Evidence map›Paper›PMID 39939958›Full record

ArticleBMC bioinformatics2025

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

Diane M Walker, Wendy A Smith, Lia Gale, Jacob T Wolff, Connor P Healy, Hannah F Van Hollebeke, Ashlie Stephenson, Marianne Kim

Abstract read
In one paragraph

Article in BMC bioinformatics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Diane M Walker *BioFire Defense, LLC, 79 West 4500 South, Suite 14, Salt Lake City, Utah, 84107, USA.
Wendy A Smith *BioFire Defense, LLC, 79 West 4500 South, Suite 14, Salt Lake City, Utah, 84107, USA.
Lia GaleBioFire Defense, LLC, 79 West 4500 South, Suite 14, Salt Lake City, Utah, 84107, USA.
Jacob T WolffBioFire Defense, LLC, 79 West 4500 South, Suite 14, Salt Lake City, Utah, 84107, USA.
Connor P HealyBioFire Defense, LLC, 79 West 4500 South, Suite 14, Salt Lake City, Utah, 84107, USA.
Hannah F Van HollebekeBioFire Defense, LLC, 79 West 4500 South, Suite 14, Salt Lake City, Utah, 84107, USA.
Ashlie StephensonBioFire Defense, LLC, 79 West 4500 South, Suite 14, Salt Lake City, Utah, 84107, USA.
Marianne KimBioFire Defense, LLC, 79 West 4500 South, Suite 14, Salt Lake City, Utah, 84107, USA. Marianne.Kim@biofiredefense.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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 such as GISAID, during the pandemic, impeded progress in meeting these post market requirements. In response, BioFire Defense developed a new bioinformatic tool to overcome scalability problems and the loss of accuracy encountered with the standard inclusivity method.

resultsThe Coronavirus Monitoring for Inclusivity Tool (CoMIT) uses the Variant Sorter Algorithm to sidestep multiple sequence alignments, a significant barrier inherent in the standard inclusivity method. The implementation of CoMIT and its Variant Sorter Algorithm are described. Automated summary tables and visualizations from a typical inclusivity evaluation are presented. We report our approach to filter and display relevant information in the pipeline outputs using risk factors tied to test performance.

conclusionsBioFire Defense has developed CoMIT, an automated bioinformatic pipeline for efficient processing and reporting of variant inclusivity from the GISAID EpiCoV™ repository. This tool ensures continuous and comprehensive post market evaluations of BioFire COVID-19 Test performance even from datasets large enough to impede standard inclusivity analyses. CoMIT's low computational space complexity and modular code allow this tool to be generalized for inclusivity monitoring of multianalyte or single analyte tests with complex assay designs and/or highly variable targets. CoMIT's databasing capabilities and metadata handling hold the potential for new investigations to improve readiness for future outbreaks.

Indexed as

Computational BiologyCOVID-19COVID-19 Nucleic Acid TestingCOVID-19 TestingSARS-CoV-2SoftwareHumansPandemicsBioFire FilmArray SystemBioinformatics toolCOVID-19DetectionGenomic variantsGISAID EpiCoV™In silico inclusivityIn vitro diagnostic devicePCRSARS-CoV-2.

Identifiers

PMID39939958
PMCPMC11817761

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.