丙型肝炎病毒抗体酶联免疫吸附试验阳性判断值在献血员血液筛检中的意义

目的探讨丙型肝炎病毒(HCV)抗体酶联免疫吸附试验(ELISA)测定阳性判断值(Cut-off)“灰区”在献血员血液筛检中的应用价值。方法采用逆转录-聚合酶链反应(RT-PCR)方法检测了503份抗-HCV ELISA测定为阴性的献血员血清(浆)标本的HCV RNA。如HCV RNA检测为阳性，则使用重组免疫印迹(RIBA)方法进一步检测抗HCV。结果在503份抗-HCV ELISA阴性献血员血清(浆)标本中，发现有5份HCV RNA阳性，其中2份标本抗HCV ELISA测定S/CO比值小于0．5，RIBA结果均为阴性。另外3份抗HCV阴性(ELISA检测的S/CO值在0．8-0．9之间)但HCV RNA为阳性的献血员血标本，进一步进行RIBA检测，发现其中2份为抗核心区(C22)单独阳性，另外1份为抗NS3单独阳性。阳性标本HCV RNA的含量测定均约为10^4拷贝/ml。结论为尽可能减少输血后HCV感染的发生，有必要将抗-HCV ELISA测定的Cut-off值下移20％，因为S/CO比值接近Cut-off值的血液有很大可能为HCV感染者。     

抗-HCV酶免试剂用于血站血液筛查的效果评价

目的 对目前国内血站采用的抗—HCV酶免试剂进行效果评价，为血站合理选用抗—HCV筛查试剂提供参考依据。方法 对不同厂家抗-HCV酶免试剂检测阳性标本分别用抗—HCV确认实验及逆转录—巢式PCR(RT—nPCR)技术进行检测，并对结果进行比较分析。结果 不同厂家抗—HCV酶免试剂对HCV的C区和NS5区抗体检测结果的差异无显性；但对NS3和NS4区抗体检测结果的差异有显性。结论 血站应根据不同抗—HCV试剂对HCV不同区段抗体的检出特性合理选择初复检试剂。     

HBsAg、抗-HCV反应性无偿献血者归队检测模式探讨

目的：探讨深圳地区无偿献血人群因血液筛查检测 HBsAg 或抗-HCV 呈阳性反应,在规定的条件下允许其再次招回重新检测,以确定是否恢复其献血资格并重新归队献血的检测模式。方法对深圳市2007年10月至2013年12月期间无偿献血人群捐血后 HBsAg、抗-HCV 初筛反应性人员,且符合我中心制定的再次招回重新检测的献血人群进行分析研究,对无偿献血者归队模式的可行性进行探讨。结果2007～2013年期间共计415759人次,HBsAg 检测阳性2506例,抗-HCV 检测阳性1357例,阳性率分别为0.60％和0.33％。笔者对符合召回条件的59例 HBsAg 和16例抗-HCV 阳性反应的多次献血者启动了归队检测的召回流程,HBsAg、抗-HCV 项目分别有31例和9例成功完成检测流程检测项。其中29例曾经 HBsAg 呈阳性反应的献血者重新恢复献血资格,2例因后续检测不合格被屏蔽献血资格,而9例曾经抗-HCV 阳性反应而召回献血者全部恢复其献血资格。结论在现有检测模式下,血液筛查的检测技术手段很难避免因试剂、设备、人员操作等原因造成假阳性反应的发生。为了保护无偿献血人群的献血资格,必须建立一套科学、合理并具有实际操作性的献血者归队检测模式,以保护有限的无偿献血资源。     

The prevalence of anti-HCV among Chinese voluntary blood donors in Taiwan

In Taiwan, the prevalence of circulating anti-HCV is 2 percent among first-time voluntary Chinese blood donors, 10 percent among donors with elevated ALT levels (greater than 45 IU/L), and higher among older men. The carrier rate for HBsAg was 18.6 percent and the frequency of positive HBV marker(s) (HBsAg, anti-HBc, anti-HBs) was 86.4 percent among first-time donors. There is no significant correlation between HBV and HCV infections in Taiwan, because there is no significant difference in the frequency of anti-HCV among donors with or without HBV markers. The frequency of anti-HCV among qualified donors in Taiwan (ALT less than 45 IU/L, not tested for anti-HBc) is 1.8 percent, which is not significantly different from the frequency (1.6%) in donors with normal ALT and negative for HBV marker(s) (qualified donors by Western Standards). Therefore, ALT is the most important surrogate marker for HCV infection in Taiwan.     

长沙大专院校学生无偿献血者HBsAg、抗-HCV的检测

自《中华人民共和国献血法》实施以来 ,无偿献血工作不断发展 ,在长沙市参加无偿献血的低危人群中 ,大专院校学生占有不可忽视的构成比 ( 60 %～70 % ) ,重视大学生献血群体 ,了解他们 HBs Ag、抗- HCV感染情况 ,有助于保证血液质量 ,促进高校无偿献血动员工作的持续稳定发展。为此笔者对2 0 0 1年长沙市 2 8所高校学生中无偿献血者的HBs Ag、抗 - HCV进行统计分析 ,现报告如下。材料与方法1　标本　长沙市 2 8所高校 (普通高校、军事院校 )2 0 0 1年两次由市献血办计划安排献血 8479人次 ,街头流动献血车自愿献血者中高校学生 3797人…     

血液安全筛查联合检测系统检测献血前血液的可行性

目的分析用血液安全筛查联合检测系统进行献血者献血前血液检测的可行性。方法收集308份无偿献血者的献血前血液标本,同时采用献血前快速筛查方法、联合检测系统和献血后常规检测技术进行检测并判断是否合格,包括血型(ABO、Rh D)、血红蛋白(Hb)、丙氨酸氨基转移酶(ALT)、乙型肝炎病毒表面抗原(HBs Ag)、丙型肝炎病毒抗体(抗HCV)、人类免疫缺陷病毒抗体(抗HIV)和梅毒螺旋体抗体(抗TP)检测。以常规检测结果为标准,对联合检测系统和快速筛查结果进行比较。结果联合检测系统鉴定的ABO/Rh D血型结果和HBs Ag阳性率与快速筛查和常规检测方法一致。联合检测系统检出的ALT和Hb不合格率分别为9.74%和1.30%,与快速筛查和常规检测方法相比差异均无统计学意义(P均0.05)。以常规方法为参考标准,联合检测系统的一致率分别为血型100%、ALT 99.35%、Hb 100%、HBs Ag 100%。联合检测系统检出3例抗HCV、1例抗HIV、5例抗TP阳性,经常规ELISA检测证明1例抗TP为假阳性。结论联合检测系统用于献血者献血前血液筛查是可行的,有助于提高血液的合格率。     

How do we manage blood donors and recipients after a positive Zika screening result?

Zika virus (ZIKV) is a mosquito‐borne flavivirus that is the focus of an ongoing pandemic. ZIKV is notable for its severe neurologic sequelae in babies born to infected mothers. High rates of subclinical infection, as evidenced by the finding of ZIKV RNA in asymptomatic donors, raise concerns of risk to the blood supply. To date, a total of four suspected cases of transfusion‐transmitted ZIKV have been reported (all in Brazil), none of which were associated with clinical infection in the transfusion recipients. In 2016, the US Food and Drug Administration issued a guidance mandating national blood donor screening for ZIKV in the United States. Five days after implementation of donor screening at our facility, we encountered a ZIKV‐positive donor. We provide a practical approach to donor, recipient, and blood product management in the setting of a positive donor ZIKV result. Such has been informed by the challenges we faced in the workup of a ZIKV‐reactive donation and recipient lookback.     

抗-HCV反应性献血者血液检测补充试验的选择分析

目的分析酶联免疫吸附法(ELISA)、电化学发光免疫分析法(ECLIA)、多重聚合酶链式反应(PCR)和重组免疫印迹试验(RIBA)等方法检测献血者血液标本HCV标志物结果。方法对本站2015年5月—2018年5月经过2种不同ELISA试剂(试剂A和试剂B)检测抗-HCV为反应性的标本250例进行ECLIA和多重PCR定性平行检测,其中多重PCR检测结果为"反应性",则进行PCR HCV RNA定量,对多重PCR结果为"无反应性"标本进行RIBA检测,分析各检测方法结果的阳性符合率,探讨抗-HCV反应性献血者补充试验的选择。结果 250例ELISA反应性标本用ECLIA、多重PCR和RIBA检测,其总阳性符合率分别为:57.60%(144/250)、31.20%(78/250)和44.40%(111/250),差异有统计学意义(P<0.01),其中ELISA双试剂反应性标本用ECLIA、多重PCR和RIBA检测的阳性符合率[99.20%(124/125)、62.40%(78/125)和81.60%(102/125)]高于单试剂反应性标本[16.00%(20/125)、0.00%(0/125)和7.20%(9/125)](P<0.05);多重PCR检测为反应性时HCV真阳性率为100%(78/78),其RNA定量浓度范围(17.6—13 100 000)IU/mL,中位数865 000 IU/mL;多重PCR无反应性而ECLIA反应性的标本真阳性率为38.80%(26/67),高于多重PCR和ECLIA同时无反应性的标本的真阳性7.62%(8/105)(P<0.05),后者仍然有60.00%(63/105)用RIBA无法确认。结论不同补充试验对抗-HCV反应性献血者标本的阳性符合率不同,ECLIA与ELISA的阳性符合率最高,重复性较好,但仍存在漏检和假阳性,建议作为初筛方法;多重PCR虽与ELISA的阳性符合率最低,但其检测的真阳性率较高,可互为补充试验及替代确证方法;RIBA对ELISA双试剂反应性标本的符合率较高,但难以确认ELISA单试剂反应性献血者,存在较多"不确定"结果。     

Prevalence of anti-HCV in Norwegian blood donors with anti-HBc or increased ALT levels

Testing for hepatitis B core antibodies (anti-HBc) was performed in 12,104 consecutive blood donors, 139 (1.15%) of whom were found to be positive. The first 6036 donors were also screened for ALT; 91 (1.51%) had repeatedly elevated values. ALT screening was of no help in detecting anti-HBc-positive donors. Those with anti-HBc or repeatedly raised ALT levels were further tested for hepatitis C virus antibodies (anti-HCV), and 3 (2.16%) and 1 (1.10%) anti-HCV-positive donors were detected, respectively. This prevalence of anti-HCV (0.5%) is not significantly different from that found in 1000 unselected donors at our blood bank. Testing for ALT and anti-HBc as surrogate markers for hepatitis C is therefore not recommended in Norwegian blood donors and should be replaced by anti-HCV screening.     

Preventive-medicine screening methods in the examination of blood donors

From a blood transfusion service with ca. 7000 donors a year, there was a loss of donors whose blood, having undergone medical tests, was found to be unsuitable. Details of all such donors were carefully documented. The results were ascertained by attentive control of the health of the donors which, in part, exceeded the minimum requirements laid down by the existing regulations. The relatively high loss of donors and the kind of disease underline the importance of these control checks, as an aspect of preventive medicine. This is of particular importance with regard to the results of so-called "new donors", who register for the first time. They had to undergo examination, and were only allowed to give blood when all the results of the tests had been submitted. The question then arises as to whether the regulations for the differing minimum requirements for the examination of "occasional donors" and "regular donors" can be maintained. A reduction of the expenditure on the present regulation examination of donors is not advocated because of both responsibility towards the blood donors, and in view of the increasing significance, to the medical care of patients, of the proximity of a clinic to an expedient transfusion service.     

广州地区抗-HCV阳性献血者核酸检测及随访

目的探讨广州地区无偿献血人群HCV感染者自然转归的相关因素。方法对ELSIA法检测为抗-HCV阳性的193名献血者采用荧光定量PCR法检测其HCV RNA,半年后随访并再次做抗-HCV和HCV RNA检测。结果 193名未经治疗的抗-HCV阳性献血者随访前后2次检测的HCV RNA及抗-HCV结果无变化;分别按性别、年龄比较其HCV RNA阳性比例:男性为60.5%(69/114)、女性为34.2%(27/79)(P0.01),35～55岁组为60.9%(42/69)、18～35岁组为43.5%(54/124)(P0.05)。结论女性HCV感染者的自然转归明显好于男性感染者,18～35岁HCV感染者的自然转归优于35～55岁感染者,提示性别及年龄均为HCV感染者自然转归的影响因素。     

加强对献血者疟原虫感染的筛检

由于我国尚未把疟原虫的筛检作为献血者常规的检测项目，致使国内近年输血相关性疟疾病例日趋增多，已经成为亟待解决的重要公共卫生问题；当前应重视献血者疟原虫感染的筛检，并进一步做好疟疾的诊断工作。筛检可首选具有多角度偏振光散射（MAPSS）功能的全自动五分类血液分析仪，有条件的单位可用流式细胞仪进行筛检，也可选用免疫层析方法筛查。对筛检出来的可疑标本再以镜检法或PCR法复查。     

献血者血液筛查ALT异常结果分析

[目的]对初复检献血者标本ALT异常与HBV和HCV感染的关系进行分析。[方法]应用IFCC推荐的速率法测定ALT，HBsAg和anti-HCV应用ELISA方法测定。[结果]6057份初检标本中ALT升高191份，占总异常率的53.7％（191／356），HBV和HCV标志物阳性分别仅占ALT升高标本的5.8％（11／191）和2、1％（4／191）；47590份复检标本巾ALT升高500例，占总异常率的70.4％（500／710），HBV和HCV标志物阳性分别仅占0.4％和1.8％；HBsAg和anti-HCV阴性的单纯ALT升高在初复检标本中分别占总ALT升高标本的92.1％和97.8％。[结论]ALT升高是导致血液报废的主要原因，目前献血者采用的ALT筛查标准（40U／L）无助于提高血液安全质量。     

无偿献血者丙氨酸氨基转移酶筛查结果分析

目的回顾性分析解放军总医院无偿献血者丙氨酸氨基转移酶(ALT)的筛查结果。方法选取2005年1月至2012年12月解放军总医院165 566例无偿献血者进行速率法的ALT检测,分别按年份、性别、年龄的情况进行统计分析。结果8年间,ALT总阳性率为6.47%,2010年阳性率最低(5.21%),2012年最高(7.76%);男性的ALT阳性率(6.90%)远大于女性(2.46%);18~25岁ALT阳性率为最低(4.55%),36~45岁最高(9.44%)。结论 ALT的不合格率有性别和年龄的倾向性,有针对性地选择献血员,建立稳定的献血队伍,有助于减少血液的报废率。     

重庆市涪陵区7年无偿献血者血液检测结果分析

目的了解重庆市涪陵区无偿献血者血液检测情况,以采取措施,提高血液质量,保障输血安全。方法用赖氏法对血液进行ALT检测,用ELISA法对血液进行HBsAg、抗-HCV、抗-HIV、抗-TP可经输血传播的病原体检测。结果共检测72868例,检出阳性总数为5512例,总阳性率为7．56％;HBsAg、抗-HCV、抗-TP、抗-HIV阳性率分别为3．09％、0．48％、1．27％、0．07％,ALT异常率为2．73％,各年度检测结果阳性率差异均有统计学意义。结论无偿献血人群中总阳性率逐年降低,HBsAg阳性率最高,ALT异常率次之,抗-TP阳性率排在第3位,抗-HCV和抗-HIV阳性率最低,提示应加强血液质量监控,确保输血安全。