title: Development of candidate reference reagent for HIV-1 RNA and comparison analysis for different HIV-1 RNA quantitative assay.
abstract: BACKGROUND
  Human immunodeficiency virus type-1 (HIV-1) RNA viral load is a surrogate marker that is routinely used to determine indications for, and monitor the effectiveness of HIV-1 treatment. We developed three reagents for potential use in routine quality control of HIV-1 RNA quantitative assays. In this report, we compare the stability of these re-agents in storage and compare their performance in three different HIV-1 RNA quantitative assays.
  
  
  METHODS
  The candidate reagents were derived from readily available pre-existing reagents and examined for stability at different storage temperatures. They were compared in three commercially available HIV-1 RNA quantitative assays: the Cobas TaqMan HIV-1 Test (Cobas TaqMan), the RealTime HIV-1 Assay (Abbott RealTime), and the NucliSens EasyQ HIV-1 Assay v1.1 (NucliSens EasyQ).
  
  
  RESULTS
  The candidate reagent derived from an HIV culture supernatant (candidate CS) was the most stable of the three candidates and showed good reproducibility. Candidate CS yielded the highest HIV-1 titer of the three candidates in the Cobas TaqMan assay and the lowest HIV-1 titer and stability of the three candidates in the NucliSens EasyQ system.
  
  
  CONCLUSIONS
  The candidate CS is the most appropriate of the three candidate reagents for quantitative testing of HIV-1 RNA. This working reagent should be useful for use in routine calibration for quality control in centers with limited financial resources. The Cobas TaqMan assay tended to yield higher viral load results than the other assays when used with our three candidate reagents.
authors.affiliation: Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Republic of Korea.
authors.forename: Borae G
authors.initials: BG
authors.lastname: Park
authors.forename: Ae Ja
authors.initials: AJ
authors.lastname: Park
authors.forename: Jee-Hye
authors.initials: JH
authors.lastname: Choi
authors.forename: Jina
authors.initials: J
authors.lastname: Park
authors.forename: Sung Soon
authors.initials: SS
authors.lastname: Kim
authors.forename: Jin-Sook
authors.initials: JS
authors.lastname: Wang
authors.forename: Mee Kyung
authors.initials: MK
authors.lastname: Kee
authors.forename: Ju-yeon
authors.initials: JY
authors.lastname: Choi
mesh_terms: D004355:Drug Stability; D015497:HIV-1 / Q000502:physiology*; D006801:Humans; D007202:Indicators and Reagents; D021141:Nucleic Acid Amplification Techniques / Q000592:standards*; D011786:Quality Control; D012367:RNA, Viral / Q000032:analysis* / Q000235:genetics*; D060888:Real-Time Polymerase Chain Reaction; D012015:Reference Standards; D020133:Reverse Transcriptase Polymerase Chain Reaction; D013696:Temperature; D013997:Time Factors; D019562:Viral Load
chemical_list: D007202:Indicators and Reagents; D012367:RNA, Viral