Physics Nuclear Physics And Radiation Physics

A Multiplexed Diagnostic Platform for Point-of-Care Pathogen Detection

Authors: Regan, J F Letant, S E Adams, K L Mahnke, R C Nguyen, N T Dzenitis, J M Hindson, B J Hadley, D R Makarewicz, T J Henderer, B D Breneman, J W Tammero, L F Ortiz, J I Derlet, R W Cohen, S Colston, W W McBride, M T Birch, J M
Abstract: We developed an automated point-of-care diagnostic instrument that is capable of analyzing nasal swab samples for the presence of respiratory diseases. This robust instrument, called FluIDx, performs autonomous multiplexed RT-PCR reactions that are analyzed by microsphere xMAP technology. We evaluated the performance of FluIDx, in comparison rapid tests specific for influenza and respiratory syncytial virus, in a clinical study performed at the UC Davis Medical Center. The clinical study included samples positive for RSV (n = 71), influenza A (n = 16), influenza B (n = 4), adenovirus (n = 5), parainfluenza virus (n = 2), and 44 negative samples, according to a composite reference method. FluIDx and the rapid tests detected 85.9% and 62.0% of the RSV positive samples, respectively. Similar sensitivities were recorded for the influenza B samples; whereas the influenza A samples were poorly detected, likely due to the utilization of an influenza A signature that did not accurately match currently circulating influenza A strains. Data for all pathogens were compiled and indicate that FluIDx is more sensitive than the rapid tests, detecting 74.2% (95% C.I. of 64.7-81.9%) of the positive samples in comparison to 53.6% (95% C.I. of 43.7-63.2%) for the rapid tests. The higher sensitivity of FluIDx was partially offset by a lower specificity, 77.3% versus 100.0%. Overall, these data suggest automated flow-through PCR-based instruments that perform multiplexed assays can successfully screen clinical samples for infectious diseases.
Publication Date: 04 Feb 2008
Report numbers: LLNL-TR-400998
DOE Contract number: W-7405-ENG-48
Resource Type: Technical Report
Research Organizations: Lawrence Livermore National Laboratory (LLNL), Livermore, CA
Sponsoring Organizations: USDOE
Country of Publication: United States
Language: English
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