Rapid and sensitive diagnosis of infectious diseases using Alere™ i NEAR technology

Early diagnosis and effective clinical management are key factors in controlling infectious disease transmission. Crucial to these factors are rapid and accurate identification of the infectious agent. Nicking Enzyme Amplification Reaction (NEAR) technology provides isothermal amplification of target DNA or RNA in reiterative cycles of polymerase extension and nicking, which rapidly yields exponential accumulation of products in the reaction. NEAR assays can be developed to detect virtually any nucleic acid sequence found in the genome of an infectious agent. The Alere™ i instrument is designed to automatically provide heating and agitation required for NEAR, as well as real-time fluorescence detection of amplified products. The Alere™ i NEAR system can accurately detect target pathogen genes in clinical samples at extremely low levels in less than 15 minutes, providing sensitive and rapid patient diagnosis. The testing procedure for Alere™ i is technically simple and provides unbiased, clear results. CLIA waivers have been granted for Influenza and Group A Streptococcus Alere™ i NEAR diagnostic assays, which allow them to be performed at a broad range of healthcare settings at the point-of-care (POC). Rapid and accurate POC testing enables physicians to act on results appropriately before the patient leaves the facility, thus reducing disease transmission to the community, patient discomfort, and misuse of antibiotics. Integrated with the Alere™i platform, NEAR technology has the ability to provide rapid and sensitive POC testing for a wide variety of infectious diseases and contribute significantly to the improvement of patient health care, and infectious disease monitoring and control.