title: Establishment of the 1st World Health Organization international standards for human papillomavirus type 16 DNA and type 18 DNA.
abstract: A World Health Organization collaborative study was conducted to evaluate candidate international standards for human papillomavirus (HPV) Type 16 DNA (NIBSC code 06/202) and HPV Type 18 DNA (NIBSC code 06/206) for use in the amplification and detection steps of nucleic acid-based assays. The freeze-dried candidate international standards were prepared from bulk preparations of cloned plasmid containing full-length HPV-16 or HPV-18 genomic DNA. Nineteen laboratories from 13 countries participated in the study using a variety of commercial and in-house quantitative and qualitative assays. The data presented here indicate that, upon freeze-drying, there is no significant loss in potency for the candidate HPV-18 DNA and a slight loss in potency for the candidate HPV-16 DNA; although this is likely not scientifically relevant when assay precision is considered. In general, the individual laboratory mean estimates for each study sample were grouped +/- approximately 2 log(10) around the theoretical HPV DNA concentration of the reconstituted ampoule (1 x 10(7) HPV genome equivalents/mL). The agreement between laboratories is improved when potencies are made relative to the candidate international standards, demonstrating their utility in harmonizing amplification and detection steps of HPV-16 and -18 DNA assays. Degradation studies indicate that the candidate international standards are extremely stable and suitable for long-term use. Based on these findings, the candidate standards were established as the 1st WHO international standards for HPV-16 DNA and HPV-18 DNA, each with a potency of 5 x 10(6) international units (IU) per ampoule or 1 x 10(7) IU mL(-1) when reconstituted as directed.
authors.affiliation: Division of Virology, National Institute for Biological Standards and Control, South Mimms, Potters Bar, Hertfordshire, UK.
authors.forename: Dianna E
authors.initials: DE
authors.lastname: Wilkinson
authors.forename: Sally A
authors.initials: SA
authors.lastname: Baylis
authors.forename: David
authors.initials: D
authors.lastname: Padley
authors.forename: Alan B
authors.initials: AB
authors.lastname: Heath
authors.forename: Morag
authors.initials: M
authors.lastname: Ferguson
authors.forename: Sonia R
authors.initials: SR
authors.lastname: Pagliusi
authors.forename: Wim G
authors.initials: WG
authors.lastname: Quint
authors.forename: Cosette M
authors.initials: CM
authors.lastname: Wheeler
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D004279:DNA, Viral / Q000032:analysis*; D052162:Human papillomavirus 16 / Q000235:genetics*; D052161:Human papillomavirus 18 / Q000235:genetics*; D006801:Humans; D007391:International Cooperation; D021141:Nucleic Acid Amplification Techniques / Q000592:standards*; D016133:Polymerase Chain Reaction; D012015:Reference Standards; D014944:World Health Organization
chemical_list: D004279:DNA, Viral