Lee, Gyu-Cheol; Jeon, Eun-Sung; Kim, Won-Shik; Le, Dung Tien; Yoo, Jong-Ha; Chong, Chom-Kyu
Virology journal
2010NA ; 7 ( 18 ) :244.
PMID : 20849665
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Lee, Gyu-Cheol -
Jeon, Eun-Sung -
Kim, Won-Shik -
Le, Dung Tien -
Yoo, Jong-Ha -
Chong, Chom-Kyu -
ABSTRACT
BACKGROUND: This study evaluated the clinical accuracy and analytical sensitivity of the NanoSign® Influenza A/B antigen kit in detecting 2009 pandemic influenza A/H1N1 viruses. The kit is one of the most popular rapid diagnostic tests for detecting influenza in Republic of Korea.
RESULTS: The NanoSign® Influenza A/B kit resulted in 79.4% sensitivity and 97.2% specificity compared to RT-PCR in the detection of the viruses from 1,023 specimens. In addition, the kit was able to detect two strains of novel influenza viruses, Influenza A/California/12/2009(H1N1) and clinically isolated wild-type novel influenza A/H1N1, both of which are spreading epidemically throughout the world. In addition, the correlation between NanoSign® Influenza A/B test and conventional RT-PCR was approximately 94%, indicating a high concordance rate. Analytical sensitivity of the kit was approximately 73 ± 3.65 ng/mL of the purified viral proteins and 1.13 ± 0.11 hemagglutination units for the cultured virus.
CONCLUSIONS: As the NanoSign® Influenza A/B kit showed relatively high sensitivity and specificity and the good correlation with RT-PCR, it will be very useful in the early control of influenza infection and in helping physicians in making early treatment decisions.
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MESH
Humans, Immunoassay/methods, Influenza A Virus, H1N1 Subtype/*isolation & purification, Influenza, Human/*diagnosis/*virology, *Reagent Kits, Diagnostic, Republic of Korea, Reverse Transcriptase Polymerase Chain Reaction, Sensitivity and Specificity, Virology/*methods
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