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Challenges in the Implementation and Analysis of a SARS-CoV-2 Longitudinal Viral Kinetics Study (305276)
*Jesse A Canchola, Roche Diagnostics
Alison Kuchta, Roche Molecular Systems
Kevin Luk, Roche Molecular Systems
Mansi Singh, Roche Molecular Systems
Keywords: SARS-CoV-2, study implementation, analysis
A novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the agent of coronavirus disease 2019 (COVID-19), has led to a global pandemic with widespread morbidity and mortality since first emerging in China in December 2019. With limited curative therapeutics and slow scale-up of preventative vaccination, timely and accurate diagnostic testing is vital to contain the spread of infection and reduce harmful delays in delivery of care. However, widespread testing shortages due to the enormous global demand have hampered current diagnostic efforts and strengths and weaknesses of available diagnostics are important to consider in clinical applications. It is essential to further understand the performance of different assays throughout the patient journey, including their association with infectivity and severity as well as their ability to be used as a combined marker to understand how to deploy the available assays most effectively. We implement a prospective longitudinal study to examine the viral kinetics of SARS-CoV-2. The logistical and statistical challenges are discussed in this introductory to intermediate presentation.