The Rapid Test FLU A_B, developed by ProGnosis Biotech, has recently undergone evaluation by the French National Agency for the Safety of Medicines and Health Products (ANSM) as part of its official market surveillance of CE-marked influenza rapid diagnostic tests available in France. This independent assessment confirmed the high analytical performance and reliability of the Rapid Test FLU A_B, highlighting its effectiveness in accurately detecting multiple influenza virus strains.
The test’s analytical sensitivity and specificity were rigorously assessed against three critical influenza strains, demonstrating superior performance:
Analytical Sensitivity Comparison (ng/mL)
| Influenza Strain | ProGnosis Biotech – Rapid Test FLU A_B | Range of Other CE-Marked Tests |
| A/H1N1 | 5 – 25 | 5 – 250 |
| A/H3N2 | 2.5 – 10 | 5 – 250 |
| B | 50 – 100 | 50 – 500 |
The results clearly demonstrate the test’s superior sensitivity relative to other CE-marked tests assessed in the study. Notably, the Rapid Test FLU A_B excelled particularly in detecting the A/H1N1 and A/H3N2 influenza strains, delivering significantly enhanced sensitivity.
Additionally, the evaluation affirmed the outstanding analytical specificity of the Rapid Test FLU A_B, including:
- No cross-reaction between influenza A and B strains
- No cross-reactivity with the SARS-CoV-2 Omicron nucleocapsid protein, even at high concentrations (5000 ng/mL)
This independent validation underscores the reliability and accuracy of ProGnosis Biotech’s Rapid Test FLU A_B, emphasizing its value for healthcare settings requiring swift and dependable influenza detection.
ProGnosis Biotech remains dedicated to delivering high-quality, user-friendly diagnostics, consistently aligning with international standards and addressing the global demand for efficient infectious disease testing.
