tetano
Editor, Senior Moderator
Clin Microbiol Infect. 2010 Nov 4. doi: 10.1111/j.1469-0691.2010.03413.x. [Epub ahead of print]
Differentiate Diagnosis of Pandemic (H1N1) 2009 Infection by Detecting Hemagglutinin Using an Enzyme-linked Immunoassay.
Yuan Q, Cheng XD, Yang BC, Zheng QB, Chen YX, Chen QR, Zeng F, Zhang R, Ge SX, Hao XK, Chen HL, Zhang J, Xia NS.
National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Life Science, Xiamen University, Xiamen, China Center of Clinical Laboratory Medicine of PLA, Xijing Hospital, Fourth Military Medical University, Xi'an, China State Key Laboratory for Emerging Infectious Diseases, University of Hong Kong, Hong Kong SAR, China.
Abstract
A sensitive and convenient immunoassay which can directly differentiate pandemic (H1N1) 2009 (pH1N1) virus from seasonal influenza can play an important function in clinic.In the presented study, a double-sandwich enzyme-linked immunosorbent assay (pH1N1 ELISA) based on two monoclonal antibodies against hemagglutinin of the pH1N1 virus was developed. After laboratory determination of the sensitivity and specificity characteristics, the performance of this assay was evaluated in a cohort of 904 patients with influenza like illness. All 7 strains of pH1N1 viral isolates tested were positive by the pH1N1 ELISA with the average lower detection limit of 10(3.0?0.4) TCID(50) /mL(or 0.009?0.005 HA titer). Cross-reaction of the assay with seasonal influenza virus and other common respiratory pathogens was rare. In pH1N1 infected patients, the sensitivity of the pH1N1 ELISA was 92.3% (84/91, 95%CI: 84.8∼96.9%), significantly higher than BD Directigen Flu A+B test (70.3%, p<0.01). The specificity of pH1N1 ELISA in seasonal influenza A patients was 100.0% (171/171, 95%CI: 97.9∼100.0%), similar as that in non-influenza A infected patients (640/642, 99.7%, 95%CI: 98.9∼100.0%). The positive predictive value (PPV) for pH1N1 ELISA was 97.7% and the negative predictive value (NPV) was 99.1% in this study population with a pH1N1 prevalence of 10.1%. In conclusions, detection of hemagglutinin of pH1N1 virus by immunoassay appears to be a convenient and reliable way to differentiate diagnosis of pH1N1 from other respiratory pathogens including seasonal influenza.
Copyright ? 2010 European Society of Clinical Microbiology and Infectious.
PMID: 21054661 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/21054661
Differentiate Diagnosis of Pandemic (H1N1) 2009 Infection by Detecting Hemagglutinin Using an Enzyme-linked Immunoassay.
Yuan Q, Cheng XD, Yang BC, Zheng QB, Chen YX, Chen QR, Zeng F, Zhang R, Ge SX, Hao XK, Chen HL, Zhang J, Xia NS.
National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Life Science, Xiamen University, Xiamen, China Center of Clinical Laboratory Medicine of PLA, Xijing Hospital, Fourth Military Medical University, Xi'an, China State Key Laboratory for Emerging Infectious Diseases, University of Hong Kong, Hong Kong SAR, China.
Abstract
A sensitive and convenient immunoassay which can directly differentiate pandemic (H1N1) 2009 (pH1N1) virus from seasonal influenza can play an important function in clinic.In the presented study, a double-sandwich enzyme-linked immunosorbent assay (pH1N1 ELISA) based on two monoclonal antibodies against hemagglutinin of the pH1N1 virus was developed. After laboratory determination of the sensitivity and specificity characteristics, the performance of this assay was evaluated in a cohort of 904 patients with influenza like illness. All 7 strains of pH1N1 viral isolates tested were positive by the pH1N1 ELISA with the average lower detection limit of 10(3.0?0.4) TCID(50) /mL(or 0.009?0.005 HA titer). Cross-reaction of the assay with seasonal influenza virus and other common respiratory pathogens was rare. In pH1N1 infected patients, the sensitivity of the pH1N1 ELISA was 92.3% (84/91, 95%CI: 84.8∼96.9%), significantly higher than BD Directigen Flu A+B test (70.3%, p<0.01). The specificity of pH1N1 ELISA in seasonal influenza A patients was 100.0% (171/171, 95%CI: 97.9∼100.0%), similar as that in non-influenza A infected patients (640/642, 99.7%, 95%CI: 98.9∼100.0%). The positive predictive value (PPV) for pH1N1 ELISA was 97.7% and the negative predictive value (NPV) was 99.1% in this study population with a pH1N1 prevalence of 10.1%. In conclusions, detection of hemagglutinin of pH1N1 virus by immunoassay appears to be a convenient and reliable way to differentiate diagnosis of pH1N1 from other respiratory pathogens including seasonal influenza.
Copyright ? 2010 European Society of Clinical Microbiology and Infectious.
PMID: 21054661 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/21054661