clínico, Hospital Israelita Albert Einstein, Albert Einstein Avenue, 627/701 Bl.E - 2nd floor, São Paulo, SP, Brazil.

Post-Graduation Program in Health Sciences, Santo Amaro University, São Paulo, SP, Brazil.

出版信息

Arch Microbiol. 2021 May;203(4):1683-1690. doi: 10.1007/s00203-020-02148-8. Epub 2021 Jan 18.

Abstract

Clostridioides difficile infection is a public health problem because of it is easily spread; with harmful consequences, it is essential to reduce hospital costs and prevent its dissemination by having a precise diagnosis. The gold standard for its diagnosis is polymerase chain reaction (PCR); however, the technique is not available for all laboratories due to the high cost. New approaches using non-molecular tests to detect C. difficile and toxin A/B production has been proposed to improve cost benefits. The objective of this study is to compare molecular methods (PCR) and rapid methods (immunochromatographic test and enzymatic immunoassay). A series of tests comprising these diagnostic techniques was performed with 50 patients with a clinical diagnosis for Clostridioides difficile on GeneXpert® devices test; a calculation of the sensitivity was executed, followed by a comparison of the efficiency of all techniques. Greater sensitivity was observed in the PCR-based methods (BD MAX™ and BioFire FilmArray®) and the GDH-based assays (RIDASCREEN® and Alere Techlab®). The proposed algorithm represents minor monetary disadvantages but a significant temporal optimization of 10%. Future studies concerning both positive and negative results could be advantageous because of the possibility of calculating more method concordance indexes, such as the specificity and Kappa index, in addition to being able to indicate a monetary profit if the proposed algorithm was applied due to the nonproceeding PCR cases.

摘要

艰难梭菌感染是一个公共卫生问题,因为它很容易传播;具有有害的后果,因此通过精确诊断来降低医院成本和预防其传播至关重要。聚合酶链反应(PCR)是其诊断的金标准;然而,由于成本高,并非所有实验室都可以使用该技术。已经提出了使用非分子测试来检测艰难梭菌和毒素 A/B 产生的新方法,以提高成本效益。本研究的目的是比较分子方法(PCR)和快速方法(免疫层析试验和酶联免疫吸附试验)。使用 GeneXpert®设备对 50 名具有艰难梭菌临床诊断的患者进行了一系列包含这些诊断技术的测试;执行了灵敏度计算,然后比较了所有技术的效率。基于 PCR 的方法(BD MAX™和 BioFire FilmArray®)和基于 GDH 的检测方法(RIDASCREEN®和 Alere Techlab®)显示出更高的灵敏度。所提出的算法代表了较小的货币劣势,但时间上的优化显著提高了 10%。由于可以计算更多的方法一致性指数,例如特异性和 Kappa 指数,并且由于如果应用所提出的算法可以获得货币收益,因此未来关于阳性和阴性结果的研究可能会很有利,因为可以避免进行非进行性 PCR 检测的案例。

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