Van Der Pol Barbara, Lillis Rebecca, Nachamkin Irving, Young Stephen, Crane LaShonda, Brown Jacqueline, Parker R Lamar, Weissfeld Alice, Liu Xiaohong, Huang Christina, Raman Aarthi
University of Alabama at Birmingham, Birmingham, AL, US.
Louisiana State University Health Science Center, New Orleans, LA, US.
BMC Infect Dis. 2025 Aug 2;25(1):975. doi: 10.1186/s12879-025-11304-8.
Vaginitis is a major cause of healthcare visits in the US, costing over $1.2 billion annually. Point-of-care (POC) nucleic acid amplification tests (NAATs) could improve accuracy of diagnosis and treatment during initial visit for vaginitis compared to send-out NAATs.
A secondary analysis of data was collected from test operators at POC testing sites where the Xpert Xpress Multiplex Vaginal Panel test ("MVP test") was performed. Users completed a survey assessing their experience with the instrument system and the PCR-based MVP test.
The MVP test demonstrated consistent performance, measured by positive and negative percent agreement, across all user categories, including both trained and untrained staff. Performance was evaluated based on job function (clinicians, non-clinicians, support staff) and educational level (bachelor's degree or higher, associate's degree or some college, high school diploma/general educational development (GED) with technical certification), with no significant differences in performance (P >0.082 and P >0.050, respectively). User feedback from 19 operators showed that 15/19 (79%) of users found the GeneXpert Xpress Instrument System easy to set up, and 18/19 (96%) found the test instructions easy to follow. Users described the system as user-friendly with clear instructions and helpful videos. Overall, 19/19 (100%) agreed that the MVP test was easy to perform.
Availability of accurate POC diagnostics will only be useful if the test can be performed by any potential user. Our study results suggest that the MVP test was acceptable to users and that results were accurate regardless of user qualifications. Thus, this test has the potential to improve the immediate clinical outcome by supporting accurate, same day treatment for causes of vaginitis.
在美国，阴道炎是医疗就诊的主要原因，每年花费超过12亿美元。与送检核酸扩增检测（NAATs）相比，即时检验（POC）核酸扩增检测可提高阴道炎初诊时诊断和治疗的准确性。
对进行Xpert Xpress多重阴道检测组（“MVP检测”）的POC检测点的检测操作人员收集的数据进行二次分析。用户完成了一项调查，评估他们使用仪器系统和基于PCR的MVP检测的体验。
MVP检测在所有用户类别中，包括经过培训和未经培训的工作人员，通过阳性和阴性百分比一致性衡量，表现出一致的性能。根据工作职能（临床医生、非临床医生、辅助人员）和教育水平（学士学位或更高、副学士学位或部分大学学历、高中文凭/普通教育发展证书（GED）及技术认证）对性能进行评估，性能无显著差异（分别为P>0.082和P>0.050）。来自19名操作人员的用户反馈显示，19名用户中有15名（79%）发现GeneXpert Xpress仪器系统易于设置，19名用户中有18名（96%）发现检测说明易于遵循。用户将该系统描述为用户友好型，说明清晰且视频有用。总体而言，19名用户全部（100%）一致认为MVP检测易于操作。
只有当任何潜在用户都能进行检测时，准确的POC诊断才有意义。我们的研究结果表明，MVP检测为用户所接受，无论用户资质如何，结果都是准确的。因此，该检测有可能通过支持对阴道炎病因进行准确的当日治疗来改善即时临床结果。
