Comparison of the PneumoGenius® and RealStar® Pneumocystis jirovecii PCR CE-IVD assays with a lab developed test for the detection of Pneumocystis jirovecii

耶氏肺孢子虫 肺孢子虫肺炎 支气管肺泡灌洗 卡氏肺孢子虫 肺炎 医学 病毒学 微生物学 生物 人类免疫缺陷病毒(HIV) 内科学
作者
R.H.T. Nijhuis,Peggy C. R. Godschalk,Jorike H I Smink,Cindy van der Zee,Erik J. van Hannen
出处
期刊:Medical Mycology [Oxford University Press]
卷期号:60 (1) 被引量:4
标识
DOI:10.1093/mmy/myab080
摘要

Pneumocystis jirovecii (Pj) is a fungal pathogen that can cause severe and potential fatal pneumonia (Pneumocystis pneumonia, PCP) in immunocompromised patients. Microbiological diagnosis is necessary to confirm PCP, for which mainly real-time PCR assays are used by detecting Pj from bronchoalveolar lavage (BAL) specimens. In this study, we evaluate the performance of the CE-IVD PneumoGenius® assay and CE-IVD RealStar® Pneumocystis jirovecii PCR assay in comparison to the lab developed test (LDT) that is used in routine diagnostics. Comparison was done by including 100 BAL specimens: 25 retrospective specimens, selected based on results obtained with LDT (15 positive/10 negative), and 75 prospectively collected specimens. LDT (targeting MSG) was performed according to local procedures and the PneumoGenius® (targeting mtLSU and DHPS fas) and RealStar® assays (targeting mtLSU) according to the manufacturer's instructions. Combining results of retrospective and prospective analysis, sensitivity was 69.7, 100 and 100% for the LDT, PneumoGenius® and RealStar®, respectively. Specificity was 100% for LDT and Pneumogenius®, whereas RealStar® showed a specificity of 97%. Correlation of fungal loads found with the PneumoGenius® and RealStar® assays was high (R2: 0.98). The PneumoGenius® and RealStar® assays performed comparable, and both showed high sensitivity in comparison to the LDT. For optimal diagnosis of PCP, the LDT has to be replaced by another, more sensitive assay.In this study, we evaluated the performance of two commercially available CE-IVD cleared real-time PCR assays to detect Pneumocystis jirovecii in comparison to the lab-developed test as used in routine diagnostics. Performance of the CE-IVD real-time PCR assay was superior to the lab-developed test.
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