1 Members of the WHO Collaborative Study Group: Mr. Cleland/Dr. Davidson, University of Edinburgh, Edinburgh, UK; Drs. Conrad/Russell, National Genetics Institute, Los Angeles, USA; Dr. Cuypers, Central Laboratory of TheNetherlands Blood Transfusion Service, Amsterdam, The Netherlands; Dr. Fang, CSL Bioplasma, Victoria, Australia; Dr. Garson/Mr. Grant, University College London Medical School, London, UK; Prof. Gerlich, Institute of Medical Virology, Giessen, Germany; Drs. Giachetti/Mimms, Gen-Probe, San Diego, USA; Dr. Gröner, Centeon Pharma GmbH, Maburg, Germany: Dr. Hämmerle, Immuno AG, Orth, Austria; Dr. Kaiser, Institute for Medical Microbiology and Immunology, Bonn, Germany; Drs. Masecar/Savage, Bayer Corporation, Clayton, USA; Dr. Marissens, Hospital Universitaire St. Pierre, Brussels, Belgium; Dr. Nübling, Paul Ehrlich Institut, Langen, Germany; Drs. Pisani/Gentili, Istituto Superiore di Sanita, Rome, Italy; Dr. Sugata, St. Marianna University, Kanagawa, Japan; Drs. Vogel/Weimer, Centeon Pharma GmbH, Marburg, Germany; Dr. Widell, Malmö University Hospital, Malmö, Sweden; Drs. Wilber/Madej, Chjiron Corporation, Emeryville, USA; Dr. York, University of Natal, Natal, South Africa; Drs. Yu/Guo, CBER/FDA, Bethesda, USA; Dr. Zerlauth, Immuno AG, Vienna, Austria.
Establishment of the First International Standard for Nucleic Acid Amplification Technology (NAT) Assays for HCV RNA
Article first published online: 4 APR 2003
Volume 76, Issue 3, pages 149–158, April 1999
How to Cite
Saldanha, J., Lelie, N., Heath, A. and WHO Collaborative Study Group (1999), Establishment of the First International Standard for Nucleic Acid Amplification Technology (NAT) Assays for HCV RNA. Vox Sanguinis, 76: 149–158. doi: 10.1046/j.1423-0410.1999.7630149.x
- Issue published online: 4 APR 2003
- Article first published online: 4 APR 2003
- Received: June 9, 1998; Accepted: November 9, 1998
Background and Objectives: The aims of this study were the establishment of a WHO International standard for HCV RNA for nucleic acid amplification technology (NAT) assays and the determination of the HCV RNA content of the candidate standard. Materials and Methods: Twenty-two laboratories evaluated three candidate materials (two lyophilised, AA and BB, which were derived from the same source and one a liquid preparation, CC). All samples were HCV genotype 1 with a concentration of approximately 105 genome equivalents/ml. The methods used included the Roche Amplicor assay (version 1), Chiron Quantiplex (bDNA) assay, Organon Teknika NASBA assay, Transcription Mediated assay and various in-house assays, using single or nested primers. Results: There was reasonable agreement between the overall mean NAT detectable units/ml obtained by the different assays except for some of the in-house assays using single primers which gave substantially lower estimates. These titres were 5.0 log10 for samples AA and BB and 4.6 log10 for sample CC. Conclusions: Sample AA was accepted as the candidate standard and assigned a titre of 105 international units (IU)/ml. The International Standard consists of a batch of vials each containing 50,000 IU/vial. Preliminary studies indicated that the material is stable at +4°C and +20°C for up to 200 days.