Department of Medicine, Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA.
Unified Women's Clinical Research, Raleigh, North Carolina, USA.
J Clin Microbiol. 2023 Mar 23;61(3):e0174822. doi: 10.1128/jcm.01748-22. Epub 2023 Feb 28.
In this prospective, observational, method comparison clinical study, the Xpert Xpress MVP test (MVP) was evaluated using both clinician-collected (CVS) and self-collected vaginal swabs (SVS) collected in a clinical setting. The study was conducted at 12 sites, including point-of-care (POC) settings, from geographically diverse locations in the United States. Participants were biologically female patients ≥ 14 years old with signs and/or symptoms of vaginitis/vaginosis. MVP test results for BV were compared to the BD MAX Vaginal Panel (BDVP). Results for Candida group and Candida glabrata and Candida krusei targets (species not differentiated) were assessed relative to yeast culture followed by mass spectrometry for species identification. Trichomonas vaginalis (TV) results were compared relative to a composite method that included results from the BDVP and InPouch TV culture. The investigational test demonstrated high positive percent agreement ranging from 93.6 to 99.0%, and negative percent agreement ranging from 92.1% to 99.8% for both CVS and SVS specimens, indicating it may be a valuable tool for the diagnosis of vaginitis/vaginosis in laboratory and POC settings.
在这项前瞻性、观察性、方法比较临床研究中，使用临床医生采集的（CVS）和自我采集的阴道拭子（SVS）评估了 Xpert Xpress MVP 测试（MVP）。该研究在包括护理点（POC）在内的 12 个地点进行，这些地点位于美国地理位置不同的地区。参与者为有阴道炎/细菌性阴道病症状和/或体征的 14 岁及以上的女性。将 MVP 测试的 BV 结果与 BD MAX 阴道面板（BDVP）进行比较。将 Candida 组和 Candida glabrata 和 Candida krusei 靶标（未区分物种）的结果与酵母培养物进行比较，然后通过质谱法进行物种鉴定。将 TV 的结果与包括 BDVP 和 InPouch TV 培养物结果的综合方法进行比较。该研究性检测对 CVS 和 SVS 标本均显示出高阳性百分比一致性，范围为 93.6%至 99.0%，阴性百分比一致性范围为 92.1%至 99.8%，表明它可能是实验室和 POC 环境下诊断阴道炎/细菌性阴道病的有价值的工具。
