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Three-dimensional paper-based slip device for one-step point-of-care testing.

ABSTRACT: In this study, we developed a new type of paper-based analytical device (PAD), the three-dimensional (3D) slip-PAD, to detect infectious human norovirus for global healthcare. The 3D configuration of the papers combined with a slip design provides unique features and versatility that overcome the limitations of fluidic manipulation and sensitivity in point-of-care (POC) tests. The assay can be carried out in a single step based on a moveable slip design, making it suitable for unskilled users. The 3D fluidic network developed by layered construction of wax-patterned papers provides different fluidic paths for the sequential delivery of multiple fluids without the need for peripheral equipment. The release and mixing of enhancement reagents on the device improved the sensitivity and detection limit. The assay results could be visualized by naked eye within 10?min, with subsequent amplification of the signal over time (<60?min). The device showed a broad dynamic range of detection and high sensitivity, with a detection limit of 9.5?×?10(4) copies ml(-1) for human norovirus. These results demonstrate that the 3D slip-PAD is a sensitive diagnostic assay for detecting human norovirus infection that is particularly suitable for POC testing in regions where resources are scarce.

SUBMITTER: Han KN

PROVIDER: S-EPMC4865726 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Three-dimensional paper-based slip device for one-step point-of-care testing.

Han Kwi Nam KN Choi Jong-Soon JS Kwon Joseph J

Scientific reports 20160513

In this study, we developed a new type of paper-based analytical device (PAD), the three-dimensional (3D) slip-PAD, to detect infectious human norovirus for global healthcare. The 3D configuration of the papers combined with a slip design provides unique features and versatility that overcome the limitations of fluidic manipulation and sensitivity in point-of-care (POC) tests. The assay can be carried out in a single step based on a moveable slip design, making it suitable for unskilled users. T ...[more]

PMID: 27174731

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Project description:Nearly 7% of the world's population live with a hemoglobin variant. Hemoglobins S, C, and E are the most common and significant hemoglobin variants worldwide. Sickle cell disease, caused by hemoglobin S, is highly prevalent in sub-Saharan Africa and in tribal populations of Central India. Hemoglobin C is common in West Africa, and hemoglobin E is common in Southeast Asia. Screening for significant hemoglobin disorders is not currently feasible in many low-income countries with the high disease burden. Lack of early diagnosis leads to preventable high morbidity and mortality in children born with hemoglobin variants in low-resource settings. Here, we describe HemeChip, the first miniaturized, paper-based, microchip electrophoresis platform for identifying the most common hemoglobin variants easily and affordably at the point-of-care in low-resource settings. HemeChip test works with a drop of blood. HemeChip system guides the user step-by-step through the test procedure with animated on-screen instructions. Hemoglobin identification and quantification is automatically performed, and hemoglobin types and percentages are displayed in an easily understandable, objective way. We show the feasibility and high accuracy of HemeChip via testing 768 subjects by clinical sites in the United States, Central India, sub-Saharan Africa, and Southeast Asia. Validation studies include hemoglobin E testing in Bangkok, Thailand, and hemoglobin S testing in Chhattisgarh, India, and in Kano, Nigeria, where the sickle cell disease burden is the highest in the world. Tests were performed by local users, including healthcare workers and clinical laboratory personnel. Study design, methods, and results are presented according to the Standards for Reporting Diagnostic Accuracy (STARD). HemeChip correctly identified all subjects with hemoglobin S, C, and E variants with 100% sensitivity, and displayed an overall diagnostic accuracy of 98.4% in comparison to reference standard methods. HemeChip is a versatile, mass-producible microchip electrophoresis platform that addresses a major unmet need of decentralized hemoglobin analysis in resource-limited settings.

Dataset Information

Three-dimensional paper-based slip device for one-step point-of-care testing.

Publications

Three-dimensional paper-based slip device for one-step point-of-care testing.

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