Department of Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.
PLoS One. 2010 Nov 30;5(11):e14144. doi: 10.1371/journal.pone.0014144.
A point-of-care test (POCT) for sexually transmitted infections (STIs), which offers immediate diagnosis resulting in patients receiving diagnosis and treatment in a single visit, has the ability to address some of the STI control needs. However, needs assessment from STI experts and end users about currently available STI POCTs and their future new development has not been evaluated since World Health Organization Sexually Transmitted Diseases Diagnostics Initiative was formed over 15 years ago. Therefore, our objective was to explore the perceptions of the ideal types of STI POCT for use in health care settings.
METHODOLOGY/PRINCIPAL FINDINGS: A qualitative study, encompassing eight focus groups, was conducted from March 2008 through April 2009. Participants included 6 STD clinic directors, 63 clinicians, and 7 public health/laboratory/epidemiology professionals in the STI field. Discussion topics included currently available POCT, perceived barriers to using POCT in clinics, priority STI for the development of new POCT, and characteristics of the ideal POCT. All discussions were recorded and transcribed verbatim. Themes raised as barriers for current POCT included complexity, long time frames of the so-called "rapid" test, multiple time-driven steps, requiring laboratory technician, difficulty in reading result, interruption of workflow, unreliability, and invasiveness. Chlamydia trachomatis was identified as the priority organism for development of a new STI POCT. Themes indicated for the ideal POCT included rapid turnaround (up to 20 minutes), ease of use, non-invasive, accurate (preferred sensitivity and specificity in the range of high 90s), Clinical Laboratory Improvement Amendments (CLIA)-waived, user-friendly (for both patients and staff), compact, durable, and sturdy.
CONCLUSIONS/SIGNIFICANCE: Focus group discussions with STI experts and professionals highlighted chlamydia as the top priority pathogen for POCT development, and identified the qualities of new POCT for STIs. Participants endorsed ease of use, rapid turnaround and high accuracy as essential characteristics of an ideal POCT.
即时诊断的床边检测(POCT)能够满足一些性传播感染(STI)控制需求,为患者提供在单次就诊时完成诊断和治疗的服务。然而,自世界卫生组织性传播疾病诊断倡议成立 15 年以来,尚未对 STI 专家和最终用户对当前可用的 STI POCT 及其未来新发展的需求进行评估。因此,我们的目标是探索用于医疗保健环境的理想类型的 STI POCT 的看法。
方法/主要发现:2008 年 3 月至 2009 年 4 月进行了一项定性研究,包括 8 个焦点小组。参与者包括 6 名性病诊所主任、63 名临床医生和 7 名 STI 领域的公共卫生/实验室/流行病学专业人员。讨论主题包括当前可用的 POCT、在诊所使用 POCT 的感知障碍、新 POCT 开发的优先 STI 以及理想 POCT 的特征。所有讨论均进行了记录和逐字转录。作为当前 POCT 障碍的主题包括复杂性、所谓的“快速”测试的时间框架较长、多个时间驱动步骤、需要实验室技术员、结果读取困难、工作流程中断、不可靠性和侵入性。沙眼衣原体被确定为开发新的 STI POCT 的优先病原体。理想 POCT 的主题包括快速周转(最多 20 分钟)、易于使用、非侵入性、准确性(高 90 年代偏好的敏感性和特异性)、临床实验室改进修正案(CLIA)豁免、用户友好(患者和工作人员)、紧凑、耐用和坚固。
结论/意义:与 STI 专家和专业人员的焦点小组讨论强调了衣原体作为 POCT 开发的首要病原体,确定了新的 POCT 用于 STI 的质量。参与者认可易于使用、快速周转和高准确性是理想 POCT 的基本特征。