Multicenter prospective evaluation of a novel rapid immunochromatographic diagnostic kit specifically detecting influenza A H1N1 2009 virus.
J Clin Virol
; 51(1): 68-72, 2011 May.
Article
in En
| MEDLINE
| ID: mdl-21324735
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. STUDYDESIGN:
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Reagent Kits, Diagnostic
/
Influenza, Human
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Influenza A Virus, H1N1 Subtype
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Antibodies, Monoclonal
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Antigens, Viral
Type of study:
Clinical_trials
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Diagnostic_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Adolescent
/
Child
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Child, preschool
/
Female
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Humans
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Infant
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Male
Country/Region as subject:
Asia
Language:
En
Journal:
J Clin Virol
Journal subject:
VIROLOGIA
Year:
2011
Document type:
Article
Affiliation country: