Point of care immunization testing system

Abstract

A point of care immunization system based upon microfluidics and micro-titration technologies 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 uniquely shaped and color distinguishing sample and test cartridges, with said test cartridges configured to meet healthcare requirements of national governing bodies. A point of care system including an easy access vaccine storage device with indicators to provide data on viability of stored vaccines.

Description

[0001]This application claims the priority of U.S. Prov. Pat. App. 61 / 563,887, filed Nov. 28, 2011 (“Point of Care Immunization Testing System”). This priority application is incorporated herein in its entirety.[0002]The present invention relates to, among other things, a system to diagnose a patient's immunization protection levels which is comprised of three elements: a point of care diagnostic instrument, targeted test cartridges and accompanying vaccine supply packs.[0003]The point of care diagnostic instrument measures the antibody levels for various targets based upon a patient's sample. The targeted test cartridge is configured with the necessary immunization tests per the healthcare guidelines of the specific country for the appropriate group by age, gender, life changing event, and the like. The accompanying vaccine supply pack is configured with vaccines corresponding to the targeted test cartridge, offering the needed vaccinations based upon the patient's test result. The...

AI Technical Summary

Benefits of technology

The patent describes a system that allows healthcare providers and patients to quickly and easily test for immunization protection and address any gaps through prompt administration of necessary vaccines. The system includes a simple but effective diagnostic instrument with ports for samples and test cartridges designed for different parameters such as age, gender, and life-changing event. The system also provides a means to update and track patient's immunization records linking it to clinical information systems. Additionally, the patent describes a biological sample cartridge for ease of use and a vaccine supply pack with ease of use, access, and sensors to detect temperature, expiration, and quantity / supply. The immunization testing device described in the patent can test a biological sample from a subject by making dilutions of the sample, contact it with vaccine- or sensitization-indicative antigens, and interpret the signals generated to output a report on the immune status of the subject with respect to an array of separate vaccine- or sensitization-indicative antigens. The patent also describes a sample prep step to ensure the blood sample is properly managed for the assay, which may include treating it with anti-coagulant to prevent blood clotting.

Problems solved by technology

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.

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.

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.

The only available testing for immunity is costly for the patient, and does not yield immediate results.

Currently no point of care device is targeted for detecting immunization levels leaving most patients unclear of how well they are protected against disease until disease sets upon them.

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