Using Proficiency Testing to Ensure Accurate SARS-CoV-2 Testing

Julie McDowell:

In the wake of the outbreak of COVID-19, clinical laboratories have shown an unwavering commitment to the patients they serve by ramping up efforts to deploy COVID-19 testing. The CAP is committed to supporting your efforts and is happy to announce CoV-2. A new proficiency testing or PT program for the detection of SARS-CoV-2 by nucleic acid amplification testing. The new PT program's material is non-infectious and targets gene regions N, E, RdRp, ORF1a and s. We're here with Dr. Bobbi Pritt, director of the Clinical Parasitology Laboratory and co-director of Vector-Borne Diseases Laboratory Services at Mayo Clinic. Dr. Pritt is also the chairperson of the CAP'S microbiology committee whose members were instrumental in designing the recently launched PT program for SARS-CoV-2, the novel Coronavirus. Dr. Pritt, please tell us why the CAP is offering this program and how this will benefit the laboratory?

Dr. Bobbi Pritt:

Sure. Well, this material will support quality initiatives for all laboratories and specifically for CAP accredited laboratories. This can meet the laboratory's needs if Covid testing is on the activity menu and the laboratories would need to perform alternative performance assessment. This gives them a commercial option where they can purchase well vetted material rather than trying to come up with their own internal product. And also this material would come in a blinded manner and be tested by their colleagues throughout multiple labs and therefore they could compare their results to what other laboratories are seeing.

Julie McDowell:

And how were you involved in the development of this program?

Dr. Bobbi Pritt:

Well, as the chair of the microbiology committee, I was responsible for working with our subject matter experts to help design what we felt an ideal proficiency testing product would be. And the College of American Pathologists has a rigorous process for designing its proficiency testing programs. We want to make sure that they're effective and that they will address multiple testing platforms. So the group thought it was very important that it include five gene targets that are present in the majority of testing systems currently available. And we're also looking ahead to the future of how we may want to modify this program as more testing platforms become available. So it's really our group of subject matter experts that help design this program and then also help direct how to pilot the material before we roll it out to the general public to make sure it's really working as intended.

Julie McDowell:

Finally, do you have any advice for laboratories who are starting up this type of testing?

Dr. Bobbi Pritt:

Yes. Well, when you begin this type of testing, of course there are numerous tests now that are rapidly becoming available. They all have emergency use authorization. So they're not cleared or approved products by the Food and Drug Administration as we're used to seeing. And therefore, it really does mean the laboratory needs to pay particular attention to quality and they have to perform appropriate validation and verification studies as part of their quality program. They need to perform some type of proficiency testing, ideally with blinded specimens coming in from an external source. And so this project that the CAP is developed can be used for that purpose. And I would refer anyone who's interested to go to the CAP website, there are a lot of resources and information about proficiency testing about COVID-19 and about this product in particular if they are interested.

Julie McDowell:

Thank you, Dr. Pritt. You can order this new program today. The program code is COV2 and the first shipment is scheduled for May 18th, 2020. Visit the COVID-19 page on the CAP'S website for the latest news and resources, including those for proficiency testing customers and CAP accredited laboratory. The COVID-19 page offers useful links to helpful tools and resources to clarify rules of compliance as you implement COVID-19 testing in your laboratory. Thank you for listening to this CAPcast. Be sure to listen to our other cap cast from the CAP on our SoundCloud channel by downloading the SoundCloud app on your mobile device. And we're also on Apple Podcasts and the Stitcher app. To find this podcast, search for the word CAPcast on these apps. Once you find our podcast, be sure to click the subscribe button so you don't miss new CAPcast episodes.

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