Breaking!!! FDA authorizes 'point of care' coronavirus test

D
Derechenz
楼主 (北美华人网)
这种新的检测方法只要45分钟就可以知道结果。美国已有5000台设备。

https://thehill.com/policy/healthcare/488807-fda-authorizes-first-rapid-point-of-care-coronavirus-test
Food and Drug Administration (FDA) has approved the first coronavirus diagnostic test that can be conducted entirely at the point of care.
The test from California-based Cepheid will deliver results in about 45 minutes – much faster than current tests that require a sample to be sent to a centralized lab, where results can take days.
The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide, of which 5,000 are in the U.S., the company said. The systems are already being used to test for conditions like HIV or tuberculosis.
The systems do not require users to have specialty training to perform testing, and are capable of running around the clock.
"An accurate test delivered close to the patient can be transformative — and help alleviate the pressure" that the COVID-19 outbreak has put on health facilities, David Persing, Cepheid's chief medical and technology officer, said in a statement.
"People in general are frustrated with the turnaround time. They don't know their status until days later. Knowing your status quickly ... this will allow much better decision making" and help doctors decide which treatment is best, Persing said in a video on the company's website.
The test initially will be used primarily by hospitals, the company said, but FDA's "emergency use authorization" covers all “patient care settings,” including doctors’ offices.
The test will begin shipping next week.
x
xinnian2013
想起来,一周还是两周前,那个罗氏企业一批设备呢?到位了吗?
T
TheGreatEscape
行了,test没问题了,治疗呢?疫苗呢?医护人员装备呢?别再宣布能test来当好消息了,没任何一个国家目前不能test的吧?
p
patx2449
算了吧,每次就吹吹吹,啥时候临床能敞开来测落实了再说吧,对白宫的这种什么振奋人心的消息已经麻木了
P
Pompom
没人给取样, 能测有P用 纽约医护就缺防护,为了安全不给取样,只给重症住院的取样
a
angliy
完全麻木,现在白宫,fda,cdc的消息我觉得还没华人靠谱
算了吧,每次就吹吹吹,啥时候临床能敞开来测落实了再说吧,对白宫的这种什么振奋人心的消息已经麻木了
patx2449 发表于 3/21/2020 3:04:53 PM
l
lulala
再观望一下,看看是否投入实战。
x
xiaoyu1985
完全麻木,现在白宫,fda,cdc的消息我觉得还没华人靠谱

angliy 发表于 3/21/2020 3:13:10 PM
m
minqidev
反正东西总在下周一
当时我记得说的的是,
下周一,可以测100万,紧接着200万,然后400万
那让人兴奋得股市都涨了10%
f
fish_fish
反正东西总在下周一
当时我记得说的的是,
下周一,可以测100万,紧接着200万,然后400万
那让人兴奋得股市都涨了10%

minqidev 发表于 3/21/2020 3:20:36 PM

想起来对吃瓜群众说下周一见,仿佛是很久以前的事了
N
NCMR
行了,test没问题了,治疗呢?疫苗呢?医护人员装备呢?别再宣布能test来当好消息了,没任何一个国家目前不能test的吧?
TheGreatEscape 发表于 3/21/2020 3:02:19 PM


你这种人也太难伺候了
剑走天涯
每天听听白宫的发布会,有帮助
f
fath2012
Test kit 应该还好,现在主要还是缺取样的棉签,还有保存样品的化学物,以及检测人员的防护用品,这样主要受制于市场供应,不是那么容易解决,这些才是目前测试的主要瓶颈了
o
oqo
反正东西总在下周一
当时我记得说的的是,
下周一,可以测100万,紧接着200万,然后400万
那让人兴奋得股市都涨了10%

minqidev 发表于 3/21/2020 3:20:36 PM

那是因为再紧急 还是要过周末 病毒可不过周末
p
pig0019
反正东西总在下周一
当时我记得说的的是,
下周一,可以测100万,紧接着200万,然后400万
那让人兴奋得股市都涨了10%

minqidev 发表于 3/21/2020 3:20:36 PM
p
pig0019
完全麻木,现在白宫,fda,cdc的消息我觉得还没华人靠谱

angliy 发表于 3/21/2020 3:13:10 PM
p
pig0019
没人给取样, 能测有P用

纽约医护就缺防护,为了安全不给取样,只给重症住院的取样
Pompom 发表于 3/21/2020 3:08:47 PM
a
arabdopsis
这种新的检测方法只要45分钟就可以知道结果。美国已有5000台设备。

https://thehill.com/policy/healthcare/488807-fda-authorizes-first-rapid-point-of-care-coronavirus-test
Food and Drug Administration (FDA) has approved the first coronavirus diagnostic test that can be conducted entirely at the point of care.
The test from California-based Cepheid will deliver results in about 45 minutes – much faster than current tests that require a sample to be sent to a centralized lab, where results can take days.
The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide, of which 5,000 are in the U.S., the company said. The systems are already being used to test for conditions like HIV or tuberculosis.
The systems do not require users to have specialty training to perform testing, and are capable of running around the clock.
"An accurate test delivered close to the patient can be transformative — and help alleviate the pressure" that the COVID-19 outbreak has put on health facilities, David Persing, Cepheid's chief medical and technology officer, said in a statement.
"People in general are frustrated with the turnaround time. They don't know their status until days later. Knowing your status quickly ... this will allow much better decision making" and help doctors decide which treatment is best, Persing said in a video on the company's website.
The test initially will be used primarily by hospitals, the company said, but FDA's "emergency use authorization" covers all “patient care settings,” including doctors’ offices.
The test will begin shipping next week.

Derechenz 发表于 3/21/2020 2:56:36 PM

无论如何总是好消息 很多人一开始就在等这个可以就地检查的 就像flu test一样
f
fasionfans
Test kit 应该还好,现在主要还是缺取样的棉签,还有保存样品的化学物,以及检测人员的防护用品,这样主要受制于市场供应,不是那么容易解决,这些才是目前测试的主要瓶颈了
fath2012 发表于 3/21/2020 3:38:15 PM

Re, agree
c
cfc006
這是好事。韓國的策略就是大量檢測。一時數字上去了,但對整體控制疫情有好處。韓國現在基本上有控制住的樣子了。
l
life99f
不错了 ,侧完等两三天又传染了一堆人。 ---发自Huaren 官方 iOS APP
w
wojiuaihuaban
这种机器Xpress在美国各医院已经有5000多台装机量,在全世界有两万多台,平时是用来做其它传染病测试用的,包括流感肝炎肺结核等。准确度还是很高的。现在上了新冠的套件,标本来了测试是很快的,45分钟出结果。 上市前也是有准临床测试的,各种FDA流程都有走,质量是可靠的,表现也很不错, 准确性稳定性都可以。 最好的地方是这机器可以流感新冠一起测,不需要分次筛查耽误时间浪费医疗资源。
c
cckk
啥玩意
太好了,说几个胜利让我们大家一起高兴一下
美国全国动员的一个个成果会让赵国疯狗傻眼
sillynut 发表于 3/21/2020 3:30:23 PM
d
darkcaramel
好消息都是给韭菜们堆肥,下周一又到了收割的时间了。
B
Baguette
这个测试应该不是高通量的
i
imniz
快速test其实是非常重要的,因为这是让健康的人可以外出自由活动最快的方法。
c
chartgame
如果能这么快出结果,那未来一周数据就会飞,不飞就是没落实推广。
g
greatlake
Test kit 应该还好,现在主要还是缺取样的棉签,还有保存样品的化学物,以及检测人员的防护用品,这样主要受制于市场供应,不是那么容易解决,这些才是目前测试的主要瓶颈了
fath2012 发表于 3/21/2020 3:38:15 PM

已经派军用飞机从意大利购医疗公司运回800,000 swabs,接下来还要飞几趟,1.5million/week的供应。
总会解决问题的
R
ReachMoon
自称百万测试盒,结果朋友发烧5天,排除Flu还是不给测
A
Adrianne
反正东西总在下周一
当时我记得说的的是,
下周一,可以测100万,紧接着200万,然后400万
那让人兴奋得股市都涨了10%

minqidev 发表于 3/21/2020 3:20:36 PM


Roche的今天就已经到美国Midwest大农村小县城的医院了,每天可以测600个,本来说要月底才到的。
A
Adrianne
Test kit 应该还好,现在主要还是缺取样的棉签,还有保存样品的化学物,以及检测人员的防护用品,这样主要受制于市场供应,不是那么容易解决,这些才是目前测试的主要瓶颈了
fath2012 发表于 3/21/2020 3:38:15 PM


所以那个小老头Tony Fauci才说,关键是可以自己取样的测试,正在开发中,看样子也快了。
A
Adrianne
这种测试的好处就是,美国大农村保住了,本来他们很少能拿到测试批准,因为不是严重疫区,优先级低。 看样子今年农产品,没有任何问题,大家窝家里,估计人人都得肥一圈了。
y
yukifangfang
这个各大药房drive through test啥时候开始呀,都一周多了。
a
angliy
我们这里target连第一小时给老年人一周只给一天?资本家最终还是资本家
这个各大药房drive through test啥时候开始呀,都一周多了。 yukifangfang 发表于 3/21/2020 11:02:00 PM
c
cable
回复 9楼minqidev的帖子 大家盯着正副总统的Twitter 每天问这些问题,我就是天天问。
笨小囡
好消息呀!
这种机器Xpress在美国各医院已经有5000多台装机量,在全世界有两万多台,平时是用来做其它传染病测试用的,包括流感肝炎肺结核等。准确度还是很高的。现在上了新冠的套件,标本来了测试是很快的,45分钟出结果。 上市前也是有准临床测试的,各种FDA流程都有走,质量是可靠的,表现也很不错, 准确性稳定性都可以。 最好的地方是这机器可以流感新冠一起测,不需要分次筛查耽误时间浪费医疗资源。 wojiuaihuaban 发表于 3/21/2020 4:51:00 PM
缓缓歌
吹吧,test这么容易为啥轻症不给测
I
Inferno
没人给取样, 能测有P用

纽约医护就缺防护,为了安全不给取样,只给重症住院的取样
Pompom 发表于 3/21/2020 3:08:47 PM

是啊。还是看华人网上不给测的帖子真实的多