Evaluation of Cepheid Xpert Xpress CoV-2/Flu/RSV plus and the Biofire Spotfire R/ST Panel Mini using CLIA-waived...

Area of Science:

• Clinical diagnostics
• Infectious disease detection
• Respiratory virus identification

Background:

• Point-of-care (PoC) testing is crucial for timely outpatient treatment decisions.
• Multiplex assays offer simultaneous detection of multiple respiratory pathogens.
• Evaluating new diagnostic tools is essential for improving patient care.

Purpose of the Study:

• To assess the analytical and clinical performance of two commercial multiplex tests.
• To compare the Xpert Xpress CoV-2/Flu/RSV plus and Biofire Spotfire R/ST Panel Mini assays.
• To determine the accuracy of these tests for detecting SARS-CoV-2, Influenza A, Influenza B, and RSV.

Main Methods:

• Analytical sensitivity was determined using contrived samples near the limit of detection.
• Clinical performance was evaluated using 1577 nasopharyngeal (NPS) specimens.
• Relative clinical performance was assessed against standard of care (SoC) results.

Main Results:

• Both assays exhibited analytical performance consistent with manufacturer data.
• High overall percent agreement was observed for all tested analytes: SARS-CoV-2 (98.7%), FluA (98.9%), FluB (99.9%), and RSV (98.9%).
• Clinical performance of both tests was found to be similar across all targets.

Conclusions:

• The Xpert Xpress CoV-2/Flu/RSV plus test is highly accurate for respiratory virus detection.
• The Biofire Spotfire R/ST Panel Mini demonstrates high accuracy in identifying common respiratory pathogens.
• Both evaluated multiplex assays are reliable tools for diagnosing respiratory infections in clinical settings.