Abstract: The present disclosure provided methods, devices, and systems for CRISPR-based screening and detection of HPV-related diseases. In particular, the present disclosure provides a CRISPR-Cas assay for rapid, enhanced screening of cervical intraepithelial neoplasia (CIN) and cancer, which can also be applied to screening for other HPV-related anogenital or head and neck cancers, whose origin is based on infections with high-risk strains of human papillomavirus (hr-HPV).

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.

Abstract: Point-of-care tools for screening biological samples for markers associated with pathogenic microbial infections. In particular, devices and systems for screening cervical cells for the expression of proteins, which occur as a result of human papillomavirus infection and progression to invasive cervical cancer.