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BOULDER, CO, United States

Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 197.47K | Year: 2011

DESCRIPTION (provided by applicant): MBio Diagnostics, Inc. proposes to develop a low-cost, point-of-care (POC), HIV-1 antigen/antibody combination diagnostic device. The goal is for the Ag/Ab combo system to deliver the performance of laboratory based, 4th generation antigen/antibody clinical analyzers, in a POC platform with cost and workflow of the widely used HIV rapid tests. This Phase I proposal will focus on development of a novel, multiple particle approach for a HIV-1 p24 antigen sandwich immunoassay that will deliver clinically relevant limits of detection. During Phase II, the p24 assay will combined with MBio's multiplexed HIV-1/2 antibody detection system. If successful, the resulting minimally instrumented Ag/Ab combination assay would be the most sensitive POC HIV screening technology available. HIV infection remains a major public health crisis both in the United States and worldwide. There is increasing awareness that acutely infected individuals disproportionately contribute to disease spread. Yet these individuals remain the most difficult to identify, as infectivity is highest prior to the appearance of the HIV antibodies that serve as the basis for serological diagnostics. There are currently no FDA-approved point-of-care (POC) tests thatdirectly target HIV viral antigens. An HIV-1 antigen/antibody (Ag/Ab) combination assay - the so-called 4th generation immunoassay - in an inexpensive, simple to use, POC format would fundamentally improve HIV-1 screening efforts in the United States andworldwide. The specific aims of this proposal are to: (1) Establish a core collection of well characterized clinical serum/plasma samples focused on acute and recent HIV infection. The Phase I collection will be based on samples from existing archives andsources, with additional testing under this award. The Phase I milestone will be a collection of 60 HIV-1 positive and 40 negative sera. (2) Demonstrate MBio's magnetic multi-particle approach for rapid, ultra-sensitive, no- enzyme detection of HIV p24 antigen. The milestone for this aim is a model assay standard curve for p24 antigen detection with a lower limit of detection of 20 pg/mL. (3) Quantitatively compare performance of the MBio antigen/antibody assay on the Aim 1 recent infection panel with gold-standard methods. The milestone for this aim is detection of 80% of HIV-1 positive samples not detected with the current market- leading FDA-approved HIV-1/2 rapid test. Upon successful completion of the Phase I project, device engineering and a larger clinical validation leading to an FDA investigational device exemption (IDE) will be proposed under Phase II. PUBLIC HEALTH RELEVANCE: The proposed point-of-care (POC) HIV-1 Ag/Ab combination diagnostic device will fill a critical unmet need for HIV screening technologies that detect recent and acutely infected individuals. The technology will be used in multi-test algorithms in public health laboratories, STD clinics, urban emergency departments, targeted outreach programs,etc., both in the United States and worldwide.


Patent
Mbio Diagnostics, Inc. | Date: 2011-09-15

A rapid diagnostic system that delivers a panel of serologic assay results using a small amount of blood, serum, or plasma is described. The system includes a disposable cartridge and a reader instrument, based on planar waveguide imaging technology. The cartridge incorporates a microarray of recombinant antigens and antibody controls in a fluidic channel, providing multiple parallel fluorescence assay results for a single sample.


Patent
Mbio Diagnostics, Inc. | Date: 2013-03-15

A rapid diagnostic system that delivers a panel of serologic assay results using a small amount of blood, serum, or plasma is described. The system includes a disposable cartridge, including an integral lens portion coupled to a planar waveguide, and a reader instrument, based on planar waveguide imaging technology. The cartridge incorporates a microarray of recombinant antigens and antibody controls in a fluidic channel, providing multiple parallel fluorescence assay results for a single sample.


Patent
Mbio Diagnostics, Inc. | Date: 2013-03-15

A device for analyzing an analyte in a sample includes a first substrate, a second substrate, a fluidic channel, an inlet port and an outlet port. Each of the first substrate and the second substrate has an inner surface and an outer surface, the inner surface of the first substrate forming, at least in part, the lower wall of the fluidic channel, and the inner surface of the second substrate forming, at least in part, the upper wall of the fluidic channel. The fluidic channel is connected to the inlet port and the outlet port. The fluidic channel includes a reagent region and a detection region, at least a portion of the reagent region being coated with one or more dried reagents. The device further includes a wicking pad located on the outer surface of the second substrate, the wicking pad being positioned at a pre-determined distance from the outlet port.


Patent
Mbio Diagnostics, Inc. | Date: 2014-03-13

A method for determining fluorescently labeled particles within a sample in presence of sample movement includes determining spatial shift between sequentially captured first and second images of the sample by using a third image of the sample, wherein the spatial shift is at least partially induced by the sample movement; and spatially correlating events between the first and second images, while accounting for the spatial shift. A method for providing a fluidic assay cartridge with dried reagents includes depositing a plurality of mutually incompatible liquid reagents in a respective plurality of mutually separated areas of the fluidic assay cartridge, and drying the plurality of mutually incompatible liquid reagents to form the dried reagents. A fluidic assay cartridge with dried reagents includes a plurality of mutually separated dried reagents, located within the fluidic assay cartridge, wherein the plurality of mutually separated dried reagents have a respective plurality of mutually different compositions.

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