April 30, 2020


The IVQAC team has played an integral role in Duke’s response to the coronavirus disease 2019 (COVID-19) pandemic caused by SARS-CoV-2. Certified as a clinical site in March, the IVQAC, led by Tom Denny, has tested thousands of samples for the Duke University Hospital (DUHS). To further understand the viral pathogen, the team is working to develop specific SARS-CoV-2 assays for ongoing studies at Duke.

The IVQAC’s extensive background in viral PCR and antibody testing and infrastructure for assay development has prepared the team to pivot quickly and adapt these assays to the coronavirus testing.

Already experts in viral testing and the Abbott m2000 – the instrument being used for COVID-19 viral load analysis – the IVQAC team began testing samples from Duke Hospital once assay validation and safety training was complete. In collaboration with DUHS Pathology, team members, Heidi Register, Sal Scianna, Julia Roberson, Chelsea Register, Jennifer Echeverria and Raul Louzao have processed and tested roughly 5,300 samples and will continue to do so for the foreseeable future.

Whereas, the current assays available determine if a patient is SARS-CoV-2 positive or negative, the IVQAC team is developing an assay that will provide quantitative viral load results to determine the amount of virus present in a sample. These efforts, led by Todd Demarco, will enable the team to identify any correlations between virus levels and severity of the disease in patients.

Viral load testing has not been the only focus of the Denny lab. The team’s experience in antibody testing for HIV related studies enabled them to quickly produce a SARS-CoV-2 specific antibody assay that will be used in multiple Duke studies.

Since March, Sarah Keinonen, Syl Hood, Chelsea Register, Nicole De Naeyer, Marleny Campuzano, William Tyson and Carmela Archual have been processing samples for antibody testing for the Molecular and Epidemiological Study of Suspected Infection (MESSI) and more recently, the Duke funded, Seroprevalence Study of Emergency Department Patients.

Led by Dr. Chris Woods, the MESSI study was designed to collect samples from community members who have been exposed, but show no symptoms and test negative against the coronavirus. Should these participants test positive, the antibody specific assay will allow Dr. Woods’s team to study the antibody response from the time the participant was exposed to the time they are confirmed positive and throughout recovery. This study will allow the entire immune response timeline to be examined and establish the length of time participants are still infectious after recovery.

Using the same specific SARS-CoV-2 antibody assay, the IVQAC team members Heidi Register, Nicole De Naeyer, Carmela Archual and Raul Louzao will examine the seroprevalence of SARS-CoV-2 by testing over 700 recently obtained samples from Duke Emergency Department patients. As the first seroprevalence study in the area, it will give researchers an idea of how many people in the community have been exposed to the virus. As the infection rates rise, Duke hopes to repeat this testing 2-3 times over the next year.

The IVQAC has done an extraordinary job in managing these new responsibilities while keeping their pre-COVID-19 responsibilities up to date. Sarah Keinonen has done an excellent job managing staff schedules, ensuring someone is always present to receive and process samples seven days a week; most days team members work until 11pm processing samples for PCR and antibody testing.

Going forward, the IVQAC team will be developing assay standardization panels for laboratories around the country. The panels will be used in clinical trials, laboratory testing and vaccine productions.

The IVQAC has done a tremendous job managing the urgency and needs of our patients, healthcare workers, researchers and community at large. The DHVI recognizes the incredible team work in managing these new responsibilities. We couldn’t be more proud or thankful of the determination behind those efforts