Kogene PowerChek Multiplex Real-time PCR Kits Versus the BioFire FilmArray Gastrointestinal Panel: Roles of Crossing...

Area of Science:

• Clinical diagnostics
• Molecular microbiology

Background:

• Accurate detection of gastrointestinal pathogens is crucial.
• Molecular diagnostic kits require thorough performance evaluation.

Purpose of the Study:

• To compare the performance of Kogene PowerChek multiplex real-time PCR kits against the FilmArray GI Panel.
• To identify discrepancies and understand the accuracy of each molecular testing platform.

Main Methods:

• 246 residual stool specimens were tested with both FilmArray GI Panel and PowerChek Bacterial/Viral Kits.
• Discrepancies were resolved using additional molecular assays and culture results.
• Analysis included positive-percent agreement (PPA), negative-percent agreement, cycle threshold (Ct)/crossing point (Cp) values, and melting curve analysis.

Main Results:

• FilmArray GI Panel exhibited 100% PPA for all targets, while PowerChek kits ranged from 50-100%.
• Both platforms had >99% negative-percent agreement, with exceptions noted for specific pathogens.
• False positives (FPs) were associated with higher Ct/Cp values, particularly for adenovirus, EPEC, and norovirus.

Conclusions:

• The FilmArray GI Panel demonstrates superior sensitivity in detecting gastrointestinal pathogens compared to PowerChek kits.
• Melting curve analysis is a valuable tool for mitigating false positives, especially for norovirus detection.