De Pace Vanessa, Bruzzone Bianca, Ricucci Valentina, Domnich Alexander, Guarona Giulia, Garzillo Giada, Qosja Rexhina, Ciccarese Giulia, Di Biagio Antonio, Orsi Andrea, Icardi Giancarlo
Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.
Laboratorio di Riferimento Regionale per le Emergenze di Sanità Pubblica (LaRESP), 16132 Genoa, Italy.
Microorganisms. 2024 Mar 27;12(4):664. doi: 10.3390/microorganisms12040664.
In 2022-23, the human monkeypox virus (MPXV) caused a global outbreak in several non-endemic countries. Here, we evaluated the diagnostic performance of four qualitative PCR assays for the laboratory diagnosis of mpox (monkeypox) monkeypox disease. From July to August 2022, 27 positive and 10 negative specimens (lesion, crust and exudate swabs) were tested in the laboratory of the Hygiene Unit of the San Martino Hospital (Genoa, Italy) by using home-made real-time PCR to detect MPXV generic G2R_G DNA. According to the manufacturer's instructions, we also retrospectively analyzed these specimens using RealCycler MONK-UX/-GX (Progenie Molecular), STANDARD M10 MPX/OPX (SD Biosensor), Novaplex MPXV (Seegene Inc.) and RealStar Orthopoxvirus PCR Kit 1.0 (Altona Diagnostics) assays, recognized as research-use-only tests. The diagnostic accuracy and sensitivity of these assays ranged from 97.3% (95% CI: 86.2-99.5%) to 100% (95% CI: 90.6-100%) and 96.3% (95% CI: 81.72-99.34%) to 100% (95% CI: 72.2-100%), respectively. The RealCycler MONK-UX and STANDARD M10 MPX/OPX did not detect one positive sample with a cycle threshold of 36. The overall specificity was 100% (95% CI: 72.2-100%), and Cohen's Kappa values ranged from 1 (95% CI: 0.67-1) to 0.93 (95% CI: 0.61-1). As they are highly accurate, reliable and user-friendly, these tests should be recommended for the routine or rapid laboratory discrimination of mpox from other rash illnesses.
2022年至2023年期间，人类猴痘病毒（MPXV）在几个非流行国家引发了全球疫情。在此，我们评估了四种定性PCR检测方法对猴痘疾病实验室诊断的性能。2022年7月至8月，在意大利热那亚圣马蒂诺医院卫生科实验室，使用自制实时PCR检测MPXV通用G2R_G DNA，对27份阳性和10份阴性标本（病变、痂皮和渗出物拭子）进行检测。根据制造商的说明，我们还使用RealCycler MONK-UX/-GX（Progenie Molecular）、STANDARD M10 MPX/OPX（SD Biosensor）、Novaplex MPXV（Seegene Inc.）和RealStar正痘病毒PCR试剂盒1.0（Altona Diagnostics）检测方法对这些标本进行回顾性分析，这些检测方法被视为仅供研究使用的检测。这些检测方法的诊断准确性和敏感性分别在97.3%（95%置信区间：86.2 - 99.5%）至100%（95%置信区间：90.6 - 100%）和96.3%（95%置信区间：81.72 - 99.34%）至100%（95%置信区间：72.2 - 100%）之间。RealCycler MONK-UX和STANDARD M10 MPX/OPX未检测到一份循环阈值为36的阳性样本。总体特异性为100%（95%置信区间：72.2 - 100%），科恩kappa值在1（95%置信区间：0.67 - 1）至0.93（95%置信区间：0.61 - 1）之间。由于这些检测方法高度准确、可靠且用户友好，应推荐用于猴痘与其他皮疹疾病的常规或快速实验室鉴别。
