Dedication & perseverance in t ry ing t imes In early April 2020, the Sandy Springs, Georgia, laboratory Ipsum Diagnostics announced it had developed its own coronavirus testing protocol and would have the capacity to process thousands of samples per day. When Ipsum started its FDA application, the sole approved protocol was for a system that could process fewer than 100 specimens at a time. Leah Roberts ’08 had been working as a molecular diagnostic supervisor at Ipsum for about a year. “When Governor Kemp announced that Ipsum Diagnostics was going to partner with the Georgia Department of Public Health and provide testing for the state, we were a staff of fifteen and had been processing between 60-100 samples a day. We immediately started receiving around 400 samples daily - more than we had previously processed in a week.”
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Leah was immediately thrust into the position of molecular diagnostics manager and led her team to develop, validate, and receive emergency use authorization and FDA clearance for performing COVID-19 testing. Her normal day-to-day tasks such as monitoring personnel, inventory, and testing quality grew on an exponential scale. Leah’s new position required validating all the new instrumentation and equipment needed to increase testing and working with the laboratory information system to develop not only paperless requisition forms to mitigate the potential of cross-contamination, but also a new barcode labeling system. The work environment went from a low volume reference lab to one of the most robust COVID-19 testing laboratories in Georgia. Labs across the country that use the same equipment began using Ipsum’s protocols to start their own processing.
of the staff and owners at Ipsum to ensure that Georgia’s population received quality COVID-19 tests within 24 hours.
Molecular biologists from independent labs in underserved areas were invited to Ipsum for on-site training and were provided the resources and supplies needed to validate and implement testing. This enabled rural communities to quickly expand testing capacity. Leah said that having worked alongside the laboratory staff and the executive team, she was most impressed with the dedication and commitment
“I’m so proud of the fact that the company executives trusted and believed in me and gave me the opportunity to use my knowledge and skills to develop a COVID-19 laboratory developed test. As a result, Ipsum was the first lab in Georgia and the twelfth in the country to receive FDA emergency use authorization
