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      Poor Clinical Sensitivity of Rapid Antigen Test for Influenza A Pandemic (H1N1) 2009 Virus

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          Abstract

          Influenza A pandemic (H1N1) 2009 virus RNA was detected by reverse transcription–PCR in 144 clinical samples from Bonn, Germany. A common rapid antigen–based test detected the virus in only 11.1% of these samples. The paramount feature of rapid test–positive samples was high virus concentration. Antigen-based rapid tests appear unsuitable for virologic diagnostics in the current pandemic.

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          Simultaneous detection of influenza viruses A and B using real-time quantitative PCR.

          R. Schuurman, P Schipper, Mitsouko van Assche … (2000)
          Since influenza viruses can cause severe illness, timely diagnosis is important for an adequate intervention. The available rapid detection methods either lack sensitivity or require complex laboratory manipulation. This study describes a rapid, sensitive detection method that can be easily applied to routine diagnosis. This method simultaneously detects influenza viruses A and B in specimens of patients with respiratory infections using a TaqMan-based real-time PCR assay. Primers and probes were selected from highly conserved regions of the matrix protein gene of influenza virus A and the hemagglutinin gene segment of influenza virus B. The applicability of this multiplex PCR was evaluated with 27 influenza virus A and 9 influenza virus B reference strains and isolates. In addition, the specificity of the assay was assessed using eight reference strains of other respiratory viruses (parainfluenza viruses 1 to 3, respiratory syncytial virus Long strain, rhinoviruses 1A and 14, and coronaviruses OC43 and 229E) and 30 combined nose and throat swabs from asymptomatic subjects. Electron microscopy-counted stocks of influenza viruses A and B were used to develop a quantitative PCR format. Thirteen copies of viral RNA were detected for influenza virus A, and 11 copies were detected for influenza virus B, equaling 0.02 and 0.006 50% tissue culture infective doses, respectively. The diagnostic efficacy of the multiplex TaqMan-based PCR was determined by testing 98 clinical samples. This real-time PCR technique was found to be more sensitive than the combination of conventional viral culturing and shell vial culturing.
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            Evaluation of multiple test methods for the detection of the novel 2009 influenza A (H1N1) during the New York City outbreak

            Christine Ginocchio, Frank Zhang, Ryhana Manji … (2009)
            Background In response to the novel influenza A H1N1 outbreak in the NY City area, 6090 patient samples were submitted over a 5-week period for a total of 14,114 viral diagnostic tests, including rapid antigen, direct immunofluorescence (DFA), viral culture and PCR. Little was known about the performance of the assays for the detection of novel H1N1 in the background of seasonal H1N1, H3N2 and other circulating respiratory viruses. In addition, subtyping influenza A became critical for the identification of high risk and/or hospitalized patients with novel H1N1 infection and for monitoring the spread of the outbreak. Study design This study analyzed the performances of the BinaxNOW Influenza A&B test (BinaxNOW), the 3M Rapid Detection Flu A + B test (3MA + B), direct immunofluorescence, R-Mix culture and the Luminex xTAG Respiratory Virus Panel (RVP) for the detection of seasonal influenza, novel H1N1 and other respiratory viruses. RVP was also evaluated for its ability to differentiate seasonal H1N1, H3N2 and novel H1N1. Results The sensitivities, specificities, PPVs and NPVs for the detection of novel H1N1, determined by comparing all four-test methods, were: rapid antigen: 17.8%, 93.6%, 77.4%, 47.9%; DFA: 46.7%, 94.5%, 91.3%, 58.9%; R-Mix culture: 88.9%, 100%, 100%, 87.9%; RVP: 97.8%, 100%, 100%, 97.3%. The individual sensitivities of BinaxNOW and 3MA + B as compared to R-Mix culture for the detection of novel H1N1 were 9.6% and 40%, respectively. All unsubtypeable influenza A specimens identified by RVP and tested with the CDC novel H1N1 specific RT-PCR assay were confirmed to be novel H1N1. Conclusions Rapid antigen tests, DFA, R-Mix culture and the xTAG RVP test all detected the novel H1N1 strain, but with highly varied sensitivity. The RVP test provided the best diagnostic option as RVP demonstrated superior sensitivity for the detection of all influenza strains, including the novel H1N1, provided accurate influenza A subtyping and identified a significant number of additional respiratory pathogens.
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              Low sensitivity of rapid diagnostic test for influenza.

              Charles Rinaldo, Timothy Uyeki, Brian Davis … (2009)
              The QuickVue Influenza A+B Test (Quidel) was used to test nasal swab specimens obtained from persons with influenza-like illness in 3 different populations. Compared with reverse-transcriptase polymerase chain reaction, the test sensitivity was low for all populations (median, 27%; range, 19%-32%), whereas the specificity was high (median, 97%; range, 96%-99.6%).
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                Author and article information

                Journal
                Journal ID (nlm-ta): Emerg Infect Dis
                Journal ID (publisher-id): EID
                Title: Emerging Infectious Diseases
                Publisher: Centers for Disease Control and Prevention
                ISSN (Print): 1080-6040
                ISSN (Electronic): 1080-6059
                Publication date (Print): October 2009
                Volume: 15
                Issue: 10
                Pages: 1662-1664
                Affiliations
                [1]Institute of Virology, Bonn, Germany
                Author notes
                Address for correspondence: Christian Drosten, Institute of Virology, University of Bonn Medical Centre, 53127 Bonn, Germany; email: drosten@ 123456virology-bonn.de
                Article
                Publisher ID: 09-1186
                DOI: 10.3201/eid1510.091186
                PMC ID: 2866420
                PubMed ID: 19861069
                SO-VID: f834ab54-e469-4906-a258-4bc3faccdc11
                History
                Categories
                Subject: Dispatch

                ScienceOpen disciplines: Infectious disease & Microbiology
                Keywords: communicable diseases,influenza virus a (h1n1),rapid antigen-based test,germany,sensitivity,influenza,influenza a pandemic (h1n1) 2009 virus,viruses,dispatch,real-time pcr
                Data availability:
                ScienceOpen disciplines: Infectious disease & Microbiology
                Keywords: communicable diseases, influenza virus a (h1n1), rapid antigen-based test, germany, sensitivity, influenza, influenza a pandemic (h1n1) 2009 virus, viruses, dispatch, real-time pcr

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