ASSURED‐compliant point‐of‐care diagnostics for the detection of human viral infections

Abstract

Viral disease outbreaks have been always a threat to global public health making affordable, rapid and accurate diagnostics highly important tools to slow down the spread of viruses and decrease the mortality rate. Point‐of‐care (POC) diagnostics have emerged as a strong tool for the diagnosis of viral infections, especially in countries where health‐care systems are inadequate to provide proper services to all citizens. According to the World Health Organization, an ideal POC diagnostic must be Affordable, Sensitive, Specific, User‐friendly, Rapid/Robust, Equipment‐free and Deliverable (ASSURED). This review surveys carefully each ASSURED criterion and identifies where existing viral POC diagnostics fail to meet these criteria. Given the widespread concern with plastic pollution, we also propose the addition of 'disposability' to the existing ASSURED criteria and consider the letter “D” as the representative of both Deliverable and Disposable. Next, the POC tests used for the diagnosis of several common human viral infections which met all the ASSURED criteria (ASSURED‐compliant) are described in detail. Finally, the future of ASSURED‐compliant POC diagnostics, capable of generating comparable results to the viral diagnostic gold standards, is discussed.

Microfluidic systems for the analysis of blood‐derived molecular biomarkers

“…POC diagnostic devices are important for people in resource-poor settings and in general to have access to better care and treatment of various diseases [337]. According to the WHO, an ideal POC diagnostic device is considered such when it meets the criteria called "ASSURED" that stands for Affordable, Sensitive, Specific, User-friendly, Robust and rapid, Equipment-free, and Deliverable to those who need them [338]. Although various microfluidic systems are currently available for biomarker detection, these devices are not necessarily POC or ASSURED [339,340].…”

REASSURED Multiplex Diagnostics: A Critical Review and Forecast

“…Naseri et al [ 48 ] have summarized POC devices based on lateral flow assays (LFAs) and paper-based analytical devices (PADS) technology that were developed in the last 10 years for common human viral infection diagnostics. Dincer et al [ 49 ] presented a survey of the existing multiplexed POC tests in academia and industry, while Kim et al [ 50 ] summarized current POC tests for multiplex molecular testing of syndromic infections; however, these reviews focused mainly on POC diagnostics rather than summarizing devices that meet REASSURED criteria.…”

Electrochemical biosensors for SARS-CoV-2 detection: Voltametric or impedimetric transduction?

“…Although RT-PCR still remains the gold standard method to detect SARS-CoV-2, antigen rapid detection tests are commonly used to detect the viral proteins and, although they are less sensitive than molecular tests, have the advantages to be relatively inexpensive and to give a fast response at the point of care [9] , [10] , [11] , [12] , [13] , [14] , [15] . Most of them are based on immunochromatographic lateral flow assays, which satisfy the so-called ASSURED (affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free and deliverable to end users) criteria, guidelines provided in 2003 by the World Health Organization (WHO) for ideal test that can be used at all levels of the health care system [16] .…”