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

FIELD[0001]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.[0002]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 system also updates the patient's immunization records and links to the appropriate electronic patient records, laboratory information system, hospital information system and insurance reporting system, am...

AI Technical Summary

Benefits of technology

[0013]In certain embodiments, the invention provides a biological sample cartridge for ease of use and prevents confusion with the targeted test cartridge. The biological sample cartridge may contain anti-coagulants in the case of blood samples to facilitate the sample prep process, enable easier transfer of the blood sample and improve assay performance.

[0015]In certain embodiments, the invention provides a vaccine supply pack providing ease of use, ease of access, organized storage, space saving, sensors to detect temperature, coding to indicate expiration, sensor to detect quantities / supply, tags to establish pedigree, and the like.

[0026]Also provided is an immunization testing device for testing a biological sample from a subject comprising, an analytical module comprising a controller, an data output device, and one or more input ports having a conjugate input comprising a test cartridge port, wherein the test cartridge port has an ID receiver for receiving an ID from a immunization test cartridge, wherein the controller is adapted to operate the analytical module to make two or more dilutions of the biological sample, contact said dilutions with separate replicates of vaccine- or sensitization-indicative antigens so as to generate a signals indicative of the amount of antigen-reactive immune molecules in the biological dilutions, interpret the received ID to identify one of a pre-set plurality of available immunization test cartridges, and to utilize the generated signals and the immunization test cartridge to output a report on the immune status of the subject with respect to an array of separate vaccine- or sensitization-indicative antigens (e.g., 4 or more). The ports can be shaped to accept their conjugate input and not accept the conjugate inputs of other ports present. The biological sample cartridge may contain anti-coagulants in the case of blood samples to facilitate the sample prep process, enable easier transfer of the blood sample and better assay performance. The first step of the immunoprofile assay is a sample prep step to ensure the blood sample is properly managed in order to serve the purposes of the assay. Part of this effort can be, as needed, to treat the blood sample with anti-coagulant to prevent the blood from clotting which in some instances can have negative effects on the assay process.

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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