Detection of Respiratory Viruses in Upper and Lower Respiratory Tract Specimens

上呼吸道和下呼吸道标本中呼吸道病毒的检测

• 批准号: 8565333
• 负责人: ANTHONY F. SUFFREDINI
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8565333
• 关键词: Age; Biological Assay; Bronchoscopy; Caring; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Data; Collection; Conflict (Psychology); Data; Detection; Evolution; Female; Future; Individual; Infectious Diseases Research; Instruction; Laboratories; Lower respiratory tract structure; Medical; Medicine; Microbiology; National Institute of Allergy and Infectious Disease; Nucleic Acids; Participant; Process; Radiology Specialty; Reporting; Research; Research Personnel; Sampling; Services; Specimen; Swab; Techniques; Testing; United States National Institutes of Health; Upper respiratory tract; Viral; Viral Pathogenesis; Virus; abstracting; male; respiratory; respiratory virus

Up to 100 male or female subjects age 12 and above who are already undergoing bronchoscopy for the collection of a BAL specimen and who will have respiratory virus PCR ordered on the BAL specimen as part of their ongoing care at the NIH Clinical Center will be eligible for inclusion in this study. NP swab specimens have been validated for testing using the FilmArray assay. Both the NP swab and the BAL specimens will have the respiratory virus PCR (FilmArray) assay ordered in CRIS and the specimens will be processed and tested by the medical technologists in the Microbiology Service of the Department of Laboratory Medicine. Results from both specimens will be reported in CRIS. Instructions from the Centers for Disease Control on the proper technique for collecting NP swab specimens are presented in Appendix A. To resolve discrepant results, NP and BAL specimens with conflicting results will be tested by a second multiplex PCR (Luminex Fast RVP) in the Laboratory of Infectious Diseases, Viral Pathogenesis and Evolution Branch, NIAID. These results will only be used for research purposes. Demographic and clinical data (including but not limited to laboratory results, microbiologic data, and radiology results) on study participants will be abstracted from CRIS and correlated with results from the FilmArray assay. Excess NP swab or BAL samples will be stored for potential future use by study investigators.

最多100例年龄在12岁及以上的男性或女性受试者有资格入选本研究，这些受试者已接受支气管镜检查以采集BAL标本，并将对BAL标本进行呼吸道病毒PCR，作为其在NIH临床中心持续治疗的一部分。 已验证NP拭子标本可使用FilmArray检测试剂进行检测。 NP拭子和BAL标本均将在CRIS中订购呼吸道病毒PCR（FilmArray）检测试剂盒，标本将由实验室医学部微生物学服务处的医学技术人员处理和检测。 将在CRIS中报告两份标本的结果。 疾病控制中心关于采集NP拭子标本的正确技术的说明见附录A。 为了解决不一致的结果，将在NIAID病毒发病机制和进化分支传染病实验室通过第二次多重PCR（Luminex Fast RVP）检测具有冲突结果的NP和BAL标本。 这些结果将仅用于研究目的。 将从CRIS中提取研究受试者的人口统计学和临床数据（包括但不限于实验室结果、微生物学数据和放射学结果），并将其与FilmArray检测试剂盒的结果进行关联。 多余的NP拭子或BAL样本将储存，供研究者将来使用。