System and method for bone loss assay
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Publication Number
US-10557857-B1
Publication Date
2020-02-11
Expiration Date
Abstract
Disclosed are embodiments of a lateral flow test strip (LFTS) platform which measure osteocalcin (OC) and deoxypyridinoline (Dpd) in saliva to identify early indications of bone loss and minimize bone fracture risk associated with osteoporosis. The OC assay embodiments are based on the experimentally identified optimal markers which exhibit selectivity with very low false positives, and sensitivity relevant to clinical requirements. A prospective clinical study sampling of 20 patients demonstrated excellent correlation of OC in saliva with bone mineral density (BMD). Salivary OC and Dpd levels were validated with a standard commercial ELISA kit against serum (OC) and urine (Dpd).
Core Innovation
The invention relates to a fluorescence-based lateral flow test strip platform for point-of-care screening of osteoporosis by measuring osteocalcin in saliva. A saliva sample from a subject is applied to a lateral flow test strip that includes a conjugate pad deposited with a fluorescently labeled detector antibody and at least one capture line reactive to osteocalcin, together with a control line. The capture line comprises a capture antibody specific to osteocalcin.
The platform uses a sandwich immunochromatographic approach with the fluorescently labeled detector antibody and osteocalcin-reactive capture line(s) on a nitrocellulose membrane. After the test strip is placed in a fluorescent reader, the reader is calibrated to quantitatively measure osteocalcin concentration at a given sample volume, and a screening diagnostic evaluation is performed according to the quantitative measurement obtained from the reader.
The disclosed system further supports described selection of antibody pairs and optionally additional biomarker inclusion through multiplexing. The capture antibody and the fluorescently labeled detector antibody are chosen from specified antibody pair combinations.
Claims Coverage
The independent claim set defines quantitative osteoporosis screening using a fluorescently labeled lateral flow test strip and a calibrated fluorescent reader. The coverage is centered on a sandwich lateral flow configuration with osteocalcin-reactive capture lines, a control line, and specified detector/capture antibody pairings.
Saliva-based lateral flow osteoporosis screening with fluorescent detector and osteocalcin capture line
Obtaining a saliva sample from a subject and applying the saliva sample to a lateral flow test strip comprising a conjugate pad deposited with a fluorescently labeled detector antibody and at least one capture line reactive to osteocalcin, wherein the strip further comprises a control line.
Quantitative fluorescent reader evaluation of osteocalcin
Placing the test strip in a fluorescent reader calibrated to quantitatively measure osteocalcin concentration at a given sample volume and performing a screening diagnostic evaluation according to a quantitative measurement obtained from the reader.
Osteocalcin capture/detector antibody pairing from specified group
The capture antibody and the fluorescently labeled detector antibody pair are chosen from the group consisting of 940/939, 11F8/939, 2H9/939, 940/H10, 2H9/H10, 940/3G8, and 11F8/3G8.
Fluorescent microparticle conjugate pad with immobilized capture line pairing
The conjugate pad comprises a fluorescently labeled detector antibody conjugated to fluorescent microparticles that pair with a capture antibody immobilized on the membrane along one capture line.
Overall, the claims cover quantitative, fluorescence-readout osteoporosis screening using saliva, with an osteocalcin-reactive capture line and a control line read in a calibrated fluorescent reader, restricted to specified antibody pairs and a fluorescent microparticle-based detector reagent format.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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