Pisani Giulio, Marino Francesco, Cristiano Karen, Bisso Guillermo Mario, Mele Caludio, Luciani Francesca, Wirz Maria, Gentili Giuliano
Dipartimento di Malattie Infettive, Parassitarie ed Immunomediate, Istituto Superiore di Sanità, Rome, Italy.
Ann Ist Super Sanita. 2007;43(1):69-76.
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.
我们组织了一项合作研究，以校准三种新的ISS参考制剂（ISS：意大利高等卫生研究院），一种用于HCV RNA，一种用于HIV RNA，一种用于HBV DNA，用于血液检测中的核酸扩增技术（NAT）。每个参与实验室在不同日期使用两种商业NAT检测方法对ISS参考制剂和各自的国际标准品进行系列稀释检测。数据由ISS收集用于统计分析。根据12个参与实验室提供的结果计算得出，HCV RNA和HIV RNA制剂的最终浓度分别确定为5700 IU/mL和4000 IU/mL。相反，无法获得HBV DNA参考材料的一致效价。这些对照各自国际标准校准的新的意大利参考制剂（HCV RNA ISS/1005和HIV RNA ISS/1005）可应任何实验室要求免费提供。
