欢迎来到艾兰博曼,请 登录 | 立即注册
查看: 1490|回复: 3

【资讯翻译】Updated: The Next Theranos? FDA Warns Qiagen Over Faulty TB...

[复制链接]

10

听众

10

收听

1954

积分

管理员

Rank: 9Rank: 9Rank: 9

积分
1954
发表于 2016-6-29 08:52:38 | 显示全部楼层 |阅读模式
Updated: The Next Theranos? FDA Warns Qiagen Over Faulty TB Test Device

The US Food and Drug Administration (FDA) on Tuesday released a warning lettter for Maryland-based Qiagen over deficiencies with its blood test used for diagnosing tuberculosis (TB), noting multiple complaints for high false positive rates.

FDA’s inspection found that Qiagen’s QuantiFERON-TB Gold (QFT) test device, first approved in 2005, “is adulterated … in that the methods used in or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation.”

Multiple corrective and preventive actions (CAPAs) had been open due to repeated complaints for high false positive rates, FDA noted in the warning letter issued on 16 May.

Qiagen’s corrective action was also cited as “not effective” because the contract manufacturer could not meet the required new specification and “there were no endotoxin spiking studies to determine what amount of endotoxin contamination of the Nil tube could cause a false negative result. Furthermore since the endotoxin specification change was implemented, the TB Antigen and Nil tubes were manufactured without process validation and released,” FDA said.

In addition, the documented quality requirements that must be met by Qiagen’s contract manufacturer of QuantiFERON blood collection tubes “do not include endotoxin.”

Another CAPA, opened due to endotoxin contamination found in two lots of one of the blood collection tubes, “could lead to potentially false negative results,” FDA said, noting that this CAPA “was not effective as portions from both lots were released despite multiple failures being obtained during lot release testing.”

The agency also took issue with the fact that the validation documents included in Qiagen’s response “do not directly address endotoxin levels and do not provide evidence that your current process has been appropriately validated.”

Reporting Violations

FDA also found the QFT device to be misbranded as Qiagen failed “to submit a report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.”

Specifically, FDA points to two Japanese recalls after malfunctions with the devices.

Thomas Theuringer, spokesman for Qiagen, told Focus that there are "no performance issues with the QuantiFERON-TB Gold (QFT) test and there is no request to discontinue selling the product ... We take these matters seriously and have already taken appropriate actions to correct the procedures and ensure FDA compliance. This includes making improvements during the ongoing transfer of QFT manufacturing and the transition to the fourth-generation version to the Qiagen site in Germantown [Maryland]."

He also said the comparison to Theranos, which has come under fire for its faulty blood testing device that has not been approved by FDA yet, as an "apples to pears" comparison.

信源地址:http://www.raps.org/Regulatory-F ... lty-TB-Test-Device/


0

听众

0

收听

387

积分

中级会员

Rank: 3Rank: 3

积分
387
发表于 2016-6-29 11:32:17 | 显示全部楼层
领了。。。。

0

听众

0

收听

387

积分

中级会员

Rank: 3Rank: 3

积分
387
发表于 2016-6-29 20:02:27 | 显示全部楼层
最新消息:下一个Theranos公司?FDA警告QIAGEN公司肺结核(TB)测试装置错误率过高

       美国食品和药物管理局(FDA)在星期二发布一份警告信,指出QIAGEN公司(总部位于马里兰州)用于诊断肺结核(TB)血液测试的不足,及其假阳性事件投诉太多。
       FDA检查发现QIAGEN公司2005年批准的QuantiFERON-TB Gold(QFT)试验装置,“掺假…,该公司用于制造,包装,储存,或安装的方法、设施和控制与质量体系法规中现行的良好生产规范要求不符合”。
       FDA在5月16日的警告信中指出,由于假阳性率的连续投诉,该试验装置多个纠正和预防措施(CAPA)被公开。
       QIAGEN的纠正措施也被指是“无效的”,因为合同制造商无法达到新规范的要求,同时缺乏内毒素扣球研究来确定会导致假阴性结果的零管内毒素污染量。此外,美国FDA指出,由于内毒素规格变化的实施,结核病抗原和零管的制造是不具备过程验证和释放的情况下进行的。
       此外,QIAGEN公司血液收集管合同制造商必须遵守的质量要求文件中不包括内毒素。
       由于在两批次的血液采集管中发现其中一个批次被内毒素污染的原因,另外一个CAPA被公开。“可能导致潜在的假阴性结果”,FDA说,指出这个CAPA不是有效的,尽管两个批次中只有一部分被放行,而其中一部分未通过批次放行试验。”
       该机构还采取了事实来说明这个问题,在内QIAGEN公司回应的验证文件文件,并不直接涉及内毒素水平,也没有提供证据证明其当前的过程被验证是适当的。”
       违反报告
       FDA将会把QFT装置列为冒牌产品,如果QIAGEN公司在收到这封警告信或者通过任何途径意识到这个问题的30天内,不能够提交相应的报告。FDA要求QIAGEN公司在报告中必须合理地提出意见,其公司的装置在市场中已经发生过故障,而且如果故障再次发生,该市场销售的这种装置或类似装置将有可能引起或导致死亡或严重伤害。”
       具体而言,美国FDA指的是两个在日本由于故障而召回的设备。
       Qiagen公司发言人Thomas Theuringer告诉Focus,QFT测试并没有问题,也没有收到要求是停止销售该产品…我们认真对待这些问题,并已采取适当的行动来纠正程序,并确保与FDA的合规性。这些措施包括正在进行QFT的制造向马里兰州日耳曼敦的Qiagen公司总部转移的过程和向第四代版本产品过渡的过程中采取的改善措施”
       他还说,Theranos是因为其未经FDA批准的血液测试装置的错误而处于水深火热之中,拿两家公司作比较就像是在作一个苹果与梨的比较。

10

听众

10

收听

1954

积分

管理员

Rank: 9Rank: 9Rank: 9

积分
1954
 楼主| 发表于 2016-6-30 08:40:34 | 显示全部楼层
收了
您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

© 2013 艾兰博曼 All Rights Reserved.
( 浙ICP备07020270号-8 )
 
快速回复 返回顶部 返回列表