Collaborative study for the calibration of HCV RNA, HBV DNA and HIV RNA reference preparations against the relative international standards.
We organised a collaborative study to calibrate three new ISS reference preparations (ISS: Istituto Superiore di Sanità), one for HCV RNA, one for HIV RNA and one for HBV DNA, to be used for nucleic acid amplification techniques (NAT) in blood testing. Serial dilution of the ISS reference preparations and the respective international standards were tested in different days by each participating laboratory using two commercial NAT assays. Data were collected by the ISS for statistical analysis. Based on the mean potency of the HCV RNA and HIV RNA preparations, calculated from the results provided by the 12 participating laboratories, a definitive concentrations of 5700 IU/mL and 4000 IU/mL, respectively, were assigned to the reference materials. On the contrary, it was not possible to obtain a consensus titre for the HBV DNA reference material. These new Italian reference preparations (HCV RNA ISS/1005 and HIV RNA ISS/1005) calibrated against the respective international standards are available free of charge to any laboratory upon request.
Pisani
Giulio
G
Dipartimento di Malattie Infettive, Parassitarie ed Immunomediate, Istituto Superiore di Sanità, Rome, Italy.
Marino
Francesco
F
Cristiano
Karen
K
Bisso
Guillermo Mario
GM
Mele
Caludio
C
Luciani
Francesca
F
Wirz
Maria
M
Gentili
Giuliano
G
D002138:Calibration; D004279:DNA, Viral / Q000592:standards*; D006678:HIV / Q000235:genetics*; D016174:Hepacivirus / Q000235:genetics*; D006515:Hepatitis B virus / Q000235:genetics*; D038622:Internationality; D007558:Italy; D021141:Nucleic Acid Amplification Techniques / Q000592:standards*; D012367:RNA, Viral / Q000592:standards*; D012015:Reference Standards; D014773:Virology / Q000592:standards*
D004279:DNA, Viral; D012367:RNA, Viral