Novel Flu 2009 caused from novel influenza A/H1N1 has been pandemic state in the world society. According to the World Health Organization, as of 6 September 2009, over 277,607 confirmed cases reported worldwide, including at least 3205 deaths. Many patients are generated and have been suffering fro...
Novel Flu 2009 caused from novel influenza A/H1N1 has been pandemic state in the world society. According to the World Health Organization, as of 6 September 2009, over 277,607 confirmed cases reported worldwide, including at least 3205 deaths. Many patients are generated and have been suffering from the disease. There are several methods for detection of Novel Flu including virus culture, rapid diagnostic test, real time and conventional reverse transcriptase (RT)-PCR. Among those methods, gene amplification methods such as real time PCR and reverse transcriptase (RT)-PCR have been used for the disease confirmation. However, these methods take greater than 3 hrs to detect the viral infection, and the testing costs for PCR are expensive. These test kits are only available for testing a set of samples which requires a certain period of time for sample collection. There are few rapid kits available for Novel Flu-specific diagnosis until now. In this study, Influenza A/B kit in detecting 2009 pandemic influenza A/H1N1 viruses were developed and evaluated for the clinical accuracy and analytical sensitivity. The newly developed kit, NanoSign?? Influenza A/B kit, has been on market in 2009, and popularly used for detecting influenza in Korea. The NanoSign?? kit showed its sensitivity by 79.4% and its specificity by 97.2% from 1,023 specimens. In addition, the kit was able to detect two strains of Novel Flu viruses, Influenza A/California/12/2009 (H1N1) and wild-type novel influenza A/H1N1, both of which are spreading epidemically throughout the world. The correlation between NanoSign?? Influenza A/B test and RT-PCR was approximately 94%, indicating that the kit has a high concordance rate. Analytical sensitivity of the kit was approximately 73 ng/mL for the purified virus and 1.13 hemagglutination units for the cultured virus. 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. In this study, for the development of rapid detection kit specific for Novel Flu A/H1N1, the hybridoma 1H7E1 and 3A3H7 were prepared. The affinity constants (Ka) of 1H7E1 and 3A3H7 were 1.10 X 1010 and 2.35 X 1010, respectively. In the clinical evaluations, the rapid kit specific for for Novel Flu A/H1N1 showed sensitivity by 90.4% and specificity by 99.2%. The kit also showed a very good relationship with real time reverse transcriptase (rRT)-PCR which were commonly and commercially used. In conclusion, NanoSign?? Influenza kit specific for A/H1N1 with high sensitivity and specificity as well as good correlation with RT-PCR will be very useful in the early control of influenza infection and in helping physicians in making early treatment decisions.
Novel Flu 2009 caused from novel influenza A/H1N1 has been pandemic state in the world society. According to the World Health Organization, as of 6 September 2009, over 277,607 confirmed cases reported worldwide, including at least 3205 deaths. Many patients are generated and have been suffering from the disease. There are several methods for detection of Novel Flu including virus culture, rapid diagnostic test, real time and conventional reverse transcriptase (RT)-PCR. Among those methods, gene amplification methods such as real time PCR and reverse transcriptase (RT)-PCR have been used for the disease confirmation. However, these methods take greater than 3 hrs to detect the viral infection, and the testing costs for PCR are expensive. These test kits are only available for testing a set of samples which requires a certain period of time for sample collection. There are few rapid kits available for Novel Flu-specific diagnosis until now. In this study, Influenza A/B kit in detecting 2009 pandemic influenza A/H1N1 viruses were developed and evaluated for the clinical accuracy and analytical sensitivity. The newly developed kit, NanoSign?? Influenza A/B kit, has been on market in 2009, and popularly used for detecting influenza in Korea. The NanoSign?? kit showed its sensitivity by 79.4% and its specificity by 97.2% from 1,023 specimens. In addition, the kit was able to detect two strains of Novel Flu viruses, Influenza A/California/12/2009 (H1N1) and wild-type novel influenza A/H1N1, both of which are spreading epidemically throughout the world. The correlation between NanoSign?? Influenza A/B test and RT-PCR was approximately 94%, indicating that the kit has a high concordance rate. Analytical sensitivity of the kit was approximately 73 ng/mL for the purified virus and 1.13 hemagglutination units for the cultured virus. 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. In this study, for the development of rapid detection kit specific for Novel Flu A/H1N1, the hybridoma 1H7E1 and 3A3H7 were prepared. The affinity constants (Ka) of 1H7E1 and 3A3H7 were 1.10 X 1010 and 2.35 X 1010, respectively. In the clinical evaluations, the rapid kit specific for for Novel Flu A/H1N1 showed sensitivity by 90.4% and specificity by 99.2%. The kit also showed a very good relationship with real time reverse transcriptase (rRT)-PCR which were commonly and commercially used. In conclusion, NanoSign?? Influenza kit specific for A/H1N1 with high sensitivity and specificity as well as good correlation with RT-PCR will be very useful in the early control of influenza infection and in helping physicians in making early treatment decisions.
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