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在中欧对360万份献血进行筛查后丙型肝炎病毒(HCV)和人类免疫缺陷病毒1型(HIV-1)核酸检测的阳性率

Yield of HCV and HIV-1 NAT after screening of 3.6 million blood donations in central Europe.

作者信息

Roth W Kurt, Weber Marijke, Buhr Sylvia, Drosten Christian, Weichert Wolfgang, Sireis Walid, Hedges Doris, Seifried Erhard

机构信息

Institute of Transfusion Medicine and Immunohematology German Red Cross, Hesse, Frankfurt.

出版信息

Transfusion. 2002 Jul;42(7):862-8. doi: 10.1046/j.1537-2995.2002.00129.x.

Abstract

BACKGROUND

HCV and HIV-1 NAT of all blood donations was initiated at our institutions in January 1997 to reduce the residual risk of transfusion-transmitted virus infections. The yield of NAT after testing more than 3.6 million donations in central Europe is reported.

STUDY DESIGN AND METHODS

Automated pipetting instruments were used to pool up to 96 donor samples including those that were antibody reactive. To compensate for dilution of the individual donor samples by pooling, viruses were enriched from the pools by centrifugation at 48,000 x g. A commercial PCR (Cobas Amplicor, Roche) and an in-house PCR were applied for HCV and HIV-1 amplification, respectively.

RESULTS

Six HCV and 2 HIV-1 PCR confirmed-positive, antibody-negative donations (yield, 1 in 600,000 and 1 in 1.8 million, respectively) were identified. Thirty-nine and 11 multiple-time donors seroconverted for HCV and HIV, respectively, and look-back procedures were initiated. Archived samples from preseroconversion donations were thawed and retested by single-sample PCR and remained negative. The recipients of the blood components were traced and tested. All traced recipients were negative for HCV and HIV antibodies.

CONCLUSION

The yield of NAT in central European Red Cross blood donors was less than expected from theoretical calculations for American and German multiple-time donors. Look-back procedures for HCV and HIV indicated that no donation given before seroconversion of the donor was missed by minipool PCR. Sensitivity of minipool PCR testing after virus enrichment seems to be sufficiently high to close the diagnostic window almost completely.

摘要

背景

1997年1月,我们机构开始对所有献血进行丙型肝炎病毒(HCV)和人类免疫缺陷病毒1型(HIV-1)核酸检测(NAT),以降低输血传播病毒感染的残留风险。本文报告了在中欧对超过360万份献血进行检测后NAT的检出率。

研究设计与方法

使用自动移液仪器将多达96份供者样本(包括抗体反应性样本)混合。为补偿混合导致的个体供者样本稀释,通过48,000×g离心从混合样本中富集病毒。分别应用商业PCR(Cobas Amplicor,罗氏公司)和内部PCR进行HCV和HIV-1扩增。

结果

确定了6份HCV和2份HIV-1 PCR确诊阳性、抗体阴性的献血(检出率分别为1/600,000和1/1,800,000)。分别有39名和11名多次献血者发生了HCV和HIV血清学转换,并启动了追溯程序。血清转换前献血的存档样本解冻后通过单样本PCR重新检测,结果仍为阴性。对血液成分的受血者进行追踪和检测。所有追踪到的受血者HCV和HIV抗体均为阴性。

结论

中欧红十字会献血者中NAT的检出率低于对美国和德国多次献血者的理论计算预期。HCV和HIV的追溯程序表明,小混合样本PCR未遗漏供者血清转换前的任何献血。病毒富集后小混合样本PCR检测的灵敏度似乎足够高,几乎可以完全关闭诊断窗口期。

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