Comparison of fluIDTM Rapid Influenza Test and BD Directigen EZ A+B Test for Detection of Influenza A & B from Nasopharyngeal Aspirates
Session III – Gary TF Lee
Comparison of fluIDTM Rapid Influenza Test and BD Directigen EZ A+B Test for Detection of Influenza A & B from Nasopharyngeal Aspirates
Chan KH1, Cheung WY1, Chan KM1, Lam YP1, Wendy Benson2, Elizabeth Krodel2, Lee TF2, Stan Vukajlovich3, Randy Madsen3, Jay Shaw3, Philip Estes3, Richard Egan3
1The University of Hong Kong, Pokfulam, Hong Kong, 2HX Diagnostics, Inc. Emeryville, USA
3Nanogen, Inc. San Diego, USA
Background: A new generation of rapid POC diagnostic is in final stages of pre-clinical testing prior to beginning a full clinical trial in early 2009. This platform offers ease-of-use, multiple results from a single sample and automated result interpretation and reporting.
Method: A challenging panel was built using 89 NPA samples. Results are summarized in the following table:
|
Method |
Gold Standard |
|
|
Positive |
Negative |
|
|
fluID: Positive |
67 |
0 |
|
fluID: Negative |
11 |
11 |
|
Sensitivity: 85.9% |
Specificity: 100.0% |
|
|
EZ A + B: Positive |
55 |
0 |
|
EZ A + B: Negative |
23 |
11 |
|
Sensitivity: 70.5% |
Specificity: 100.0% |
|
Summary: While clinical performance of the fluID assay will not be established until completion of clinical studies, this preliminary data indicates an important increase in sensitivity. The fluIDTM test is not available for sale but is anticipated to be available commercially in the latter half of 2009. HX Diagnostics is honored to collaborate on the development of these rapid influenza products with Prof. Yi Guan and Prof. Honglin Chen from the University of Hong Kong, and Prof. Ningshao Xia from Xiamen University. HX Diagnostics thanks Prof Malik Peiris (The University of Hong Kong) and his professional team on participation in this study.
HX Diagnostics, in collaboration with Nanogen, Inc., acknowledges support from the Biomedical Advanced Research and Development Authority Office (BARDA) of Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS), and the Centers for Disease control (CDC) for advanced product development under contract No. HHS200-2007-19345. BARDA and the CDC are not responsible for the content in this Abstract.
