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Evaluation of a rapid diagnostic test, NanoSign(R) Influenza A/B Antigen, for detection of the 2009 pandemic influenza A/H1N1 viruses

tetano

Editor, Senior Moderator
Evaluation of a rapid diagnostic test, NanoSign(R) Influenza A/B Antigen, for detection of the 2009 pandemic influenza A/H1N1 viruses

Gyu-Cheol Lee email, Eun-Sung Jeon email, Won-Shik Kim email, Dung Tien Le email, Jong-Ha Yoo email and Chom-Kyu Chong email

Virology Journal 2010, 7:244doi:10.1186/1743-422X-7-244
Published: 20 September 2010
Abstract (provisional)

Background

This study evaluated the clinical accuracy and analytical sensitivity of the NanoSign(R) 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(R) 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(R) 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(R) 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.

http://www.virologyj.com/content/pdf/1743-422x-7-244.pdf
 
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