The accurate and rapid diagnosis of infectious disease can lead to improved patient care, appropriate use of antimicrobial drugs, and ultimately greater control of communicable diseases within populations. In this exercise, we noted significant differences in performance among these technologies and identified those most promising for potential further development. In the current study we evaluated performance of eight novel nucleic acid amplification and detection technologies from seven developers using blinded panels of RNA and/or DNA from three pathogens to assess both diagnostic accuracy and suitability as an essential component for low-cost NAAT in LRS. In prior work we reported the performance and workflow capacity for the nucleic acid extraction component. Two essential components of integrated NAAT tools are: 1) efficient nucleic acid extraction technologies for diverse and complex sample types and 2) robust and sensitive nucleic acid amplification and detection technologies. Therefore, there is an urgent need for low-cost, integrated NAAT tools specifically designed for use in low-resource settings (LRS). However, decentralized settings in many low- and middle-income countries with large burdens of infectious disease are challenged by extreme environments, poor infrastructure, few trained staff and limited financial resources. For certain diseases, fully integrated NAAT devices and assays are available for use in environmentally-controlled clinics or emergency rooms where relatively untrained staff can perform testing. The complexities associated with test methods, reagents, equipment, quality control and assurance require dedicated laboratories with trained staff, which can exclude their use in low-resource and decentralized healthcare settings. They are widely used in high-income countries to diagnose disease and improve patient care. Nucleic acid amplification technologies (NAATs) are high-performance tools for rapidly and accurately detecting infectious agents.
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