Evaluation of twenty rapid antigen tests for the detection of human influenza A H5N1, H3N2, H1N1, and B viruses

Abstract

Twenty rapid antigen assays were compared for their ability to detect influenza using dilutions of virus culture supernatants from human isolates of influenza A H5N1 (clade 1 and 2 strains), H3N2 and H1N1 viruses, and influenza B. There was variation amongst the rapid antigen assays in their ability to detect different influenza viruses. Six of the 12 assays labeled as distinguishing between influenza A and B had comparable analytical sensitivities for detecting both influenza A H5N1 strains, although their ability to detect influenza A H3N2 and H1N1 strains varied. The two assays claiming H5 specificity did not detect either influenza A H5N1 strains, and the two avian influenza-specific assays detected influenza A H5N1, but missed some influenza A H3N2 virus supernatants. Clinical trials of rapid antigen tests for influenza A H5N1 are limited. For use in a pandemic where novel influenza strains are circulating (such as the current novel influenza A H1N1 09 virus), rapid antigen tests should ideally have comparable sensitivity and specificity for the new strains as for co-circulating seasonal influenza strains.

Comparison of a Rapid Antigen Test with Nucleic Acid Testing during Cocirculation of Pandemic Influenza A/H1N1 2009 and Seasonal Influenza A/H3N2

“…Previous experience has demonstrated high specificities of 94 to 100% but variable sensitivities of 39 to 80% compared to viral culture (1,3,5,10). Furthermore, RAT do not distinguish the different influenza A virus subtypes.…”

“…Performance characteristics of various RAT in the detection of seasonal influenza virus strains (A/H1N1, A/H3N2, and B) have been previously established (4,8,10), but their performance in the current H1N1 09 pandemic remains uncertain. The sensitivity of the QuickVue RAT is consistent with previously published data, but a significant reduction in RAT sensitivity was observed when it was applied to H1N1 09-containing samples.…”

Fast High-Throughput Screening of H1N1 Virus by Parallel Detection with Multichannel Microchip Electrophoresis

“…2 In recent years, to prevent and control epidemic disease, various protein-and gene-based detection methods have been used in the clinical and laboratory diagnosis of H1N1 virus. [3][4][5][6][7][8] For instance, protein-based methods such as the rapid influenza A virus diagnostic test (RIDT), which is based on immunochromatographic lateral flow tests and uses monoclonal antibodies directed against the nucleocapsid protein (NP) of influenza virus, has been widely used in influenza diagnoses. 3 However, the RIDT assay cannot distinguish between influenza A virus subtypes and has limited accuracy (< 70%).…”

“…[3][4][5][6][7][8] For instance, protein-based methods such as the rapid influenza A virus diagnostic test (RIDT), which is based on immunochromatographic lateral flow tests and uses monoclonal antibodies directed against the nucleocapsid protein (NP) of influenza virus, has been widely used in influenza diagnoses. 3 However, the RIDT assay cannot distinguish between influenza A virus subtypes and has limited accuracy (< 70%). 4,5 In comparison, gene detection methods based on polymerase chain reaction (PCR) assays are able to detect the influenza virus with 97% accuracy.…”

Fast High-throughput Screening of the H1N1 Virus by Parallel Detection with Multi-channel Microchip Electrophoresis

“…2 In recent years, to prevent and control epidemic disease, various protein-and gene-based detection methods have been used in the clinical and laboratory diagnosis of H1N1 virus. [3][4][5][6][7][8] For instance, protein-based methods such as the rapid influenza A virus diagnostic test (RIDT), which is based on immunochromatographic lateral flow tests and uses monoclonal antibodies directed against the nucleocapsid protein (NP) of influenza virus, has been widely used in influenza diagnoses.…”