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化学发光免疫分析中具有生物学假反应性的无偿献血者分析及其对献血者管理的意义。

Analysis of voluntary blood donors with biologic false reactivity on chemiluminescent immunoassays and implications for donor management.

作者信息

Kiely Philip, Stewart Yvonne, Castro Lea

机构信息

Virus Serology Unit, Australian Red Cross Blood Service-Victoria, PO Box 354, South Melbourne, Victoria 3205, Australia.

出版信息

Transfusion. 2003 May;43(5):584-90. doi: 10.1046/j.1537-2995.2003.00386.x.

DOI:10.1046/j.1537-2995.2003.00386.x
PMID:12702178
Abstract

BACKGROUND

Biologic false-reactive (BFR) results in blood donors are problematic due to both component loss and donor-management issues. This report analyzes the results of a longitudinal study of BFR donors and the implications for donor management.

STUDY DESIGN AND METHODS

Donors who gave BFR results on HBsAg, HIV-1/HIV-2, HCV, or HTLV-I/HTLV/II chemiluminescent immunoassays (ChLIAs) (PRISM, Abbott) between May 1997 to March 1999 were analyzed. Donors were followed up for up to three donations after an index BFR episode. In addition, results of any negative donations before the index BFR result but within the study period were included in the analysis.

RESULTS

For donors who gave an index BFR result on the HBsAg ChLIA, 14.3 percent remained BFR at subsequent donations, whereas for the anti-HIV-1/HIV-2, anti-HCV, and anti-HTLV-I/HTLV-II ChLIAs, the figures were 66.0, 77.4, and 71.6 percent, respectively. For donors who gave a second BFR result, the percentage who remained BFR at subsequent donations was 75.0, 80.6, 84.6, and 74.5 percent for the four assays, respectively. The rate at which negative repeat donors became BFR during the study period was 0.02, 0.07, 0.12, and 0.02 percent for the HBsAg, anti-HIV-1/HIV-2, anti-HCV, and anti-HTLV-I/HTLV-II assays, respectively.

CONCLUSIONS

Our results indicate that donors who give an index BFR result on the ChLIAs (PRISM, Abbott) should be allowed to continue donating because most donors with a HBsAg BFR result were negative at subsequent donations, and between 22.6 and 34.0 percent of those with BFR results on the HIV-1/HIV-2, HCV, or HTLV-I/HTLV-II assays gave subsequent negative donations. However, donors who give a second BFR result should be counseled and deferred because they were very unlikely to give subsequent negative results.

摘要

背景

献血者出现生物学假阳性反应(BFR)会导致血液成分损失和献血者管理问题,因而颇具争议。本报告分析了对BFR献血者进行的一项纵向研究结果以及对献血者管理的影响。

研究设计与方法

对1997年5月至1999年3月期间在乙肝表面抗原(HBsAg)、人类免疫缺陷病毒1型/2型(HIV-1/HIV-2)、丙型肝炎病毒(HCV)或人类嗜T淋巴细胞病毒1型/2型(HTLV-I/HTLV-II)化学发光免疫分析(ChLIAs)(PRISM,雅培公司)检测中出现BFR结果的献血者进行分析。在首次出现BFR事件后,对献血者进行长达三次的随访献血。此外,在首次出现BFR结果之前但在研究期间内的任何阴性献血结果也纳入分析。

结果

在HBsAg ChLIA检测中首次出现BFR结果的献血者,后续献血时仍为BFR的比例为14.3%,而在抗HIV-1/HIV-2、抗HCV和抗HTLV-I/HTLV-II ChLIAs检测中,这一比例分别为66.0%、77.4%和71.6%。对于出现第二次BFR结果的献血者,在后续献血时仍为BFR的比例在四项检测中分别为75.0%、80.6%、84.6%和74.5%。在研究期间,阴性重复献血者出现BFR的比例在HBsAg、抗HIV-1/HIV-2、抗HCV和抗HTLV-I/HTLV-II检测中分别为0.02%、0.07%、0.12%和0.02%。

结论

我们的结果表明,对于在ChLIAs(PRISM,雅培公司)检测中首次出现BFR结果的献血者,应允许其继续献血,因为大多数HBsAg BFR结果的献血者后续献血结果为阴性,而在HIV-1/HIV-2、HCV或HTLV-I/HTLV-II检测中出现BFR结果的献血者中,有22.6%至34.0%的人后续献血结果为阴性。然而,对于出现第二次BFR结果的献血者,应给予咨询并延期献血,因为他们后续不太可能出现阴性结果。

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