As the COVID-19 pandemic continues to spread, processing tests quickly has become a hurdle for many municipalities, leading to backlogs. In order to efficiently process incoming tests, some states have partnered with private labs. We spoke with members of one forensic lab that is now assisting with COVID-19 testing to see what steps they took.
GeneTrait Laboratories, a subsidiary of PTC Laboratories, has changed their operations to begin processing COVID-19 tests. We spoke with Kim Gorman, president of PTC Laboratories, to learn more about what was involved in this decision, the equipment necessary for testing, and additional requirements.
What factors led you to make the decision to process SARS-CoV-2 (Coronavirus) tests?
We were asked by the University of Missouri Columbia if we would be interested in partnering with them to process COVID-19 samples. We had already considered the possibility and decided that with the support of the University, it would be possible to go online as a high-throughput facility.
What changes did you need to make in your laboratory to be able to process the SARS-CoV-2 tests? What are the instrumentation and equipment requirements for processing these tests?
We were already a BSL2 (Biosafety Level 2) CAP (College of American Pathologists) accredited facility. The only thing that we were missing was an adequate biosafety cabinet. We had to obtain the new cabinet/hood in order to work with the samples. Beyond the biosafety cabinet, it is necessary to have a real-time PCR instrument and some method for DNA/RNA extraction.
How long did it take to prepare your lab for processing these tests? Was there any required certification? Did you collaborate with any other agencies as you were preparing?
It is necessary to be at least a clinical BSL2 CLIA (Clinical Laboratory Improvement Amendments certified) or CAP facility. I don’t know if forensic laboratories can put this online without at a minimum a High Complexity CLIA compliance certificate. The COVID 19 test is a clinical test. It took less than 2 weeks to go online with this test, but we already had all of the licenses and the instruments.
Did you receive any guidance from officials on how best to process these tests? Are there resources available for other labs considering doing the same?
The WHO, CDC and the FDA have guidelines for testing and validation.
Are you still processing forensic samples as well in your laboratory at this time? If so, are there any challenges to processing both concurrently?
We are not currently processing forensic cases. As things slow, we may start processing forensic samples again. We are still processing paternity cases.
Do you have any words of advice for other labs that may be switching their operations over to processing tests?
Make sure that you will be able to meet the minimum safety and licensing requirements. If your laboratory completes the validation but does not have the necessary clinical licenses, I am not sure if the FDA will grant the Emergency Use Authorization (EUA) necessary to begin testing.
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