Laboratory for Medical Microbiology and Medical Immunology, Meander Medical Center, 3813 TZ, Amersfoort, The Netherlands.
Laboratory for Medical Microbiology and Immunology, St. Antonius Hospital, 3435 CM, Nieuwegein, The Netherlands.
Med Mycol. 2022 Jan 10;60(1). doi: 10.1093/mmy/myab080.
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.
检测肺孢子菌（Pj）在免疫功能低下患者中引起严重且潜在致命性肺炎（PCP）的作用。微生物学诊断是确诊 PCP 的必要条件，主要通过实时 PCR 检测支气管肺泡灌洗液（BAL）标本中的 Pj 来进行。在本研究中，我们评估了经 CE-IVD 认证的 PneumoGenius®检测和经 CE-IVD 认证的 RealStar® Pneumocystis jirovecii PCR 检测与常规诊断中使用的实验室开发检测（LDT）相比的性能。比较是通过纳入 100 份 BAL 标本进行的：25 份回顾性标本，根据 LDT 结果选择（15 份阳性/10 份阴性），75 份前瞻性采集标本。LDT（针对 MSG）按照当地程序进行，PneumoGenius®（针对 mtLSU 和 DHPS fas）和 RealStar®检测（针对 mtLSU）按照制造商的说明进行。将回顾性和前瞻性分析的结果结合起来，LDT、PneumoGenius®和 RealStar®的敏感性分别为 69.7%、100%和 100%。LDT 和 PneumoGenius®的特异性为 100%，而 RealStar®的特异性为 97%。PneumoGenius®和 RealStar®检测之间发现的真菌负荷相关性很高（R2：0.98）。PneumoGenius®和 RealStar®检测性能相当，与 LDT 相比均显示出较高的敏感性。为了优化 PCP 的诊断，LDT 必须被另一种更敏感的检测方法所取代。
在这项研究中，我们评估了两种市售的经 CE-IVD 认证的实时 PCR 检测方法在常规诊断中与实验室开发检测（LDT）相比检测肺孢子菌的性能。CE-IVD 实时 PCR 检测方法的性能优于实验室开发的检测方法。
