新型コロナ検体を一括で検査、FDAが緊急使用許可ー件数増目指す

●2020年7月20日 11:04 JST 最大4つの検体が入ったサンプルを一括で検査できる ファウチ所長と調整官のバークス氏も検査件数増やす手段として支持 米食品医薬品局(FDA)は18日、「プール・テスティング」と呼ばれる手法による新型コロナウイルス検査に初めて緊急使用許可(EUA)を出した。使用する検査資源を抑えつつ、検査対象を広げる狙いがある。   FDAの発表資料によると、米臨床検査ラボのクエスト・ダイアグノスティクスはスワブ(綿棒)を使用した検体最大4つが入ったサンプルを一括で検査できるようになる。陽性となった場合は、検体の1つ以上が陽性の可能性があるため、今度は個々の検体が検査される。 続きを読む
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Mugen UJIIE (氏家 無限) @carpe_diem0820

プールした検体のうち最初の検査が陽性の場合のみ全検体を検査する戦略の効率性が高い 検査感度70%有病率1%なら13人のプールが最適で検査数は16%に Simulation of Pool Testing to Identify Patients With COVID-19 2019 Under Conditions of Limited Test Availability jamanetwork.com/journals/jaman… pic.twitter.com/ejK5CgAO7y

2020-06-27 05:59:23
拡大
Mugen UJIIE (氏家 無限) @carpe_diem0820

米国でCOVID-19検査必要数の削減及び効率化のため、プールした検体から最初の検査が陰性の場合は全ての検体が陰性と判断するプール検査の導入を検討 Officials are discussing a possible shift to ‘pool testing,’ Fauci says. nytimes.com/2020/06/26/wor… twitter.com/carpe_diem0820…

2020-06-27 06:01:56
U.S. FDA @US_FDA

Today, the FDA issued the first Emergency Use Authorization (EUA) for sample pooling in a #COVID19 diagnostic test. fda.gov/news-events/pr… pic.twitter.com/WF7Im9dIXP

2020-07-19 00:37:46
拡大
U.S. FDA @US_FDA

We reissued the EUA to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with up to four pooled samples collected under observation. fda.gov/media/136228/d…

2020-07-19 00:37:46
U.S. FDA @US_FDA

Sample pooling allows labs to combine & test samples in a batch. Ultimately, pooling is expected to require fewer tests, meaning fewer test supplies are used & more tests can be run at the same time so patients can get results faster in most cases.

2020-07-19 00:37:47
U.S. FDA @US_FDA

The FDA continues to work with a number of diagnostic test developers to facilitate new approaches and get additional tests to more Americans more quickly.

2020-07-19 00:37:47
U.S. FDA @US_FDA

We reissued an Emergency Use Authorization (EUA) to Quest Diagnostics for the Quest SARS-CoV-2 rRT-PCR test for use with pooled samples. It’s the first #COVID19 diagnostic test authorized for use with pooled samples. twitter.com/US_FDA/status/…

2020-07-21 08:28:17
U.S. FDA @US_FDA

Today, the FDA authorized the first #COVID19 diagnostic test for screening of people without known or suspected COVID-19 infection. The authorization is also second to allow testing of pooled samples. fda.gov/news-events/pr… pic.twitter.com/aJiB7gD6e6

2020-07-25 09:55:18
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CDC @CDCgov

Laboratory professionals: New guidance now available for using pooled samples for #COVID19 diagnostic, screening, and surveillance testing. Guidance includes information on reporting, limitations, and testing systems. See full guidance here: bit.ly/39oepQ1. pic.twitter.com/UVzIpZei1N

2020-07-25 04:15:04
拡大
U.S. FDA @US_FDA

The FDA reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications: testing for people who do not have COVID-19 symptoms or have no reason to suspect COVID-19 infection, and to allow pooled sample testing. fda.gov/media/136148/d…

2020-07-25 09:55:18
U.S. FDA @US_FDA

The FDA recognizes that organizations may want to conduct screening of asymptomatic people as part of a broader strategy to help ensure the safety of their employees, patients, students and others.

2020-07-25 09:55:19
U.S. FDA @US_FDA

Sample pooling allows for fewer tests to be run overall, conserving resources and potentially allowing more samples to be evaluated quicker.

2020-07-25 09:55:19
U.S. FDA @US_FDA

We reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization to include two new indications for use: testing for people who do not have #COVID19 symptoms or who have no reason to suspect COVID-19 infection, & to allow pooled sample testing. fda.gov/news-events/pr…

2020-07-28 07:42:16
Evaluate Japan @EvaluateJP

FDAはQuest社のRNAテスト(The Quest Sars-CoV-2 rRT-PCR)の緊急使用許可を再発行し、最大4人のプールされたサンプルを検査が可能に。多検体の迅速なテストが可能にはなるが、プールサンプルで陽性だった場合は、個別再検査が必要となる。 evaluate.com/vantage/articl… #エバリュエート #Evaluate

2020-07-25 14:21:48
LabCorp @LabCorp

LabCorp received an EUA from the @US_FDA to conduct pooled testing of individuals for #COVID19. Pooled testing will allow several samples to be analyzed at once, improving efficiency and increasing overall testing capacity. Learn more: bit.ly/2WVkyOG pic.twitter.com/DrJNQWY9RO

2020-07-25 23:33:11
拡大
Medical Xpress @physorg_health

Pooling strategy in the wake of the COVID-19 pandemic: A solution for mass #population #screening of SARS-CoV-2 medicalxpress.com/news/2020-07-p…

2020-07-31 04:19:21
The Wall Street Journal @WSJ

Ramping up Covid-19 surveillance in the U.S. could mean labs and companies turn to an old technique called pooled testing. @Brabbott42 explains. #WSJWhatsNow on.wsj.com/2EpS3SA pic.twitter.com/EM7MQQ1JEN

2020-07-30 04:30:00
U.S. Surgeon General @Surgeon_General

#DYK: Pooled testing is a strategy that can be used to test multiple people for #COVID19 with a single test, which can help conserve testing materials. Watch to see how pooled testing works. bit.ly/39oepQ1 pic.twitter.com/lxlKi79Nru

2020-07-31 00:17:49
kurimushi @kurimushi3

FDAが承認 ・Covid19の症状のない人、感染の疑う理由のない人へのへの検査 ・5検体までの混合検体を用いた検査 twitter.com/tyonarock/stat…

2020-07-30 20:19:40
Mugen UJIIE (氏家 無限) @carpe_diem0820

米国FDAは、LabCorp COVID-19 RT-PCR検査の緊急使用を追加承認 COVID-19 の無症状者や感染が疑われない人での検査と検体のプールテストが可能に FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection fda.gov/news-events/pr…

2020-07-28 08:05:38
mm @tyonarock

アメリカFDA 15万人国民が死んだところで、無症状で感染を疑う理由のない、スクリーニング目的のPCR検査を許可 fda.gov/news-events/pr…

2020-07-30 17:25:59
mm @tyonarock

つまり、事前確率の低いところでのPCR検査をFDAも認めたてこと。 検査抑制派の最後の最後の砦が崩れた感じ? twitter.com/tyonarock/stat…

2020-07-30 17:31:21
ASB @ABSSBAABS

@tyonarock これは集団プールサンプルです。前から重篤な症状なくても受けれましたよ

2020-07-30 18:16:33
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コメント

にゃあ @kirikami 2020年7月31日
まとめを更新しました。
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にゃあ @kirikami 2020年7月31日
まとめを更新しました。
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