A table comparing the turnaround times (test time), methodologies, analytical sensitivity, and positive predictive values (separated by influenza A and B subtypes) of 6 different randomly selected test methods selected from the CDC’s “Available FDA-Cleared Rapid Influenza Diagnostic Tests”22 and “FDA-cleared Nucleic Acid Detection Based Tests for Influenza Viruses”24 tables found on the CDC website. Sensitivity and positive predictive values for each test were calculated individually using package insert clinical study data of each methodology.26-31
Sensitivity | Positive Predictive Value | ||||||
|---|---|---|---|---|---|---|---|
| Platform and/or Instrument | Influenza Virus Types Detected | Test Time | Methodology | A | B | A | B |
| GeneXpert Xpress | Influenza A and B | approximately 30 min or less | nucleic acid detection | 97.50% | 93.80% | 100.00% | 96.80% |
| FilmArray®Film Array® Torch | Influenza A and B | 1-2 hr | nucleic acid detection | 90.00% | 100% | 99.8%* | 100% |
| ABI 7500 Fast Dx | Influenza A and B | 4 hr | nucleic acid detection | 100% | 100% | 100% | 100% |
| Sofia 2 FIA Analyzer | Influenza A and B | 10-15 minutes | Antigen Detection | 97.00% | 90.00% | 74.60% | 84.20% |
| BD Veritor Reader | Influenza A and B | 10-15 minutes | Antigen Detection | 83.60% | 81.30% | 93.60% | 93.30% |
| Alere Reader | Influenza A and B | 10-15 minutes | Antigen Detection | 84.30% | 89.50% | 83.10% | 94.40% |
Note: hr, hour; min, minutes