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采用保密单位排除程序的献血者的人口统计学特征及血清学标志物流行情况:逆转录病毒流行病学献血者研究

Demographic characteristics and prevalence of serologic markers among donors who use the confidential unit exclusion process: the Retrovirus Epidemiology Donor Study.

作者信息

Korelitz J J, Williams A E, Busch M P, Zuck T F, Ownby H E, Matijas L J, Wright D J

机构信息

Westat, Inc., Rockville, Maryland.

出版信息

Transfusion. 1994 Oct;34(10):870-6. doi: 10.1046/j.1537-2995.1994.341095026972.x.

DOI:10.1046/j.1537-2995.1994.341095026972.x
PMID:7940658
Abstract

BACKGROUND

Most blood centers utilize a confidential unit exclusion (CUE) process, intended to reduce the risk of transfusion-associated infectious diseases by allowing high-risk donors confidentially to exclude their blood from use for transfusion. The effectiveness of this method remains controversial.

STUDY DESIGN AND METHODS

Confirmatory or supplemental test results for antibodies to human immunodeficiency virus, human T-lymphotropic virus type I, and hepatitis C virus, as well as hepatitis B surface antigen and syphilis and screening test results for antibodies to hepatitis B core (antigen) and alanine aminotransferase levels were obtained for approximately 1.8 million units donated during 1991 and 1992 at five blood centers within the United States. The prevalences of these infectious disease markers in units that the donors confidentially excluded (CUE+) and units that the donors did not exclude (CUE-) were calculated and examined within demographic subgroups.

RESULTS

Units that were CUE+ were 8 to 41 times more likely to be seropositive for antibodies to human immunodeficiency virus and hepatitis C virus, hepatitis B surface antigen, and syphilis and three to four times more likely to react for antibody to hepatitis B core (antigen) or to have elevated alanine aminotransferase levels than units that were CUE- (p < 0.001). The positive predictive value of CUE (the percentage of CUE+ units that were confirmed seropositive for any marker) was 3.5 percent, and the sensitivity of CUE (the percentage of confirmed-seropositive units that were CUE+) was 2.3 percent.

CONCLUSION

The current CUE process has low sensitivity and apparently low positive predictive value, and in many cases, it appeared that donors misunderstood it. Yet, CUE was not a "random process," as CUE+ units were more likely to be seropositive for any infectious disease marker than CUE- units. This suggests that efforts to improve the CUE system may be warranted. As risk factors for transfusion-transmitted infection become more difficult to identify by history-based screening, however, such efforts may have limited effect.

摘要

背景

大多数血液中心采用保密单位排除(CUE)程序,旨在通过允许高危献血者秘密排除其血液用于输血,降低输血相关传染病的风险。该方法的有效性仍存在争议。

研究设计与方法

获取了1991年和1992年在美国五个血液中心捐献的约180万单位血液的人类免疫缺陷病毒抗体、I型人类嗜T淋巴细胞病毒抗体、丙型肝炎病毒抗体以及乙型肝炎表面抗原和梅毒的确认或补充检测结果,以及乙型肝炎核心(抗原)抗体和丙氨酸氨基转移酶水平的筛查检测结果。计算并在人口统计学亚组中检查了献血者秘密排除的单位(CUE+)和未排除的单位(CUE-)中这些传染病标志物的患病率。

结果

CUE+单位的人类免疫缺陷病毒抗体、丙型肝炎病毒抗体、乙型肝炎表面抗原和梅毒抗体呈血清阳性的可能性比CUE-单位高8至41倍,乙型肝炎核心(抗原)抗体反应或丙氨酸氨基转移酶水平升高的可能性比CUE-单位高3至4倍(p<0.001)。CUE的阳性预测值(任何标志物呈血清阳性确认的CUE+单位的百分比)为3.5%,CUE的敏感性(确认呈血清阳性的单位中CUE+的百分比)为2.3%。

结论

当前的CUE程序敏感性低且阳性预测值明显低,在许多情况下,献血者似乎误解了该程序。然而,CUE并非“随机过程”,因为CUE+单位比CUE-单位更有可能对任何传染病标志物呈血清阳性。这表明改进CUE系统的努力可能是必要的。然而,随着基于病史的筛查越来越难以识别输血传播感染的风险因素,此类努力可能效果有限。

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