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European Commission, Enterprise Directorate-General; Working Party on Control of Medicines and Inspections. Revision Annex 14 of the EU Guide to Good Manufacturing Practice. Manufacture of Medicinal Products Derived from Human Blood or Blood Plasma. Brussels, European Commission [M].2000.58-64.

has been cited by the following article:

  • TITLE: New Standpoint of ALT Test for Blood Safety in Dongguan Blood Center

    AUTHORS: Ziyi He, Fuping Liu, Dewen Wang, Jialin Che, Jialin Che

    KEYWORDS: Blood Donor; ALT; NAT-HBV/HCV; ELISA-HBV/HCV; Investigation

    JOURNAL NAME: Open Journal of Clinical Diagnostics, Vol.4 No.1, March 21, 2014

    ABSTRACT: Objective: To investigate the relationship between the single ALT positive (ELSIA-HBV/HCV negative) and NAT-HBV/HCV on blood donor samples. Methods: 28710 samples were surveyed retrospectively from Dec. 2010 to Dec. 2011. ALT was detected by rate method, and the single ALT positive samples were detected by ELSIA-HBV/HCV and NAT-HBV/HCV. The relationship between the single ALT positive and NAT-HBV/HCV were analyzed. 21 samples, values in 40 U/L ≤ ALT ≤ 70 U/L, were selected at random from 2516 samples with single ALT positive, which were second detected by ELISA and NAT in the second donation. Results: 2516 (8.74%) single ALT positive samples (ELSIA-HBV/HCV negative) were found in 28710 donors. Among these samples, 8 (2.8/10000) positive were detected by NAT, including 5 HBV-DNA-positive and 3 HCV-RNA-positive. Obviously, positive rate of NAT from the donors whose ALT value ≤ 70 U/L were lower than those of ≥ 71 U/L (P