Clare Morris

Preparation and evaluation of the 1st international standard for the quantitation of HIV-2 RNA in plasma

An international standard for the quantitation of HIV-2 RNA in plasma samples was developed. A collaborative study involving 29 laboratories from 15 countries was carried out in order to evaluate HIV-2 RNA candidate materials for use with nucleic acid-based tests (NATs). Candidate reference standards consisted of duplicate copies of two HIV-2 genotype A viruses, HIV-2 CAM2 and HIV-2 ROD and were coded S1-S4. Each laboratory assayed all four candidates on at least three separate occasions and data were collated and analysed at NIBSC. Of the data sets returned the majority were from qualitative assays. All assays detected both candidate standards with the exception of one commercial assay, the Nuclisens Easy Q, which was designed primarily for HIV-1 detection which did not detect HIV-2 CAM2 but showed good detection of HIV-2 ROD. This highlighted possible cross reactivity with HIV-2 ROD with some NAT primer/probe combinations; as a result the HIV-2 CAM2 material was established as the 1st international standard for HIV-2 RNA with an assigned unitage of 1000 International Units (IU) per ampoule and is available upon request from the National Institute for Biological Standardisation and Control (NIBSC) (www.nibsc.ac.uk).

Complete Genome Sequence of the WHO International Standard for HIV-2 RNA Determined by Deep Sequencing

ABSTRACT The World Health Organization (WHO) International Standard for HIV-2 RNA nucleic acid assays was characterized by complete genome deep sequencing. The entire coding sequence and flanking long terminal repeats (LTRs), including minority species, were assigned subtype A. This information will aid design, development, and evaluation of HIV-2 RNA amplification assays.

Complete Genome Sequence of the WHO International Standard for Hepatitis B Virus DNA

ABSTRACT The World Health Organization (WHO) international standard (IS) for hepatitis B virus (HBV) DNA for use in nucleic acid amplification assays was characterized by determining the complete genome sequence, which was assigned genotype A. This information will aid the design, development, and evaluation of HBV DNA amplification assays.