Open AccessA Multiplexed Diagnostic Platform for Point-of-Care Pathogen Detection
Author(s) -
J F Regan,
S E Letant,
Kristl L. Adams,
R C Mahnke,
N T Nguyen,
J M Dzenitis,
B J Hindson,
D R Hadley,
T J Makarewicz,
B D Henderer,
J W Breneman,
L F Tammero,
J I Ortiz,
R W Derlet,
S Cohen,
W W Colston,
M T McBride,
J M Birch
Publication year - 2008
Language(s) - English
Resource type - Reports
DOI - 10.2172/926006
Subject(s) - point of care testing , point of care , virology , medicine , virus , immunology , pathology
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