Ethical challenges in voluntary blood donation in Kerala, India

The National Blood Policy in India relies heavily on voluntary blood donors, as they are usually assumed to be associated with low levels of transfusion-transmitted infections (TTIs). In India, it is mandatory to test every unit of blood collected for hepatitis B, hepatitis C, HIV/AIDS, syphilis and malaria. Donors come to the blood bank with altruistic intentions. If donors test positive to any of the five infections, their blood is discarded. Although the blood policy advocates disclosure of TTI status, donors are not, in practice, informed about their results. The onus is on the donor to contact the blood bank. Out of approximately 16 000 donations in the past 2 years, 438 tested positive for TTI, including 107 for HIV. Only 20% of the donors contacted the blood bank; none of them were HIV positive. Disclosure by blood banks of TTI status by telephone or mail has resulted in serious consequences for some donors. Health providers face an ethical dilemma, in the absence of proper mechanisms in place for disclosure of test results, regarding notification to donors who may test positive but remain ignorant of their TTI status. Given the high cost of neglecting to notify infected donors, the authors strongly recommend the use of rapid tests before collecting blood, instead of the current practice, which takes 3 h to obtain results, and disclosure of results directly to the donor by a counsellor, to avoid dropouts and to ensure confidentiality.     

湖北省仙桃市无偿献血血液标本检测情况分析

目的分析仙桃市无偿献血血液标本检测情况,探讨血液标本不合格因素及输血相关病原体感染的危险性,为临床安全用血提供技术支持。方法对仙桃市血站2006年1月～2010年12月31602名献血人员资料进行分析,比较不同性别、不同年龄献血者血液检测不合格率。结果无偿献血者血液总标本数31602份,检测合格标本数30330份,检测合格率为95．98％;检测不合格标本数1272份,检测不合格率为4．02％。其中ALT阳性检测不合格率2．13％;HBsAg阳性检测不合格率1．02％;抗-HCV阳性检测不合格率0．35％;SYP阳性检测不合格率0．38％;抗-HIV阳性检测不合格率0．15％。结论了解和掌握无偿献血群体、制定符合临床用血规律的采供血计划十分必要,而实行血液集中检测、严格筛查经血液感染性疾病直接关系到供血者的身体健康和受血者的安全,是提高临床安全用血的关键。     

献血员HBsAg筛查的安全性和病毒变异分析

目的探讨国内血站对献血员乙型肝炎病毒表面抗原（HBsAg）筛查的安全性和可靠性。方法收集经血站筛查HBsAg阴性的合格献血员血浆983份,用雅培Architect12000电化学发光仪定量检测HBsAg;巢式PCR扩增乙肝病毒S区、C区、X区。诊断为隐匿性乙肝病毒感染者,巢式PCR扩增病毒PreS／S区,产物直接测序并与标准病毒序列对比分析病毒株变异。结果经雅培Architect I2000复检HBsAg弱阳性率为6．5％（64／983）,HBsAg滴度中位数为0．171U／ml;60．9％（39／64）病毒两个区扩增阳性,4．0％（39／983）健康献血员为隐匿性HBV携带者;35．9％（14／39）病毒PreS／S区段扩增阳性,未发现“a”决定簇内的变异株。结论目前经血站常规检测ItBsAg为阴性的合格血液用敏感性更高的试剂仍能检测出HBsAg及HBV DNA。     

深圳市献血人群丙肝感染现状分析

目的 大力宣传无偿献血,提倡低危献血人群定期献血和加强采血前筛查,降低抗-HCV的阳性率。有效地提高血源质量,降低输血风险。方法 通过对不同献血人群中抗-HCV的阳性率的比较分析,找出降低输血风险的有效方法。结果 检测表明,深圳市献血人群抗-HCV的阳性率从1996年的2．67％降到2003年0．25％,低于全国平均水平。经过采血前筛查和提高无偿献血员定期、多次献血比例,深圳市无偿献血人群抗-HCV阳性率逐年下降。结论 无偿献血可降低人群丙肝感染率。     

无偿献血血液检测现况研究

目的了解无偿献血人群的一般特征,为加强献血者招募的质量控制提供依据。方法收集2008年1月～2010年12月,到我中心采血点无偿献血的38974名无偿献血者资料,内容包括年龄、性别、职业及血液质量各项指标的检测结果(ALT、HBsAg、梅毒抗体、抗HIV、抗HCV)。分析各项指标的阳性率与年龄、性别、职业的关系。结果不同年龄组及不同性别献血者之间HBsAg阳性率的差异具有统计学意义,其余各项指标在年龄组间及不同性别间均无差异。不同职业间各项血液指标阳性率的差异具有统计学意义,工人的各项指标阳性率均较高,而军人及专业技术人员的各项指标阳性率均较低。结论职业应当作为今后招募固定献血者的重要限制因素,青年军人、专业技术人员、学生应当作为重要的招募对象人群,同时还应加强对军人及专业技术人员献血相关信息的宣传。     

用PCR方法检测献血员的B_(19)病毒感染情况

目的：研究人微小病毒Ｂ１９在献血员中的感染情况。方法：采用ＰＣＲ技术对５００份献血员血清标本进行检测。结果：发现一例Ｂ１９病毒ＤＮＡ阳性，并用Ｋｏｃｈ设计的引物扩增标本和用ＨａｅⅢ，ＰｓｔⅠ和ＳｔｙⅠ酶切分析都证实为人微小病毒Ｂ１９。结论：国内献血者中有Ｂ１９病毒携带者。血液和血液制品有可能污染有Ｂ１９病毒。这个情况值得进一步研究。     

对“合格血”用固相放射免疫法复检乙型肝炎病毒感染标记的研究

为了评价现有供血员筛检方法的质量,1984～1985年对武汉市某医院血库供应的128份“合格血”,用固相放射免疫(SPRIA)法进行复检HBsAg、抗-HBs、抗-HBc。结果均阴性者21.88％(28/128),HBsAg或/和抗-HBc阳性者71.88％(92/128),其中HBsAg阳性10.94％(14/128)。抗-HBc阳性46.88％(60/128),HBsAg和抗-HBc双阳性为14.06％(18/128)。并对供血员筛检方法提出建议。     

Screening of antibodies to human T-cell leukemia virus type I (HTLV-I) in sera of blood donors and comparison of different methods

Nine hundred and sixty five serum samples of blood donors from the blood bank of Veterans General Hospital Taipei were screened for antibodies to human T-cell leukemia virus type I (HTLV-I) by different methods. Adult T-cell Leukemia cell lines MT-1, MT-2, KH-2 and MT-2 stimulated by phorbol 12-myristate 13-acetate (PMA) were used as target cells in immunofluorescence microscopy (IF) examination with positive rates as 0.20% (2/965), 0.62% (6/965), 0.20% (2/965) and 0.51 (5/965) respectively. In addition to these, enzyme-linked immunosorbent assay (ELISA) gave a 2.59% (25/965) positive rate and particle agglutination (PA) test revealed a positive rate of 0.93% (9/965). The samples positive in IF were also positive in PA and those positive in PA were found positive in ELISA without exceptions. The 25 ELISA positive samples as well as 75 samples randomly chosen from the ELISA negative ones received Western blot (WB) analysis as a confirmation test. Only 3 of these 100 were considered positive in WB, giving a final positive rate of 0.31%, (3/965), and all of them were originally positive in both PA and ELISA. Particle agglutination test as the screening test and Western blot analysis as the confirming one were suggested to be a routine procedure for detecting anti-HTLV-I antibodies in blood banks through detailed comparison and discussion.     

Laboratory and epidemiologic evaluation of an enzyme immunoassay for antibodies to HTLV-III

The enzyme immunoassays (EIAs) for antibody to human T-cell lymphotropic virus type III (HTLV-III) were rapidly adopted for screening donated blood and plasma. To evaluate the significance of a positive EIA reaction, test performance was examined in a blood bank screening program. Specimens were tested by EIA, Western blot assay, and HTLV-III/lymphadenopathy-associated virus (LAV) culture. The EIA was positive in 0.25% of 67 190 blood donations. Specimens were categorized and 57.3% had low (weak) reactivity, 12.7% had moderate reactivity, and 30.0% had high reactivity. Highly reactive specimens were strongly associated with a positive Western blot or culture (86.7%) in contrast to moderately and weakly reactive specimens (1.9%). Twenty-five of 29 donors interviewed with a highly reactive EIA had risk factors for HTLV-III/LAV infection. Risk factors were not identified for 74 of 75 interviewed donors with specimens of lower reactivity. The minimum calculated specificity was 99.82%. The use of the HTLV-III EIA has virtually eliminated the use of blood and plasma from HTLV-III/LAV infected donors.     

Profile of blood donors and reasons for deferral in coastal South India

Background

A blood transfusion is a life-saving procedure in many instances. An adequate supply of safe blood is ensured by exercising donor deferral criteria and screening for Transfusion Transmitted Infections (TTI). The aim of this paper is to study the profile of blood donors and reasons for donor deferral in coastal South India.

Method

The study was conducted at a tertiary care hospital in Mangalore. All those who donated between 1 January 2008 and 31 December 2008 were included in the study. Data was collected using a pre-tested semi-structured proforma and analysed using SPSS version 11.5.

Results

Most of the donors were under the age of 25 (42.92%).Donors were predominantly male (95.20%). In terms of occupation, most subjects were students (28.01%) followed by businessmen (18.61%). Slightly more than three-quarters of the donors (77.20%) were replacement donors. The main reasons for deferral were consumption of medication in the past 72 hours (15.15%), hypertension (13.18%), a low haemoglobin level (12.34%) and alcohol intake in the past 72 hours (12.20%). Among the TTIs identified, most samples were positive for Hepatitis B surface Antigen – HBsAg (0.87%) or tested positive for Anti-Hepatitis C (HCV antibodies (0.36%).

Conclusion

From the study it was concluded that the majority of the donor population was young and educated. The reason for donation was mainly replacement rather than voluntary. This issue needs to be addressed by exercising proactive measures to increase the number of voluntary, nonremunerated, low-risk donors.     

郑州地区输血相关疾病的调查

目的 :调查郑州地区输血相关疾病阳性率分布情况。方法 :除血型采用凝集法以及HBV_DNA和HCV_RNA采用荧光定量PCR法外 ,其余检测项目均采用ELISA法。利用Excel对检测结果进行分析。结果 :郑州地区无偿献血人群中 ,抗_HCV阳性率为 1 11% ,女性抗_HCV阳性率高于男性 ( χ2 =9 60 15 ,P <0 0 5 ) ;TRUST阳性率为 0 12 % ,女性比男性更易感染梅毒 ( χ2 =7 6991,P <0 0 5 ) ;ALT和脂血淘汰率最高 ( 3 2 6%和 2 3 1% ) ,ALT阳性率男女有极显著差异 ( χ2 =16 7418,P <0 0 0 1) ,ALT阳性率男性是女性的 5倍 ,ALT阳性率夏季高于其它季节 2个百分点 ,大中专学生ALT阳性率最低 ;无偿献血人群中存在艾滋病携带者 ;HB sAg经街头快速初筛后其漏检率 ( 1 0 6% )男女无显著差别 ( χ2 =2 7991,P >0 0 5 ) ;郑州地区ABO血型分布为B >O >A >AB ,Rh阴性率为 0 3 6% ,接近我国汉族人群的分布值 ,建立了 42 4名Rh阴性的稀有血型档案库 ;抗_HGV的阳性率为 1 42 % ;在无偿献血者中未发现HTLV阳性者 ;抗_TTV阳性率为 4 17% ;HCV_RNA和HBV_DNA阳性率分别为 0 0 8%和 0 2 5 % ;输血反应发生率为 0 2 9%。结论 :郑州地区无偿献血人群中输血相关疾病属于低发病区 ,建议增加HBV、HCV、HIV的核酸检测技术以及HGV和TTV检测     

Alternative test sequences for HIV screening of donated blood

Human Immunodeficiency Virus (HIV) infection is extremely rare among volunteer blood donors. The highly sensitive Enzyme Linked Immunoassay (ELISA) test and the highly specific Western blot confirmation constitute the test sequence now used to minimize the possibility of transfusion associated HIV infection and to minimize the loss of donors due to false positive test results. The estimated operating characteristies for the test sequence permit the estimation of true infection rates which may be higher or lower than “observed” rates among subcategories of blood donors with progressively lower prevalence rates. The probability that a positive test result indicates true infection also declines with decreasing prevalence. The potential benefits of changing the test sequence so that complete HIV screening is implemented only for donations which are hepatitis-free include a reduction in the costs of Western blot testing and donor counseling, a reduction in the number of donors who use the blood bank inappropriately for personal HIV testing, and a more explicit recognition of the false positive problem when counseling donors.     

Screening of Danish blood donors for hepatitis B surface antigen using a third generation technique

The profit to be gained by testing Danish blood donors for hepatitis B surface antigen (HBsAg) with a third generation technique instead of the currently used immunoelectrophoresis was investigated by additional screening of 48 750 blood units by radioimmunoassay three weeks after donation. Twenty nine units were positive for HBsAg on radioimmunoassay (0.059%). Only six of these were found by immunoelectrophoresis (0.012%). Most of the 23 donors positive on radioimmunoassay and negative on immunoelectrophoresis were healthy carriers of HBsAg (20) or had asymptomatic chronic liver disease (two). One donor had acute hepatitis B. Fifteen of the 23 blood units were transfused. The 15 recipients were monitored biochemically and serologically for up to nine months. One recipient developed fulminant hepatitis B, three developed acute hepatitis B, and one became a healthy carrier of HBsAg. All these patients had received blood from healthy carriers of HBsAg. Two recipients were immunised against HBsAg, and in one patient no seroconversion was observed. The remaining recipients died soon after transfusion or were protected by antibodies to HBsAg that had been present before the transfusion. Testing of Danish blood donors using a third generation technique identified a substantial number of donors positive for HBsAg overlooked by immunoelectrophoresis. Most of these donors were healthy carriers of HBsAg. Blood taken from such carriers is highly infectious when transfused, probably because of the large amount of material transmitted.     

南京地区TTV分子流行病学调查

目的 :探讨经血传播病毒 (TTV)在南京地区分子流行学状况及TTV可能的传播途径。方法 :选择各型病毒性肝炎 975例 ,献血员 30例 ,慢性肾功能衰竭长期血透者 1 50例及健康者 32例作为研究对象 ,用n -PCR法检测各种人群中 (TTVDNA)的感染情况。并研究TTVDNA阳性与输血的关系。结果 :在各种人群中TTVDNA的检出率分别为非甲～庚型肝炎 2 2 % ,病毒性肝炎 1 3 .9% ,献血员 33 .3 % ,长期血透者 2 7.3 % ,健康人 9.4% ,1 36例TTVDNA阳性病毒性肝炎患者仅 1 9.9% (2 7/ 1 36)有输血史。结论 :献血员及其它经常接触血制品的人群是TTV感染的高危人群 ,输血是TTV感染的途径之一 ,肠道传播可能也是TTV传播的一条途径     

献血者丙型肝炎病毒(HCV)核心抗原的初步检测及意义

目的 :探讨在无偿献血者中开展丙型肝炎病毒核心抗原 (HCV CAg)检测的可能性及意义。方法 :采用美国强生 (ORTHO)公司HCV核心抗原酶联免疫 (ELISA)检测试剂 ,对无偿献血者样进行检测 ,并对结果进行分析 ,阳性者用荧光定量PCR方法进行HCV检测 ,并将抗体检测、抗原检测、病毒核酸检测 (nucleicacidtesting ,NAT)的检测结果进行比较。结果 :献血者合格血样 90 3份 (抗 HCV等检测阴性 )中未发现HCVC抗原阳性者 ,不合格血样 (n =197)共发现 6份阳性 ( 6/ 197) :HBsAg( +)中有 1份阳性 ( 1/ 43 ) ,抗 HCV( +)中有4份阳性 ( 4 / 2 1) ,ALT( +)中有 1份阳性 ( 1/ 12 8) ;抗HIV( +) 12份、抗 PT( +) 3份中未检出阳性。结论 :现行的抗 HCV检测方法有可能出现HCV感染的漏检 ,HCVC抗原检测方法可提高检测的灵敏度 ,在献血者中开展该项检测是可行的     

宝鸡地区初次无偿献血人群梅毒感染状况调查分析

目的提高血液质量,增强输血安全,切断TP经输血传播途径。方法采用ELISA对96076例初次无偿献血者进行梅毒抗体筛选,初复检结果阳性者用TPPA进行确认,确认阳性者按梅毒螺旋体感染者统计。统计学方法采用χ^2检验,以P〈0.01为有显著性差异。结果96076例初次无偿献血者血液标本确认结果阳性者826例,阳性率为0.86%;2005年、2006年、2007年和2008年梅毒感染阳性率分别为1.56%,1.11%,0.67%,0.65%;18岁～55岁3组不同年龄段梅毒感染阳性率分别为0.51%,1.13%,1.12%;5组不同职业阶层以工人和农民梅毒感染阳性率最高,分别为1.14%和1.02%。结论初次无偿献血人群中31岁～55岁是梅毒高发年龄段;工人和农民是梅毒高发职业阶层;梅毒感染阳性率呈逐年下降趋势。     

Prevalence, donation practices, and risk assessment of blood donors with hemochromatosis

CONTEXT: Despite changes in eligibility policies, practical barriers limit blood donations from individuals with hemochromatosis. Increased knowledge of hemochromatosis donor characteristics may help foster further changes that will promote more donations. OBJECTIVES: To estimate the prevalence of donors diagnosed as having hemochromatosis and to compare rates of unreported deferrable risks for transfusion-transmissible viral infections (TTVIs), positive screening test results for TTVIs, and donation patterns between hemochromatosis patient donors and donors reporting no medical conditions necessitating phlebotomy (non-health-related donors). DESIGN: An anonymous mail survey conducted in 1998 as part of the ongoing Retrovirus Epidemiology Donor Study. SETTING AND PARTICIPANTS: Among a stratified probability sample of 92 581 blood donors from 8 geographically diverse US blood centers, 52 650 (57%) responded. MAIN OUTCOME MEASURES: Prevalence of hemochromatosis among blood donors; prevalence of unreported deferrable risks and positive screening test results for TTVIs among hemochromatosis patient donors vs non-health-related donors. RESULTS: One hundred ninety-seven respondents (0.4%) identified themselves as hemochromatosis patients and 50 079 (95.1%) as non-health-related donors. An estimated 0.8% of all donations were from hemochromatosis patients, 45.8% of whom reported that they had donated blood to treat their illness. The proportion of repeat donors was higher in hemochromatosis patients than in non-health-related donors (83.5% vs 76.5%; P =.03). Among repeat donors, 68.7% of hemochromatosis patients reported donating at least 3 times in the past year compared with 49.1% of non-health-related donors (P<.001). The prevalence of unreported deferrable risks for TTVIs was similar in hemochromatosis patients (2.0%) and non-health-related donors(3.1%) as was the overall prevalence of positive screening test results (1.3% of hemochromatosis patients vs 1.6% of non-health-related donors). CONCLUSIONS: Although significant numbers of hemochromatosis patients reported donating blood for therapeutic reasons, our findings suggest that this population does not present a greater risk to blood safety than other donors.     

海南省黎族永生细胞库的建立

采用ＥＢ病毒转化外周血Ｂ淋巴细胞同时加环孢菌素Ａ法,建立了海南黎族永生细胞库。该库共含有５４株“润黎”永生细胞株,供血者均身体健康,且三代无与不同民族或不同支系通婚史。其中男性占５６％,女性占４４％,有亲缘关系者仅占１３％     

1840名献血员丙型肝炎感染血清学调查

输血是ＨＣＶ的主要传播方式之一。本文调查表明，我市两所血库献血员抗－ＨＣＶ阳性率为１．６８％，年龄组间差异无显著性。不同性别间差异有显著性，女性大于男性。献血３年以上者抗－ＨＣＶ阳性率明显高于３年以下者。据分析，我市献血员ＨＣＶ感染的主要危险因素是曾共用注射器。接种针，采血针等。献血员与肝炎患者密切接触以及反复多次献血等因素也不容忽视。建议筛检献血员应把抗－ＨＣＶ作为必查项目。     

2000~2004年信阳市无偿献血者及血液筛查结果分析

目的了解信阳市无偿献血者及血液质量状况。方法对信阳市中心血站2000~2004年站内及流动采血车的无偿献血者及血液安全性指标的筛查结果进行统计分析。结果血液初、复检不合格淘汰率,除2001年与2002年、2003年与2004年比较无显著差异外,其它各年份之间两两比较均有显著差异(P<0.001);血液不合格淘汰率和因HBsAg、梅毒阳性淘汰率男女献血员之间有显著差异(P<0.001,P<0.05);登记的无偿献血者以18~25岁年龄人群为主,26~35岁年龄段血液不合格淘汰率最高,与其他年龄段比较均有显著差异(P<0.001)。结论加强健康教育及献血知识的宣传力度,对于改善血液质量具有重要的意义。