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梅毒血清学阳性献血者的检测与分析。

Detection and analysis of blood donors seropositive for syphilis.

机构信息

Divisão de Pesquisa & Medicina Transfusional, Fundação Pró-Sangue Hemocentro de São Paulo, São Paulo, Brazil.

Disciplina de Ciências Médicas, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

出版信息

Transfus Med. 2021 Apr;31(2):121-128. doi: 10.1111/tme.12761. Epub 2021 Jan 21.

Abstract

BACKGROUND

The increasing incidence of syphilis worldwide has called attention to the risk of transmission by transfusion.

AIMS

To determine the prevalence of active syphilis in blood donors and characterise the serological profile of syphilis-positive donors.

METHODS

Samples positive for Treponema pallidum using the chemiluminescent microparticle immunoassay (CMIA) during blood donor screening from 2017 to 2018 were tested by the Venereal Disease Research Laboratory (VDRL) non-treponemal test and for anti-T. pallidum IgM by ELISA (Immunoassay Enzyme test for detection of IgM antibodies). The INNO-LIA Syphilis test (Line Immuno Assay solid test for confirmation antibodies to Treponema pallidum) was performed as a confirmatory test on samples that were positive on ELISA-IgM but negative on VDRL. ELISA-IgM (+) samples were also tested for T. pallidum DNA in sera by real-time polymerase chain reaction (PCR).

RESULTS

Of 248 542 samples screened, 1679 (0.67%) were positive for syphilis by CMIA. Further analysis was performed on 1144 (68.1%) of these samples. Of those tested, 16% were ELISA IgM(+)/VDRL(+), 16.5% were ELISA IgM(-)/VDRL(+), 4.1% were ELISA IgM(+)/VDRL(-), and 63.4% were ELISA IgM (-)/VDRL(-). The INNO-LIA Syphilis test results were 33 (3%) positive, 2 (0.2%) undetermined and 12 (1%) negative. Of the 230 EIA-IgM(+) samples (20.1%), 5 (2.2%) were PCR positive. The prevalence of active syphilis in 2017 and 2018 was 0.1% and 0.07%, respectively, and overall prevalence of serologic markers for syphilis was highest among male, unmarried, 25-34-year-olds with a high school education and who were first-time donors.

CONCLUSION

There is a risk of transfusion-transmitted syphilis in blood banks that exclusively use the VDRL test for donor screening, as is currently the situation in some Brazilian blood centres, as well as in other blood centres around the world.

摘要

背景

梅毒在全球的发病率不断上升,引起了人们对输血传播风险的关注。

目的

确定献血者中活动性梅毒的流行率,并描述梅毒阳性献血者的血清学特征。

方法

在 2017 年至 2018 年期间,采用化学发光微粒子免疫分析(CMIA)筛查献血者时,对梅毒螺旋体呈阳性的标本进行非梅毒螺旋体酶联免疫吸附试验(VDRL)和梅毒螺旋体免疫球蛋白 M(IgM)酶联免疫吸附试验(ELISA)检测。对 ELISA-IgM 阳性但 VDRL 阴性的标本进行 INNO-LIA 梅毒试验(用于检测梅毒螺旋体抗体的线免疫测定固相试验)作为确证试验。对 ELISA-IgM(+)的标本进行实时聚合酶链反应(PCR)检测血清中的梅毒螺旋体 DNA。

结果

在 248542 例筛查标本中,1679 例(0.67%)CMIA 检测梅毒螺旋体呈阳性。对其中 1144 例标本进行了进一步分析。在这些标本中,16%的标本 ELISA-IgM(+)/VDRL(+),16.5%的标本 ELISA-IgM(-)/VDRL(+),4.1%的标本 ELISA-IgM(+)/VDRL(-),63.4%的标本 ELISA-IgM(-)/VDRL(-)。INNO-LIA 梅毒试验结果为 33 例(3%)阳性,2 例(0.2%)不确定,12 例(1%)阴性。在 230 例 EIA-IgM(+)标本(20.1%)中,5 例(2.2%)PCR 阳性。2017 年和 2018 年的活动性梅毒患病率分别为 0.1%和 0.07%,梅毒血清学标志物的总体患病率在男性、未婚、25-34 岁、高中学历和首次献血者中最高。

结论

在仅使用 VDRL 试验筛查献血者的血库中,存在经输血传播梅毒的风险,目前巴西的一些血库以及世界其他血库的情况就是如此。

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