Avian Influenza Test Accuracy

In validation studies the Alveo Sense Poultry Avian Influenza Test showed positive percent agreement and negative percent agreement of 99 percent or greater against a reference RT-PCR assay, across both oropharyngeal and cloacal samples. Validation covered limit of blank, limit of detection, inclusivity and exclusivity across twelve influenza A strains, cross-reactivity against nineteen non-influenza organisms, and reproducibility across two laboratories, four operators, and three days. Because clinical positive samples were not available under avian influenza testing restrictions, positive sample validation was performed using contrived samples. Positive and presumptive positive results should be confirmed by an authorized reference laboratory.