江苏省反应性献血者屏蔽、保留与归队情况分析

目的对江苏省反应性献血者屏蔽、保留与归队工作进行总结分析,观察保留与归队策略的可行性。方法 ELISA单试剂反应性/NAT(-)及ELISA(-)/NAT(+)的献血者标本,经确认为阴性者,血液淘汰,献血资格保留。屏蔽6个月以上的献血者可在省内任一家血站提出归队申请,经常规检测及江苏省血液中心复检合格后允许其归队。用χ2检验比较保留、归队后再献血的不合格率与普通献血者是否存在差异。结果 2014年10月至2016年6月,单ELISA试剂(+)/NAT(-)标本1 615例,经确认阳性67例,不确定42例,阴性1 506例;ELISA(-)/NAT(+)标本831份,经确认阳性809例,阴性22例。共1 528例确认为阴性,保留献血资格。经保留的献血者中,89例再次献血,79例血液检测合格,不合格率11.24%,与普通献血者不合格率(1.55%)比较,差异有统计学意义(P0.001)。同期,全省共596例提出归队申请,218例被归队血站方淘汰,在余下的378份送检江苏省血液中心的标本中,有359份合格,符合归队条件。其中有332例在归队后献血,血液检测均合格。结论江苏省反应性献血者的归队策略合理可行,但献血者保留策略仍需进一步优化和完善。     

基于抗-TP检测结果细化反应性献血者屏蔽策略的研究

目的 探讨现行献血者屏蔽策略中对抗-TP ELISA反应性献血者实施屏蔽的准确性和适宜性.方法 使用2种不同的抗-TP ELISA试剂常规检测后的标本,进行TPPA确证试验.根据抗-TP ELISA初筛结果及确证结果对双试剂反应性和单试剂反应性献血者检测数据进行分析和整理,从而判定献血者真阳性的可能性.结果 共收集抗-...     

HBV DNA阳性献血者感染标志物定量分析

目的 探究乙型肝炎病毒核酸（HBV DNA）阳性献血者感染标志物含量特征。方法 收集2019年9月至2021年5月金华市中心血站HBV DNA阳性献血者标本,运用时间分辨荧光免疫分析（TRFIA）定量检测乙肝五项和实时荧光PCR技术定量检测HBV DNA,并按照HBsAg阴性和HBsAg阳性进行分组比较感染标志物含量。结果共检测46 324例标本,发现HBV DNA阳性124例,阳性率0.27%,平均HBV DNA浓度（1.82±0.94）lgIU/mL。其中,HBsAg阴性组64例、HBsAg阳性组60例。HBsAg阴性组HBcAb阳性率为93.75%,主要以HBeAb(+)+HBcAb（+）及单独HBcAb（+）血清学模式为主,HBcAb平均浓度9.01(6.10,11.51)PEIU/mL,HBsAb平均浓度为3.18(1.06,14.86)mIU/mL,HBV DNA平均浓度为1.33(0.90,1.70)lgIU/mL。HBsAg阳性组HBcAb阳性率为100%,主要以HBeAb(+)+HBcAb（+）模式为主,HBcAb平均浓度14.85(9.90,18.48)PEIU/m...     

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。     

HBsAg反应性/核酸筛查无反应性献血者乙肝感染多方法确认研究

目的 了解深圳市HBsAg ELISA反应性核酸筛查无反应性献血者乙肝感染状况.方法 收集2019～2020年HBsAg ELISA反应性NAT无反应性标本,应用全自动时间分辨荧光分析法(TRFIA)和罗氏电化学发光免疫法(ECLIA)及中和试验检测HBsAg;分别采用商用罗氏MPX和Ultrio Elite单人份检测...     

对ELISA单试剂反应性屏蔽献血者归队探讨

目的讨论现行献血者归队模式在本血站的实施现状,关爱献血者,保留和稳定献血者队伍。方法对4项血液传染病ELISA法检测单试剂反应性献血者,间隔6个月后追踪采样,对上一次屏蔽项目进行双试剂双孔追踪检测,结果均为无反应性时,送检上级机构再次检测和确认,合格后方可归队。结果 2015年1月～2017年2月共献血38424人次,其中138例为单试剂反应性屏蔽献血者,通知归队追踪检测37人,合格34人,归队合格率91%,归队后完成再献血共20人次。结论本血站启动无偿献血者归队模式,成效显著,对保障献血者权益,增加献血者信心,巩固献血者队伍,推动无偿献血事业健康发展具有积极的现实意义。     

献血者HBsAg ELISA检测屏蔽界限值研究

目的建立酶联免疫吸附法(ELISA)对献血者进行乙肝表面抗原(HBsAg)检测的高特异性S/CO屏蔽界限值。方法对783份HBsAg ELISA反应性标本和588份非反应标本,采用HBsAg化学发光法和中和实验确认检测。根据确认检测结果和ELISA检测S/CO值建立受试者工作特征曲线(ROC曲线),确定95%和99%特异度对应的S/CO界限值。另选择124份HBsAg ELISA反应性标本对设定的屏蔽界限值进行验证,同时以乙肝五项化学发光发检测结果作为补充,判断屏蔽界限值的实用性。比较不同实验室采用相同试剂设定的99%特异度对应的HBsAg ELISA检测S/CO界限值。结果该实验室采用的2种ELISA试剂95%特异度对应的S/CO界限值分别为0.24和0.65,99%特异度对应的S/CO界限值分别为3.89和3.62,将99%特异度对应的S/CO界限值设定为该实验室献血者屏蔽界限值。验证实验证实,大于或等于试剂1和试剂2屏蔽界限值的标本均为HBV感染标本。与该实验室采用相同HBsAg ELISA检测试剂的3家实验室,试剂1的99%特异度对应S/CO界限值分别为3.77、3.60、13.42,试剂2分别为27.73、31.75、1.17。结论该研究建立的献血者HBsAg ELISA检测屏蔽界限值可在该实验室有效甄别出真阳性献血者,有助于减少进入归队流程的献血者数量。即使采用相同的ELISA检测试剂,不同实验室也不适用统一的献血者屏蔽界限值。     

HBsAg不同状态下NAT反应性献血者血清学标志物特征分析

目的 了解HBsAg不同状态下核酸检测(NAT)反应性献血者HBV血清学标志物特征。方法 收集2021年9月～2022年5月核酸检测反应性标本,且ELISA检测HBsAg-/初筛HBsAg+复检阴性/单试剂HBsAg+标本,TMA鉴别非反应性标本加做罗氏PCR单人份复检,用电化学发光免疫法(ECLI)定量检测乙肝两对半进行统计分析。结果 共收集66份标本,HBsAg-/NAT+标本55份,抗-HBc阳性率为87.3%(48/55),抗-HBs、抗-HBc 2项阳性率为43.6%(24/55),抗-HBe、抗-HBc 2项阳性率为45.5%(25/55),单项抗-HBs阳性率为10.9%(6/55)和全阴性占比1.8%(1/55);酶免初筛HBsAg+复检阴性/NAT+标本7份,抗-HBc阳性率为100%(7/7),抗-HBe、抗-HBc 2项阳性率为71.4%(5/7);单试剂HBsAg+/NAT+标本4份,HBsAg、抗-HBs、抗-HBe、抗-HBc 4项阳性率为50%(2/4),抗-HBe、抗-HBc 2项阳性率为100%(4/4)。TMA鉴别非反应性且抗-HBc-标本PCR单人...     

加样时差对献血者HBsAg ELISA结果的影响

目的　探讨加样时差对献血者HBsAgELISA结果的影响。方法　在同一块酶标板相邻位置上对同一份弱阳性或高值阴性标本分别双孔加样 ,保证同一份标本的加样时差为 8～ 10min ,进行检测。结果　 71份标本在不同的加样时差所检测的结果不一致 ,加样时差对弱阳性标本的结果有影响。结论　常规操作中应将初试中的高值阴性标本做复试 ,且保证复试标本加样优先 ,以避免漏检弱阳性标本     

Whole blood donor deferral rate and characteristics of the Turkish population

Whole blood (WB) donors are deferred for several reasons, either permanently or temporarily. In this retrospective study, we quantified the rate of and reasons for donor deferral among Turkish donors. Computer records of the last 5 years were analysed to quantify the deferral rate and reasons. Deferrals were categorized as temporary short-term (1-56 days), long-term (57-365 days) and multiple years or permanent (more than 365 days). Deferred donors were also analysed according to gender, age and education level. A total of 95 317 persons were admitted for WB donation: 89.1% of them were male donors and 59.9% were in the 30 to 49-year old age category. Rates of deferral for temporary short-term, long-term, permanent or for unknown reasons were 66, 22.5, 10 and 1.5% respectively. Female donors were deferred more frequently than male donors (25.8 vs. 13.3%, P 0.05). The main reason for deferral was common cold and/or sore throat or elevated temperature (20.4%) in male donors and low haemoglobin (51.6%) in female donors. Although the three uppermost reasons for deferral in women were identical for all age categories, these varied in the male group (high-risk sex partner for the younger group vs. hypertension and low haemoglobin for the older group). Although permanent and temporary deferral rates are similar between the Turkish population and western countries, leading causes vary widely.     

影响献血者 ALT 初筛结果的原因分析

目的：探讨采用干化学法初筛献血者丙氨酸氨基转移酶(ALT)的影响因素,以有效建立初筛 ALT 标准,减少血液浪费。方法收集2013年1~6月茂名市中心血站无偿献血者血样标本21065份,对比测试标本溶血、脂血、加样量、加样后等待时间等因素对干化学法检测 ALT 的影响,并根据结果规范操作,设定适宜的初筛限值标准。结果标本溶血对 ALT 检测结果产生影响,溶血率小于或等于0.5%对 ALT 检测无明显影响;脂血对检测结果无明显影响;加样量为(32±3)μL、加样后等待时间为10~40 s,ALT 检测结果可接受。设定初筛限值标准为 ALT≤40 U/L(女),ALT≤45 U/L(男)。结论标本溶血、加样量、加样后等待时间对干化学法检测 ALT 产生影响,而脂血对检测结果无明显影响,规范操作、合理设置正常限值可保证检测的准确性和稳定性,节约血液资源,进一步保证血液安全,值得广泛应用和推广。     

Variation in the sensitivity of HBsAg screening kits

Summary. Fifteen HBsAg kits from 14 manufacturers were assessed. Their sensitivity was evaluated by testing 150 HBsAg-positive sera, sera from four donors who were low-level HBsAg carriers, and sequential specimens from 22 seroconverting individuals together with dilutions of six of these specimens. The British HBsAg Working Standard (0.5IUmL^-1) and the NIBSC/UKBTS HBsAg Monitor Sample (0.125IUmL^-1) were also tested. Five assays failed to detect one of the 150 routine HBsAg-positive sera. Four assays (Auszyme Monoclonal; Monolisa Ag HBs 2nd generation; Murex HBsAg; Ortho HBsAg Test Systems 3) were able to detect HBsAg in all but one of the six sera from low-level carriers, whereas one assay (MicroTrak II HBsAg) detected only one of the six. The most sensitive kit (Monolisa Ag HBs 2nd generation) detected HBsAg in 79 specimens from the seroconversion panels; four other kits detected HBsAg in at least 70 specimens, seven in 60–69, two in 50–59 and the least sensitive in 31. Further analysis of the findings on seroconverters indicated a median reduction in the duration of HBsAg detection of 5 days or more for four assays when compared with the most sensitive assay. One kit (Auszyme Monoclonal) detected HBsAg in 15 of the 18 dilutions prepared from the seroconversion specimens, whereas three kits detected HBsAg in fewer than 10 dilutions. Two kits gave negative reactions with the British HBsAg Working Standard on all of five occasions and six were consistently unreactive with the NIBSC/UKBTS HBsAg Monitor Sample; only three kits (Bioelisa, Enzygnost, Murex) were always reactive. There is therefore substantial variation in sensitivity among the HBsAg kits currently available.     

HBsAg blood screening and diagnosis: performance evaluation of the ARCHITECT HBsAg qualitative and ARCHITECT HBsAg qualitative confirmatory assays

A low initial reactive rate for screening assays is important for time- and cost-effective infectious disease testing. Therefore, the new ARCHITECT HBsAg Qualitative screening assay, in conjunction with the new ARCHITECT HBsAg Qualitative Confirmatory assay, was introduced. As the role of hepatitis B surface antigen (HBsAg) as surrogate marker for HBV resolution and the monitoring of drug effectiveness are becoming increasingly important, the established ARCHITECT HBsAg Quantitative assay remains available on the market. Precision, sensitivity, and specificity of the newly developed screening assay were in the range of established HBsAg assays. Seroconversion sensitivity was slightly superior compared to other commercially available assays. An initial reactive rate of 0.2% (without HBsAg-confirmed positive samples of 0.17%) for the ARCHITECT HBsAg Qualitative assay was observed. As the new screening assay is a 1-step assay format, the "high-dose hook effect" was investigated to assess the risk of false-negative results, but even very high positive HBsAg samples obtained signals clearly above the cutoff.     

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。     

HBcAb单项或HBcAb与HBeAb二项阳性时HBsAg定量检测分析

目的用酶联免疫吸附试验(ELISA)法检测乙型肝炎病毒(HBV)标志物,若乙型肝炎病毒核心抗体(HBcAb)单项或HBcAb与乙型肝炎病毒e抗体(HBeAb)二项阳性,再进行乙型肝炎病毒表面抗原(HBsAg)定量和HBV载量测定,了解HBV携带及病毒复制情况。方法 ELISA检测HBV标志物HBsAg、HBsAb、HBeAg、HBeAb、HBcAb,选取1 098例HBcAb阳性、966例HBeAb和HBcAb二项阳性样本及832例HBV标志物全阴性标本为对照,用化学发光法定量复检HBsAg,并用PCR的方法检测HBV载量。结果 1 098例HBcAb单项阳性检测出HBsAg定量436例(39.7%)、PCR-DNA230例(20.9%);966例HBeAb、HBcAb二项阳性的标本分别定量检测出HBsAg定量387例(40.1%)、PCR-DNA 212例(21.9%),HBV标志物全阴性的HBsAg定量和PCR-DNA比较,差异有统计学意义(P0.05)。结论 ELISA法检测HBV标志物时,若只HBcAb阳性或HBcAb与HBeAb二项阳性,仍可检出表面抗原和病毒的复制,需做进一步的检测,以免漏检,造成医疗风险。     

Improved strategy for screening prospective blood donors for anaemia

SUMMARY. Women (568) and men (531) attending blood donation sessions in Wessex in September, 1992, were assessed for anaemia by the standard CuSO₄ method on finger-prick (FP) blood samples. The haemoglobin (Hb) concentration on FP samples and on venous blood was also checked using the HemoCue. Different FP samples from the same donors revealed a wide variation on HemoCue. We recommend retaining the CuSO₄ method on FP samples as the initial screen, and follow-up of apparent failures by determining the Hb concentration on venous sampling with the HemoCue. As 54% of females were found on venous samples to be below the current recommended threshold (125 g/L) for Hb concentration, we also recommend lowering the threshold to 115 g/L for women, and to 130 g/L for men. We further recommend a close re-examination of normal haematology values for adults.