S Zou1, E P Notari, F Musavi, R Y Dodd. 1. Jerome H. Holland Laboratory for the Biomedical Sciences, American Red Cross, Rockville, Maryland 20855, USA. zous@usa.redcross.org
Abstract
BACKGROUND: In 1986, the FDA recommended using a confidential unit exclusion (CUE) option in blood centers; this was rescinded in 1992. The American Red Cross (ARC) has continued using the option. This study assessed its current impact. STUDY DESIGN AND METHODS: Donor records from ARC for 1995 through 2001 were examined for CUE use in association with the prevalence and frequency of seroconversion of infectious disease markers. The likely yield of CUE was also estimated. RESULTS: Donations with CUE use had a higher prevalence of HIV, HBV, HCV, and syphilis markers than those without CUE use, although both the sensitivity and positive predictive value (PPV) of CUE were low. Seroconverters had a higher frequency of using the CUE option than nonseroconverters. Similarly, the sensitivity and PPV of CUE were low. Based on analysis of infectious disease residual risk, the CUE option was estimated to have prevented the collection of 0.2 to 1.3 window-period units annually within the entire ARC system. CONCLUSION: The CUE option had minimal effectiveness in further reducing the transmission of infectious diseases through window-period units. Further study of its current impact on reduction of units from risky but test-negative donors, as well as on loss of safe donors, may be warranted.
BACKGROUND: In 1986, the FDA recommended using a confidential unit exclusion (CUE) option in blood centers; this was rescinded in 1992. The American Red Cross (ARC) has continued using the option. This study assessed its current impact. STUDY DESIGN AND METHODS: Donor records from ARC for 1995 through 2001 were examined for CUE use in association with the prevalence and frequency of seroconversion of infectious disease markers. The likely yield of CUE was also estimated. RESULTS: Donations with CUE use had a higher prevalence of HIV, HBV, HCV, and syphilis markers than those without CUE use, although both the sensitivity and positive predictive value (PPV) of CUE were low. Seroconverters had a higher frequency of using the CUE option than nonseroconverters. Similarly, the sensitivity and PPV of CUE were low. Based on analysis of infectious disease residual risk, the CUE option was estimated to have prevented the collection of 0.2 to 1.3 window-period units annually within the entire ARC system. CONCLUSION: The CUE option had minimal effectiveness in further reducing the transmission of infectious diseases through window-period units. Further study of its current impact on reduction of units from risky but test-negative donors, as well as on loss of safe donors, may be warranted.
Authors: Cesar de Almeida-Neto; Jing Liu; David J Wright; Alfredo Mendrone-Junior; Pedro L Takecian; Yu Sun; Joao Eduardo Ferreira; Dalton de Alencar Fischer Chamone; Michael P Busch; Ester Cerdeira Sabino Journal: Transfusion Date: 2011-01 Impact factor: 3.157
Authors: Flávia Cristine Martineli Loureiro; Cláudia Di Lorenzo Oliveira; Anna Bárbara F Carneiro Proietti; Fernando Augusto Proietti Journal: Rev Bras Hematol Hemoter Date: 2011