COVID-19 Testing

Kelly additionally there is the A1C test from PTS diagnostics available as a POC test which is simple and easy doesn't require an instrument can be done in conjunction with a Cov-19 test

Hello

Currently there is only one FDA EUA serology test cellexcovid.com has an IgG & IgM test for moderate or high complexity settings.  You can go the website and look at the data, PPV & NPP, etc.  The company received their approval 6 days ago.  There are a great deal of kits out there but it's buyer beware...some have "research only" attached to the products and I think some are outright scams.

My suggestion is to hop on the CDC/FDA Laboratory Update on Monday afternoons.  You get all the updates directly from the powers that be ;)  It is geared directly for laboratories. 

Clinical Laboratory COVID-19 Response Weekly Calls

https://www.cdc.gov/safelabs/resources-tools/covid-19-weekly-clinical-calls.html/LOCS0406

Hope this helps & stay safe

Thank You

1) Cellex would be nice to have.  The studies were done by Mayo Labs.   

2) Another serological kit that determines IGG or IGM was approved by FDA under EUA called SD Biosensor by Biomedomics.  It is high complexity sold by Henry Schein.  They start shipping this week. 

3) Chembio Launches their DPP Covid 10 serological POC test  on April 8, 2020, but will have to be run in their MicroReader.

Interesting that 130 laboratories  are working on COVID Testing diagnostic, PCR, molecular, or other methods.  25  have been approved by FDA for EUA; 6  more are in the process of being applying for FDA approval; 3 are approved for Diagnostic ( serological kits).

Hope you all are well and Safe!

HEROES.docx

Pet,

Which 3 serological kits are approved for diagnostic use?  Thank you in advance!

Pet, you are awesome!

Pet,

I just looked at the approved EUA list and do not see the SD Biosensor by Biomedomics as I would like to look at the letter.  Our Henry Schein rep had told my co-worker the test would not take us up to moderate complexity.

When I was first tasked with looking at possible tests kits, I know that SD Biosensor stated that they didn't need an EAU since it is a serological test and not diagnostic as a both a positive and negative would potentially need confirmation.

Can you provide information that it is high complexity, just so that I have back up when I try to explain it to my team.

the following was posted on the AACC Artery this morning:

The U.S. Food and Drug Administration (FDA) recently clarified that, when it grants an Emergency Use Authorization (EUA) for a point-of-care test, that test is deemed to be CLIA-waived. For the duration of the national emergency declaration for COVID-19, such tests can be performed in any patient care setting that operates under a CLIA Certificate of Waiver or Certificate of Compliance/Certificate of Accreditation.

In addition, FDA clarified that tests for SARS-CoV-2 that are offered prior to or without an EUA have not been reviewed by FDA, are not FDA authorized, and have not received a CLIA categorization. Thus, those tests are considered high complexity by default until they receive an EUA or other FDA approval that indicates they may be performed as moderate complexity or waived tests.

For more information, visit this FDA Web page, navigate to the section titled "General FAQs," and view the first two questions and their corresponding answers.

Thank you Marcia!

Hello Heather,
I hope this email finds you well.
I wanted to chime in and clarify some recent posts on the Covid-19 Rapid Serology Antibody kits that Henry Schein is promoting. There are two brands, SD BioSensor and BioMedomics. Both are manufacturers that are bringing their product to the US market.

When we originally launched the SD Covid-19 Serology Antibody kits, they fell under FDA’s policy dated 3/16/20 for use to address the Covid-19 outbreak without the EUA. Note, that the manufacturer, SD BioSensor, has performed a validation on their kits. Below is a link to this policy. SD Biosensor has been transparent to the FDA and notified them early on that they intended to enter the US market under this policy. Now there are updates since then.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help

As of the end of last week 4/3, the FDA updated their policy regarding Serology Antibody test kits, stating language that would give the interpretation of the kits falling under High Complexity. Currently, SD BioSensor and BioMedomics are both in the process of obtain the EUA approval. Once approved, again this would allow these kits to be used in any medical setting and administered by clinical personnel under CLIA-Waiver. Please see the latest FDA posting from 4/7.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-tests

Currently, Henry Schein is abiding by these new rules and is educating our current customer base so that they understand what’s going on in the market regarding all brands of Serology Rapid Antibody test kits.

As of today, we have plenty of SD BioSensor Antibody kits in our warehouse and are only shipping to highly complex labs, per the latest update. Again, this manufacturer has already submitted all the paperwork to obtain their EUA approval.
Also, our inventory on the BioMedomics has not arrived yet, but they too have applied for their EUA.

Thank you for your time and stay well.
If you can pass this info along, we would greatly appreciate it.
Respectfully,
T2
[HS_LabTeam_wtag]

Troya Thomas
POCT LAB Specialist
FLORIDA & S. GA
321.917.6557: Mobile
1321.248.0488: Fax
800.428.9200: Lab Customer Service
troya.thomas@henryschein.com

LAB CATALOG LINK: https://www.nxtbook.com/nxtbooks/henryschein/pol_2019/

Thanks Marcia. I bet you are keeping up with CDC conference calls, etc. (I am not).

My guestion is 'did it change that NP swabs for COVID and using viral media was the best choice?' for highest sensitivity?

AACC Artery had one article posted that indicated (a very small sampling though) that NPs were the way to go for sensitivity.

But other info may have come out as far as using nasal-oral (in methods where that had been validated, and example the ID Now where package insert says all 3 can be used for COVID testing) which definitely would help in the limited NP swab/media challenge.

Thanks in advance!

Hello Troya,

Thank you so much for the information, and I will be happy to pass it along.  I hope that you are staying well too!

Hi Peggy-

Yes, lots of different sample types are allowed, but NP swab with viral transport media gives the best sensitivity.

That being said, if the choice is somewhat reduced sensitivity or no testing since the VTM and NP swabs are scarce, I would say the decreased sensitivity needs to be understood, but testing should be done.

My opinion only. 

Is anyone using an inhouse developed IGM/IGG test? Or is anyone performing any IGM/IGG testing at all for COVID-19? If so what manufacturer are you using.

We are trying to figure out what serology methods other hospitals in the country are using.