Abstract
The ability to perform laboratory testing near the patient and with smaller blood volumes would benefit patients and physicians alike. We describe our design of a miniaturized clinical laboratory system with three components: a hardware platform (ie, the miniLab) that performs preanalytical and analytical processing steps using miniaturized sample manipulation and detection modules, an assay‐configurable cartridge that provides consumable materials and assay reagents, and a server that communicates bidirectionally with the miniLab to manage assay‐specific protocols and analyze, store, and report results (i.e., the virtual analyzer). The miniLab can detect analytes in blood using multiple methods, including molecular diagnostics, immunoassays, clinical chemistry, and hematology. Analytical performance results show that our qualitative Zika virus assay has a limit of detection of 55 genomic copies/ml. For our anti‐herpes simplex virus type 2 immunoglobulin G, lipid panel, and lymphocyte subset panel assays, the miniLab has low imprecision, and method comparison results agree well with those from the United States Food and Drug Administration‐cleared devices. With its small footprint and versatility, the miniLab has the potential to provide testing of a range of analytes in decentralized locations.
Highlights
We describe our design of a miniaturized clinical laboratory system with three components: a hardware platform that performs preanalytical and analytical processing steps using miniaturized sample manipulation and detection modules, an assay-configurable cartridge that provides consumable materials and assay reagents, and a server that communicates bidirectionally with the miniLab to manage assay-specific protocols and analyze, store, and report results
We demonstrate the functionality of the system with analytical performance metrics across a variety of analyte classes, as represented by a Zika virus[30,31] molecular diagnostic assay, an anti-herpes simplex virus type 2 (HSV-2) immunoglobulin G (IgG) immunoassay, a clinical chemistry lipid panel, and a lymphocyte subset hematology panel
We evaluated the analytical sensitivity of the assay by examining the limit of detection (LoD) using Zika virus spiked into whole blood with concentrations ranging from 0 to 3,520 genomic copies/ml
Summary
Clinical laboratory tests are invaluable in diagnosing and managing diseases.[1,2] Currently, such tests are most often conducted in centralized laboratories using a variety of analytical methods executed on a multitude of large-scale analyzers.[3,4] These tests can require clinically important amounts of blood,[5–13] sometimes including oversampling volumes[11,13,14] and often involve complex pre-analytical and analytical processing subject to human error.[15]. Clinical laboratory tests are invaluable in diagnosing and managing diseases.[1,2] Such tests are most often conducted in centralized laboratories using a variety of analytical methods executed on a multitude of large-scale analyzers.[3,4]. These tests can require clinically important amounts of blood,[5–13] sometimes including oversampling volumes[11,13,14] and often involve complex pre-analytical and analytical processing subject to human error.[15]. Available point of care systems have made progress toward multiplexing commonly ordered tests,[22–28] but sometimes suffer from performance limitations when compared to centralized laboratories.[23]. Many point of care analyzers lack connectivity that would allow for comprehensive oversight and tracking of system performance. When implemented with the same analytical performance specifications and relevant test menu as centralized laboratories, a connected, decentralized bench top testing platform could potentially augment standard clinical laboratory services.[29]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
