COVID-19 Testing for the Physician Office Laboratory (POL)

POLs can quickly join the COVID fight by leveraging a LIMS solution specially designed for rapid deployment and high throughput.

Published by LabLynx, Inc.

For information and help in ramping up to provide COVID-19 testing services, contact LabLynx, Inc., [email protected], or call 866-522-5969.

Do I really want to get involved in testing for SARS-CoV-2? Why?

Like it or not, physician or not, the current pandemic is already affecting you in some ways or others. And those physicians on the front line seeing patients cannot avoid being involved. If you have testing equipment of your own, at least you may be able to recoup some of the costs of seeing potential COVID-19 patients, handling specimens and meeting reporting requirements.

Moreover, the FDA is fast-tracking provisional approval of new test kits and protocols so that there are more and more options. You can choose the equipment and methodology that suits you best, and either use what you have or purchase. Abbott’s new 5-13 minute test kit is one recent example, offering simple-to-use, quick and relatively inexpensive results.

However, if you don’t already have appropriate testing equipment it will be a couple of months or more before you are able to get one of the new kits, according to a source at the CDC. “The fact is that they are being prioritized to states with the highest numbers of cases,” the source added. At the moment, that includes, in diminishing order, New York, New Jersey, California, Michigan, Massachusetts, Florida, Washington and Illinois. Most should not expect availability for another 1-3 months.

The source went on to say, “The game changer will be lateral flow assays, which are POC [Point-of-Care] and don’t need highly trained staff to operate. These will be what physician’s offices and clinics can use to very quickly test for COVID-19. You lose a little in accuracy – say, from about 98% down to about 90% – but they will still be very useful in initially screening large numbers of patients.”

Once these hit the market – in about one or two months – the ability to test will begin to meet demand, and shift from the CDC, reference labs and state public health departments to local private practices, clinics and hospitals, according to the source.

With the current predicted curve of increasing cases, it’s clear that the answer to “why should I test” becomes “when and how should I test,” as we become inundated with patients for whom testing is indicated.

What are my costs/benefits?

The benefits of testing for COVID-19 in-house are clear: faster turnaround of an almost overwhelming throughput of patients. That means the ability to handle more business and, ultimately, save lives.

Costs are a little more difficult to quantify at this point. Of course if you already have sufficient equipment and staff to operate it, it’s simply a matter of adopting the method(s) you find most appropriate. That also means you are probably a lab. For the vast majority of CLIA-waived entities and physician practices, you’ll need to decide if you want to extend your existing laboratory capabilities to what basically amounts to a small reference lab. Otherwise, your best bet is to send your samples out and await the availability of lateral flow assay kits, which should be similar in price to ones with which you may already be familiar, like those for pregnancy, flu and strep.

What must I do to prepare?

The best things you can do to prepare for SARS-CoV-2 testing (when POL-appropriate instruments/kits are available) are:

1. Locate and follow national, state and WHO guidance for handling patients and samples, including acquiring and using PPE. Some resources include:

• FDA Policy Guide:
  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health-emergency
• Laboratory testing for coronavirus disease (COVID-19) in suspected human cases: Interim Guidance, 19 March 2020
  http://www.cidrap.umn.edu/covid-19/lab-guidance-diagnostics
• CIDRAP COVID-19 Lab Guidance & Diagnostics
  http://www.cidrap.umn.edu/covid-19/lab-guidance-diagnostics
• CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)
  https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html
• UK Public Health COVID-19: safe handling and processing for samples in laboratories
  https://www.gov.uk/government/publications/wuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories/wuhan-novel-coronavirus-handling-and-processing-of-laboratory-specimens
• Check your State and County sites for guidance
• Keep abreast of progress in the release of SARS-CoV-2 lateral flow assay kits. Good sources are LinkedIn.com and LIMSforum.com, as well as the FDA EUA (Emergency Use Authorizations) site
  https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov

What is involved in testing for SARS-CoV-2?

Right now, as we have discussed, it involves molecular diagnostics. Even the very latest quick and simple solutions are still MolDx, and thus while much simpler than most NGS PCR-based methods, still probably stretching the POL budget – and in any case unavailable for awhile unless you are in New York or one or two other highly affected states. So the POC process is to take swabs, send them off and report to both the patient and the state in accordance with the handling and reporting guidelines.

In the next couple of months, you should be able to take on the POC testing yourself, improving TAT and thus increasing your capacity for seeing patients.

How can I get started/find out more?

For information and help in ramping up to provide COVID-19 testing services, contact LabLynx, Inc., [email protected], or call 866-522-5969.

References

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

https://www.alere.com/en/home/product-details/id-now-covid-19.html?sf232069945=1

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

https://www.statista.com/statistics/1102807/coronavirus-covid19-cases-number-us-americans-by-state/

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health-emergency