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【资讯翻译】FDA approves first HPV test for use with SurePath Preservat...

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发表于 2016-7-13 14:38:27 | 显示全部楼层 |阅读模式
FDA approves first HPV test for use with SurePath Preservative Fluid
TheU.S. Food and Drug Administration today approved the Roche cobas HPV Test asthe first test for Human Papilloma Virus (HPV) that can be used with cervicalcells obtained for a Pap test and collected in SurePath Preservative Fluid.

The FDAapproves HPV tests to be used with specific collection fluid, which store andpreserve cervical cell samples for testing in the laboratory. Until today, theFDA had not approved any HPV tests to be used with SurePath Preservative Fluid,one of two approved liquid collection fluids commonly used for Pap tests.

“Health careproviders have been using samples stored in the SurePath Preservative Fluidwith HPV tests for some time now, but there have been concerns about falsenegative results,” said Alberto Gutierrez, Ph.D., director of the Office of InVitro Diagnostics and Radiological Health in the FDA’s Center for Devices andRadiological Health. “Now health care providers have access to an FDA-approvedtest and the information they need to use it properly to ensure the mostaccurate results for their patients.”

Prior totoday’s approval, some laboratories used cervical cell samples collected inSurePath Preservative Fluid to run HPV tests, in lieu of collecting anadditional sample in a separate collection fluid that had been approved for usewith those tests. In 2012, the manufacturer of SurePath warned laboratoriesthat using cervical cell samples in SurePath Preservative Fluid with a specificHPV test may lead to false negative results. Patients who receive false negativeHPV test results may not receive appropriate follow-up care, which could leadto cervical cancer progression. The Roche cobas HPV Test now provides specificinstructions for laboratories to process cervical samples collected in SurePathPreservative Fluid to minimize the risk of false negative results.

HPVinfections are the most common sexually-transmitted infections in the UnitedStates, and HPV genotypes 16 and 18 cause approximately 70 percent of cervicalcancers worldwide. According to the National Cancer Institute, there will be anestimated 12,990 new cases and 4,120 deaths from cervical cancer in the UnitedStates during 2016.

TheRoche cobas HPV Test with SurePath Preservative Fluid is approved for use withcervical cell samples obtained for a Pap test to screen women age 30 and olderfor HPV in order to determine whether additional follow-up and diagnosticprocedures are needed. The FDA also approved the Roche cobas HPV Test withSurePath in women age 21 and older who have already had an abnormal Pap testresult (borderline cellular cytology) in order to determine whether additionalfollow-up and diagnostic procedures are needed. The test with SurePath is alsoable to detect high-risk HPV genotypes 16 and 18 in the same populations ofwomen.

The Rochecobas HPV Test with SurePath is not approved as a first-line primary HPVscreening test. In addition, health care professionals should use the cobas HPVTest results together with other information, such as the patient screeninghistory and risk factors.

The FDAbased its approval of the Roche cobas HPV Test with SurePath Preservative Fluidon a clinical study of 952 eligible women 21 years and older with abnormal Paptest results. The Roche cobas HPV Test with SurePath Preservative Fluiddemonstrated similar clinical performance when compared to a previouslyapproved cervical sample type. Of the samples that tested positive for HPVusing the Roche cobas HPV Test with SurePath, 95.4 percent obtained the sameresult as the reference sample. Of the samples that tested negative for HPVusing the Roche cobas HPV Test with SurePath, 93.2 percent obtained the sameresult as the reference sample.

The Rochecobas HPV Test is manufactured by Roche Molecular Systems, Inc., a part of theRoche Group, headquartered in Basel, Switzerland. SurePath Preservative Fluidis manufactured by Becton Dickinson and Company, located in Franklin Lakes, NewJersey.



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发表于 2016-7-13 15:04:20 | 显示全部楼层
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发表于 2016-7-14 10:45:11 | 显示全部楼层
FDA批准SurePath保存液作为第一款HPV检测

美国食品和药物管理局今天批准罗氏Cobas HPV检测作为人类乳头瘤病毒(HPV)的第一个测试,它是通过巴氏试验得到宫颈细胞,用SurePath保存液收集。

美国食品和药物管理局批准用于特定收集液的人乳头状瘤病毒检测,并在实验室中保存和保存宫颈细胞样本进行检测。直到今天为止,FDA还没有批准SurePath保存液用于任何的HPV检测,两个已批准的液体收集液常用语巴氏试验。

“医疗机构已将做HPV测试时的样品保存在SurePath保存液中一段时间,但有假阴性结果的担忧” 美国FDA设备和放射卫生中心的体外诊断和放射健康办公室主任阿尔伯托古铁雷斯博士说,“现在,卫生保健提供者可以使用FDA批准的测试和信息,他们需要正确地使用它,以确保提供他们的病人最准确的结果。”

在今天的批准之前,一些实验室使用宫颈细胞样本收集在 SurePath 保存液中,用于运行人乳头瘤病毒测试,代替收集已被批准用于这些测试的单独的收集液中的一个额外的样品。在 2012 年,制造商 SurePath 警告实验室在特定的HPV测试中使用宫颈细胞样本可能会导致假阴性结果。接受假阴性的HOV检测结果的患者可能没有得到适当的后续护理,可能会导致宫颈癌的进一步扩展。现在,罗氏公司 cobas HPV 检测提供了有关实验室处理宫颈样品 SurePath 保存液的特定说明,尽量减少假阴性结果的风险。

人乳头瘤病毒感染是美国最常见的性传播感染,人乳头瘤病毒基因型 16 和 18导致全世界大约 70%的宫颈癌。根据美国国家癌症研究所,2016年期间美国将有估计 12,990 新发病例和 4,120 死于宫颈癌。

随着罗氏Cobas HPV检测的SurePath保存液被批准用于宫颈细胞样本的巴氏试验,来筛选女性30岁及以上的人乳头状瘤病毒,以确定是否需要额外的后续和诊断程序是必要的。FDA还批准用是罗氏 cobas SurePath的 HPV 检测 与在21岁及以上的妇女,已经有一个异常的巴氏试验结果(交界性细胞细胞学),以确定是否需要额外的后续和诊断程序。与 SurePath 测试也是能够检测在同一种群的妇女的高危人乳头瘤病毒基因型 16 和 18 。

用SurePath进行罗氏HPV 检测并未被批准作为一线的主要 HPV扫描测试。此外,健康护理专业人员应使用 cobas HPV测试比对其他信息,如患者扫描历史和风险因素。

FDA基于952例21岁及以上妇女的临床研究,证实了罗氏公司cobas HPV测试时使用SurePath 防腐剂液的Paptest的结果异常。在确认为宫颈样本类型中,罗氏公司cobas HPV 检测与 SurePath 防腐剂 Fluiddemonstrated 类似临床表现相似。在 HPV测试使用罗氏 cobas 与 SurePath HPV 检测呈阳性的样本中,95.4%获得相同结果的作为参考样本。HPV测试使用罗氏 cobas 与 SurePath HPV 检测为阴性的样本中,93.2%获得相同结果的作为参考样本。

罗氏公司的HPV测试是由总部设在瑞士巴塞尔的罗氏集团旗下的罗氏分子系统公司制造的。SurePath 防腐剂 Fluidis 是由位于新泽西州富兰克林湖的贝克顿•迪金森及其公司制造的。

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 楼主| 发表于 2016-7-14 10:58:57 | 显示全部楼层
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