Low-Cost Instrument-free Point-of-Care Test for Chlamydia and Gonorrhea

低成本、免仪器的衣原体和淋病即时检测

基本信息

  • 批准号:
    10374833
  • 负责人:
  • 金额:
    $ 98.3万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2020
  • 资助国家:
    美国
  • 起止时间:
    2020-04-22 至 2024-03-31
  • 项目状态:
    已结题

项目摘要

Summary Chlamydia trachomatis (Ct) and Neisseria gonorrhoeae (Ng) cause over 3 million sexually transmitted infections (STI) annually in the U.S. The estimated global rates are ~131 million and 78 million, respectively. These rates have been increasing 6% to 18% over the last few years. Both are responsible for severe morbidity, including pelvic inflammatory disease, infertility, ectopic pregnancy, chronic pelvic pain, and preterm birth, with an annual cost of several billion dollars in the U.S. alone. Ct and Ng are treated empirically, relying on antibiotic treatment algorithms because diagnostics for Ct and Ng are not available at the point-of- care (POC). The inability to diagnose and treat at the POC means that many patients are lost to follow up, fueling the transmission of untreated or inappropriately treated STIs. This problem is exacerbated by the high rates of asymptomatic Ct and Ng infections (~10-50% for males & ~70-80% for females) among individuals who are unlikely to seek care. Current diagnostics rely on commercial nucleic acid (NA) amplification tests (NAAT) that are expensive and provide results in a day or days. Most patients are unwilling to wait more than 20-30 minutes for a result. Currently, there is no FDA approved CLIA-waived POC test for either Ct or Ng. Our team has been developing instrument-free POC tests for infectious pathogens that can utilize different sample types with our proprietary lysis buffer and microfluidic amplification assays with easy-to-read colorimetric results in <30 minutes. No equipment, sample collection or detection kits, or technical expertise are required. Because Ct rectal infections now outnumber those in the urogenital tract among women, and continue to increase among men who have sex with men (MSM) as do Ng infections, there is an urgent need for a rapid POC test that can utilize these samples for Ct/Ng screening and also for test-of-cure since a single dose of an antibiotic that is used for urogenital infections is inadequate to treat rectal infections. Our aim therefore is to build on our POC test platform to further develop our lysis buffer and microfluidic assays to provide a rapid, disposable, sensitive and specific Ct/Ng POC test that can accommodate endocervical, vaginal, urethral, rectal and urine samples. The WHO global action plan to control STDs emphasizes “the development of affordable point-of-care STI diagnostics.” And the CDC stresses that, “Providers should make STD screening a standard part of medical care.” Our Ct/Ng POC diagnostic test will meet this urgent medical need by increasing early detection, informing treatment at the POC, and reducing infection rates, transmission, and sequelae with the capability for in-home use and deployment to every type of clinic, health station, emergency room and resource constrained setting in the world.
总结 沙眼衣原体(Ct)和淋病奈瑟菌(Ng)导致300多万人通过性传播 据估计,全球感染率分别为约1.31亿和7800万。 这些比率在过去几年中上升了6%至18%。两者都是严重的 发病率,包括盆腔炎、不孕症、异位妊娠、慢性盆腔疼痛,以及 早产,仅在美国每年就花费数十亿美元。Ct和Ng根据经验进行治疗, 依赖抗生素治疗算法,因为Ct和Ng的诊断在治疗时不可用。 护理(POC)。在POC无法诊断和治疗意味着许多患者无法随访, 助长了未经治疗或治疗不当的性传播感染的传播。高血压加剧了这个问题 个体中无症状Ct和Ng感染率(男性约10-50%,女性约70-80%) 他们不太可能寻求治疗。目前的诊断依赖于商业核酸(NA)扩增测试 (NAAT)是昂贵的,并在一天或几天内提供结果。大多数患者不愿意等待超过 20-30分钟的结果。目前,没有FDA批准的CLIA豁免的POC测试用于Ct或Ng。 我们的团队一直在开发针对传染性病原体的无仪器POC测试, 使用我们专有的裂解缓冲液和易于读取的微流控扩增分析, 比色结果在<30分钟。没有设备、样本采集或检测工具包或技术专长 are required.因为CT直肠感染现在在女性中超过了泌尿生殖道感染, 继续增加的男性与男性发生性关系(MSM),因为Ng感染,迫切需要 对于快速POC测试,可以利用这些样本进行Ct/Ng筛选,也可以用于治愈测试,因为单个 用于泌尿生殖道感染的抗生素剂量不足以治疗直肠感染。我们的目标 因此,我们将在POC测试平台的基础上,进一步开发我们的裂解缓冲液和微流体分析, 提供一种快速、一次性、灵敏和特异的Ct/Ng POC检测, 阴道、尿道、直肠和尿液样本。世卫组织控制性传播疾病全球行动计划强调, 开发负担得起的护理点STI诊断。”CDC强调,“供应商应该 性病检查是医疗保健的标准组成部分。”我们的Ct/Ng POC诊断测试将满足这一紧急医疗需求。 需要通过增加早期发现,告知POC的治疗,并降低感染率, 传播和后遗症的能力,在家里使用和部署到每一个类型的诊所,卫生 车站、急诊室和资源有限的环境。

项目成果

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DEBORAH Anne DEAN其他文献

DEBORAH Anne DEAN的其他文献

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{{ truncateString('DEBORAH Anne DEAN', 18)}}的其他基金

Impact of ocular microbiome, immune response and Chlamydiae on trachoma following MDA
MDA 后眼部微生物群、免疫反应和衣原体对沙眼的影响
  • 批准号:
    10646357
  • 财政年份:
    2022
  • 资助金额:
    $ 98.3万
  • 项目类别:
Impact of ocular microbiome, immune response and Chlamydiae on trachoma following MDA
MDA 后眼部微生物组、免疫反应和衣原体对沙眼的影响
  • 批准号:
    10519058
  • 财政年份:
    2022
  • 资助金额:
    $ 98.3万
  • 项目类别:
Natural History of C. trachomatis urogenital and rectal infections
沙眼衣原体泌尿生殖道和直肠感染的自然史
  • 批准号:
    10580821
  • 财政年份:
    2020
  • 资助金额:
    $ 98.3万
  • 项目类别:
Natural History of C. trachomatis urogenital and rectal infections
沙眼衣原体泌尿生殖道和直肠感染的自然史
  • 批准号:
    10356116
  • 财政年份:
    2020
  • 资助金额:
    $ 98.3万
  • 项目类别:
Low-Cost Instrument-free Point-of-Care Diagnostic for Neisseria gonorrhoeae
低成本、免仪器的淋病奈瑟氏菌即时诊断
  • 批准号:
    9256272
  • 财政年份:
    2017
  • 资助金额:
    $ 98.3万
  • 项目类别:
Low-Cost Instrument-free Point-of-care Platform for Multiplexed Chlamydia Diagnostics
用于多重衣原体诊断的低成本无仪器即时护理平台
  • 批准号:
    9202973
  • 财政年份:
    2014
  • 资助金额:
    $ 98.3万
  • 项目类别:
Low-Cost Instrument-free Point-of-care Platform for Multiplexed Chlamydia Diagnos
用于多重衣原体诊断的低成本无仪器即时护理平台
  • 批准号:
    8782420
  • 财政年份:
    2014
  • 资助金额:
    $ 98.3万
  • 项目类别:
Low-Cost Instrument-free Point-of-care Platform for Multiplexed Chlamydia Diagnostics
用于多重衣原体诊断的低成本无仪器即时护理平台
  • 批准号:
    9302265
  • 财政年份:
    2014
  • 资助金额:
    $ 98.3万
  • 项目类别:
A novel vaccine against vaginal Chlamydia trachomatis
一种针对阴道沙眼衣原体的新型疫苗
  • 批准号:
    8481512
  • 财政年份:
    2012
  • 资助金额:
    $ 98.3万
  • 项目类别:
Multiplex diagnostic for biothreat C. psittaci & non-threat respiratory pathogens
生物威胁鹦鹉热衣原体的多重诊断
  • 批准号:
    8481514
  • 财政年份:
    2012
  • 资助金额:
    $ 98.3万
  • 项目类别:

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