美疾控中心實驗室汙染致試劑失靈 病毒檢測工作被延遲數週

美疾控中心实验室污染致试剂失灵 病毒检测工作被延迟数周

据《华盛顿邮报》当地时间18日报道,美国疾病控制与预防中心(CDC)的实验室污染问题导致该机构未能迅速研发出新型冠状病毒的检测工具,从而导致全美新冠病毒检测工作的延迟。报道称,由于美国疾控中心生产试剂盒的实验室违反了合理的生产规范,导致用于高灵敏度检测过程的三个测试组件之一受到污染。

A delay by the U.S. Centers for Disease Control and Prevention (CDC) in quickly making COVID-19 test kits available was the result of "a glaring scientific breakdown" at the CDC's central lab, The Washington Post reported on Saturday.

A report, citing scientists and federal regulators, said that CDC facilities which assembled the testing kits "violated sound manufacturing practices, resulting in contamination of one of the three test components used in the highly sensitive detection process."

Though the contaminated component was "not critical to detecting the novel coronavirus," CDC officials took over a month to remove the unnecessary step from the test kits, which aggravated national delays in testing for the virus, and in turn hampered the efforts to contain the spread of the virus, according to the Post

《华盛顿邮报》称,1月下旬,美国疾病控制与预防中心向全国26个公共卫生实验室发送了首批检测盒,部分地方公共卫生实验室发现检测盒的缺陷。据知情人士表示,在分析从病人身上采集的样本之前,使用试剂盒的26个实验室中有24个出现了假阳性反应,从而引发了对这批试剂盒的关注。

The malfunction was said to be first found in late January, when the CDC sent the first batch of test kits to 26 local public health labs across the country. False positive results were reported in 24 of them before they analyzed samples taken from patients, which raised concerns about the kits.

Benjamin N. Haynesm, a spokesman of the CDC, acknowledged substandard "quality control" in its manufacturing of the test kits in a statement on Friday.

美国食品和药物管理局(FDA)认为,疾控中心似乎违反了自己的生产规程,污染最有可能发生在生产过程中。

The U.S. Food and Drug Administration (FDA) concluded that the issue is a consequence of substandard manufacturing practices rather than its design after examination, saying the CDC did not make its test consistent with its own protocol.

美疾控中心实验室污染致试剂失灵 病毒检测工作被延迟数周

An electron microscope image shows the spherical particles of the new coronavirus, colorized blue, from the first U.S. case of COVID-19. Antibody blood tests for the coronavirus could play a key role in deciding whether millions of Americans can safely return to work and school. (Hannah A. Bullock, Azaibi Tamin/CDC/AP)

《华盛顿邮报》根据对联邦政府文件的审查,以及对30多名现任和前任联邦政府科学家及其他知情人士的采访后了解到,在出现问题后,美国疾控中心官员花了一个多月的时间才移除不必要的实验步骤,加剧了在生产和分发试剂盒上的延误,从而导致了全国范围内的检测延误。目前,美国卫生与公共服务部正在对测试套件的生产和分发进行调查。

The issue is now under assessment by the U.S. Department of Health and Human Services, the parent agency of CDC, and more will be shared when it is completed, said CNBC citing an email with Haynesm.

此新闻一出,引起舆论的一片哗然。

CDC在此次新冠病毒试剂盒上的表现,标志着它的公众信任感陷入了成立74年以来的历史低点。

病毒学家,前CDC官员,现任德克萨斯州加尔维斯顿国家实验室主任詹姆斯•勒杜克表示,“听闻检测没有成功时,我感到既难过又尴尬。这是CDC的一个可怕污点,对这个国家的影响是毁灭性的。”

"The CDC's performance with the test kits marks an unparalleled low common trust in its 74-year history," The Post reported.

"I was just saddened and embarrassed when this test didn't work out," James Le Duc, a virologist and former CDC officer who now heads the Galveston National Laboratory in Texas, told The Post, adding "It's really a terrible black mark on the CDC, and the impact was devastating to the country."

美国网友的反应如何?

美疾控中心实验室污染致试剂失灵 病毒检测工作被延迟数周

“《华盛顿邮报》精彩阐述了在药厂、医疗设备领域,相关部门对其高标准的必要性。这就是为什么一些非医疗公司兑现了他们的承诺,而另一些却没有。”

美疾控中心实验室污染致试剂失灵 病毒检测工作被延迟数周

引用美国疾控中心前实验室主任的话说,“我的疑问是,监管在哪里?” “一个有能力的实验室不会出现这样的问题,我真不明白这些有问题的试剂盒是怎么流出的?”

美疾控中心实验室污染致试剂失灵 病毒检测工作被延迟数周

如果把公共卫生领域全都交给官僚或者政客,错误就很容易产生。

美疾控中心实验室污染致试剂失灵 病毒检测工作被延迟数周

“CDC对检测的糟糕处理使我们失去了遏制新冠病毒关键的一个月,这真是可耻的,《华盛顿邮报》的文章应该让每一个美国公民感到愤怒。”


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