Poor Sensitivity of Rapid Test for Pandemic (H1N1) | CDC EID

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Volume 15, Number 10–October 2009
Dispatch
Poor Clinical Sensitivity of Rapid Antigen Test for Influenza A Pandemic (H1N1) 2009 Virus
Jan Felix Drexler, Angelika Helmer, Heike Kirberg, Ulrike Reber, Marcus Panning, Marcel Müller, Katja Höfling, Bertfried Matz, Christian Drosten, and Anna Maria Eis-Hübinger
Author affiliation: Institute of Virology, Bonn, Germany

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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.

In April 2009, a novel human influenza virus A (H1N1) variant, influenza A pandemic (H1N1) 2009 virus, was identified in Mexico and the United States (1). Efficient human-to-human transmission facilitated global spread of this virus. On June 11, 2009, the World Health Organization (WHO) raised its pandemic alert level to Phase 6, indicating ongoing pandemic transmission. By July 27, WHO had registered 134,503 laboratory-confirmed cases and 816 confirmed deaths caused by pandemic (H1N1) 2009 virus infection worldwide (2).

In Germany, 5,324 cases were confirmed by July 30 (3). Almost 50% (n = 2,184) of these cases occurred in the federal state of North Rhine-Westphalia in western Germany, where our institution is located. As of July 30, we had tested 1,838 suspected cases and confirmed 221. All testing was based on real-time reverse transcription–PCR (RT-PCR) specific for the hemagglutinin (HA) gene of pandemic (H1N1) 2009 virus in clinical specimens. Although the real-time RT-PCR format provides considerably decreased turnaround times in molecular diagnostics, delays associated with shipping of samples and laboratory-based testing are a concern when many patients have to be seen in short time. Antigen-based rapid assays can be used as bedside tests and have been successfully applied in studies of influenza caused by the seasonal strains A (H1N1) and A (H3N2) (4).

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