An overview of clinical testing
With COVID-19, it is important to identify individuals with no or low antibody titers to the SARS-CoV2 virus, especially in healthcare settings with vulnerable populations. With this in mind, testing within a research-based clinical laboratory allowed us to define “clinical” and provide blood collections and antibody titers to many long-term care facility staff and residents in Flagstaff, Arizona. A review of the CLIA ’88 clinical laws outlined the guidelines that must be followed in order to provide testing and results to patients and their caregivers.
The FDA, CDC and CMS share clinical laboratory governance and oversight. To gain approval, clinical laboratories must adhere to all regulations. TGen North followed each step as outlined to validate and gain approval for its SARS-CoV2 IgG ELISA kit, specimen procurement, testing and result return.
It was determined that a very defined criteria of laboratory personnel, space, equipment use, temperature, reagent kits, pipettes, all the way down to the blood tubes and collection cards were clearly defined and never deviated from in clinical use. This rigidness is the defining line between a certified clinical laboratory and a laboratory established for research use only.
Whereas methodologies are constantly changing to achieve the best possible outcome in research, the methodologies in a clinical laboratory are consistent and constant. These have been tested, validated and defined for the rigid guidelines set forth in clinical settings.
We visited many long-term health care facilities in the Flagstaff area in hopes of offering free IgG antibody testing for staff and residents in order to give this population an idea of their individual protection against the virus responsible for the COVID-19 pandemic.
The challenges presented during this phase occurred mostly over access, given that the COVID-19 pandemic strained many aspects of care and delivery. With the backing of an infectious disease physician, and collaboration with the Coconino County Health Department, we gained access to four long-term care facilities for the collection, testing, results return and data analysis of dried blood spot samples on individuals for antibody testing.