SANDWICH ELISA-BASED POINT-OF-CARE TEST FOR DETECTION OF OXIDATIVE STRESS IN BLOOD SAMPLES

Abstract

This invention provides a portable point-of-care testing (POCT) device for detecting malondialdehyde (MDA) in blood samples. The device is based on a sandwich ELISA platform, featuring gold-labeled antibodies for visual result interpretation. Designed for ease of use and rapid testing, this POCT device enables timely monitoring of oxidative stress, ideal for both clinical and remote healthcare settings.

Specification

Description:FIELD OF THE INVENTION
This invention relates to medical diagnostics, specifically point-of-care testing (POCT) devices designed for rapid detection of oxidative stress biomarkers, particularly malondialdehyde (MDA), in blood samples. This device facilitates on-site, efficient testing for oxidative stress in various clinical and resource-limited settings.
BACKGROUND OF THE INVENTION
Oxidative stress, indicated by lipid peroxidation markers such as malondialdehyde (MDA), plays a significant role in the pathogenesis of numerous diseases, including cardiovascular disorders, diabetes, and cancer. Conventional methods for MDA detection require laboratory equipment and trained personnel, often making these tests inaccessible in rural or resource-limited settings. Traditional approaches also involve lengthy processing times, which can delay timely clinical decisions. Addressing these challenges, the invention proposes a portable, user-friendly POCT device for rapid MDA detection. This test strip-based diagnostic tool is built on a sandwich ELISA platform, providing a fast, reliable, and accessible method for monitoring oxidative stress at the point of care.
SUMMARY OF THE INVENTION
This summary is provided to introduce a selection of concepts, in a simplified format, that are further described in the detailed description of the invention.
This summary is neither intended to identify key or essential inventive concepts of the invention and nor is it intended for determining the scope of the invention.
To further clarify advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof, which is illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail with the accompanying drawings.
The invention provides a sandwich ELISA-based POCT device designed for detecting malondialdehyde (MDA) levels in blood samples. This device leverages a highly specific antigen-antibody interaction, using a detection antibody labeled with gold particle conjugates. The POCT device consists of a sample application pad, a detection antibody loading pad, a nitrocellulose membrane for immobilizing capture antibodies, and a sample absorption pad. The result interpretation is straightforward, with visible signals indicating positive or negative results, allowing healthcare providers to make immediate clinical decisions. The device is portable and intuitive, ideal for use in various healthcare environments, from urban clinics to remote healthcare centers.
BRIEF DESCRIPTION OF THE DRAWINGS
The illustrated embodiments of the subject matter will be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. The following description is intended only by way of example, and simply illustrates certain selected embodiments of devices, systems, and methods that are consistent with the subject matter as claimed herein, wherein:
FIGURE 1: ILLUSTRATES THE LAYOUT OF THE POCT DEVICE, HIGHLIGHTING KEY COMPONENTS SUCH AS THE SAMPLE APPLICATION PAD, DETECTION ANTIBODY PAD, AND NITROCELLULOSE MEMBRANE.
The figures depict embodiments of the present subject matter for the purposes of illustration only. A person skilled in the art will easily recognize from the following description that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the disclosure described herein.
DETAILED DESCRIPTION OF THE INVENTION
The detailed description of various exemplary embodiments of the disclosure is described herein with reference to the accompanying drawings. It should be noted that the embodiments are described herein in such details as to clearly communicate the disclosure. However, the amount of details provided herein is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure as defined by the appended claims.
It is also to be understood that various arrangements may be devised that, although not explicitly described or shown herein, embody the principles of the present disclosure. Moreover, all statements herein reciting principles, aspects, and embodiments of the present disclosure, as well as specific examples, are intended to encompass equivalents thereof.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments. As used herein, the singular forms "a"," "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises," "comprising," "includes" and/or "including," when used herein, specify the presence of stated features, integers, steps, operations, elements and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components and/or groups thereof.
It should also be noted that in some alternative implementations, the functions/acts noted may occur out of the order noted in the figures. For example, two figures shown in succession may, in fact, be executed concurrently or may sometimes be executed in the reverse order, depending upon the functionality/acts involved.
In addition, the descriptions of "first", "second", "third", and the like in the present invention are used for the purpose of description only, and are not to be construed as indicating or implying their relative importance or implicitly indicating the number of technical features indicated. Thus, features defining "first" and "second" may include at least one of the features, either explicitly or implicitly.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example embodiments belong. It will be further understood that terms, e.g., those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
The proposed sandwich ELISA-based POCT device for malondialdehyde (MDA) detection comprises several layers and components designed for efficient and rapid testing. The sample application pad serves as the entry point, where a blood sample is introduced. This pad is in contact with a detection antibody loading pad, pre-treated with antibodies conjugated to gold particles. The gold-labeled antibodies facilitate a clear and visible signal upon binding with the MDA antigen, enabling easy result interpretation.
The nitrocellulose membrane, positioned beneath the detection pad, contains immobilized capture antibodies specific to MDA. When the sample flows through the membrane, MDA present in the sample binds to these capture antibodies, completing the antigen-antibody sandwich structure. The signal generated is dependent on the concentration of MDA in the sample, providing qualitative and semi-quantitative insights into the oxidative stress level. The result is displayed as either positive or negative based on signal visibility, with a control line ensuring test accuracy.
The final layer of the POCT device includes a sample absorption pad, which absorbs excess fluid and maintains flow consistency across the test. This structural design ensures that the device is portable, stable, and capable of delivering results within minutes. The device's user-friendly design allows non-specialist healthcare providers to operate it effectively, making it suitable for both urban and rural healthcare settings.
, Claims:1. A point-of-care test (POCT) device for detecting oxidative stress, comprising a sample application pad, detection antibody loading pad, nitrocellulose membrane, and sample absorption pad.
2. The device as claimed in Claim 1, wherein the detection antibody is labeled with gold particles, facilitating visual result interpretation upon binding with malondialdehyde (MDA).
3. The device as claimed in Claim 1, wherein the nitrocellulose membrane is embedded with immobilized capture antibodies specific to malondialdehyde.
4. The device as claimed in Claim 1, configured to display results based on antigen-antibody interaction, providing a positive or negative indication of oxidative stress.
5. The device as claimed in Claim 1, designed for ease of use, allowing non-specialist healthcare providers to operate the device effectively in resource-limited settings.
6. A method for detecting oxidative stress as claimed in Claim 1, wherein the device provides real-time results based on the presence of malondialdehyde in blood samples.
7. The device as claimed in Claim 1, configured to be portable and self-contained, suitable for rapid testing in clinical and field environments.
8. The device as claimed in Claim 1, further featuring a sample absorption pad for maintaining consistent fluid flow and ensuring accurate test results.

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