Current impact of the confidential unit exclusion option.
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In 1986, the FDA recommended using a confidential unit exclusion (CUE) option in blood centers; this was rescinded in 1992.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.


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.


CONCLUSIONS
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.
Zou
S
S
Jerome H. Holland Laboratory for the Biomedical Sciences, American Red Cross, Rockville, Maryland 20855, USA. zous@usa.redcross.org
Notari
E P
EP
Musavi
F
F
Dodd
R Y
RY
D015415:Biomarkers; D001782:Blood Donors; D003219:Confidentiality; D006801:Humans; D007239:Infections / Q000453:epidemiology / Q000635:transmission; D015995:Prevalence
D015415:Biomarkers