Translating in vitro diagnostics from centralized laboratories to point-of-care locations using commercially-available handheld meters

Abstract

There is a growing demand for high-performance point-of-care (POC) diagnostic technologies where in vitro diagnostics (IVD) is fundamental for prevention, identification, and treatment of many diseases. Over the past decade, a shift of IVDs from the centralized laboratories to POC settings is emerging. In this review, we summarize recent progress in translating IVDs from centralized labs to POC settings using commercially available handheld meters. After introducing typical workflows for IVDs and highlight innovative technologies in this area, we discuss advantages of using commercially available handheld meters for translating IVDs from centralized labs to POC settings. We then provide comprehensive coverage of different signal transduction strategies to repurpose the commercially-available handheld meters, including personal glucose meter, pH meter, thermometer and pressure meter, for detecting a wide range of targets by integrating biochemical assays with the meters for POC testing. Finally, we identify remaining challenges and offer future outlook in this area.

Keywords: Handheld meters; In vitro diagnostics; Personal glucose meter; Point-of-Care testing; Signal transduction strategies.

Conflict of interest statement

Declaration of Interest Yi Lu is a co-Founder of GlucoSentient, Inc.

Figures

Figure 1.

Schematic illustration of typical steps and strategies of in vitro diagnostics of biological samples.

Figure 2.

(A) Scheme of the method using a PGM to detect a wide range of targets beyond glucose. Reprinted from Xiang et al., 2011 [10] with permission of Nature Publishing Group. (B) Schematic illustration of detection process using glucose encapsulating liposome (GEL) on test trip device linked with a PGM. Reprinted from Zhao et al., 2017 [127] with permission of Elsevier. (C) Schematic illustration of NADH/PGM system for non-glucose target detection using NADH-dependent enzymes. Reprinted from Zhang et al., 2016 [129] with permission of Wiley. (D) Installing of logic gate on PGMs for the portable, resettable, and quantitative Point-of-Care detection of many targets in clinical care. Reprinted from Zhang et al., 2018 [130] with permission of Wiley.

Figure 3.

(A) Illustration of the synthetic process for Con A-GOx-CaHPO4 organic-inorganic hybrid nanoflowers and the corresponding scheme for immunoassay of E. coli O157:H7. Reprinted from Ye et al., 2016 [136] with permission of Wiley. (B) Schematic representation for the screening of thrombin inhibitors (lower four sensing areas) and detection of thrombin (upper four sensing areas) using a single eight-zone self-powered, portable, and light-addressable photoelectrochemical sensor. Reprinted from Wang et al., 2018 [147] with permission of ACS. (C) Translating molecular detections into a simple temperature test using a target-responsive smart thermometer. Reprinted from Zhang et al., 2018 [11] with permission of RSC. (D) Principle of the temperature-based immunosensor based on the exothermic reaction between H2O and CaO using a common thermometer as readout. Reprinted from Ma et al., 2019 [151] with permission of ACS.