Comparison of FilmArray and Quantitative Real-Time Reverse Transcriptase PCR for Detection of Zaire Ebolavirus from...

Area of Science:

• Medical Diagnostics
• Virology
• Infectious Diseases

Background:

• Rapid, reliable diagnostic assays for Zaire ebolavirus (ZEBOV) are critical for effective Ebola Virus Disease (EVD) management.
• Existing emergency use authorization (EUA) tests require thorough evaluation for accuracy and agreement.

Purpose of the Study:

• To assess the diagnostic agreement between the BioFire FilmArray panels and Centers for Disease Control and Prevention (CDC) quantitative real-time reverse transcriptase PCR (qRT-PCR) assays for ZEBOV detection.
• To determine the performance of these assays using both contrived and clinical specimens.

Main Methods:

• Comparison of BioFire FilmArray BioThreat (BT) and BT-E panels against NP2 and VP40 qRT-PCR assays.
• Testing of whole blood spiked with inactivated ZEBOV and clinical specimens (whole blood, plasma, urine) from EVD patients.
• Analysis of agreement rates and discordant results between the different assay types.

Main Results:

• 100% agreement observed between FilmArray and qRT-PCR for contrived whole-blood specimens across ZEBOV dilutions.
• Limit of detection for both assay types was determined to be 4 × 10(2) TCID50/ml.
• Agreement rates for clinical specimens ranged from 85% to 90%, with minor discordant results noted.

Conclusions:

• The BioFire FilmArray panels demonstrate effectiveness and reliability as rapid diagnostic tools for ZEBOV detection in EVD evaluation.
• High concordance between FilmArray and CDC qRT-PCR assays supports their utility in clinical settings.
• These findings underscore the value of accessible and user-friendly diagnostic solutions during outbreaks.