Developing target product profiles forNeisseria gonorrhoeaediagnostics in the context of antimicrobial resistance: An expert consensus
Developing target product profiles forNeisseria gonorrhoeaediagnostics in the context of antimicrobial resistance: An expert consensus
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DOI：
10.1371/journal.pone.0237424
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发表时间：
2020-09-01
期刊：
影响因子：
3.7
通讯作者：
Wi, Teodora
中科院分区：
文献类型：
--
作者：
Ferreyra, Cecilia;Osborn, Jennifer;Wi, Teodora
背景需要一种快速诊断的护理点检测来检测淋病奈瑟菌（NG）感染，以防止在低资源环境中由于目前的综合征管理而导致的不正确、缺乏或过度治疗。鉴定NG抗微生物剂耐药性（AMR）的测定也是高度期望的，以促进抗生素管理。在这里，我们描述了两个目标产物谱（TPPs）的开发：一个用于NG和沙眼衣原体（CT）的病原学诊断试验（TPP 1），另一个用于检测NG AMR/敏感性（TPP 2）。方法TPPs草案最初是根据现有诊断和专家意见的景观分析制定的。通过在线德尔菲调查，对68名受访者的两轮投入进行了完善。TPP的特点，结果需要一个测试，以确定NG患者的尿道或阴道分泌物被确定为TPP 1的最低要求，与测试，可以诊断NG无症状患者的最佳要求。在综合征管理或筛查高危人群的背景下，80%的灵敏度被认为是可接受的。对于TPP 2，商定的最低要求是在2级及以上医疗机构使用的检测，最佳要求为1级或以上。横向流动形式是TPP 1的首选，而TPP 2被认为可能需要分子形式。TPP 1中总共包含31个测试特征，TPP 2中总共包含27个测试特征。在工作组修订之后，技术方案伙伴关系在网上公布了两个月，供公众反馈意见，现已定稿。最终的TPP目前正在指导符合规定特征的新诊断方法的开发，以在两年内进入市场。
Background There is a need for a rapid diagnostic point of care test to detectNeisseria gonorrhoeae(NG) infection to prevent incorrect, lack or excess of treatment resulting from current syndromic management in low-resource settings. An assay to identify NG antimicrobial resistance (AMR) is also highly desirable to facilitate antibiotic stewardship. Here we describe the development of two target product profiles (TPPs): one for a test for etiological diagnosis of NG andChlamydia trachomatis(CT) (TPP1) and one for the detection of NG AMR/susceptibility (TPP2). Methods Draft TPPs were initially developed based on a landscape analysis of existing diagnostics and expert input. TPPs were refined via an online Delphi survey with two rounds of input from 68 respondents. TPP characteristics on which Results The need for a test to identify NG in patients with urethral or vaginal discharge was identified as a minimal requirement of TPP1, with a test that can diagnose NG in asymptomatic patients as the optimal requirement. A sensitivity of 80% was considered acceptable, either in context of syndromic management or screening high-risk populations. For TPP2, the agreed minimal requirement was for a test to be used at level 2 healthcare facilities and above, with an optimal requirement of level 1 or above. A lateral flow format was preferred for TPP1, while it was considered likely that TPP2 would require a molecular format. A total of 31 test characteristics were included in TPP1 and 27 in TPP2. Conclusions Following the working group revisions, TPPs were posted online for public feedback for two months, and are now finalized. The final TPPs are currently guiding the development of new diagnostics that meet the defined characteristics to reach the market within two years.