广州地区ALT不合格献血者再次献血血液筛查结果分析

目的探讨ALT筛查在无偿献血血液安全中的作用。方法采用回顾性调查方法。追踪广州地区2007—2008年ALT单项检测首次不合格的献血者再次献血时的血液筛查结果，并进行比较分析。结果2007—2008年广州地区9122位ALT单项检测首次不合格的献血者中，1005人（11％）再次来献血，其中，五项传染病指标全部标合格者747人（74．3％），258人（25．7％）不合格，其中ALT单项仍为阳性者240人，为不合格总人数的93％，有18人（7％）献血者传染病指标转为不合格，其中ALT阴性而其他四项指标不合格者15人，ALT合并其他传染病指标不合格者3人。结论ALT筛查在一定程度上能够减少肝炎病毒窗口期或隐匿性感染的漏检．在其他更敏感和特异的检测方法引入我国血液筛查之前，ALT筛查对降低输血传染病残留风险仍具有不可忽视的作用。     

单采血小板捐献者献血前血液筛查不合格因素分析

目的分析单采血小板捐献者献血前血液筛查不合格的主要原因,探讨降低单采血小板捐献者淘汰率的有效措施,为献血者招募及献血预约模式的完善提供参考依据。方法募集单采血小板捐献者11 039人次, 2016年10月起采用预约为主,临时招募为辅的献血模式。所有捐献者献血前一般征询及体格检查合格后,抽取静脉血3 mL,分别采用血细胞分析仪、干式生化分析仪检测丙氨酸转氨酶(ALT)、血小板(PLT)数、红细胞比容(HCT)、白细胞(WBC)计数、血红蛋白(Hb)含量,病原体快速检测试剂检测乙型肝炎表面抗原(HBsAg)、抗丙型肝炎病毒(HCV)抗体、抗人类免疫缺陷病毒(HIV)抗体、抗梅毒螺旋体(TP)抗体,采用离心法观察血脂情况。对检测结果作分类统计,并采用SPSS25.0软件进行数据分析。结果 11 039人次单采血小板捐献者中男性约占88%,且男性单采血小板捐献者淘汰率明显高于女性。ALT高、血脂高、 PLT计数低、 HCT低是单采血小板献血者献血前血液筛查不合格的主要因素; WBC低、 Hb低, HBsAg阳性、抗HCV抗体阳性、抗HIV抗体阳性、抗TP抗体是单采血小板献血者献血前血液筛查不合格的次要因素。不同年份总体筛查不合格率呈下降趋势。结论针对献血者血液筛查不合格原因制定相应的招募保留策略,建立预约献血模式,并加强献血前对单采血小板献血者的健康征询,有助于降低单采血小板献血者的淘汰率。     

核酸检测技术在血液筛查中的应用研究

目的大样本、多方法调查深圳地区无偿献血人群中乙肝、丙肝和艾滋病病毒血清学阴性者的核酸阳性率,探讨在我国血液筛查中引进核酸扩增技术的必要性,了解和分析献血者血清学阴性核酸阳性感染状况。方法采用大样本数调查,应用ROCHE PCR-ELISA、PCR-微流芯片、实时荧光PCR方法和CHIRON TMA（转录依赖的扩增技术）多种方法对血清学检测阴性的献血者进行HBV DNA、HCV RNA和HIV-1RNA检测,对乙肝阳性献血者追踪检测ALT和乙肝两对半标志物,对丙肝核酸阳性献血者追踪检测ALT及抗-HCV及HBV DNA和HCV RNA病毒载量。结果共对141288人份血样进行了检测,检出HBsAg（-）、HBV DNA阳性28例,总阳性率为0.020%,其中21例为anti-HBc阳性,占0.015%。HIV-1RNA未检出阳性,17例HBsAg（-）、HBV DNA阳性样本追踪发现,9例发生了血清转换现象,4例呈窗口期特征,所有追踪的HBV DNA阳性献血者ALT检测结果正常。1例anti-HCV（-）、HCV RNA阳性献血者追踪发现为典型窗口期献血,ALT显著升高。结论应采用高灵敏度的核酸扩增技术筛查血液中的乙肝和丙肝病毒,可提高血液安全。     

北京某医院2012～2016年无偿献血者血液感染性指标检测结果分析

目的 了解近几年我院无偿献血者血液感染性指标的流行趋势,不断提高血液质量,降低血液报废率,确保输血安全,更好地为无偿献血招募宣传提供方向.方法 收集2012年至2016年我院无偿献血者血液感染性指标HBsAg、抗-HCV、抗-HIV、抗-TP、及ALT检测结果并进行调查分析.结果 我院近几年206962位无偿献血者中,血液感染性指标ALT、HBsAg、抗-HCV、抗-HIV、抗-TP的总体不合格率分别为5.8%、0.64%、0.45%、0.31%、0.61%.其中ALT的不合格率位居第一,其次为HBsAg和抗-TP;血液检测不合格各项目男女比较差异均有统计学意义;人群中抗-HIV阳性检出率较高,抗-HIV总体检出率为5.31/万.结论 我院无偿献血者血液中,ALT的不合格率位居第一,其次为HBsAg和抗-TP;人群中抗-HIV的阳性检出率较高,且有逐年上升趋势.应加强献血前宣传、征询和初筛工作,建立固定自愿的献血队伍,加强质量管理和规范操作,最大程度降低经血传播疾病的发生,确保临床输血安全.     

自贡市无偿献血血液检测不合格率构成分析

目的 分析自贡市献血者血液检测不合格的构成情况,降低血液检测不合格率。方法 分析本市2012~2016年无偿献血者的构成、血液检测不合格情况,对不合格献血者的不合格项目、性别、文化程度进行相关性分析。结果 ①2012~2016年本市血液检测总体不合格率6.51%,不合格率呈逐年降低趋势;②文化程度大专及以上不合格率为1.71%,中等职业不合格率为1.56%,初中及以下文化程度不合格率为3.24%;③男性不合格率3.89%,女性不合格率2.62%;④ALT不合格占总不合格样本的36.01%,HBsAg不合格占总不合格样本的29.81%,两者所占比例最大,其次是抗-TP,占19.63%。结论 ①血液检测不合格的原因主要是ALT和HBsAg不合格,其次是抗-TP;②文化程度越低的献血者血液不合格率越高;③男性献血者血液不合格率大于女性献血者血液不合格率。     

无偿献血者丙氨酸氨基转移酶（ALT）检测不合格情况的调查与分析

目的通过分析无偿献血者实验室检查不合格情况,探讨ALT不合格发生率与献血员性别和年龄,献血季节,采集者,采集地点,经血传播传染病等有无相关性。方法按季度统计2013年1月~12月南京市血站无偿献血者资料,对ALT检测不合格情况进行回顾性分析。结果 ALT不合格在所有检测不合格项中所占比例最大;不合格发生率男性高于女性,分别为0.65%和0.12%;ALT不合格主要集中在26~35岁人群;ALT单项不合格为335例,占98.82%,存在着个别特例合并梅毒抗体、抗-HCV、HBsAg双项不合格。结论重视ALT初筛工作,有效地降低检测不合格率以节约血液资源。     

广州地区1226507例无偿献血者梅毒筛查结果分析

目的了解广州地区无偿献血者梅毒感染状况,确定梅毒感染低危人群,为安全输血提供有效的预防措施。方法选择广州地区2005—2009年无偿献血者梅毒筛查数据进行分析。梅毒血清学筛查试验采用ELISA试验,梅毒血清学筛查阳性标本采用TPPA试验确认。结果1226507例无偿献血者中梅毒阳性率为0．45％。其中单位员工、大专院校学生、流动人员和其他献血人员（包括无偿机采成分献血者）梅毒抗体阳性率分别为0．44％、0．14％、0．69％、0．29％;年龄在20～39岁梅毒抗体阳性献血者5126例,占梅毒抗体阳性者的93．4％;梅毒阳性率不同年龄和职业分布差异均有统计学意义（P〈0．01）。各年份无偿献血者中梅毒抗体阳性率差异无统计学意义（P〉0．05）。结论广州地区2005—2009年无偿献血人群梅毒感染率保持相对稳定水平,无明显上升趋势。大专院校学生和单位员工为梅毒感染低危人群,可作为主要献血人群,发展献血者队伍。采供血部门应加强对流动人员的无偿献血筛查工作,以保证血液安全。     

北京市某医院献血者不规则抗体筛查阳性结果分析

目的 通过交叉配血次侧不合发现不规则抗体筛查阳性的献血者并鉴定不规则抗体特异性,保障输血安全。方法通过交叉配血次侧均不相合且复查血型发现不规则抗体筛查阳性的献血者,并鉴定抗体特异性;将其中4袋不规则抗体筛查阳性的悬浮红细胞制备为洗涤红细胞,并跟踪其输注效果。结果 2016年11月至2017年12月期间,34297例献血者中发现11例为不规则抗体筛查阳性,其中抗-E5例、抗-M4例、自身抗体1例、非特异性抗体1例。两名患者输注抗筛阳性洗涤红细胞后,输注有效,无不良输血反应发生。结论 常规开展献血者不规则抗体筛查项目具有重要的临床意义,将抗筛阳性的悬浮红细胞制备为洗涤红细胞,可以保障输血安全,节约血液资源。     

抗-HBc单项阳性患者中的隐匿性HBV感染

目的 研究抗-HBc单项强阳性患者中的隐匿性HBV感染发生率并分析发生原因.方法 收集183例血清学检测抗-HBc单项强阳性（A≤0.1）患者血清标本,采用实时定量PCR进行HBV DNA含量检测.对于DNA定量阳性的标本,PCR扩增HBV pre-S/S区基因,并进行克隆测序.结果 183例血清标本中3例HBV DNA定量结果大于103拷贝/ml,占1.6%.这3例标本中有2例得到pre-S/S区测序结果,2例标本均存在S基因＂a＂决定簇内Q129R/P点突变,且突变株与野生型共存.结论 抗-HBc单项阳性患者中存在隐匿性HBV感染,HBsAg血清免疫学方法的漏检与HBV S基因突变有关,同时与循环中HBsAg量低于检测限也有一定关系.HBV隐匿感染不仅可以造成临床诊断失误,更为严重的是献血员HBV隐匿感染造成血液的污染.     

ALT初筛对无偿献血者血液不合格率的影响

目的探讨无偿献血前进行ALT初筛对血液不合格率的影响。方法回顾性分析我中心实施献血前ALT初筛前后9个月的血液检测不合格率，并对ALT淘汰率进行分析。结果实施前ALT不合格率为%，实施后降为%，差异有统计学意义(P<0.05)。实施前ALT不合格数占总不合格数的%，实施后降为%，差异有统计学意义(P<0.05)。结论采取献血前ALT初筛能很好的降低血液不合格率，减少血液浪费。     

新生儿疾病筛查不合格血片原因分析及对策

目的分析不合格血片的原因,采取相应对策提高工作质量。方法对2012年1月～2013年9月不合格新生儿疾病筛查血片的不合格原因进行分类统计分析。结果血片不合格率为0.43%,血片不合格主要原因为血斑被污染（36.6%）。乡镇卫生院不合格率最高。结论应采取措施对标本采集人员加强培训,提高血片合格率。     

献血人群隐匿性乙型肝炎病毒感染的流行病学和血清学研究

目的了解广州地区献血人群隐匿性乙型肝炎病毒感染（OBI）的流行病学和血清学情况。方法对广州地区199631例无偿献血者标本同时用ELISA法检测HBsAg、紫外-乳酸脱氢酶法检测ALT、核酸扩增技术（NAT）联合检测HBV/HCV/HIV及HBV单项鉴别试验,对HBsAg阴性HBV DNA阳性者进行随访,用荧光定量PCR检测病毒载量,用ELISA法检测乙肝两对半。结果 199631例标本中共检出104例HBsAg阴性HBV DNA阳性者,经随访有54例为OBI,OBI检出率为0.027%,年龄以46～55岁组检出率最高（P〈0.01）,外地身份证的献血者检出率高于广州市身份证者（P〈0.01）,OBI检出率与性别和献血次数无关（P〉0.05）。104例HBsAg阴性HBV DNA阳性的标本ALT均正常,病毒载量均〈1000IU/ml,平均值为162IU/ml。随访标本中,除6例ALT异常外其余均正常,54例OBI标本病毒载量均〈1000IU/ml,平均值为122IU/ml,乙肝两对半中抗-HBc阳性率明显高于其他项目（P〈0.01）。结论 HBsAg阴性献血者中存在OBI,有必要在献血者中开展核酸检测。     

抗-HCV和HCV-RNA检测及其与ALT的相关性分析

目的探讨化学免疫发光法（CLIA）定量检测抗-HCV和FQ-PCR法检测HCV-RNA含量与丙氨酸氨基转移酶（ALT）水平的相关性。方法用CLIA定量筛选抗-HCV阳性的100例病人标本,以荧光定量PCR法检测HCV-RNA含量和酶速率法检测ALT浓度水平,并对所得数据进行统计分析。结果在100份抗-HCV阳性标本中,检出HCV-RNA阳性者76例,阳性率为76%。随着抗-HCV的S/CO值增高,HCV-RNA检出率增高较明显;ALT水平与HCV-RNA含量无显著相关性（P〉0.05）,但ALT异常率与HCV-RNA含量呈正相关。结论在HCV诊断与疗效观察中,血清抗HCV、HCV-RNA和ALT指标各有利弊,3者有机结合能正确诊断和预测肝脏损伤及评价疗效。     

Status analysis and evaluation of the blood scrap rate from 2015–2017 for a blood center in China

ObjectivesThe objective of this study was to ascertain the current conditions and development in the past three years of clinical transfusion practice in Nanjing, Jiangsu province, China.Materials and methodsBlood quality control practices and the blood production scrap rate from 2015–2017 were monitored and measured using different quality statistics and management tools.ResultsThe causes of unqualified and scrapped blood during blood collection and supply were analyzed and evaluated. The analysis of the key indices for blood component quality control showed that the qualified rate of FVIII activity (from fresh frozen plasma) was 54.55%, which failed to meet the threshold of 75%. Retrospective analysis of conventional blood scrapping factors showed that laboratory scraps accounted for the majority. The composition ratio of TTI screening results included ALT (31.91%), HBV (21.92%), TP (12.15%), NAT (10.78%), HCV (8.45%), and HIV (7.43%). Retrospective analysis of unconventional blood scrapping factors showed that the total unconventional blood depletion rate was 0.565%. Insufficient or small quantities of collected blood was the most important factor related to unconventional scrapping. The blood donor and blood hospital service satisfaction rates were over 95% and 90%, respectively, which achieved the quality target.ConclusionsNonconforming product control was proposed and determined as the urgent theme of the first QCC. It is necessary for blood stations to effectively control blood scrapping, which can reduce the cost of blood collection, protect the blood donation of unpaid blood donors, increase the rate of repeated blood donation, and improve blood safety.     

Novel approach for detection of hepatitis E virus infection in German blood donors

The risk of transfusion-transmitted hepatitis E virus (HEV) infections by contaminated blood products remains unknown. In the present study, we evaluated and compared different nucleic acid amplification technique (NAT) methods for the detection of HEV in blood components. Minipools of a total of 16,125 individual blood donors were screened for the presence of HEV RNA using the highly sensitive RealStar HEV RT-PCR kit, revealing a minimum detection limit of 4.66 IU/ml. Thirteen donors were HEV RNA positive (0.08%), and of these donors, only three already showed reactive IgM antibody titers. The detected HEV strains all belonged to genotype 3 and were most closely related to German HEV strains from wild boars and pigs as well as from human hepatitis E cases. Furthermore, HEV RNA and HEV-specific IgM and IgG titers were determined in 136 blood donors with elevated alanine aminotransferase (ALT) levels and in 200 donors without pathological findings. HEV RNA was not detectable, but 8.08% (elevated ALT) and 0.5% (nonelevated ALT) of donors showed reactive HEV IgM titers. The overall seroprevalence rate of HEV IgG amounted to 5.94% (elevated ALT, 5.88%; nonelevated ALT, 6.0%). The clinical relevance of transfusion-associated hepatitis E infection still requires further investigation. However, in connection with raising concerns regarding blood safety, our NAT method provides a sensitive possibility for HEV testing.     

广州地区无偿献血者不规则抗体筛查结果分析

目的了解广州地区无偿献血者不规则抗体的频率、类型、特异性和抗体效价。为输血前检查策略的制定提供依据。方法随机抽取2012年11月至2013年3月广州血液中心无偿献血者血液样本20160例。选择含特定抗原的筛选红细胞,采用聚凝胺介质微板法进行不规则抗体初筛,阳性样本使用试剂筛选细胞和试管法进行确证试验,仍然阳性的样本采用谱细胞微柱法进行特异性鉴定并测定效价。结果20160名广州地区无偿献血者中共筛查出不规则抗体97例,检出率为0．48％,其中IgG型抗-E1例,IgM型抗体96例,包括抗-P14例,抗-M2例,抗-Lewisnn1例,上述抗体效价均不超过8;冷自身抗体59例和非特异性不规则抗体30例。女性不规则抗体阳性率显著高于男性（xz=18．7201,P=1．51E．05）。结论广州献血人群中存在低比例的不规则抗体,对献血者进行不规则抗体筛查有利于电子配血及血液预警系统的建立,对提升临床用血安全性、有效性和智能化水平有着重要意义。     

Current concepts in serological testing – TTID

Introduction Blood components play a major part in a huge number of therapeutic interventions in oncology, haematology, surgery and other medicine disciplines. Therefore, the supply of safe blood products is a major ongoing challenge for blood transfusion services. Serology screening tests were developed to improve blood safety. As screening for antibodies reflects an immune reaction in response to infection, the diagnostic window period is longer for antibody tests than for direct screening assays, such as nucleic amplification tests (NAT). The introduction of mini-pool NAT (MP-NAT) and individual donation NAT (ID-NAT) as well as the development of antigen screening assays, such as the hepatitis C virus antigen test (which detects the NS3 antigen) and the p24 antigen assay for HIV-1, have been able to reduce the diagnostic window period. Methods Currently, blood donor screening for HBsAg, anti-HBc, anti-HCV, anti-HIV-1/2 and syphilis antibodies is mandated by the German authority (the Paul Ehrlich Institute). All blood donations must also be screened for HCV and HIV-1 using MP-NAT. The German Red Cross Blood Donor Services Baden-Württemberg-Hessen has implemented additional blood donor screening for anti-CMV (for platelet products from repeat donors) and MP-NAT screening for HBV, HAV and Parvovirus B19 on a voluntary basis. Results The epidemiology data within the last 4 years have found that 98% and 89% of hepatitis B and hepatitis C positive donors belonged to the first time donor population. Between 1997 and 2005, the German Red Cross Blood Donor Services detected hepatitis B, hepatitis C and HIV-1 in 43, 23 and 7 donors, respectively, using NAT. About 50% (22 out of 43) of these HBV-infected donors were in the acute phase of infection, while 21 were in the occult phase. Improvements in NAT technology, especially the introduction of full-automated extraction robot systems (e.g. the Zelos × 100), have been able to reduce the diagnostic window period, especially for hepatitis B, by improving the 95% level of detection. Nevertheless, five cases of NAT failures in detecting HIV-1 have been reported to the Paul-Ehrlich-Institute within the last decade. In 2010 in particular, three cases occurred in Germany due to mutations in the primer and probe binding regions. These cases restarted a discussion about risk analysis for NAT screening tests and serology methods in general. Conclusion In Germany, blood donor screening is performed using parallel serological assays (antigen and antibody detection) and by MP-NAT for hepatitis B, hepatitis C and HIV-1. The risk of false-negative test results due to mutations in primer and probe binding regions is higher for NAT systems than for antibody/antigen detection tests. Therefore, the manufactures of the NAT systems are advised to improve their systems by utilising amplification in at least two conserved regions (dual- or triple-targeting). The diagnostic window period for new screening strategies (e.g., antigen screening for HCV)