SCREENING SYSTEMS AND METHODS FOR HPV-ASSOCIATED CERVICAL DISEASE
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United States of America
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Dec 12, 2024
app pub date -
Aug 28, 2024
filing date -
Aug 28, 2024
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Abstract
Devices and methods described herein provide improved methods of screening for cervical disease. In certain embodiments, a sample transfer and preparation vial is provided, enabling self-collection and pre-processing of cervical samples to expedite sample processing and eliminate the need for a patient to travel to a medical facility for screening. In certain embodiments, an analysis cartridge having a multiplexed biomarker panel and an immunoassay-based analyzer are provided for sample analysis. The multiplexed biomarker panel provides high sensitivity and specificity to enable effective screening with a single procedure and thus, eliminates the need for multiple tests. In certain embodiments, a method of screening for cervical disease is provided, utilizing the aforementioned multiplexed biomarker panel. The method includes detecting levels of at least two biomarkers in a cervical sample, wherein one of the biomarkers is an oncoprotein from a high-risk strain of human papilloma virus (HPV) and another is a cellular protein.
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