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【技术产业】FDA批准第一项DNA检测试验用于检测
The COBAS TaqMan HBV Test extracts and then amplifies sections of viral DNA from human plasma or serum. The viral DNA sections are measured to establish a baseline level before beginning treatment, and then used again during treatment to assess an individual’s response to therapy. (The baseline level of hepatitis B virus should decrease with successful treatment.) The test is used with other clinical findings, such as results from biochemical and serological testing.
“Measuring a patient’s HBV viral load is an important aspect of managing chronic hepatitis B infections,” said Daniel G. Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “The COBAS TaqMan test gives health care providers a new and sensitive tool for this process.”
HBV is the most serious type of viral hepatitis, infecting about two billion people worldwide each year, according to the World Health Organization. A vaccine for HBV has been available in the United States since 1982. However, according to the Centers for Disease Control and Prevention, about 1.25 million people in the United States have chronic hepatitis B. Another 60,000 become infected each year and some 5,000 die from hepatitis B-related complications.
HBV is spread through sexual exposure, use of infected needles, and transmitted from infected mother to child during birth. Symptoms occur in about 70 percent of patients, and include abdominal pain, jaundice, fatigue, loss of appetite, nausea, and vomiting.
COBAS TaqMan HBV Test is manufactured by Roche Diagnostic Division, Basel, Switzerland.
转自：FDA网站 本人认领，48小时未上交译文则视为放弃，请其他战友继续。 The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient’s blood. Assessing a patient’s viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.
今天美国FDA批准第一项用于检测患者血中乙肝病毒载量的DNA检测试验。高度专一敏感性的方法评价慢性乙肝患者的病毒载量来衡量抗病毒治疗的疗效。
The COBAS TaqMan HBV Test extracts and then amplifies sections of viral DNA from human plasma or serum. The viral DNA sections are measured to establish a baseline level before beginning treatment, and then used again during treatment to assess an individual’s response to therapy. (The baseline level of hepatitis B virus should decrease with successful treatment.) The test is used with other clinical findings, such as results from biochemical and serological testing.
COBAS TaqMan 乙肝检测提取，接着从人的血清或血浆中扩大病毒DNA的部位。通过测定病毒DNA的位置建立治疗前的基线水平，然后在治疗过程中再次使用来评价个体对治疗的反应。（乙肝病毒的基线水平应该随着有效治疗而下降）。这种检测可以用于其他的临床结果，例如生物化学和血清学试验的结果。
“Measuring a patient’s HBV viral load is an important aspect of managing chronic hepatitis B infections,” said Daniel G. Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “The COBAS TaqMan test gives health care providers a new and sensitive tool for this process.”
“测试病人的HBV病毒载量是检测慢性乙肝传染的重要一面”FDA设备和放射保健的中心主任Daniel G. Schultz说到,“CONAS TaqMan检测带给给健康保健者一套新的敏感性的工具”
HBV is the most serious type of viral hepatitis, infecting about two billion people worldwide each year, according to the World Health Organization. A vaccine for HBV has been available in the United States since 1982. However, according to the Centers for Disease Control and Prevention, about 1.25 million people in the United States have chronic hepatitis B. Another 60,000 become infected each year and some 5,000 die from hepatitis B-related complications.
HBV是病毒性肝炎最严重的一型，根据世界卫生组织的报告，每年全世界约20亿人感染HBV。美国1982年就出产了HBV疫苗。然而，根据疾控中心的报道，美国约125万患慢性乙肝。另外，每年有6万人感染，5000人死于乙肝相关并发症。
HBV is spread through sexual exposure, use of infected needles, and transmitted from infected mother to child during birth. Symptoms occur in about 70 percent of patients, and include abdominal pain, jaundice, fatigue, loss of appetite, nausea, and vomiting.
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作者:admin@医学,生命科学 2011-01-02 05:14
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