title: Isothermal amplification using a chemical heating device for point-of-care detection of HIV-1.
abstract: BACKGROUND
  To date, the use of traditional nucleic acid amplification tests (NAAT) for detection of HIV-1 DNA or RNA has been restricted to laboratory settings due to time, equipment, and technical expertise requirements. The availability of a rapid NAAT with applicability for resource-limited or point-of-care (POC) settings would fill a great need in HIV diagnostics, allowing for timely diagnosis or confirmation of infection status, as well as facilitating the diagnosis of acute infection, screening and evaluation of infants born to HIV-infected mothers. Isothermal amplification methods, such as reverse-transcription, loop-mediated isothermal amplification (RT-LAMP), exhibit characteristics that are ideal for POC settings, since they are typically quicker, easier to perform, and allow for integration into low-tech, portable heating devices.
  
  
  RESULTS
  In this study, we evaluated the HIV-1 RT-LAMP assay using portable, non-instrumented nucleic acid amplification (NINA) heating devices that generate heat from the exothermic reaction of calcium oxide and water. The NINA heating devices exhibited stable temperatures throughout the amplification reaction and consistent amplification results between three separate devices and a thermalcycler. The performance of the NINA heaters was validated using whole blood specimens from HIV-1 infected patients.
  
  
  CONCLUSIONS
  The RT-LAMP isothermal amplification method used in conjunction with a chemical heating device provides a portable, rapid and robust NAAT platform that has the potential to facilitate HIV-1 testing in resource-limited settings and POC.
authors.affiliation: Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America. czv2@cdc.gov
authors.forename: Kelly A
authors.initials: KA
authors.lastname: Curtis
authors.forename: Donna L
authors.initials: DL
authors.lastname: Rudolph
authors.forename: Irene
authors.initials: I
authors.lastname: Nejad
authors.forename: Jered
authors.initials: J
authors.lastname: Singleton
authors.forename: Andy
authors.initials: A
authors.lastname: Beddoe
authors.forename: Bernhard
authors.initials: B
authors.lastname: Weigl
authors.forename: Paul
authors.initials: P
authors.lastname: LaBarre
authors.forename: S Michele
authors.initials: SM
authors.lastname: Owen
mesh_terms: D015492:AIDS Serodiagnosis / Q000295:instrumentation* / Q000379:methods*; D017931:DNA Primers / Q000235:genetics; D004279:DNA, Viral / Q000235:genetics; D004867:Equipment Design; D015658:HIV Infections / Q000175:diagnosis / Q000235:genetics; D015497:HIV-1 / Q000378:metabolism*; D006361:Heating; D006801:Humans; D021141:Nucleic Acid Amplification Techniques / Q000379:methods; D019095:Point-of-Care Systems; D012367:RNA, Viral / Q000235:genetics; D013696:Temperature
chemical_list: D017931:DNA Primers; D004279:DNA, Viral; D012367:RNA, Viral