Evaluation of the GeneXpert for Human Monkeypox Diagnosis
Evaluation of the GeneXpert for Human Monkeypox Diagnosis
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DOI：
10.4269/ajtmh.16-0567
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发表时间：
2017-01-01
影响因子：
3.3
通讯作者：
Reynolds, Mary G.
中科院分区：
文献类型：
--
作者：
Li, Daniel;Wilkins, Kimberly;Reynolds, Mary G.
猴痘病毒（MPXV）是一种人畜共患正痘病毒（OPX），是刚果民主共和国（DRC）的地方病。目前，人猴痘（MPX）的诊断检测主要集中在实时定量聚合酶链反应（PCR）检测，通常在复杂的实验室环境中进行。在此，我们评估了使用GeneXpert平台的多重MPX检测的准确性和实用性，GeneXpert平台是一种便携式快速诊断设备，可用作诊断流行地区感染的即时检测。多重MPX/OPX检测包括MPX特异性PCR检测、OPX通用PCR检测和内部对照PCR检测。根据国家监测指南，从刚果民主共和国Tshuapa省的疑似MPX病例中共收集了164份诊断标本（50份结痂和114份水泡拭子）。在金沙萨国家生物医学研究所（INRB）使用GeneXpert MPX/OPX检测试剂盒和OPX PCR检测试剂盒对标本进行检测。在美国疾病控制和预防中心，采用MPX特异性PCR检测方法对每份标本的等分试样进行平行检测。MPX PCR的结果用作所有分析的金标准。在INRB进行的GeneXpert MPX/OPX检测试剂盒的灵敏度为98.8%，特异性为100%。GeneXpert检测试剂盒对痂皮和囊泡样本均表现良好。GeneXpert MPX/OPX检测采用了一种简单的方法，在实验室和现场条件下均表现良好，表明其作为诊断平台的可行性，可以扩展和加快当前MPX检测能力。
Monkeypox virus (MPXV), a zoonotic orthopoxvirus (OPX), is endemic in the Democratic Republic of Congo (DRC). Currently, diagnostic assays for human monkeypox (MPX) focus on real-time quantitative polymerase chain reaction (PCR) assays, which are typically performed in sophisticated laboratory settings. Herein, we evaluated the accuracy and utility of a multiplex MPX assay using the GeneXpert platform, a portable rapid diagnostic device that may serve as a point-of-care test to diagnose infections in endemic areas. The multiplex MPX/OPX assay includes a MPX-specific PCR test, OPX-generic PCR test, and an internal control PCR test. In total, 164 diagnostic specimens (50 crusts and 114 vesicular swabs) were collected from suspected MPX cases in Tshuapa Province, DRC, under national surveillance guidelines. The specimens were tested with the GeneXpert MPX/OPX assay and an OPX PCR assay at the Institut National de Recherche Biomedicale (INRB) in Kinshasa. Aliquots of each specimen were tested in parallel with a MPX-specific PCR assay at the Centers for Disease Control and Prevention. The results of the MPX PCR were used as the gold standard for all analyses. The GeneXpert MPX/OPX assay performed at INRB had a sensitivity of 98.8% and specificity of 100%. The GeneXpert assay performed well with both crust and vesicle samples. The GeneXpert MPX/OPX test incorporates a simple methodology that performs well in both laboratory and field conditions, suggesting its viability as a diagnostic platform that may expand and expedite current MPX detection capabilities.