Abstract

Influenza viruses which cause human disease may include viruses that originate from humans, animals, or animal/human reassortants. This study evaluated the diagnostic sensitivity and specificity of a commercial FluA-Ag rapid assay in detecting influenza A viruses, either common or reassortant strains, to meet the need of influenza A virus early screening. The laboratory accuracy of the rapid assay was evaluated using influenza A virus isolated strains and other related respiratory virus strains. The diagnostic sensitivity and specificity were assessed using clinical specimens from hospitals, poultry and pig farms. Nucleic acid testing (real-time RT-PCR) was used as the reference method, and all samples with different results detected by the rapid assay and real-time RT-PCR were confirmed by sequencing for full identification. Compared with the detection results of real-time RT-PCR, the rapid assay showed high laboratory accuracy with influenza A virus strains and other respiratory virus strains, and it also showed a higher relative diagnostic sensitivity and specificity of the rapid assay with clinical samples. The high accuracy and the higher diagnostic sensitivity and specificity for influenza A virus detection proved that this rapid assay will be a valuable tool for the quick detection of influenza A virus in the laboratory or on-site locations.

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