The Results of External Proficiency Tests to Prevent Transfusion-transmitted Virus Infection: There Is a Need for a Quality Assurance Program for Donor Screening Tests to Prevent Blood-borne Virus Infections / 대한수혈학회지

ABSTRACT

BACKGROUND: We analyzed the results of external proficiency tests for HBsAg, anti-HCV and anti-HIV, and these tests are currently used for blood donor screening in Korea. METHODS: The external proficiency testing (EPT) data was retrospectively collected from 2001 to 2009 from the Korean Association of Quality Assurance for Clinical Laboratories, and this association includes those institutes that have blood centers. The pooled patient sera or converted sera from the plasma were used for EPT. The year 2004 data includes the Recombinant HBsAg variant (Gly/Arg 145). RESULTS: A total 806 institutes participated in this evaluation. The average discordant rate for HBsAg, anti-HCV and anti-HIV in the blood centers was 0.2%, 0.6% and 1.0%, respectively for the years 2001~2009. For the HBsAg test, the discordant rate was less than 0.5% in 2009, yet there was a much higher rate (1.6~22.2%) in 2004 when using the recombinant HBsAg variant. CONCLUSION: HBV variants or low positive antigen or antibody titers were problematic in the current clinical laboratory, and so a systematic quality assurance program should be conducted with using control materials.