Automated, cloud-based, point-of-care (POC) pathogen and antibody array detection system and method
Inventors
Shachar, Josh • Felgner, Philip • Madou, Marc
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11130994-B2
Publication Date
2021-09-28
Expiration Date
Abstract
The illustrated embodiments of the invention include an automated method of assaying a viral and antibody analyte in a sample in a portable, handheld microfluidic reader having a SAW detector with a minimal mass sensitivity limitation. The automated method includes the steps of automatically performing the assay with the SAW detector with enhanced sensitivity as in Optikus I, but also includes the steps of automatically disposing a second portion of the sample on a microarray, selectively automatically probing the second portion of the sample for antibodies corresponding to the at least one selected virus using the microarray, and automatically reading the microarray using a fluorescent camera to identify antibodies in the second portion of the sample.
Core Innovation
The invention provides an automated method in a cloud-based ecosystem of diagnostically field testing a sample taken from a subject in a portable handheld instrument to determine the presence of viral antigens and/or antibodies thereto. The sample is disposed into a receiving chamber in a rotatable disc in the instrument and is processed under automated control using the instrument according to a nature of the sample and a corresponding means of detection. Under automated control, a quantitative measure of the viral antigens and/or antibodies is detected, and a data output corresponding to the subject is generated and communicated to a cloud-based database.
In the cloud-based ecosystem, the communicated data output corresponding to the subject is comparatively analyzed under automated control relative to a plurality of different types of viral antigens and/or antibodies to diagnose a type of viral infection, if any, the subject most likely carries or has previously carried. The comparative analysis is configured to include analyzing communicated data output for positive and/or negative indications of Covid-19 antigens and/or antibodies. The method further compares the communicated data output for positive and/or negative indications of Covid-19 to communicated data output for positive and/or negative indications of a microarray for a plurality of viral infections sharing at least some of the Covid-19 antigens and/or antibodies.
The invention also determines under automated control whether the communicated data output of positive and/or negative indications of Covid-19 are statistically indicative of Covid-19 rather than the plurality of viral infections sharing at least some of the Covid-19 antigens and/or antibodies, so that false positives and/or false negatives are substantially reduced. Corresponding automated cloud-based system aspects include providing a detector and reader for automatically processing the sample in the rotatable disc, generating a detected quantitative measure, communicating the data output to a cloud-based database, and using a cloud based ecosystem module to automatically analyze microarray data outputs to distinguish Covid-19 indications from other infections sharing at least some of the Covid-19 antigens and/or antibodies.
Claims Coverage
The document includes two independent claims that cover an automated, cloud-connected field diagnostic workflow using a portable handheld instrument with a rotatable disc and automated detection/quantification, followed by cloud comparative analysis against microarray indications for multiple viral antigen/antibody types. Across the independents and their dependents, the claims specify automated processing, quantitative detection output, cloud communication, comparative diagnosis of most-likely current or prior infection, and statistical discrimination to reduce false positives and/or false negatives.
Automated cloud-based diagnostically field testing workflow
An automated method in a cloud-based ecosystem of diagnostically field testing a sample taken from a subject in a portable handheld instrument to determine the presence of viral antigens and/or antibodies thereto, including disposing the sample into a receiving chamber in a rotatable disc in the instrument, processing under automated control using a corresponding means of detection to detect a quantitative measure, generating a data output corresponding to the subject, communicating the data output to a cloud-based database, comparatively analyzing in the cloud ecosystem relative to a plurality of different types of viral antigens and/or antibodies to diagnose a type of viral infection, if any, the subject most likely carries or has previously carried.
Cloud comparative diagnosis using Covid-19 vs shared-antigen microarray indications
Comparatively analyzing under automated control the communicated data output corresponding to the subject relative to a plurality of different types of viral antigens and/or antibodies to diagnose the type of viral infection, if any, the subject most likely carries or has previously carried, where the comparative analysis comprises analyzing communicated data output for positive and/or negative indications of Covid-19 antigens and/or antibodies, comparing communicated data output for positive and/or negative indications of Covid-19 to communicated data output for positive and/or negative indications of a microarray for a plurality of viral infections sharing at least some of the Covid-19 antigens and/or antibodies, and determining whether the communicated data output of positive and/or negative indications of Covid-19 are statistically indicative of Covid-19 rather than the plurality of viral infections sharing at least some of the Covid-19 antigens and/or antibodies.
Statistical discrimination to substantially reduce false positives and/or false negatives
Determining under automated control whether the communicated data output of positive and/or negative indications of Covid-19 are statistically indicative of Covid-19 rather than the plurality of viral infections sharing at least some of the Covid-19 antigens and/or antibodies, so that false positives and/or false negatives are substantially reduced.
Automated cloud-based system architecture for portable disc processing and cloud module analysis
An automated cloud-based system for diagnostically field testing a sample taken from a subject using an automated portable handheld instrument to determine a presence of viral antigens and/or antibodies thereto, including a sample receiving chamber in a rotatable disc in the instrument, a reader for automatically processing the sample in the rotatable disc, a detector for automatically detecting a quantitative measure, a data output circuit for automatically generating the detected quantitative measure corresponding to the subject, a communication circuit for communicating the data output to a cloud-based database, and a cloud based ecosystem configured to comparatively analyze the communicated data output relative to a plurality of different types of viral antigens and/or antibodies and to automatically communicate results.
Overall, the independent claims cover a portable handheld instrument with a rotatable disc that generates a quantitative data output for viral antigens and/or antibodies, a cloud-based database that receives the communicated output, and a cloud-based ecosystem that comparatively analyzes against multiple viral antigen/antibody types using microarray indications for Covid-19 discrimination. The claimed novelty centers on cloud comparative analysis of Covid-19 vs infections sharing overlapping Covid-19 antigen/antibody targets, with statistical determination to substantially reduce false positives and/or false negatives.
Stated Advantages
False positives and/or false negatives are substantially reduced.
Documented Applications
Diagnostically field testing a sample taken from a subject to determine the presence of viral antigens and/or antibodies and diagnose a type of viral infection, if any, the subject most likely carries or has previously carried, including Covid-19 indication analysis.
Interested in licensing this patent?