Brainstorming on “How to expedite testing for the virus causing COVID-19”

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Brainstorming on “How to expedite testing for the virus causing COVID-19”

As Chair of the SCV EMBS chapter I apologize for the late notice for this meeting regarding COVID-19 testing.   The policies on COVID-19 testing that have been handed down by our national, state and county leaders have been changing frequently, and this has required that I modify the plan for the EMBS Chapter activity I am proposing in this meeting.   This will become clearer as we proceed.
To register for the meeting click on the link below or copy and paste it into the address bar of your browser.

You are invited to a Zoom meeting.
When: May 21, 2020 07:00 PM Pacific Time (US and Canada)

Register in advance for this meeting:

https://us02web.zoom.us/meeting/register/tZYsde6vrzotHdEOdJMLIEkO6402e5VEdjWQ

After registering, you will receive a confirmation email from YP SCV containing information about joining the meeting.  We are borrowing the Zoom account from YP SCV, but it will actually be for an EMBS SCV chapter Zoom meeting.

 
Agenda:
7:00pm – 7:10pm: Welcome to attendees joining; test mic and announce your first name
7:10pm – 7:20pm: Introduction and background on COVID-19 illness and testing for SARS-CoV-2 virus
7:20pm – 7:55pm: Survey of clinical labs with questions that may reveal obstacles or hinderances to testing [Review and discuss changing; also see related zip code list & sample lab list]
7:55pm – 8:30pm: Survey of manufacturers of SARS-CoV-2 detection test kits that may reveal obstacles or hinderances to producing these test kits [Review and discuss changing]
8:30pm – Close of virtual meeting
Please see attached documents to be discussed in the meeting
Introduction:
The moderator will be me, Lee Carmack, Chair of the SCV-EMBS chapter.  Our chapter Treasurer, Joseph Wei, will host the meeting, and I will be co-host so I can screen-share some Power Point slides.  These slides will relate to comments from highly competent national leaders in healthcare who are guiding America’s response to the COVID-19 pandemic.  These experts have been insisting that we need to do more testing to detect the virus causing COVID-19 and we need more test kits for doing the tests.  We are conducting this online brainstorming session to develop a plan to reveal the causes of the shortage of clinical laboratory test kits developed to detect the SARS-CoV-2 virus causing the COVID-19 illness.  Online information from the FDA reveals an increasing number of FDA-approved manufacturers of the virus detection kits.  One manufacturer I spoke to said that there was no overwhelming domestic demand for the test kits at clinical labs.  This begs the question: why are our national leaders in healthcare saying there is a lack of sufficient testing to track changes in the COVID-19 pandemic?  News reports indicate long lines of people in their cars line up when drive-thru testing is offered to the public.  There may be some supply chain interruptions or other obstacles hindering delivery or utilization of many of the SARS-CoV-2 test kits.  This inspired the interest in a plan to survey clinical labs that do the testing and the manufacturers of test kits to learn what is really causing the shortage of test kits or hindering the rate of testing for the SARS-CoV-2 virus.

To keep the project manageable we will limit the scope of our surveys of clinical labs to Santa Clara County with the expectation that our findings may reflect what is occurring in many other parts of our state and our country.  I have also prepared a thumbnail sketch of a plan that initially requires only that we make telephone inquiries of approved clinical labs in Santa Clara County and test kit manufacturers based in the US.  If we ask the right questions we may learn more about the true cause of the shortage of SARS-CoV-2 virus detection kits.  The certified clinical labs allowed to do the SARS-CoV-2 testing are identified as “CLIA certified labs that meet requirements to perform high complexity tests.”  If we ask the right questions and receive enough answers from enough clinical labs and test kit manufacturers, we may be able to uncover the cause of this shortage of virus detection tests.

Thumbnail sketch of the proposed project to survey clinical labs and kit manufacturers:

Learn whether the shortage of SARS-CoV-2 virus detection kits extends to clinical labs in Santa Clara County.

1) Phone Survey of Clinical Labs

Find at least three clinical labs in 3 different regions of Santa Clara County that are CLIA-certified to perform high complexity testing, including the SARS-CoV-2 virus detection tests.  See the following website to search for CLIA certified labs that meet requirements to perform high complexity tests:

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Laboratory_Demographic_Information

Note: This website above provides a search tool that works well if you provide a zip code for your searches.  I used the following  “Free Zip-Code Finder”:

https://www.zip-codes.com/county/ca-santa-clara.asp

When you call introduce yourself, say you represent the local EMBS chapter who is doing a survey to learn if there is a shortage of SARS-CoV-2 virus detection test kits in the Santa Clara County area.  Then ask to speak to a lab manager or supervisor.  Then introduce yourself to the manager/supervisor and ask about the reported shortage of test kits and testing.

[I have prepared some questions to start the conversation at the EMBS chapter meeting. If you have some ideas for questions to ask about the shortage of test kits or testing, please bring them to the meeting.  If you have ideas on a different way to expedite the SARS-CoV-2 testing, please bring this up at the meeting.]
 
2) Phone Survey of companies authorized to manufacture and sell SARS-CoV-2 virus detection kits with FDA Emergency Use Authorization (EUA).

Contact companies in the U.S. that are authorized to manufacture and sell SARS-CoV-2 virus detection kits with FDA Emergency Use Authorization (EUA).  Since there aren’t many of these companies in California this survey will extend across the U.S.  The link below provides addresses for manufacturers but not phone numbers.  Follow with a search of the company websites to get phone numbers.  For the first step click on the following link to get a list of companies with EUAs:

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd

This link takes you to a table of test kit manufacturers.  Choose a company listed in the second column and click on the link in the third column to get the company address.  If it is a U.S. based company, search the company website to get the phone number to call.  When you call introduce yourself, and say you represent the local EMBS chapter who is doing an informal survey to learn if there is a shortage of SARS-CoV-2 virus detection test kits.  Then ask to speak to a production manager or supervisor of the facility.  Then introduce yourself to the manager/supervisor and ask about the reported shortage of test kits and testing.

[I have prepared some questions to start the conversation at the EMBS chapter meeting.  If you have some ideas for questions to ask about the shortage of test kits or testing, please bring them to the meeting.]
Event Information

Event Topic:
Brainstorming on “How to expedite testing for the virus causing COVID-19”

Event Description:

Date/Time:
Date(s) - 05/21/20
7:00 pm - 8:30 pm

Event Location:
Other: Webinar- requires registration

Event Details

Event Type