Comparison of fluIDTM Rapid Influenza Test and BinaxNOW Influenza A & B Test for Detection of Influenza A & B from Nasopharyngeal Aspirates
Session III – Gary TF Lee
Comparison of fluIDTM Rapid Influenza Test and BinaxNOW Influenza 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
The performance of the fluIDTM Rapid Influenza Test and BinaxNOW Influenza A & B Test were compared in a study with a panel of archived nasopharyngeal aspirates (NPA) submitted in viral transport medium (VTM). Results were compared to those obtained from Immunofluorescence (IF) and cell culture. A challenging panel was built using 100 NPA samples which had been selected based on average to unusual reactivity were tested with fluIDTM, BinaxNOW, cell culture and IF; true positives were defined as positive result obtained from either IF and/or cell culture.
Results are included in the following table:
|
Method |
Gold Standard (Culture and/or IF Pos) |
|
|
Positive |
Negative |
|
|
fluID: Positive |
77 |
0 |
|
fluID: Negative |
12 |
11 |
|
Sensitivity: 86.5% |
Specificity: 100.0% |
|
|
BinaxNOW: Positive |
61 |
0 |
|
BinaxNOW: Negative |
28 |
11 |
|
Sensitivity: 68.5% |
Specificity: 100.0% |
|
While clinical performance of the fluIDTM assay will not be established until completion of clinical studies, this preliminary data indicates an important increase in clinical sensitivity. The fluIDTM test is not for sale but is anticipated to be available commercially in the latter half of 2009.
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. HX Diagnostics recognizes professional inputs and comments from Prof. Yi Guan and Prof. Honglin Chen from the University of Hong Kong, and Prof. Ningshao Xia from the Xiamen University.
HX Diagnostics thanks Prof. Malik Peiris (The University of Hong Kong) and his professional team on participation in this study.
