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Multicenter prospective evaluation of a novel rapid immunochromatographic diagnostic kit specifically detecting influenza A H1N1 2009 virus

tetano

Editor, Senior Moderator
J Clin Virol. 2011 Feb 14. [Epub ahead of print]
Multicenter prospective evaluation of a novel rapid immunochromatographic diagnostic kit specifically detecting influenza A H1N1 2009 virus.

Kawachi S, Matsushita T, Sato T, Nunoi H, Noguchi H, Ota S, Kanemoto N, Nakatani K, Nishiguchi T, Yuge A, Imamura H, Kitajima H, Narahara K, Suzuki K, Miyoshi-Akiyama T, Kirikae T.

Surgical Operation Department, National Center for Global Health and Medicine, Japan.
Abstract

BACKGROUND: Definitive diagnosis is crucial in reducing morbidity and mortality from pandemic influenza A H1N1 2009 (A/H1N1/2009), especially in high-risk populations. We recently developed a rapid diagnosis kit (RDK) capable of specifically detecting A/H1N1/2009.

OBJECTIVES: To evaluate the diagnostic capability of the RDK in a multicenter, prospective trial.

STUDY DESIGN: Samples were obtained by nasal swab from patients with suspected influenza. The diagnostic capability of the RDK was compared with that of the standard, real-time reverse transcription-polymerase chain reaction (RT-PCR) method.

RESULTS: Of 266 patients who met the criteria, 122 and 92 were positive for A/H1N1/2009 influenza by PCR and by the newly developed RDK, respectively. The sensitivity, specificity and positive and negative predictive values of the RDK were 73.0%, 97.9%, 96.7% and 81.0%, respectively. A/H1N1/2009 detection rates by the RDK were significantly lower in samples obtained from patients more than 3 days after onset than in samples obtained between 1 and 2 days.

CONCLUSIONS: The A/H1N1/2009-specific RDK is a reliable test that can be used easily at a patient's bedside for rapid diagnosis of A/H1N1/2009. This test will be of key importance in the control of A/H1N1/2009.
Copyright ? 2011 Elsevier B.V. All rights reserved.

PMID: 21324735 [PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/21324735
 
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