CoMIT: a bioinformatic pipeline for risk-based prediction of COVID-19 test inclusivity.

ABSTRACT:

Background

The global Coronavirus Disease 2019 (COVID-19) pandemic highlighted the need to quickly diagnose infections to identify and prevent viral spread in the population. In response to the pandemic, BioFire Defense leveraged its PCR-based "lab-in-a-pouch" technology for expedited development of the BioFire® COVID-19 Test, a novel in vitro diagnostic detecting SARS-CoV-2 nucleic acid in human samples. Following clearance of an in vitro diagnostic device, regulatory bodies such as the U.S. Food and Drug Administration (FDA) require regular post market surveillance to monitor test performance against viral lineages circulating in the field, using predictive in silico inclusivity evaluations. Exponential increases in the number of sequences deposited in bioinformatic repositories

SUBMITTER: Walker DM 

PROVIDER: S-EPMC11817761 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature