Abstract
Reports manifest a continuing need for the development of rapid and on-site (point of care) assays. Current diagnostic methods commonly used for detection of antibodies and antigens have significant limitations. Scientists at Micro Detect, Inc. have developed an innovative diagnostic device (method) that can be utilized broadly for antibody/antigen interactions including diagnostic assays in the medical, veterinary and food industries. The developed device can be utilized for the detection of antibodies against a single antigen or vice versa. It can also be tailored for specific panels that detect antigens or antibodies for diverse infectious agents, proteins, hormones, tumor markers, autoimmune markers, and allergens. Additionally, it can also be used for detection of toxins, antitoxins, nucleic acids, enzymes, drugs, etc. in both humans and animals. Specimens used in different formats of the device can be tears, saliva, whole blood, serum, plasma, urine, stool, and other bodily discharges. The good intra and inter precisions and acceptable linearity of the device support reliable use of the device. The CV of the device is 1.9% - 2.2%. Likewise, the performance of the device using 92 confirmed negative and positive specimens via a typical assay showed 100% sensitivity, 80% specificity, 96.8% efficacy, 80% positive predictive value, and 100% negative predictive value. The results of our feasibility study suggest reliable utility of a device for rapid, easy-to-use, inexpensive, and on-site (point of care) diagnostic assays. This presents a potential breakthrough in diagnostic methodologies that can be integrated into modern medicine and food industries.
Highlights
Current diagnostic methods commonly used for detection of antibodies and antigens have significant limitations
In lateral-flow, which can be considered as an on-site method delivering rapid results, gold or colored latex particles are coated with specific antigens or antibodies
In order to measure the titer of a specific antibody to a specific antigen, the antigen/antibody complex is used as the baseline data and after addition of the second antibody to the device and washing, the titer of IgG is measured numerically
Summary
The known antibodies or antigens fixed on a membrane capture corresponding antigens or antibodies coated on the gold or latex particles This method has several limitations and cannot be widely used, for the detection of certain analytes and screening purposes, it remains the best choice. The innovative technology, UV Laser Spectroscopy Diagnostic (UVLSD) developed at Micro Detect, Inc. has the ability to readily detect antigens or antibodies from either single or multiple analytes (specific panels). This includes pathogenic infectious agents (viruses, bacteria, fungi, chlamydia, and/or protozoa), antibodies to autoimmune markers, and allergens. The extracts of foods containing microorganisms or their toxins may be utilized
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