FDA批准首个巨细胞病毒(CMV)基因检测法

2012年7月5日，美国食品与药物管理局（FDA）批准了首个巨细胞病毒（CMV）DNA检测法，用于评估实质器官移植患者的抗病毒治疗是否有效。

在患者正在接受抗巨细胞病毒治疗期间，医师可以借助该方法评估治疗过程中患者血清样本中CMV载量变化情况。如果两次检测期间病毒载量显著降低则说明治疗有效，反之则应该更换治疗方案。检测结果可以辅助其他临床和实验室检查结果有助于医生优化治疗方案。

CMV是一种常见的病毒，能够导致免疫功能低下人群（包括实质性器官移植患者）发生肺炎、肠炎等严重疾病。实质器官移植包括：心脏、肺、肾脏或小肠移植，而骨髓、皮肤以及肌肉等组织或细胞移植不包括在内。根据 美国卫生资源及服务管理局器官获取移植网络报道，2011年美国共有28,538例移植实质器官移植。 FDA体外诊断器械与安全性评估办公室主任，医学博士Alberto Gutierrez认为：“CMV检测在医生正确治疗患者具有很重要的作用”。

FDA批准这项检测的原因是基于一项证实该检测CMV载量以及评价病毒载量变化的准确性随机化研究，研究样本是211例确诊CMV感染的肾移植患者的冻存血清，这些患者均接受7周抗CMV治疗。研究结果发现，病毒载量低者CMV感染治愈时间更短，病毒载量显著降低与CMV感染治愈高度相关。

CMV检测不能用于以下情况：筛查血液或血液制品中是否存在CMV DNA，CMV感染诊断性试验。该检测未在新生儿、儿童、艾滋病（AIDS）或其他免疫功能低下的患者进行评估。在进行这项检测之前，临床医师应该先比较和了解现有不同检测方法可能得到不同的检测结果。

 FDA approves first DNA test to help manage CMV infection in organ transplant patients

The U.S. Food and Drug Administration today approved the first DNA test to help health care professionals gauge the progress of anti-viral treatment in solid organ transplant patients undergoing cytomegalovirus (CMV) antiviral therapy.

The COBAS AmpliPrep/COBAS TaqMan CMV Test is a viral load test that can help determine the amount of CMV nucleic acid present in a sample of a patient’s blood plasma.

While a patient is undergoing anti-CMV therapy, a clinician can use the device to perform a series of tests to look for changes in a patient’s CMV viral load. A significant decrease in viral load from one test to the next may indicate that a particular therapy is effective, while an increase or no change may indicate the need for a different therapy. When used along with other clinical and laboratory data, this information can aid clinicians to manage and optimize patient care.

CMV is a common virus that can cause severe diseases such as pneumonia or colitis in people with weakened immune systems, including solid organ transplant patients. Solid organ transplants include heart, lung, pancreas, kidney, or small intestine transplants. Transplants of tissue or cells, such as bone marrow, skin, or muscle, are not included.

The U.S. Health Resources and Services Administration’s Organ Procurement and Transplantation Network reports that there were 28,538 solid organ transplants in the United States in 2011. 

“Tests such as the COBAS AmpliPrep/COBAS TaqMan CMV Test can play an important role in helping health care professionals appropriately treat patients,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health.

The FDA’s approval of the COBAS AmpliPrep/COBAS TaqMan CMV Test was based on information that included an assessment of the test's accuracy in measuring viral load and its ability to accurately measure variations in the amount of CMV virus.

 The agency evaluated clinical data from a randomized, three-site study of frozen plasma samples from 211 kidney transplant patients with confirmed CMV diagnosis who underwent a seven-week course of anti-CMV therapy. Study results showed that a lower baseline viral load can predict a shorter time to resolution of CMV disease, and that significant declines in viral load are highly correlated to resolution of CMV disease. 

The test is not approved for use as a screening test for the presence of CMV DNA in blood or blood products or as a diagnostic test to diagnose CMV infection. It has not been evaluated in newborns, pediatric patients, AIDS, or other immunocompromised patients. Before switching to the COBAS AmpliPrep/COBAS TaqMan CMV Test, clinicians should compare and understand how the test method and results may differ from test methods and results currently used in their practice.

 The COBAS AmpliPrep/COBAS TaqMan CMV Test is manufactured by the Roche Molecular Systems in Somerville, N.J.

新闻链接：http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310691.h