A prototype rapid antigen test for the on-site detection of respiratory syncytial virus (RSV) infection was developed and evaluated. The platform uses instrumented assay analysis, eliminating potential operator bias in the interpretation of the test result that may occur with visually interpreted rapid antigen assays. The device was tested as the first point-of-care (POC) infectious disease application of novel reporter up-converting phosphor technology (UPT) using a specifically designed portable UPT reader (UPlink). Assays were performed by mixing nasopharyngeal specimen with RSV-specific UPT reporter particles and addition of the mixture to a disposable cassette containing a lateral flow (LF) strip with RSV capture antibodies. UPT reporters bound on the specific capture zone were analyzed with the UPlink reader. Reproducibility testing of the UPlink-RSV (UPR) test by naïve users confirmed the potential of UPlink for POC applications where testing is not always performed by highly trained medical staff. The performance of UPR was further evaluated with clinical nasopharyngeal specimens. A prospective study at an independent test site demonstrated clinical parameters of 90% sensitivity and 98.3% specificity with an overall correlation of 96.2% as compared to viral culture with RT-PCR verification. These results are in agreement with in-house retrospective studies and results obtained with other available commercial rapid antigen assays.
Yttrium oxysulfide upconverting phosphor particles can absorb infrared light and emit dopant‐dependent visible phosphorescence. This unique optical property has been used for particle‐based immunoassay applications. In this study, upconverting phosphor particles were encapsulated with a functionalized polymer (carboxylated polystyrene) shell layer via several approaches, which included the following: (1) the physical adsorption of the carboxylated polystyrene polymer onto the phosphor surfaces, (2) the miniemulsification of the preformed carboxylated polystyrene in a solvent in the presence of the phosphor particles and the subsequent stripping off of the solvent, and (3) the miniemulsification and miniemulsion copolymerization of styrene and methacrylic acid in the presence of the phosphor particles with hexadecane as a costabilizer in combination with a surfactant (sodium dodecyl sulfate, sodium dodecylbenzene sulfonate, or sodium dihexyl sulfosuccinate). Miniemulsion technology proved to be the most effective method for forming a functionalized polymeric nanoshell surrounding the phosphor particles. The morphology of the encapsulated phosphor particles was found to vary from symmetric core–shell (i.e., a uniform nanoshell layer with varying shell thicknesses), asymmetric core–shell, dumbbell‐like, or raspberry‐like partial encapsulation to multiparticle encapsulation. The amount of multiparticle encapsulation could be reduced by the postaddition of a surfactant, but it could not be eliminated completely. © 2006 Wiley Periodicals, Inc. J Polym Sci Part A: Polym Chem 45: 1038–1054, 2007
Rapid, point of care (POC) testing has been increasingly deployed as an aid in the diagnosis of infectious disease, due to its ability to deliver rapid, actionable results. In the case of HIV, a number of rapid test devices have been FDA approved and CLIA-waived in order to enable diagnosis of HIV infection outside of traditional laboratory settings. These settings include STD clinics, community outreach centers and mobile testing units, as well as identifying HIV infection among pregnant women and managing occupational exposure to infection. The OraQuick ® rapid test platform has been widely used to identify HIV in POC settings, due to its simplicity, ease of use and the ability to utilize oral fluid as an alternative specimen to blood. More recently, a rapid test for antibodies to hepatitis C virus (HCV) has been developed on the same test platform which uses serum, plasma, finger-stick blood, venous blood and oral fluid. Clinical testing using this POC test device has shown that performance is equivalent to state of the art, laboratory based tests. These devices may be suitable for rapid field testing of blood and other body fluids for the presence of infectious agents.
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