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US-20260126432-A1 - POINT OF CARE IMMUNIZATION TESTING SYSTEM-DETECTION METHODS

US20260126432A1US 20260126432 A1US20260126432 A1US 20260126432A1US-20260126432-A1

Abstract

A point of care immunization system based upon a range of detection methods to rapidly test a patient in order to ascertain an immunization profile so that vaccinations can be administered to address identified gaps. A point of care system comprised of sample and test strips/cartridges, with said test strips/cartridges configured to meet healthcare requirements of national governing bodies. A point of care system is provided that can function as a stand-alone diagnostic system, a stand-alone kit or with a device.

Inventors

  • Sudip Ghatak

Assignees

  • IMMUNOPROFILE, LLC

Dates

Publication Date
20260507
Application Date
20251219

Claims (17)

  1. 1 . An immunization method comprising administration of one or more vaccines to a subject identified as having a deficiency in immunization or sensitization status to one or more pathogens wherein the status is determined using a diagnostic method comprising: (i) contacting a diluted or undiluted biological sample obtained from the subject with a device comprising a diagnostic set of reagents for simultaneously conducting label-based immunoassays wherein the label-based assay utilizes one or more labels selected from the group consisting of: a fluorescence label; a fluorogenic label; an electrochemical-luminescent label; a microparticle label; and a nanoparticle label and wherein said immunoassays include a plurality of vaccination-indicative antigens or sensitization-indicative antigens derived from multiple pathogens disposed on a test strip or cartridge; (ii) detecting the presence or absence of a threshold amount of a plurality of antigen reactive antibodies present in the biological sample based on the contacting, wherein the contacting of step (i) is performed on a microfluidics lab-on-a-chip, and wherein the detecting comprises use of one or more assays selected from the group consisting of an enzyme assay; an ELISA assay; a fluorogenic reporter assay; an electro-chemiluminescent assay; a competitive assay; a noncompetitive assay; and a sensor-based assay wherein said sensor-based assay utilizes one or more sensors selected from the group consisting of a chemical sensor; a paramagnetic sensor; and an optical sensor; (iii) comparing established standard levels of antibodies indicative of protective immunization to the threshold amount of a plurality of antigen reactive antibodies present in the biological sample; wherein detection of lower levels of antigen reactive antibodies as compared to the established standard levels of antibodies indicative of protective immunization indicates a deficiency in immunization or sensitization status; and (iv) where a deficiency in immunization or sensitization status is indicated, one or more vaccines are administered to the subject.
  2. 2 . The method of claim 1 , wherein the diagnostic method is performed at a point-of-care.
  3. 3 . The method of claim 1 , wherein the diagnostic method is performed at a point-of-assessment.
  4. 4 . The method of claim 1 , wherein the diagnostic method is performed at a point-of-diagnosis.
  5. 5 . The method of claim 1 , wherein the contacting is conducted in one or more immune-responsive sensors, and the detecting comprises signals from the sensors, wherein the signal size for a given vaccination- or sensitization-indicative antigen is indicative of whether the threshold amount is present.
  6. 6 . The method of claim 1 , wherein the detecting is performed in panel with multiple tests simultaneously or in sequence.
  7. 7 . The method of claim 1 , wherein the contacting and detecting is performed using the test strip or cartridge and a detector or analyzer.
  8. 8 . The method of claim 7 , wherein the detector or analyzer is a point-of-care detector or point-of-care analyzer.
  9. 9 . The method of claim 1 , wherein the diagnostic assay is performed using a test strip or cartridge and a handheld device.
  10. 10 . The method of claim 9 , wherein the handheld device is a point-of-care handheld device.
  11. 11 . The method of claim 1 , wherein the biological sample comprises blood, sera, lymph fluid, urine, tears, or saliva.
  12. 12 . The method of claim 1 , wherein the test strip or cartridge contains one or more vaccination-indicative antigens or sensitization-indicative antigens which are selected for a specific patient population.
  13. 13 . The method of claim 12 , wherein the patient population is classified based on age, gender, location, or any combination thereof.
  14. 14 . The method of claim 1 , wherein a dose response curve is deduced based on the amount of antigen-reactive antibodies detected in the diluted sample.
  15. 15 . The method of claim 1 , wherein the plurality of vaccination-indicative antigens or sensitization-indicative antigens are derived from the group of pathogens consisting of measles, mumps, rubella, diphtheria, tetanus, pertussis, polio, hepatitis A, hepatitis B, hepatitis C, rotovirus, haemophilus, pneumococcal, influenza, varicella and meningococcal.
  16. 16 . A method for testing a biological sample from a subject for immunization or sensitization status comprising: in a label-based assay contacting an undiluted biological sample obtained from the subject with a plurality of vaccination-indicative antigens or sensitization-indicative antigens disposed on a test strip or cartridge; detecting the presence or absence of a threshold amount of a plurality of immune mediators reactive to the antigens present in the biological sample based on the contacting, thereby determining immunization or sensitization status with respect to the antigens; and generating a report on which of the one or more types of vaccination- or sensitization-indicative antigens correspond with a threshold amount of the plurality of antigen-reactive immune mediators present in the biological sample.
  17. 17 . A method for testing a biological sample from a subject for immunization or sensitization status comprising: in a label-based assay contacting a biological sample obtained from the subject with a plurality of vaccination-indicative antigens or sensitization-indicative antigens disposed on a test strip or cartridge; and with a detector or analyzer, detecting the presence or absence of a threshold amount of a plurality of immune mediators reactive to said antigens present in the biological sample based on the contacting, thereby determining immunization or sensitization status with respect to the antigens.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation U.S. patent application Ser. No. 18/307,192 filed Apr. 26, 2023 which is a continuation of U.S. patent application Ser. No. 15/978,751 filed May 14, 2018, which is a continuation of U.S. patent application Ser. No. 15/599,775, filed May 19, 2017, which is a divisional of U.S. patent application Ser. No. 14/360,763, filed May 27, 2014, which is the U.S. National Phase of International Application Serial No. PCT/US2012/066226, filed Nov. 21, 2012, which claims the benefit of U.S. Provisional Application Ser. No. 61/563,887, filed Nov. 28, 2011; U.S. patent application Ser. No. 15/978,751 is also a continuation of the U.S. patent application Ser. No. 14/749,044 filed Jun. 24, 2015, which claims the benefit of U.S. Provisional Application Ser. No. 62/016,975 filed Jun. 25, 2014; U.S. patent application Ser. No. 15/978,751 is also a continuation of the U.S. patent application Ser. No. 14/619,435 filed Feb. 11, 2015, which claims the benefit of U.S. Provisional Application Ser. No. 61/938,482 filed Feb. 11, 2014, which entire contents of each of which are incorporated by reference herein. This application is also a continuation of U.S. patent application Ser. No. 14/749,044, filed Jun. 24, 2015, which claims the benefit of U.S. Provisional Patent Application Ser. No. 62/016,975, filed Jun. 25, 2014, the entire contents of each of which are incorporated by reference herein. This application is also a continuation of U.S. patent application Ser. No. 14/619,435, filed Feb. 11, 2015, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/938,482, filed Feb. 11, 2014, the entire contents of each of which are incorporated by reference herein. TECHNICAL FIELD The present disclosure relates to, among other things, a system to diagnose a patient's immunization protection levels. BACKGROUND Point of care diagnostic instruments have been employed for years in medical offices and clinical settings to target various applications. Typically, point of care instruments are targeted at rapid testing to detect a patient's exposure to an infectious agent or to provide general information on vital statistics such red blood cell count, white blood cell count and amount of lead present. Infectious disease tests include situations such as determining the presence of streptococcal (strep) bacteria in diagnosing strep throat. Many of these tests fall in the category of CLIA (Clinical Laboratory Improvement Amendments) waived tests, which are defined as simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly. The main problem is that no point of care device exists to quickly and inexpensively detect a patient's antibody levels to determine immunization protections. Currently, to make such a diagnosis the patient must have blood drawn at a clinical setting and the blood sample tested in a clinical laboratory. The tests are ordered on an individual basis, such as measles, and can take more than a week for response time at high “per test” costs. If a patient needs to be tested for multiple immunization levels, separate and individual tests must be ordered. There is no availability to quickly diagnose a patient's immunity level across the recommended healthcare guidelines in an easy, rapid and cost effective manner. Furthermore, poor record tracking of individual patient's immunizations can result in patients themselves generally not knowing if they are protected. The range of vaccine efficacies is wide—some as low as 50%—, especially in patients with compromised immune systems, and there is no way to know how an individual will respond to the vaccine. Not only is the duration of protection unpredictable, but other factors can affect a vaccine's efficacy, including missed booster shots, a change in medical condition (HIV, hepatitis, obesity), age of vaccinations, age of vaccines, compromised vaccines, or the like. Certain vaccines cannot be given to children or pregnant women, or while a patient is immuno-compromised. If a patient is administered an old or even expired vaccine, the patient may not receive full immunity. Recalls occasionally pull out problem vaccine batches, but they are not a guarantee that all vaccines are viable and effective. Another growing problem is that patients are opting out of vaccines, so communities no longer have near 100% immunization rates. This leads to disease outbreaks in the US and other developed countries when a disease carrier enters a vulnerable population. Disease outbreaks for measles and whooping cough have occurred in the US in 2011, along with outbreaks in Europe. Given the ease of travel from vast geographies, a disease carrier can travel almos