Pre-clinically evaluated visual lateral flow platform using influenza A and B nucleoprotein as a model and its potential applications

A visual colorimetric rapid screening system based on a lateral flow device for simultaneous detection and differentiation between influenza A and B nucleoprotein as a model was developed. Monoclonal antibodies, specific for either influenza A or B nucleoproteins, were evaluated for their reactivities and were used as targeting ligands. With the best antibody pairs selected, the system exhibited good specificity to both viruses without cross reactivity to other closely related respiratory viruses. Further semi-quantitative analysis using a strip reader revealed that the system is capable of detecting influenza A and B protein content as low as 0.04 and 1 ng per test, respectively, using a sample volume as low as 100 mu L, within 10 minutes (R-2 = 0.9652 and 0.9718). With a performance comparison to the commercial tests, the system demonstrated a four-to-eight-fold higher sensitivity. Pre-clinical evaluation with 101 nasopharyngeal swabs reveals correlated results with a standard molecular approach, with 89% and 83% sensitivity towards influenza A and B viruses, and 100% specificity for both viruses.

Automated summary

The visual colorimetric rapid screening system, based on a lateral flow device, demonstrated good specificity to influenza A and B nucleoproteins without cross reactivity to other closely related respiratory viruses. It showed high sensitivity, detecting as low as 0.04 and 1 ng of influenza A and B protein content per test, respectively, within 10 minutes. Comparing to commercial tests, the system exhibited a four-to-eight-fold higher sensitivity and correlated well with standard molecular approaches in pre-clinical evaluation.