Last Friday, I sat down with Jason Amsbaugh (Samba Scientific) to discuss the SARS-CoV-2 (COVID-19) pandemic. Here’s a link to the interview: Angie Purvis, PhD on Science Spotlight. In this interview, we discuss four important aspects of laboratory diagnostic testing to consider as your CLIA laboratory initiates COVID-19 testing.
Containment and Safety
One of my primary concerns as a Laboratory Director is the safety of the laboratory testing staff. The laboratory environment must include engineering controls to ensure containment of the SARS-CoV-2 in the primary patient specimen. The laboratory and its equipment must be sanitized and decontaminated routinely over the course of each work day. The laboratory staff must be trained to handle specimens containing highly infectious pathogens and to don personal protective equipment (PPE). The CLIA laboratory must ensure that the laboratory staff has access to PPE at all times.
The Pre-Analytic Phase
The pre-analytic phase includes all of the processes required from the point of specimen collection from the patient through the point where the specimen is received and accepted by the laboratory. In the pre-analytic phase, specimen quality and integrity are paramount. If the specimen quantity is inadequate, for example, the risk of a false negative increases. The pre-analytic phase is so important to the overall quality of diagnostic testing that I have written an entire blog dedicated to this topic (Read my Pre-Analytic blog).
The Analytic Phase
The analytic phase includes all of the processing and analysis steps performed on specimens in your CLIA laboratory. In this interview, I talk about the importance of ensuring that your laboratory has standard operating procedures (SOPs) and has performed validations on all processes prior to initiating diagnostic testing (My Services). Previously, I created a blog discussing some of the often-over-looked critical elements of the analytic phase (Read my Analytic blog). I will have more to say about the analytic phase in future blog posts.
The Post-Analytic Phase & Emergency Use Authorization
The post-analytic phase covers the test result report generation and delivery aspects of diagnostic testing. In the interview, I discussed the importance of turning around high-quality test results quickly due to the risks associated with delayed results. Further, COVID-19 is a nationally reportable infectious disease, be sure your laboratory is in compliance with federal, state, and local reporting requirements. I plan to say more on these topics in future blogs.
Lastly, I touched on the importance of submitting an Emergency Use Authorization (EUA) to the FDA, when necessary and appropriate, based on the specific COVID-19 diagnostic test that your CLIA laboratory plans to perform. Your laboratory team may have questions about the circumstances requiring an EUA for your laboratory or the requirements for the EUA. Feel free to reach out with questions about the EUA requirements and processes or any other aspect of establishing COVID-19 testing in your CLIA laboratory (Contact Me).
Be sure to check out the interview: Angie Purvis, PhD on Science Spotlight
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