A portable magnetofluidic platform for detecting sexually transmitted infections and antimicrobial susceptibility.

A portable magnetofluidic platform for detecting sexually transmitted infections and antimicrobial susceptibility.
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DOI:
10.1126/scitranslmed.abf6356
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发表时间:
2021-05-12
影响因子:
17.1
通讯作者:
Wang TH
Wang TH
中科院分区:
医学1区
文献类型:
--
作者:
Trick AY;Melendez JH;Chen FE;Chen L;Onzia A;Zawedde A;Nakku-Joloba E;Kyambadde P;Mande E;Matovu J;Atuheirwe M;Kwizera R;Gilliams EA;Hsieh YH;Gaydos CA;Manabe YC;Hamill MM;Wang TH

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性传播感染的有效治疗受到诊断方法的限制,这些诊断方法不能在患者仍在诊所时迅速提供结果。鉴定性传播感染的金标准方法是核酸扩增试验,这种方法太昂贵,不能广泛使用,而且周转时间长。为了满足快速和负担得起的诊断需求,我们开发了一种便携式,快速,盒上磁流体纯化和测试(PROMPT)聚合酶链反应(PCR)测试。我们表明,它可以检测淋病奈瑟菌,病原体引起淋病,同时基因分型的病原体的耐药性抗菌药物环丙沙星在<15分钟。双重测试集成到一个低成本的热塑性盒与自动化处理的阴茎拭子样本从患者使用磁珠。一个紧凑的仪器进行DNA提取、PCR和结果分析,同时通过智能手机应用程序将数据传递给用户。该平台对来自美国马里兰州巴尔的摩(n = 66)和乌干达坎帕拉(n = 151)性健康诊所的阴茎拭子样本进行了测试,总体灵敏度和特异性为97.7%(95% CI,94.7 - 100%)和97.6%(95% CI,94.1 - 100%)。淋病检测和100%的一致性与培养结果的环丙沙星耐药性。这项研究为提供可访问的PCR诊断方法铺平了道路,以便在护理点快速检测性传播感染,帮助指导治疗决策并打击耐药性病原体的增加。
Effective treatment of sexually transmitted infections (STIs) is limited by diagnostics that cannot deliver results rapidly while the patient is still in the clinic. The gold standard methods for identification of STIs are nucleic acid amplification tests (NAATs), which are too expensive for widespread use and have lengthy turnaround times. To address the need for fast and affordable diagnostics, we have developed a portable, rapid, on-cartridge magnetofluidic purification and testing (PROMPT) polymerase chain reaction (PCR) test. We show that it can detect Neisseria gonorrhoeae, the pathogen causing gonorrhea, with simultaneous genotyping of the pathogen for resistance to the antimicrobial drug ciprofloxacin in <15 min. The duplex test was integrated into a low-cost thermoplastic cartridge with automated processing of penile swab samples from patients using magnetic beads. A compact instrument conducted DNA extraction, PCR, and analysis of results while relaying data to the user via a smartphone app. This platform was tested on penile swab samples from sexual health clinics in Baltimore, MD, USA (n = 66) and Kampala, Uganda (n = 151) with an overall sensitivity and specificity of 97.7% (95% CI, 94.7 to 100%) and 97.6% (95% CI, 94.1 to 100%), respectively, for N. gonorrhoeae detection and 100% concordance with culture results for ciprofloxacin resistance. This study paves the way for delivering accessible PCR diagnostics for rapidly detecting STIs at the point of care, helping to guide treatment decisions and combat the rise of antimicrobial resistant pathogens.
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