Method, system, and apparatus for measurement and recording of blood chemistry and other physiological measurements

Abstract

A multi-component test strip for analyzing a plurality of blood components in a single blood sample. The test strip comprises a porous medium having a sample receiving region, and two or more sample analysis regions. The sample receiving region is fluidically in series with the two or more sample analysis regions, and the two or more sample analysis regions are fluidically in parallel with each other. The two or more sample analysis regions contain indicating reagents specific to two or more specific blood components. Also disclosed is a system using the test strip for blood characterization, and a method of blood characterization and analysis.

Description

FIELD OF THE INVENTION [0001] The invention relates to methods, systems, and apparatus for in-vitro testing of blood specimens by means of visible light, in which the blood specimen is collected on a single, unitary, integral absorbent test strip, and analyzed blood components. The analysis is based on optical properties of blood components with indicators or series, sequences, or systems of indicators. A further aspect of the invention is storing blood component measurements, optionally with other biological, physiological, and medical data for analysis and transmission, for example, to a health care provider. BACKGROUND [0002] 1. Background—medical. Diabetes and coronary artery disease are major killers, but ones that are capable of detection, monitoring, and management through blood chemistry. [0003] a. Coronary Artery Disease. Far too many people still die, and die too young, from cardiovascular disease. The American Heart Association reports that cardiovascular disease still ki...

AI Technical Summary

Benefits of technology

[0077] A user friendly, home health care blood chemistry apparatus, method and system is provided. The invention requires only a “pin prick” sample (1 to 50 microliters) of capillary blood, eliminating the need for puncturing arteries and veins by a trained technician to obtain a blood sample. The sample is applied to a test strip including a sample receiving pad and sample analysis pads. The blood sample is applied to the sample receiving pad and flows, by surface tension, hydrophobicity, and capillary flow, to the separate analysis pads that are fluidically in parallel with each other and fluidically in series with the sample receiving pad. Each sample analysis pad contains reagents, including enzymes and dyes, that are specific to producing an optically detectable effect for a specific blood component. The optical effects are detected by a reflectance meter that is used in conjunction with the test strip. The optical effects are converted to digital data, and stored in a storage device associated with the meter, for transmission to a health care provider.

Problems solved by technology

Far too many people still die, and die too young, from cardiovascular disease.

If reduced flow occurs in the coronary (heart) arteries, it can lead to a type of chest pain called angina pectoris.

A tear or rupture in the plaque may cause a blood clot to form.

If the flow of blood to a part of the heart is stopped, a person will have a heart attack.

Although it's often discussed as if it were a poison, one can't live without it.

However, after menopause, women's total cholesterol rises and the protective HDL drops unless they take hormone replacement therapy.

If members of the family have undesirable lipid levels and cardiovascular problems, the risks for these problems are increased.

Generally, in Type I diabetes (“insulin dependent” or “childhood onset” diabetes) the pancreas does not secrete sufficient amounts of insulin into the bloodstream to regulate carbohydrate metabolism.

Diabetes accelerates the development of atherosclerosis, which, in turn, increases the risk for heart attack, stroke and reduced circulation to the feet.

This is a challenge for the patient and clinician because of changing health care practices, paradigms, and economics in the United States.

The overarching medical challenge is to effectively control blood glucose, blood cholesterol, and lipoproteins.

These early tests were used in glucose monitoring for years, even though they had significant limitations.

The sample size required was rather large for a finger stick test and was difficult to achieve for some people whose capillary blood does not express readily.

The fact that the reaction was stopped by removing the sample led to uncertainty in the result, especially in the hands of the home user.

Overwashing gave low results and underwashing gave high results.

Another problem that often existed in simple end user calorimetric determinations is the necessity for initiating a separate timing sequence when blood is applied to a reagent pad.

This is particularly difficult since it is often necessary to insure that the timing circuit is started only when blood is applied to the test strip.

The presence of red blood cells or other colored components often interfered with the measurements of these absolute color values, thereby calling for exclusion of red blood cells in the prior art methods as they were most widely practiced.

For this reason, glucose measurements alone do not give an accurate picture of the patient's blood chemistry.

While user friendly, home individual tests to directly and indirectly measure glucose have been developed, as described above, there has been no convenient, user-friendly, home test system available which allows a diabetic patient or a physician to assess both the immediate glucose level as well as an intermediate or long-term glycemic condition.

Currently, while the glucose test is routinely run by the doctor or the patient, however, the glycosolated protein testing is typically performed in a clinical lab setting using complicated techniques and expensive instrumentation.

Results from these clinical lab tests are usually not available to the doctor and patient for several days.

This delay in information transfer decreases the value of the test result.

The traditional method of measuring HDL cholesterol has been through wet chemistry tests that are time consuming and not well suited to home testing by patients.

This was clearly not a patient friendly, home diagnostic test.

This method is even more laborious and time consuming, requires considerable technical skill, and is quite expensive.

Electrophoresis of lipoproteins has also been used but this again is slow, expensive and semi-quantitative.

Again, these methods are neither user friendly nor suited for home diagnostic testing.

HDL cholesterol measurements therefore tended to be time consuming with manual methods.

The automated analyzers which can dispense and process the reagents automatically are available but can be quite complex and expensive.

Even though this presents a significant improvement, for accurate results, it needs careful operator supervision if done manually or expensive instrumentation if automated.

While this method represents a step in the right direction, it is neither user friendly, nor inexpensive, nor adaptable to home diagnosis.

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