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RealStar 肺孢子菌 PCR 试剂盒在诊断肺孢子菌肺炎中的性能。

Performance of the RealStar Pneumocystis jirovecii PCR kit for the diagnosis of Pneumocystis pneumonia.

机构信息

Laboratoire de Microbiologie, CHU de Nîmes, Nîmes, France.

MIVEGEC, Univ. Montpellier, CHU de Nîmes, CNRS, IRD, Montpellier, France.

出版信息

Mycoses. 2021 Oct;64(10):1230-1237. doi: 10.1111/myc.13354. Epub 2021 Aug 15.

DOI:10.1111/myc.13354
PMID:34346113
Abstract

BACKGROUND

Pneumonia due to Pneumocystis jirovecii (PCP) is a frequent infection in HIV-positive and also in immunocompromised HIV-negative patients. PCR analysis of pulmonary samples has become an essential element in PCP laboratory diagnosis. Currently, many commercially PCR-based tests are available for P jirovecii detection and need to be evaluated.

OBJECTIVES

We evaluated the performance of the RealStar P jirovecii PCR kit for PCP diagnosis.

METHODS

We performed the RealStar P jirovecii PCR and an in-house PCR in 219 pulmonary samples. We then assessed the performance of the RealStar P jirovecii PCR kit by classifying patients in proven, probable, possible PCP or no final diagnosis, on the basis of the clinical and radiological signs and direct examination of bronchoalveolar lavage samples.

RESULTS

The results showed excellent concordance (96.8%) with another in-house PCR, previously used in the laboratory. The available clinical data allowed classifying 219 patients as having proven PCP (n = 6), probable PCP (n = 27), possible PCP (n = 29) and no final diagnosis of PCP (n = 157). The RealStar P jirovecii PCR kit performed well with samples from patients with proven and probable PCP, as indicated by the detection of P jirovecii DNA in all these samples. The percentage of positive samples in the possible PCP category was 75.9%. In patients with no final diagnosis of PCP, P jirovecii DNA was detected in 13.4% of samples, indicating colonisation by this pathogen.

CONCLUSIONS

The RealStar P jirovecii PCR kit shows excellent performance for PCP diagnosis.

摘要

背景

卡氏肺孢子虫肺炎(PCP)是 HIV 阳性和免疫功能低下的 HIV 阴性患者中常见的感染。肺部样本的 PCR 分析已成为 PCP 实验室诊断的重要组成部分。目前,有许多基于 PCR 的商业检测方法可用于检测 P 巨细胞病毒,需要对其进行评估。

目的

我们评估了 RealStar P 巨细胞病毒 PCR 试剂盒在 PCP 诊断中的性能。

方法

我们对 219 例肺部样本进行了 RealStar P 巨细胞病毒 PCR 和内部 PCR。然后,根据临床和影像学特征以及支气管肺泡灌洗液直接检查,将患者分为确诊、疑似、可能 PCP 或无最终诊断,评估 RealStar P 巨细胞病毒 PCR 试剂盒的性能。

结果

该结果与实验室之前使用的另一种内部 PCR 具有极好的一致性(96.8%)。现有的临床数据允许将 219 例患者分为确诊 PCP(n=6)、疑似 PCP(n=27)、可能 PCP(n=29)和无最终 PCP 诊断(n=157)。RealStar P 巨细胞病毒 PCR 试剂盒在确诊和疑似 PCP 患者的样本中表现良好,所有这些样本均检测到 P 巨细胞病毒 DNA。可能 PCP 组的阳性样本比例为 75.9%。在无最终 PCP 诊断的患者中,13.4%的样本中检测到 P 巨细胞病毒 DNA,表明该病原体定植。

结论

RealStar P 巨细胞病毒 PCR 试剂盒在 PCP 诊断中具有优异的性能。

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