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Establishment of the 1st World Health Organization international standards for human papillomavirus type 16 DNA and type 18 DNA
Author(s) -
Wilkinson Dianna E.,
Baylis Sally A.,
Padley David,
Heath Alan B.,
Ferguson Morag,
Pagliusi Sonia R.,
Quint Wim G.,
Wheeler Cosette M.
Publication year - 2010
Publication title -
international journal of cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.475
H-Index - 234
eISSN - 1097-0215
pISSN - 0020-7136
DOI - 10.1002/ijc.25039
Subject(s) - dna , potency , ampoule , genomic dna , biology , computational biology , genetics , virology , chemistry , in vitro
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 ±∼2 log 10 around the theoretical HPV DNA concentration of the reconstituted ampoule (1 × 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 × 10 6 international units (IU) per ampoule or 1 × 10 7 IU mL −1 when reconstituted as directed.