Walker DM, Smith WA, Kim M, et al.

CoMIT: A Bioinformatic Pipeline for Risk-based Prediction of COVID-19 Test Inclusivity

 Journal (2024); Volume. Doi etc…

Background

Amidst the global COVID-19 pandemic, the urgent need to swiftly identify infections and prevent viral spread has become paramount. In response, BioFire Defense harnessed its PCR-based “lab-in-a-pouch” technology to expedite the development of the BioFire® COVID-19 Test—an innovative in vitro diagnostic capable of detecting SARS-CoV-2 nucleic acid in human samples. Regulatory bodies, including the U.S. Food and Drug Administration (FDA), mandate regular post-market surveillance for authorized or cleared in vitro diagnostic devices. This surveillance involves monitoring viral lineages for mutations using predictive in silico inclusivity assessments. However, the exponential growth of sequence data in repositories like GISAID posed challenges. To address scalability issues and accuracy concerns associated with the standard inclusivity method, BioFire Defense introduced the Coronavirus Monitoring for Inclusivity Tool (CoMIT).

Clinical evaluation of the BioFire Global Fever Panel for the identification of malaria, leptospirosis, chikungunya, and dengue from whole blood: a prospective, multicentre, cross-sectional diagnostic accuracy study. 

Lancet Infect Dis. 2022;S1473-3099(22)00290-0. doi:10.1016/S1473-3099(22)00290-0

Background

Acute febrile illness is a common presentation for patients at hospitals globally. Assays that can diagnose a variety of common pathogens in blood could help to establish a diagnosis for targeted disease management. We aimed to evaluate the performance of the BioFire Global Fever Panel (GF Panel), a multiplex nucleic acid amplification test performed on whole blood specimens run on the BioFire FilmArray System, in the diagnosis of several pathogens that cause acute febrile illness.

Clinical and Industrial Diagnostic

FilmArray: User-friendly multiplex PCR