Collaborative study for the calibration of a new Italian HCV RNA reference preparation against the international standard

Annali dell'Istituto Superiore di Sanita

Volumn 39, Issue 2, 2003, Pages 183-187

  Gentili, Giuliano ^a   Cristiano, Karen ^a   Pisani, Giulio ^a   Bisso, Guillermo M ^a   Miceli, Michela ^b   Wirz, Maria ^a  

^a ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^b Centro Trasfusionale Universitario   (Italy)

Author keywords

Collaborative study; HCV RNA; International standard; Reference preparation

Indexed keywords

REAGENT; VIRUS RNA;

ALGORITHM; ARTICLE; CALIBRATION; DIAGNOSTIC TEST; HEPATITIS C VIRUS; ITALY; LABORATORY; NONHUMAN; POLYMERASE CHAIN REACTION; STANDARDIZATION; VIRUS IDENTIFICATION;

CALIBRATION; HEPATITIS C; INDICATORS AND REAGENTS; INTERNATIONAL COOPERATION; ITALY; REFERENCE STANDARDS; RNA, VIRAL;

EID: 0141995799     PISSN: 00212571     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. Committee for Proprietary Medicinal Products. The introduction of nucleic acid amplification technology (NAT) for the detection of hepatitis C virus in plasma pools. (CPMP/BWP/269/95). London: CPMP; 1997.
2. The European Department for the Quality of Medicines. Human plasma for fractionation (2000:0853). In: European Pharmacopoeia. 3rd ed. (Supplement 2000). Strasbourg (France): Council of Europe; 2000. p. 801-2.
3. Saldanha J, Lelie N, Heath A and the WHO Collaborative Study Group. Establishment of the first international standard for nucleic acid amplification technology (NAT) assays for HCV RNA. Vox Sang 1999;76:149-58.
4. Saldanha J, Heath A, Lelie N, Pisani G, Nübling M, Yu M and the Collaborative Study Group. Calibration of HCV working reagents for NAT assays against the HCV international standard. Vox Sang 2000;78:217-24.
5. Gentili G, Pisani G, Bisso G, Cristiano K, Wirz M, Mele C and the EQA participants. Hepatitis C virus testing of plasma pools by nucleic acid amplification technology: external quality assessment. Vox Sang 2001;81:143-7.
6. Pisani G, Cristiano K, Wirz M, Bisso GM, Gentili G and the EQA participants. Further evidence on the high proficiency of laboratories involved in plasma pool testing for HCV RNA by nucleic acid amplification technology. Vox Sang 2002;2:211-2.
7. Pisani G, Cristiano K, Wirz M, Bisso GM, Gentili G. Overestimation of the hepatitis C virus RNA content of reference preparations by the Amplicor HCV Monitor Test, version 2.0. J Clin Microbiol 2002;40:4765-7.