Abstract
Advances in nucleic acid amplification technologies have revolutionized diagnostics for systemic, inherited, and infectious diseases. Current assays and platforms, however, often require lengthy experimental procedures and multiple instruments to remove contaminants and inhibitors from clinically-relevant, complex samples. This requirement of sample preparation has been a bottleneck for using nucleic acid amplification tests (NAATs) at the point of care (POC), though advances in “lab-on-chip” platforms that integrate sample preparation and NAATs have made great strides in this space. Alternatively, direct NAATs—techniques that minimize or even bypass sample preparation—present promising strategies for developing POC diagnostic tools for analyzing real-world samples. In this review, we discuss the current status of direct NAATs. Specifically, we surveyed potential testing systems published from 1989 to 2017, and analyzed their performances in terms of robustness, sensitivity, clinical relevance, and suitability for POC diagnostics. We introduce bubble plots to facilitate our analysis, as bubble plots enable effective visualization of the performances of these direct NAATs. Through our review, we hope to initiate an in-depth examination of direct NAATs and their potential for realizing POC diagnostics, and ultimately transformative technologies that can further enhance healthcare.
Highlights
IntroductionNucleic acid amplification tests (NAATs) have become indispensable tools in biology and medicine
Nucleic acid amplification tests (NAATs) have become indispensable tools in biology and medicine.For example, for infectious diseases diagnostics, NAATs are generally faster, more sensitive, and more specific than the current gold standard of culture-based techniques
A number of DNA- and RNA-based diagnostics are recommended by the US Food and Drug Administration (FDA) for infectious diseases such as human immunodeficiency virus (HIV) [1,2]
Summary
Nucleic acid amplification tests (NAATs) have become indispensable tools in biology and medicine. These platforms present breakthrough technologies for rapid,are cost-effective, error-free enough for developed and developing settings, they demonstrate the feasibility of user-friendly diagnostics While it remains to be seen whether these systems are simple and error-free implementing existing nucleic acid amplification methods for POC use [6,7,8,9]. We surveyed the literature from 1989–2017 and came across a significant number of works that reported NAATs from bodily samples (e.g., blood-based liquids, oral samples, swabs) without the complex steps generally involved in sample preparation This meant discarding the works that depended on sophisticated instruments and operations that are labor-, time-, and cost-intensive, such as enzymatic (proteinases), chemical (acids, detergents), or physical (temperature shock, mechanical disruptions) treatments. It is our hope that in reviewing technologies such as these, and presenting these promising early findings in an information-rich and accessible fashion, we can help to accelerate the development of approaches that make POC nucleic acid testing rapid, accurate, simple, and affordable
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