RAPID DETECTION AND TYPING OF HSV DNA

生殖器疱疹是一个重要的公共卫生问题， 以及原发性和复发性发作的医疗后果。 目前的HSV诊断方法不够灵敏、快速， 或者对于常规临床使用是成本有效的。 需要一种灵敏的检测、分型和定量HSV的方法 改善临床和亚临床生殖器疱疹的管理， 免疫功能低下的人也会复发疱疹。 这样的测试 可以监测抗病毒药物治疗的有效性和发展 抗药性的证据。 一种能从宫颈检测HSV的试验 标本可以解决无症状感染的产前诊断 在孕妇中。 该应用要求该方法给出 在6小时内得到结果，并且对于常规临床使用足够稳健。 在我们的第一阶段SBIR中，Digene的混合捕获R II（HCII）信号- 采用扩增DNA检测技术， HSV-1和HSV-2 DNA的灵敏检测、分型和定量， 病变 进一步的发展将提高灵敏度、特异性 和测试的易用性;减少结果的时间;提供 定量输出;证明分析和临床性能 在选定的人群中进行测试;并验证制造和 质量控制程序的工具包，以满足这些需要。

Genital herpes is an important public health problem with adverse social and medical consequences for both primary and recurrent episodes. Current diagnostic methods for HSV are not sufficiently sensitive, rapid or cost effective for routine clinical use. A sensitive method for detecting, typing and quantitating HSV is needed to improve the management of clinical and subclinical genital herpes and also recurrent herpes in immunocompromised individuals. Such a test could monitor effectiveness of antiviral drug therapies and development of drug resistance. A test capable of detecting HSV from cervical specimens could address predelivery diagnosis of asymptomatic infections in pregnant women. This application requires that the method give results within 6 hours and be robust enough for routine clinical use. In our Phase I SBIR, Digene's Hybrid Capture R II (HCII) signal- amplified DNA detection technology was adapted for the rapid and sensitive detection, typing and quantitation of HSV-1 and HSV-2 DNA from lesions. Further development will increase the sensitivity, specificity and ease of use of the tests; decrease time to results; provide quantitative output; demonstrate analytical and clinical performance of the tests in selected populations; and validate manufacturing and quality control procedures for the kit to meet these needs.