FDA批準首個巨細胞病毒(CMV)基因檢測法
2012年7月5日，美國食品與藥物管理局（FDA）批準了首個巨細胞病毒（CMV）DNA檢測法，用于評估實質器官移植患者的抗病毒治療是否有效。
在患者正在接受抗巨細胞病毒治療期間，醫師可以借助該方法評估治療過程中患者血清樣本中CMV載量變化情況。如果兩次檢測期間病毒載量顯著降低則說明治療有效，反之則應該更換治療方案。檢測結果可以輔助其他臨床和實驗室檢查結果有助于醫生優化治療方案。
CMV是一種常見的病毒，能夠導致免疫功能低下人群（包括實質性器官移植患者）發生肺炎、腸炎等嚴重疾病。實質器官移植包括：心臟、肺、腎臟或小腸移植，而骨髓、皮膚以及肌肉等組織或細胞移植不包括在內。根據 美國衛生資源及服務管理局器官獲取移植網絡報道，2011年美國共有28,538例移植實質器官移植。 FDA體外診斷器械與安全性評估辦公室主任，醫學博士Alberto Gutierrez認為：“CMV檢測在醫生正確治療患者具有很重要的作用”。
FDA批準這項檢測的原因是基于一項證實該檢測CMV載量以及評價病毒載量變化的準確性隨機化研究，研究樣本是211例確診CMV感染的腎移植患者的凍存血清，這些患者均接受7周抗CMV治療。研究結果發現，病毒載量低者CMV感染治愈時間更短，病毒載量顯著降低與CMV感染治愈高度相關。
CMV檢測不能用于以下情況：篩查血液或血液制品中是否存在CMV DNA，CMV感染診斷性試驗。該檢測未在新生兒、兒童、艾滋病（AIDS）或其他免疫功能低下的患者進行評估。在進行這項檢測之前，臨床醫師應該先比較和了解現有不同檢測方法可能得到不同的檢測結果。
?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.
新聞鏈接：http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310691.h
