We’re sharing our blueprint to help other organizations set up COVID-19 diagnostic testing facilities.
As our first step in responding to the COVID-19 pandemic, we aimed to ramp up novel coronavirus testing in the Bay Area. The IGI assembled a dedicated team that worked around the clock for three weeks to set up a CLIA-certified SARS-CoV-2 testing lab that is now testing patient samples.
We learned a lot in the process, and want to share these lessons. We hope that many other groups will follow suit and set up their own testing labs.
Please read our open access how-to guide, linked below. If you have questions that cannot be answered in our guide, contact firstname.lastname@example.org. We will do our best to respond to inquiries.
Nature Biotechnology paper (June 18, 2020)
Contains content of preprint, plus fully-automated method validation and observations from early testing.
medRxiv preprint (April 24, 2020)
Contains description of regulatory navigation to date and semi-automated method validation. See supplementary files at the end of this page.
IGI pop-up COVID-19 testing lab timeline
Our timeline for establishing the testing lab.
A key factor in our quick success was the in-depth support we have received from Third Wave Analytics, Salesforce, and MuleSoft.
In a matter of weeks, Third Wave Analytics built a robust Laboratory Information Management System (LIMS) on their LockBox platform to manage the technical data flow of clinical samples in and out of the lab. Subsequently and with pro bono support from Salesforce and MuleSoft, Third Wave Analytics also built and implemented a HIPAA-compliant, secure physician portal wrapped around the technical LIMs to accept requisitions and return clinical-grade results to providers working with the facility.
Establishing this system was only possible due to a discounted framework and a herculean effort made by the tireless and unrelenting hours of Third Wave Analytics programmers and support from Salesforce.
In an effort to allow other colleagues to quickly and affordably build off of our efforts, Third Wave Analytics has agreed to release the identical framework of the IGI build for 50% off the licensing fee alone for other UCs ($4500) and a similarly nominal cost for non-UC facilities.
It should be understood that other fees will be required for customization and alterations to the IGI system to fit any variations at individual facilities. For reference, however, the IGI has spent over $100K to build what others can now access for a nominal fee. Integrations with third-party companies that provided services (Salesforce and Mulesoft) are not under the current MOU and may be needed.
Third Wave Analytics: Chris Gawronski (email@example.com)
Salesforce (required for physician portal): Tyson Read (firstname.lastname@example.org)
MuleSoft (Incorporation into EMR systems): Sam Steiny (email@example.com)
Internal UCB reference for questions and introductions: Shana McDevitt (firstname.lastname@example.org)
*Please put “Third Wave MOU” in subject line
Our earlier preprint is freely available on medRxiv. Supplementary files referenced in that preprint are included below. All supporting material for the Nature Biotechnology version are linked directly within that manuscript.
|File Description and Link|
|Hamilton Microlab STARlet Automation Process|
|Kit Preparation and Patient Sample Collection and Transport|
|Personnel Training and Compliance|
|Semi-Manual LIMS Interface|
|Supplementary Figure 1|
|Supplementary Figure 2|
|Supplementary Figure 3|