Abstract
The diagnosis of infectious diseases is ineffective when the diagnostic test does not meet one or more of the necessary standards of affordability, accessibility, and accuracy. The World Health Organization further clarifies these standards with a set of criteria that has the acronym ASSURED (Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free and Deliverable to end-users). The advancement of the digital age has led to a revision of the ASSURED criteria to REASSURED: Real-time connectivity, Ease of specimen collection, Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free or simple, and Deliverable to end-users. Many diagnostic tests have been developed that aim to satisfy the REASSURED criteria; however, most of them only detect a single target. With the progression of syndromic infections, coinfections and the current antimicrobial resistance challenges, the need for multiplexed diagnostics is now more important than ever. This review summarizes current diagnostic technologies for multiplexed detection and forecasts which methods have promise for detecting multiple targets and meeting all REASSURED criteria.
Highlights
Clinical diagnostics are devices or methods that are used to detect biomarkers in the genome, proteome and metabolome for diagnosis, subclassification, prognosis, susceptibility risk assessment, treatment selection, and response to therapy monitoring [1,2].Biomarker analytes include nucleic acids, proteins, peptides, lipids, metabolites, and other small molecules [3,4]
This review summarizes current diagnostic technologies for multiplexed detection and forecasts which methods have promise for detecting multiple targets and meeting all Keywords: diagnostics; multiplex; point-of-care diagnostics; REASSURED
We present the current state of multiplexed diagnostic technology that meet REASSURED criteria based on an in-house developed scoring scheme
Summary
Clinical diagnostics are devices or methods that are used to detect biomarkers in the genome, proteome and metabolome for diagnosis, subclassification, prognosis, susceptibility risk assessment, treatment selection, and response to therapy monitoring [1,2]. Diagnostic tests in hospitals or reference labs are able to meet analytical and clinical standards for accuracy and performance because complexity and cost are not an issue. It is much more difficult for point-of-care diagnostics, which must minimize cost and complexity in their design and manufacturing. Diseases (WHO/TDR) concluded, in a study in 2003, that POC diagnostics should meet the ASSURED (Affordable, Sensitive, Specific, User-Friendly, Rapid, Equipment-Free, Delivered) criteria [8]. The ASSURED criteria represent three main attributes that are significant for a diagnostic test These attributes are accessibility, affordability, and accuracy. Detection of biomarkers of cancer, cardiovascular disease and metabolic diseases, such as diabetes and hypertension, have reduced the mortality rate of humans over the years [14,15,16,17]
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