COVID-19 testing

[Med Director New England]

Is anyone aware of specific labs other than CDC labs testing for COVID-19?

I saw the CDC press release over the weekend mentioning that some labs (no specifics) are now being allowed to test. Also some of the west coast cases initially reported positive cases pending CDC conformation. Anyone on the west coast know who is testing out there?

I know for sure none of the big labs capable of testing (hospital / academic or commercial) in and around Boston are testing as of today.

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[Napoleon1801]

Viracor is supposedly going to have one up and running within the next 2-3 weeks according some targeted advertising.

Mildly related - S. Korea has drive through testing:

 

[gbwillner]

University of Washington in seattle is definitely testing.

 

[deleted642280]

Columbia and Cornell are both testing as well

 

[Med Director New England]

Testing is becoming widespread now.

Anyone with Roche Cobas analyzer can validate and test for Covid.

 

[ClinPathDO]

Testing is becoming widespread now.

Anyone with Roche Cobas analyzer can validate and test for Covid.

AMP listserv said the Roche kits are only available to CDC affiliated labs for now. TriCore (UNM reference lab) has an LDT up and running as well.

 

[KeratinPearls]

CMS has issued a number of blanket waivers in response to the COVID-19 Public Health Emergency. Learn more about what is specifically covered in the bulletin below:

https://www.cms.gov/files/document/se20011.pdf

 

[Med Director New England]

AMP listserv said the Roche kits are only available to CDC affiliated labs for now. TriCore (UNM reference lab) has an LDT up and running as well.

Hopkins running now, Quest and Labcorp too. I know there are others. The validation under the EUA with cobas is straightforward.

The CDC won’t deny any lab with the cobas (any lab with the instrument would also have the expertise) who wants to validate. There are probably 100 cobas instruments around the country. In a few days 20K tests a day In the us will be happening

 

[ClinPathDO]

Hopkins running now, Quest and Labcorp too. I know there are others. The validation under the EUA with cobas is straightforward.

The CDC won’t deny any lab with the cobas (any lab with the instrument would also have the expertise) who wants to validate. There are probably 100 cobas instruments around the country. In a few days 20K tests a day In the us will be happening

The posting just said only CDC and the federal government has selected a few sites to approve and receive the SARS-COV-2 test, due to limited supplies and global demand their is no plan to expand past that. CDC might not but Roche is only supplying certain labs currently. Maybe in the future it will expand. Hopefully at least.

 

[ClinPathDO]

it looks like 400,000 tests are going out this week and next week. At 30 locations.

Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US to begin patient testing under FDA Emergency Use Authorization

Roche announced today that it has begun shipping the first allotment of its cobas^® SARS-CoV-2 Test for COVID-19 (coronavirus) to a network of hospital and reference laboratories across the U.S. to enable automated, high-volume patient testing.

diagnostics.roche.com

Roche Receives FDA Emergency Approval To Ship 400,000 Coronavirus Test Kits Across US

Roche Holding AG (OTC: RHHBY) is shipping COVID-19 test kits approved under emergency use authorization (EUA) by the FDA.What Happened Roche's Sars-CoV-2 Test for COVID-19 has begun shipping to hospitals and laboratories across the U.S. The test will enable high-volume, automated patient...

finance.yahoo.com

 

[Med Director New England]

The posting just said only CDC and the federal government has selected a few sites to approve and receive the SARS-COV-2 test, due to limited supplies and global demand their is no plan to expand past that. CDC might not but Roche is only supplying certain labs currently. Maybe in the future it will expand. Hopefully at least.

Trust me bro - middle of next week Around 20 k / tests per day will be run in the US.

Most labs That are now running the modified cdc method will switch over to roche in the next week. Higher thru put and better for large scale testing b/c you can send the specimen at room temperature instead of on ice.

 

[ClinPathDO]

Trust me bro - middle of next week Around 20 k / tests per day will be run in the US.

Most labs That are now running the modified cdc method will switch over to roche in the next week. Higher thru put and better for large scale testing b/c you can send the specimen at room temperature instead of on ice.

hopefully that would be great.

 

[Med Director New England]

hopefully that would be great.

I am certain about this.
The most limiting factor is the instrument capacity. The swabs, media, primers can all be made faster than can be consumed by every roche cobas In the country running 24/7.

 

[ClinPathDO]

Genmark and cepheid are rolling out testing as well.

GenMark Diagnostics Announces Submission of Emergency Use Authorization for its ePlex® SARS-CoV-2 Test | GenMark

CARLSBAD, Calif., March 11, 2020 (GLOBE NEWSWIRE) — GenMark Diagnostics, Inc. (GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today announced submission for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its ePlex...

genmarkdx.com

Could mPOC come to the rescue in COVID-19 outbreak?

What IVD technology to use? Lab-based molecular IVD tests are in development, but they can't always be where the need is. Immunoassays take long periods to develop and, generally speaking, may not be sensitive enough for a "must-know" identification task of disease.

www.labpulse.com