Thomas-White Krystal, Hilt Evann E, Olmschenk Genevieve, Gong Maryann, Phillips Caleb D, Jarvis Courtney, Sanford Nicholas, White Jennifer, Navarro Pita
Evvy, New York, NY 10016, USA.
Department of Pathology and Laboratory Medicine, University of Minnesota Medical Center, Minneapolis, MN 55455, USA.
Diagnostics (Basel). 2024 Sep 13;14(18):2039. doi: 10.3390/diagnostics14182039.
Vaginitis is a widespread issue for women worldwide, yet current diagnostic tools are lacking. Bacterial vaginosis (BV) is the most prevalent type of vaginitis, found in 10-50% of reproductive-aged women. Current diagnostic methods for BV rely on clinical criteria, microscopy, or the detection of a few microbes by qPCR. However, many vaginal infections lack a single etiological agent and are characterized by changes in the vaginal microbiome community structure (e.g., BV is defined as a loss of protective lactobacilli resulting in an overgrowth of anaerobic bacteria). Shotgun metagenomic sequencing provides a comprehensive view of all the organisms present in the vaginal microbiome (VMB), allowing for a better understanding of all potential etiologies. Here, we describe a robust VMB metagenomics sequencing test with a sensitivity of 93.1%, a specificity of 90%, a negative predictive value of 93.4%, and a positive predictive value of 89.6% certified by Clinical Laboratory Improvement Amendments (CLIA), the College of American Pathologist (CAP), and the Clinical Laboratory Evaluation Program (CLEP). We sequenced over 7000 human vaginal samples with this pipeline and described general findings and comparisons to US census data.
阴道炎是全球女性中普遍存在的问题，但目前缺乏诊断工具。细菌性阴道病（BV）是最常见的阴道炎类型，在10%至50%的育龄妇女中存在。目前BV的诊断方法依赖于临床标准、显微镜检查或通过qPCR检测少数微生物。然而，许多阴道感染缺乏单一病原体，其特征是阴道微生物群落结构发生变化（例如，BV被定义为保护性乳酸杆菌减少，导致厌氧菌过度生长）。鸟枪法宏基因组测序提供了阴道微生物组（VMB）中所有存在的生物体的全面视图，有助于更好地了解所有潜在病因。在这里，我们描述了一种强大的VMB宏基因组测序测试，其灵敏度为93.1%，特异性为90%，阴性预测值为93.4%，阳性预测值为89.6%，该测试已通过临床实验室改进修正案（CLIA）、美国病理学家学会（CAP）和临床实验室评估计划（CLEP）认证。我们使用该流程对7000多个人类阴道样本进行了测序，并描述了一般发现以及与美国人口普查数据的比较。
