title: Reference panel of cloned HIV-2 plasmid DNA for nucleic acid assay development, evaluation, and quality monitoring.
abstract: BACKGROUND
  Currently, no FDA-approved HIV-2 nucleic acid assay is commercially available in the United States, although several laboratories have developed in-house assays to confirm HIV-2 infections. A major limitation in the development of novel HIV-2 diagnostic assays is the lack of reference materials that can be used to evaluate, optimize, and monitor assay performance.
  
  
  METHODS
  Eleven viral stocks of HIV-2 isolates from various West African countries, including the Ivory Coast, Senegal, and Guinea-Bissau, were used to clone the entire LTR and pol regions from each virus.
  
  
  RESULTS
  We successfully cloned, sequenced, and group classified 22 HIV-2 DNA plasmids including 11 full length LTR (∼849 bp) and 11 pol (∼2995 bp) sequences. There were eight HIV-2 group A and three group B in both the LTR and pol regions.
  
  
  CONCLUSIONS
  This reference panel provides a robust, quantifiable, renewable, and non-infectious set of reagents that can be used for the development and evaluation of new HIV-2 molecular diagnostic assays and quality assurance and quality control reagents for use in the clinical laboratories.
authors: Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States. Electronic address: ads8@cdc.gov.
authors: Ae S
authors: AS
authors: Youngpairoj
authors: Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors: Kelly A
authors: KA
authors: Curtis
authors: Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors: Susan K
authors: SK
authors: Wells
authors: Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors: Chou-Pong
authors: CP
authors: Pau
authors: Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors: Timothy C
authors: TC
authors: Granade
authors: Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States.
authors: S Michele
authors: SM
authors: Owen
mesh_terms: D004279:DNA, Viral / Q000235:genetics; D015658:HIV Infections / Q000175:diagnosis*; D016325:HIV Long Terminal Repeat / Q000235:genetics; D015498:HIV-2 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods / Q000592:standards*; D010957:Plasmids; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods / Q000592:standards*; D012015:Reference Standards; D014481:United States; D054302:pol Gene Products, Human Immunodeficiency Virus / Q000235:genetics
chemical_list: D004279:DNA, Viral; D054302:pol Gene Products, Human Immunodeficiency Virus
keywords: Clone; HIV-2; HIV-2 group; NAT; Plasmid; Real-time PCR