RÉSUMÉ
BACKGROUND: Since December 15 2017, donors showing a non-discriminated reactive (NDR) result in the nucleic acid amplification test (NAT) have been temporarily deferred and anti-HBc and anti-HBs assays as additional tests were performed. Donors with an anti-HBc reactive result and less than 100 IU/L of anti-HBs could not be released and can request a reentry test after more than six months. This study considered the effects of additional tests for NDR donors by analyzing the reentry test results in donors not released in the additional test. METHODS: This study examined the results of the additional test for NDR donors from January 2017 to September 2018 and the reentry test of the donors not released in the additional test. RESULTS: NAT was conducted on 4,706,051 blood donors over the period and 2,545 (0.05%) of them showed NDR. A total of 656 (25.8%) of the NDR donors were not released in the additional test. Among them, 246 donors requested a reentry test; 222 (90.2%) donors were not reentered, and 23 (10.4%) showed HBV NAT reactive results in the reentry test. Among the remaining 24 reentered donors, 2 donors (8.3%) showed anti-HBc nonreactive results in the reentry test and 22 donors (91.7%) showed higher than 100 IU/L of anti-HBs. CONCLUSION: The follow-up of NDR donors may be significant because some donors showed different results between screening test and reentry test. In addition the effectiveness of the introduction of additional tests for the NDR donors has been proved to be effective.
Sujet(s)
Humains , Donneurs de sang , Études de suivi , Dépistage de masse , Techniques d'amplification d'acides nucléiques , Donneurs de tissusRÉSUMÉ
BACKGROUND: If donors who were deferred due to the reactivity or grey zone in HBV surface antigen (HBsAg) assay want to donate blood again, they need to pass reentry tests. On the other hand, approximately half of the donors who are subject to the reentry tests cannot be reentered. This study examined the association between the sample to cutoff (S/Co) value of the HBsAg assay and the final results of the reentry test. METHODS: This study analyzed the S/Co values of the HBsAg assay and the final results of the reentry tests for the 3,947 donors from January 2008 to December 2017 using the database of Blood Information Management System of the Korean Red Cross. RESULTS: 1,767 donors (44.8%) were not reentered among 3,947 deferred donors. Among 1,585 donors showing ≥10 of the S/Co value in the HBsAg screening test, 1,542 donors (97.3%) were not reentered. The additional reentry tests were performed on 120 donors who were not reentered in the first reentry test; 98 donors (81.7%) were still not reentered. Overall, 4.6% of the donors showing a grey zone in the HBsAg assay were not reentered. CONCLUSION: The reentry test needs to be restricted for the deferred donors showing a more than 10 S/Co value. The application of the grey zone of current HBsAg assay will need to be continued to enhance the HBV-related blood safety.
Sujet(s)
Humains , Antigènes de surface , Sécurité transfusionnelle , Main , Antigènes de surface du virus de l'hépatite B , Dosage immunologique , Gestion de l'information , Dépistage de masse , Croix-Rouge , Donneurs de tissusRÉSUMÉ
BACKGROUND: A leukoreduction filter was recently developed in Korea to reduce various kinds of adverse transfusion reactions. The objective of this study was to propose a domestic evaluation system for leukoreduction filters and to apply this evaluation system to assess the newly developed leukoreduction filter. METHODS: We prepared packed red blood cells from 60 units of whole blood (400 mL) collected from 60 normal individuals and evaluated the efficacy of the newly developed filter (FINECELL, KOLON INDUSTRIES, Gumi, Korea) and a control filter (RCM1, Haemonetics, MA, USA). To verify the evaluation system, we assessed the filtration time, residual leukocyte count, RBC recovery, RBC hemolysis, hemoglobin concentration, and hematocrit using a control filter RCM1 and compared the results with those of an evaluation performed by the American Red Cross (ARC) in 2013. We then evaluated the efficacy of the test filter FINECELL using the methods established in this study and compared the results with those of the control filter RCM1. RESULTS: The results of the current study were similar to those of the ARC with the control filters. The test filters developed in Korea were not inferior to commonly used control filters regarding residual leukocyte count, RBC recovery, and RBC hemolysis at 35 days after filtration. All of the results in the evaluation satisfied the international standards. CONCLUSION: These results of this study showed that the efficacy of the newly developed domestic leukoreduction filter were satisfactory and will contribute to improvement of quality of blood components in Korea.