流感和呼吸道合胞病毒的自动检测：Xpert® Flu/RSV XC

wwwkkk83

美国食品药品管理局（FDA）上市了一种快速可靠的按需自动分子检验法，用于确定流感病毒A、流感病毒B和分化的呼吸道合包病毒（RSV）感染的。季节性和新兴流感病毒毒株检测目标宽泛。

FDA上市的Xpert流感/RSV XC卡盒式试剂盒是Cepheid（Sunnyvale，CA，USA）的产品，在GeneXpert系统中使用，这个系统是Cepheid的领先分子诊断平台，在全球的安装量超过了7500份。
                                                                     http://www.cepheid.com/us/

上呼吸道感染是去医院问诊的最常见原因之一，在美国是导致学生和工人请病假的最常见疾病。RSV是1岁以下婴幼儿发生细支气管炎和肺炎的最常见原因。拥有Xpert流感/RSV XC后，医院和临床医师能实时诊断和区分流感菌株以及RSV。“流感病毒株是出了名的不可预知，流感疫情的严重程度因季节而异，”Cepheid的董事长兼首席执行官John Bishop说。“近期媒体报告的严重病毒，如肠病毒 D68和埃博拉病毒，提高了公众意识，并更需要医务工作者提供及时准确的流感或RSV感染的检测结果。”

Geisinger Health系统的研究者，Donna M. Wolk 和 Raquel M. Martinez博士，参与了Cepheid产品开发阶段Xpert 流感病毒/RSV XC的研究性检验。其微生物团队正在计划一个名为FluWorks的试点项目，其目的是让测试结果通过电子健康档案、门户网站或短信立即发送给医生和患者或指定的家庭成员。

“我们渴望清晰Xpert流感/RSV XC检验在Geisinger的FluWorks计划中发挥的作用，以改善患者护理、临床操作和实验室管理工作。严谨的研究性检验结果表明了方法的高准确度和快速，”Wolk博士说，“今年冬天，我们计划利用测试的独特设计快速检测急诊、门诊和选定的紧急护理诊所的流感样患者。”

“我们采用了一种新型硅胶法，识别多个互补的目标片段，避免季节性基因漂变的影响，并预测新兴的流感病毒株。Xpert流感病毒/RSV XC不仅操作简单，还是一种高度复用的最先进测试手段，能快速准确检测和分化流感病毒A、流感病毒B和RSV感染，”Cepheid的首席医疗和技术官David Persing博士说，“这项检验还将成为预测流感流行的宝贵工具，因为产品初始设计前所未有的覆盖了人类流感病毒株和禽流感病毒株。”

wwwkkk83

Rigorous investigational testing documented the Xpert Flu/RSV XC’s high accuracy and speed. This winter, we plan to leverage the test’s unique design to quickly test patients presenting with influenza-like illness at Emergency Departments, out-patient clinics, and in selected Urgent Care Clinics."
Donna M. Wolk, MHA, Ph.D., D(ABMM) System Director, Clinical and Molecular Microbiology,
Geisinger Health System
Professor, Wilkes University

The Need
COLLAPSE
Respiratory viruses, especially influenza, mutate rapidly and novel strains can emerge with little notice.
Overwhelming evidence now shows that rapid influenza and RSV tests lack adequate clinical performance and,
therefore, clinical usefulness.1,2

Influenza: Evolution in Action
Emerging Flu Strains are a Constant Challenge



(1) Harper SA, et al. Seasonal Influenza in Adults and Children—Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management: Clinical Practice Guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2009 Apr 15;48(8):1003-32. (2) Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). Accessed Nov 2014. http://www.cdc.gov/rsv/about/faq.html

The Solution
COLLAPSE
A quick, easy to use, next-generation test that is designed to detect and differentiate Flu A, Flu B, and RSV infection maximizes medical decision making – enabling real-time testing during a patient presentation.

Be Prepared with Extended Coverage
Extended coverage and redundant target segments ensure accurate and reliable detection of Flu A, Flu B, and RSV infection
Unprecedented human and avian influenza strain coverage
Enhanced infection control and antiviral/antibiotic stewardship
Improved operation and patient workflow
On-demand testing provides peace of mind to both physician and patient
The Impact
COLLAPSE
Single-test confidence will accelerate your laboratory’s workflow with on-demand, random-access flexibility. Combine performance with the capability to run other Xpert tests (including GBS, MRSA, C. difficile, CT/NG, and MTB/RIF) on Cepheid’s GeneXpert® System to achieve proven productivity increases in overall laboratory service.3-7

Shift your lab from reactive to proactive

Achieve rapid results and improve patient management
Early assay termination option: deliver results in as little as ~40 minutes*
Quickly deliver targeted therapies and peace of mind to patients
* For positive result with Flu only or RSV only reporting. 63 minutes for negative.

(3) Morgan MG. The Perfect Storm. Cepheid Impact. 2012 Jun;2:4-7. (4) Parada JP. Increase Revenue and Improve Patient Safety. Cepheid Impact. 2012 Jun;2:8-11. (5) El Helali N. Less Uncertainty - Better Safety - More Healthy Newborns. Cepheid Impact. 2012 Jul;3:4-7. (6) Haynes L. The C. difficile Challenge. Cepheid Impact. 2012 Jul;3:10-15. (7) Parada JP. Improving Patient Safety. Cepheid Impact. 2012 Oct;4:8-11.

http://www.cepheid.com/us/cephei ... es/xpert-flu-rsv-xc