Assessment of eight nucleic acid amplification technologies for potential use to detect infectious agents in low-resource settings

• Published in: PloS one 2019-04, Vol.14 (4), p.e0215756
• Main Authors: Cantera, Jason L, White, Heather, Diaz, Maureen H, Beall, Shivani G, Winchell, Jonas M, Lillis, Lorraine, Kalnoky, Michael, Gallarda, James, Boyle, David S
• Format: Article
• Language: English
• Subjects: Acids; Amplification; Analysis; Automation; Chlamydia - genetics; Communicable diseases; Communicable Diseases - diagnosis; Communicable Diseases - microbiology; Communicable Diseases - virology; Control equipment; Control methods; Cost-Benefit Analysis; Deoxyribonucleic acid; Diagnosis; Diagnostic systems; Diagnostic tests; Disease control; Disease prevention; DNA; Ebola virus; Emergency medical care; Emergency medical services; Enzymes; Extreme environments; Food; Health care; Health Resources - economics; HIV; HIV-1 - genetics; Human immunodeficiency virus; Humans; Income; Infectious diseases; Infrastructure; Infrastructure (Economics); Laboratories; Low cost; Medical care quality; Neisseria gonorrhoeae - genetics; Nosocomial infections; Novels; Nucleic Acid Amplification Techniques - instrumentation; Nucleic Acid Amplification Techniques - methods; Nucleic acids; Nucleic Acids - genetics; Pathogenic microorganisms; Patient care; Point-of-Care Systems - economics; Quality assurance; Quality control; Reagents; Reproducibility of Results; Respiratory diseases; Ribonucleic acid; RNA; Salmonella; Technology; Tuberculosis; West Nile virus; Work capacity; Workflow; Workflow software; Zika Virus - genetics
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0215756

Nucleic acid amplification technologies (NAATs) are high-performance tools for rapidly and accurately detecting infectious agents. They are widely used in high-income countries to diagnose disease and improve patient care. 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. 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. 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. Therefore, there is an urgent need for low-cost, integrated NAAT tools specifically designed for use in low-resource settings (LRS). 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. In prior work we reported the performance and workflow capacity for the nucleic acid extraction component. 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 this exercise, we noted significant differences in performance among these technologies and identified those most promising for potential further development.