Automated, cloud-based, point-of-care (POC) pathogen and antibody array detection system and method
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.
1. 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 comprising:
disposing the sample into a receiving chamber in a rotatable disc in the instrument;
processing under automated control of the sample in the rotatable disc using the instrument according to a nature of the sample and a corresponding means of detection in the portable handheld instrument of the viral antigens and/or antibodies subject to diagnostic testing;
detecting under automated control a quantitative measure of the viral antigens and/or antibodies in the sample using the corresponding means of detection in the portable handheld instrument;
generating under automated control a data output of the detected quantitative measure of the viral antigens and/or antibodies in the sample corresponding to the subject;
communicating under automated control the data output corresponding to the subject to a cloud-based database;
comparatively analyzing under automated control in a cloud based ecosystem the communicated data output corresponding to the subject 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; and
communicating under automated control results of the comparative analysis to the subject from the cloud-based ecosystem,
where comparatively analyzing under automated control in a cloud based ecosystem 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 comprises:
analyzing under automated control the communicated data output for positive and/or negative indications of Covid-19 antigens and/or antibodies;
comparing under automated control 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; and
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.
2. The automated method of claim 1 where 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 comprises determining under automated control whether corresponding Z-scores of the communicated data output of positive and/or negative indications of Covid-19 are indicative of Covid-19 rather than Z-scores of the plurality of viral infections sharing at least some of the Covid-19 antigens and/or antibodies.
3. The automated method of claim 1 where comparing under automated control the communicated data output for positive and/or negative indications of Covid-19 to communicated data output for positive and/or negative indications of the microarray for a plurality of viral infections sharing at least some of the Covid-19 antigens and/or antibodies comprises comparing under automated control 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 acute respiratory infections selected from the group including SARS-CoV-2, SARS-CoV, MERS-CoV, common cold coronaviruses (including HKU1, OC43, NL63, and 229E), and multiple subtypes of influenza, adenovirus, metapneumovirus, parainfluenza, and/or respiratory syncytial virus.
4. The automated method of claim 1 where the means of detection comprises a microarray of antigen and/or antibody fluorescent spots and where detecting under automated control a quantitative measure of the viral antigens and/or antibodies in the sample using the corresponding means of detection in the instrument comprises generating under automated control an image file of a color image of the microarray of antigen and/or antibody fluorescent spots.
5. The automated method of claim 1 where processing under automated control the sample in the rotatable disc using the instrument according to the nature of the sample and the corresponding means of detection in the instrument of the viral antigens and/or antibodies subject to diagnostic testing comprises performing under automated control an ELISA blood test check for immunoglobulin G (IgG) and for Immunoglobin M (IgM) antibodies.
6. The automated method of claim 1 where processing under automated control the sample in the rotatable disc using the instrument according to the nature of the sample and the corresponding means of detection in the instrument of the viral antigens and/or antibodies subject to diagnostic testing comprises performing under automated control an immunofluorescence assay using a conjugated fluorescent label by direct or indirect immunofluorescence wherein an amount of conjugation of an antibody to an antigen is directly correlated with an amount of the fluorescence produced source.
7. 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 comprising:
a sample receiving chamber in a rotatable disc in the instrument;
a reader for automatically processing the sample in the rotatable disc using the instrument according to a nature of the sample and a corresponding means of detection in the portable handheld instrument of the viral antigens and/or antibodies subject to diagnostic testing;
a detector for automatically detecting a quantitative measure of the viral antigens and/or antibodies in the sample using the corresponding means of detection in the portable handheld instrument;
a data output circuit for automatically generating the detected quantitative measure of the viral antigens and/or antibodies in the sample corresponding to the subject;
a communication circuit for automatically communicating the data output corresponding to the subject to a cloud-based database;
a cloud based ecosystem configured to comparatively analyze 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, and for automatically communicating the results of the comparative analysis to the subject from the cloud based ecosystem,
where the cloud based ecosystem configured to comparatively analyze 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 type of viral infection, if any, the subject most likely carries or has previously carried comprises a cloud-based module configured to automatically analyze the communicated data output of the microarray for positive and/or negative indications of Covid-19 antigens and/or antibodies, to automatically compare 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, and to automatically determine 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.
8. The automated cloud-based system of claim 7 where the cloud-based module configured to automatically determine 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 comprises a cloud-based module configured to automatically determine under automated control whether corresponding Z-scores of the communicated data output of positive and/or negative indications are indicative of Covid-19 rather than Z-scores of the plurality of viral infections sharing at least some of the Covid-19 antigens and/or antibodies.
9. The automated cloud-based system of claim 7 where the cloud-based module configured to automatically compare under automated control the communicated data output for positive and/or negative indications of Covid-19 to communicated data output for positive and/or negative indications of the microarray for a plurality of viral infections sharing at least some of the Covid-19 antigens and/or antibodies comprises a cloud based module configured to automatically compare the communicated data output for positive and/or negative indications of Covid-19 to communicated data output for positive and/or negative indications of the microarray for a plurality of acute respiratory infections selected from a group including SARS-CoV-2, SARS-CoV, MERS-CoV, common cold coronaviruses (including HKU1, OC43, NL63, and 229E), and multiple subtypes of influenza, adenovirus, metapneumovirus, parainfluenza, and/or respiratory syncytial virus.
10. The automated cloud-based system of claim 7 where the cloud-based module configured to automatically determine 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 comprises a cloud based module configured to automatically determine under automated control sensitivity and specificity for Covid-19 from a combination of a plurality of antigens based on a corresponding Youden Index calculated for the combination of plurality of antigens.