从支气管肺泡灌洗液样本评估 DiaSorin 分子肺炎支原体 -CMV 多重实时 PCR 检测的性能。
Evaluation of the performance of DiaSorin molecular Pneumocystis jirovecii-CMV multiplex real-time PCR assay from bronchoalveolar lavage samples.
机构信息
Department of Pathology, Wake Forest Baptist Medical Center, Medical Center Boulevard, Winston-Salem, NC 27157, USA.
Department of Pathology, Wake Forest Baptist Medical Center, Medical Center Boulevard, Winston-Salem, NC 27157, USA.
出版信息
J Mycol Med. 2020 Jun;30(2):100936. doi: 10.1016/j.mycmed.2020.100936. Epub 2020 Jan 31.
The aim of this study was to evaluate the performance of the DiaSorin Molecular PJ-CMV multiplex real-time PCR (PJ-CMV PCR) assay (DiaSorin Molecular LLC, USA) in bronchoalveolar lavage (BAL) samples compared to direct immunofluorescence assay (IFA) for the detection of Pneumocystis jirovecii and assess CMV and P. jirovecii co-infection rate in immunosuppressed patients with suspected pneumonia. A total of 125 BAL samples from immunosuppressed patients submitted for PJP-IFA were tested. Surplus samples were saved and further tested by using the PJ-CMV PCR assay. Among the 125 samples, P. jirovecii was detected in 31.2% (39/125) and in 40% (50/125) of the specimens using IFA and PJ-CMV PCR respectively. Eleven of the PJ-CMV PCR positive samples were negative by direct IFA for P. jirovecii. All samples positive by direct IFA were also positive by PJ-CMV PCR. Using the direct IFA as a gold standard, the PJ-CMV PCR sensitivity, specificity, positive predictive value and negative predictive value for detection of P. jirovecii were 100%, 87.2%, 78% and 100%, respectively. However, after reviewing the clinical diagnosis, the specificity and PPV increased to 100%. Of the 50 P. jirovecii samples positive by PJ-CMV PCR, 18 (36%) were also positive for CMV by the PJ-CMV PCR. The co-infection rate was found to be 37.5% (6/16) and 35.2% (12/34) in HIV infected and non-HIV infected patients. This study indicated that the DiaSorin Molecular PJ-CMV multiplex real-time PCR assay has higher sensitivity than direct IFA for detection of P. jirovecii and provides rapid detection of PJ and CMV infection in BAL samples.
本研究旨在评估 DiaSorin Molecular PJ-CMV 多重实时 PCR（PJ-CMV PCR）检测试剂盒（美国 DiaSorin Molecular LLC）在支气管肺泡灌洗液（BAL）样本中检测肺孢子菌的性能，并评估疑似肺炎的免疫抑制患者中 CMV 和 P. jirovecii 的合并感染率。共检测了 125 份来自免疫抑制患者的 BAL 样本，这些样本用于进行 PJP-IFA。保存了多余的样本，并进一步使用 PJ-CMV PCR 检测试剂盒进行检测。在 125 个样本中，IFA 检测到 31.2%（39/125）和 40%（50/125）的样本中存在 P. jirovecii，而 PJ-CMV PCR 分别检测到 31.2%（39/125）和 40%（50/125）的样本中存在 P. jirovecii。11 份 PJ-CMV PCR 阳性样本的 P. jirovecii 检测结果为阴性。所有 IFA 阳性样本均为 PJ-CMV PCR 阳性。以直接 IFA 为金标准，PJ-CMV PCR 检测 P. jirovecii 的灵敏度、特异性、阳性预测值和阴性预测值分别为 100%、87.2%、78%和 100%。然而，在重新审查临床诊断后，特异性和阳性预测值提高到 100%。在 50 份 PJ-CMV PCR 阳性的 P. jirovecii 样本中，18 份（36%）也通过 PJ-CMV PCR 检测到 CMV 阳性。在 HIV 感染和非 HIV 感染患者中，合并感染率分别为 37.5%（6/16）和 35.2%（12/34）。本研究表明，与直接 IFA 相比，DiaSorin Molecular PJ-CMV 多重实时 PCR 检测试剂盒对 P. jirovecii 的检测灵敏度更高，并能快速检测 BAL 样本中的 PJ 和 CMV 感染。
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