A new antigen test device for rapid influenza A and B detection.

Introduction: Tests for detection of influenza must demonstrate high sensitivity and specificity, affordability, and rapidness.

Methods: This study aimed to evaluate the performance of the LabOn-Time™ Influenza A + B Rapid test device (BMT Diagnostics, Ltd), as compared to Real-time polymerase chain reaction (RT-PCR), in identifying influenza A/B among 183 nasopharyngeal samples collected between February and April 2023 from patients with Influenza-like symptoms.

Results: Out of 70 participants with a positive RT-PCR result, 53 (75.7 %) had a positive LabOn-Time result. The LabOn-Time kit had a sensitivity of 75.7 % and specificity of 100 %. The odds ratio for showing a false negative LabOn-Time result for influenza B, compared to influenza A was 5.24 (95%CI: 1.35-20.31). All false negative LabOn-Time samples had a RT-PCT cycle threshold ≥20. Mean time from symptom onset was significantly lower in the false negative LabOn-Time cases compared to the positive cases (36 ± 15.3 vs. 42.6 ± 10.1, respectively). The mean number of symptoms reported per patient was significantly higher in positive compared to negative LabOn-Time cases (2.5 ± 0.5 vs. 1.9 ± 0.4,  < 0.001).

Conclusions: The LabOn-Time device, which is very simple and intuitive to operate, could significantly contribute to early detection of influenza A/B infection.