BACKGROUND: Definitive diagnosis is crucial in reducing morbidity and mortality from pandemic @entity683 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 @entity1 with suspected @entity683 . 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 @entity1 who met the criteria, 122 and 92 were positive for A/H1N1/2009 @entity683 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 @entity1 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 @entity1 's bedside for rapid diagnosis of A/H1N1/2009. This test will be of key importance in the control of A/H1N1/2009.

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

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity683 :: ('MESH:D007251', 'Disease') :: ['influenza']
@entity683 :: (MESH:D007251,Disease) :: ['influenza']
