[Objective] To analyze the influence of the cycle length of hepatitis B surface antigen (HBsAg) double reagent positive samples collected from voluntary blood donors in Guangzhou on the detection results. [Methods] A total of 127 044 blood samples from voluntary blood donors at Guangzhou Blood Center from August 10 to December 9, 2023 were selected. Two ELISA reagents were used for HBsAg detection, and samples with HBsAg double reagent positive and S/CO values<10 were tested continuously for 7 days to observe the changes in their S/CO values. [Results] A total of 505 HBsAg double reagent positive samples were detected, of which 52 had S/CO values less than 10. After 7 consecutive days of uninterrupted testing, the S/CO values of Wantai (median 5 decreased to 3) and Xinchuang (median 5 decreased to 3) showed an overall downward trend, and the HBsAg missed detection rate showed an upward trend (from 0 on the first day to 1/10 000 on the seventh day). A total of 13 cases had negative double reagent test results within the 7-day testing cycle. [Conclusion] With the extension of the detection cycle, the S/CO value of HBsAg detection shows a downward trend, and the missed detection rate of HBsAg shows an upward trend. Samples used for HBsAg detection should be tested promptly after sampling to improve the quality of blood testing.

Objective To investigate the condition of confidential unit exclusion(CUE)in Guangzhou,so as to en-sure blood safety.Methods The number of CUE donors,demographic characteristics of CUE donors,reasons for CUE,and response time of CUE after blood donation in Guangzhou from 2009 to 2022 were statistically analyzed.Results From 2009 to 2022,the response ratios of CUE was 0.006 2％(260/4 170 984)and the ratios had statistically significant difference between different years(P＜0.05).For the response ratios of CUE,no statistically significant difference was no-ticed in gender and occupation(P＞0.05),but statistically significant differences were found in age,number of blood do-nations,education background,and marital status(P＜0.05).Blood donors aged 18～30(0.007 3％,P＜0.05)and first-time blood donors(0.010 8％,P＜0.05)were the main groups of CUE.High risk sexual behavior(28.46％,74/260)was the primary reason for CUE.The CUE response peak was within 72 hours after blood donation,and the response ratios within 24-72 hours after blood donation was the highest(68.46％,178/260).Conclusion CUE is a crucial measure to ensure blood safety.Detailed pre-donation health consultations are suggested for blood donors aged 18-30 and first-time blood donors so as to better excluding high-risk blood donors.Strengthening the publicity of CUE response and process,registering and classifying the reasons for CUE are also important.

Objective To investigate the distribution,phenotype and genotype of D-elute type(Del)in blood donors with RhD negative blood in Guangzhou,so as to understand the molecular biological background of DEL blood group in this area.Methods During the period from November 1,2021 to June 30,2022,the RhD-negative blood initially screened by saline method was confirmed by indirect anti-human globulin test(IAT)serology,and RhCE phenotype was determined by RhCE typing card.A total of 1 146 RhD-negative samples,including all RhD-negative samples with RhCE C+(n=459)and a randomly selected subset of RhCE C-(n=175),were subjected to adsorption-elution(Del)screening(a total of 634 sam-ples).DNA from Del-positive samples was extracted for real-time fluorescent PCR detection of the RHD gene c.1227 locus using high-resolution melting curve analysis(HRM).For samples without mutations detected at the RHD∗1227 locus by HRM,restriction fragment length polymorphism polymerase chain reaction(PCR-RFLP)was performed to amplify the prod-uct which was subsequently digested with Pst I enzyme and analyzed by electrophoresis to determine RHD gene haplotypes.Sanger sequencing was performed for exon sequencing(exon 1-10)of the RHD gene,and gene mutations were analyzed u-sing SeqMan software.Suspected Del-positive samples were subjected to RHD whole gene analysis using third-generation sin-gle-molecule sequencing technology.Results Among the 634 confirmed RhD-negative samples,229(36.1%)displayed Del phenotype,accounting for20%(229/1 146)of the total confirmed RhD-negative samples.The RhCE phenotypes of the 229 DEL cases were as follows:Ccee in 181 cases,CCee in 40 cases,CcEe in 7 cases,and ccEe in 1 case.HRM combined with RHD haplotype analysis showed that there were 170 cases with RHD gene as RHD∗1227A/01N.01,32 cases with RHD gene as RHD∗1227A/1227G,26 cases with RHD gene as RHD∗1227A/1227A,and 6 cases with RHD gene as RHD∗1227G/1227G(sequencing results included 1 case of weak D type 12,4 cases of D-,and 1 case of RHD∗01EL.02).Con-clusion The individual genotype of DEL blood donors in Guangzhou area is mainly characterized by RHD∗1227A/01N.01,and their RhCE phenotypes are all C+.HRM can be used as a molecular biology method for routine screening of Asian-type DEL blood type genes.

Objective To investigate the distribution of ABO and RhD blood groups among voluntary blood donors in Guangzhou,in order to ensure clinical blood safety and better serve blood donors.Methods Routine ABO and RhD blood group screening tests were carried out among voluntary blood donors from January 2021 to December 2022.The composition ratio of ABO blood group was statistically analyzed.The samples with discrepancy between forward and reverse blood group-ing and negative RhD blood group samples were further verified by serological test to analyze the ABO subtypes and the rea-sons for missed detection.Results A total of 749123 blood samples were screened from January 2021 to December 2022,and 513291 samples were collected after excluding repeat blood donors,with the ABO blood groups as 208126(40.55%)of O type,138859(27.05%)of A type,130987(25.52%)of B type and 35319(6.88%)of AB type.The screening re-sults showed discrepancy between forward and reverse blood grouping in 506 samples,of which 58 were with weak/non-e-rythrocyte reaction,16 with erythrocyte reaction,215 with weak/non-serum reaction,and 217 with serum reaction.Further serological test indicated that 44 samples were ABO subtypes,among which 13 were subtype A,26 subtype B,5 subtype AB and 3 B(A)and 14 Bombay-like blood group.The blood group with the highest missed detection rate in repeat blood donors were A3/B3 subtype(68.42%).A total of 128 unexpected antibody positive samples were detected among 513291 samples A total of 2277 samples were screened negative for RhD blood type,of which 2188 were confirmed to be Rh nega-tive(2188/513291,0.43%),89 were D variants(89/513291,0.02%,)and 30 were detected with unexpected antibod-ies(30/2188,1.37%).Conclusion The ABO blood group distribution of blood donors in Guangzhou is O>A>B>AB,and the proportion of RhD negative population is 0.43%,slightly highter than 0.3%-0.4%of Han population nationwide.The ABO blood group subtype is dominated by B subtype.The detection rate and missed detection rate of A3/B3 subtypes in routine blood group tests are the highest.

BACKGROUND:China's significant population affected by HIV poses a substantial threat to blood transfusion safety. Despite advancements in blood testing techniques, a residual risk of HIV transmission persists. Accurately assessing HIV epidemic and the residual risk is vital for monitoring blood supply safety and evaluating the effectiveness of new screening tests. METHODS:We conducted a retrospective analysis of HIV detection results among voluntary blood donors from 2003 to 2022. The study included data on HIV-confirmed positive donors, HIV prevalence, infection risk factors, and an incidence-window period mathematical model to estimate the residual risk of HIV. RESULTS:Between 2003 and 2022, HIV prevalence among blood donors in Guangzhou showed a peak-shaped trend, initially increasing before declining. The overall HIV prevalence was 18.9 infections per 100,000 donations. Male donors had a significantly higher prevalence compared with female donors. Donors aged 26-35 years had the highest prevalence. Ethnic minority donors had a higher prevalence compared with Han donors. Repeat donors had a lower prevalence compared with first-time donors. Donors from other provinces had a higher prevalence compared with local donors. During the period of 2003 to 2022, the residual risk of HIV in Guangzhou steadily decreased, reaching a notable 1 in 526,316 donations in the past two years. CONCLUSION:The HIV epidemic among blood donors in Guangzhou remains severe, but the residual risk of HIV is decreasing. Novel detection methods have proven advantageous in reducing this residual risk. Implementing additional effective measures is imperative to ensure blood safety and curb the spread of HIV.

Objective To explore the correlation between serological screening of human T-lymphotropic virus antibodies (anti HTLV) and Western blot(WB) confirmatory tests among blood donors, so as to explore the infection status of HTLV Ⅰ/Ⅱ in Guangzhou. Methods The anti HTLV Ⅰ/Ⅱ enzyme-linked immunosorbent assay(ELISA) kit was used to screen voluntary blood donors from Guangzhou Blood Center from July 2016 to August 2022. WB was used to confirm 395 reactive blood samples by ELISA. The correlation between the S/CO values of anti HTLV Ⅰ/Ⅱ ELISA reagents and the confirmatory test was analyzed using ROC curves. Results The results showed that 25 out of 395 initially screened reactive blood donor samples were confirmed as HTLV positive by WB, while 16 were uncertain. ROC curve analysis showed a correlation between the S/CO values by ELISA and the confirmatory test results: the S/CO value at the highest Youden index was 3.789, which was the optimal threshold. The S/CO value had a certain correlation with the predicted positive rate of confirmatory results (P<0.05): the larger the S/CO value, the higher the predicted positive value. The overall prevalence of HTLV in Guangzhou is relatively low. Conclusion The prevalence of HTLV among blood donors in Guangzhou is low.Since the false positive rate of HTLV Ⅰ/Ⅱ antibody by ELISA serological screening is high, the confirmatory testing is particularly important.

Objective To assess the trend of hepatitis B virus (HBV) prevalence and associated risk factors among voluntary blood donors in Guangzhou area from 2011 to 2020, and to explore the impact of hepatitis B vaccination in neonates on the risk of HBV infection. Methods Blood samples of 2 624 434 voluntary blood donors from 2011 to 2020 in Guangzhou were tested by HBV surface antigen (HBsAg) enzyme-linked immunosorbent assay (ELISA) reagents twice and nucleic acid test (NAT) reagent once. Samples reactive to ELISA twice, or ELISA once + NAT were considered as HBV infection. The gender, age, ethnicity and region of HBV infected blood donors were collected, and the incidence of HBV infection in blood donors born before and after 1992 (when HBV vaccination was conducted in neonates) was compared. The trend and risk factors of HBV infection in blood donors in Guangzhou from 2011 to 2020 were analyzed. Results An overall HBV prevalence of 0.75% was found in voluntary blood donors in Guangzhou area from 2010 to 2020, showing an overall downward trend(P<0.05). HBV prevalence was lower in blood donors born after 1992 (0.49 %, 4 825/98 5362) than prior to 1992 (P<0.05). HBV prevalence in male blood donors (0.89%, 15 049/1 695 062) was significantly higher than that in female blood donors (P<0.05). HBV prevalence in blood donors aged 18~25(0.52%, 6 337/1 219 282)was lower than that in other age groups (P<0.05). HBV prevalence was similar in donors resident in Guangdong and other provinces(P>0.05), but both were significantly higher than that in Hong Kong, Macao, Taiwan and foreign countries (P<0.05). HBV prevalence in Han nationality donors was significantly higher than the ethnic minority donors (P<0.05). Gender, age, ethnicity and birth vaccination are the main risk factors for HBV infection among blood donors. Conclusion The overall HBV prevalence among voluntary blood donors in Guangzhou area from 2011 to 2020 has shown a decreasing trend, and differences have been found in gender, age, region, ethnicity and birth vaccination, which is helpful to formulate targeted recruitment strategies, thus reducing the risk of transfusion transmitted HBV.

目的 了解日立7180生化仪在无偿献血者血液筛查丙氨酸转氨酶(ALT)检测中交叉污染情况.方法 使用日立7180生化仪对以下组合进行常规检测,设计4组试验检测生化仪是否在加样过程中出现交叉污染:①测试A组试验:将按1份乙型肝炎病毒表面抗原(HBsAg)-酶联免疫吸附试验(ELISA)强阳性标本和1份HBsAg-ELISA阴性标本(a1)的间隔放置生化仪专用检测转盘,1个检测转盘批次为88份标本,常规生化仪检测之后对共44份HBsAg-ELISA阴性标本进行HBsAg-ELISA检测以及核酸检测检测(NAT).执行清洗程序后,将1份无菌0.9％氯化钠注射液和1份全项阴性标本(a2)间隔放置1个检测转盘进行检测,对44份全项阴性标本进行HBsAg-ELISA检测以及核酸检测(NAT)技术.②测试B组试验:将1份ALT阳性标本和1份ALT阴性标本间隔放置检测转盘,检测1个检测转盘批次后继续检测1个转盘批次ALT阴性标本.③测试C组试验:脂肪血标本和ALT阴性标本间隔放置检测一个转盘批次后再继续检测1个转盘批次ALT阴性标本,对溶血标本执行同样测试程序.④测试D组试验:将按1份脂肪血标本(或1份溶血标本)和1份ALT阳性标本的间隔放置生化仪专用检测转盘,脂肪血和溶血标本共检测22份.每个测试组后均执行1次清洗反应杯程序再进行下一组测试.结果 A组中44例标本(a1)处理后NAT检测7例标本为阳性[污染率占比16％(7/44)],检测再次检测HBsAg-ELISA均为阴性,阴性对照44例标本(a2)处理后NAT和HBsAg-ELISA检测均为阴性,a1与a2 HBsAg-ELISA的S/CO值比较差异无统计学意义(P>0.05);B、C和D组处理后,ALT检测阴阳性结果与原检测结果符合率为100％.结论 日立7180检测ALT时标本间存在病毒DNA交叉污染,ALT阳性标本、脂肪血和溶血标本不存在交叉污染或互相影响结果的问题;仪器的性能验证可以大大保障血液筛查的质量.

目的了解本地区18～25岁青年献血者HIV感染人群特征,为相应献血人群制定献血招募策略提供依据,降低HIV输血传播风险。方法采用2种不同厂家ELISA试剂和核酸检测试剂对2 973 685例无偿献血者标本进行HIV项目进行初检、复检2遍检测,阳性者送第三方机构（广州金域医学检验中心）采用免疫印迹方法进行HIV确证,对18～25岁青年献血者HIV感染人群特征统计分析。结果 2 973 685例献血者标本中确证为抗-HIV阳性有736例,其中1 561 660例18～25岁青年献血者中抗-HIV确证病例为289例,占总确证病例的39.27%;289例HIV确认青年献血者中男性明显高于女性（P ＜0.01）。其他分布特征是:初次献血占218例（75.45%）,献血次数达3次或以上占比少（4.15%）;街头与单位团体分别占84.43%、15.56%;献全血的有286例（98.96%）,其余3例为成分献血;本市户籍和外省分别占35.99%和36.68;在校学生与非在校献血者分别占24.57%和60.9%。结论广州地区18～25岁献血者中男性献血者感染HIV风险远高于女性,固定献血者、单位团体献血者和在校学生为感染HIV低风险人群;本地区献血招募中应加强对青年人群的关于男男同性恋等健康征询和HIV宣传工作,保证临床用血的安全。

目的 探讨贝克曼全自动血型仪PK7300使用抗-A、抗-B及抗-D抗血清试剂不同配制比例对正定型血型及Rh血型的影响,并验证血型仪性能.方法 配制不同比例的抗-A、抗-B及抗-D稀释抗血清在血型仪PK7300检测110例已确定血型标本,抗血清原液:盐水配制比例为原液;1:20;1:40;1:60;1:80;1:100;1:120,根据血型符合率分析其不同比例的抗血清试剂在血型实验的效果;统计分析已确定血型标本100例采用不同孵育时间20、30、40、50、60 min时的实验情况;统计分析2016—2017年ABO亚型及Rh阴性检测数据.结果 不同配制浓度抗血清(原液～1:120)在PK7300测试中,ABO及Rh血型符合率均为100％;孵育时间为20、30、40、50、60 min时ABO血型符合率分别是28％、77％、99％、100％、99％;2016—2017年在血型仪PK7300检测正常情况下正反不一致血型84例,全部确认为ABO亚型,2825例Rh阴性可疑结果中确认Rh阴性2733例,RhD变异型92例.结论 本实验室血型仪PK7300使用抗血清原液:盐水配制比例为1:40以及孵育时间为60 min效果满足实验需求;ABO亚型血型和Rh阴性血型能在血型仪检测中有效发现,检测可靠.

目的 了解广州地区献血人群ABO及Rh血型的检测情况,以及本地区人群的ABO血型构成分布及Rh阴性血型分子生物学状况,为保证临床用血安全和更好给献血者服务提供依据.方法 对2016年1月至2019年12月健康献血者进行常规ABO、Rh血型检测;统计分析ABO构成比,ABO疑难血型、Rh初筛阴性可疑标本在本中心血型实验室进行系统的血型血清学确认与分型,分析ABO血型错误原因,Rh阴性表型分型情况.结果 2016年1月至2019年12月本地区共献血1412960(人)份,ABO血型分布为O型(40.95％)>A型(26.98％)>B型(25.28％)>AB型(6.76％).2148份ABO血型错误,其中实验室血型检测正反一致错血型(Ⅰ类)1328份[61.82％(1328/2148)];ABO正反不一致或O型指示细胞阳性类错血型(Ⅱ类)820份[38.17％(820/2148)],Ⅱ类中确认147例ABO亚型[B亚+AB亚91例(61.90％),A亚+A亚B 38份(25.85％),其他18份(12.24％)]、不规则抗体阳性283份.Rh阴性表型确认5727份[0.41％(5727/1412960)],表型构成分布为:ccdee 51.65％(2958/5727)、Ccdee 35.88％(2055/5727)、CCdee 7.44％(426/5727)、CcdEe 1.73％(99/5727)、ccdEe2.85％(163/5727)、CCdEe 0.45％(26/5727),156份D变异型.结论 血型检测正反一致血型错误(Ⅰ类)是本中心血型错误的主要原因.

目的 回顾性分析采血不足量发生的原因,为进一步采取有针对性的措施提供依据,以降低采血环节中不足量全血报废和防止献血者流失.方法 在广州血液中心信息管理系统中统计2018～2020年每年全血献血人次和采血环节中全血不足量发生人次,通过SPSS(22.0)软件对数据进行x2检验和线性趋势检验.结果 2018～2020年采血不足量发生率为0.066 4％(531/799 439),血流不畅、晕针和其他原因导致的采血不足量发生率分别为0.048 7％(389/799 439),0.010 6％(85/799 439)和0.007 1％(57/799 439).各年间采血不足量发生率差异有统计学意义(P＜0.05),其中血流不畅导致的采血不足量发生率呈上升趋势且有统计学意义(0.036 3％＜0.038 2％＜0.072 7％,P＜0.05).结论 采血环节中血流不畅引起的不足量全血有上升的趋势,需进一步采取针对性的措施.新冠疫情常态化下,采血护士除了进行疫情防控专业知识学习及培训,还需不断加强静脉穿刺技能、心理护理和处理献血不良反应的能力,为献血者提供优质服务.

目的 回顾性分析采血环节中血流不畅导致的不足量全血发生情况,为采取有效的措施提供依据,以降低不足量全血报废和防止献血者流失.方法 在广州血液中心信息管理系统中,按照性别、年龄、是否首次献血、选择献血量和献血时间分类统计2019年全血献血人次和不足量全血发生人次,通过SPSS 22.0软件对数据进行2和Fisher检验.结果 2019年采血环节中献血者血流不畅导致不足量全血发生率在性别和是否首次献血方面均无统计学性差异(P>0.05),而在年龄、选择献血量和献血时间上有统计学差异(P<0.05),其中18～30岁献血者(0.0452％,P<0.05)、选择捐献300 mL献血者(0.0640％,P<0.05)和在10～12月份捐献全血的献血者(0.0577％,P<0.05)血流不畅导致不足量全血发生率在各分类中最高.结论 提高本中心采血护士穿刺技术和处理血流不畅问题的能力,为18～30岁、选择捐献300 mL的献血者提供更加全面的献血服务,同时关注献血环境的舒适度,降低采血环节中血流不畅导致的不足量全血发生.

目的 探讨广州地区RhD变异型个体D抗原表位特征及基因突变遗传分子机制.方法 收集2019年1月～8月广州地区献血者及医院送检本中心做疑难RhD鉴定的RhD变异型标本59(人)份,用2种单克隆抗-D试剂及D-screen抗原表位检测试剂盒进一步分析D抗原表位的血清学特征,并做RhCE表型分型;采用QuickGene DNA提取试剂盒提取标本的基因组DNA,采用PCR-RFLP方法做RHD基因合子型分析;利用多重连接依赖探针扩增(MLPA)基因分型法做RHD基因型检测,并对仍存疑标本做RHD外显子(exon1一exon10)Sanger测序,使用DNAS-tar/SeqMan软件做综合分析.结果 本组广州地区RhD变异型个体中,检出自献血者的占27.12％(16/59)[占同期广州中献血者比例0.007％(16/232793)],医院送检的患者疑难标本占72.88％ (43/59).RHD基因型检测:40.68％ (24/59)为RHD* weak partial 15、25.42％ (15/59)为RHD*DⅥ.3以及33.90％(20/59)较少见的RhD变异型类型[其中合并2种不同等位基因的RhD变异型又占76.92％(10/13)];血清学D-screen:RHD *DⅥ.3型细胞与抗-D(克隆号P3*21223B10)呈阳性反应,其他均为阴性的相对固定格局;RhD变异型CE表型分布比例为Ccee38.98％(23/59)、ccEe35.59％ (21/59)和CcEe25.42％(15/59).结论 弱D15和部分DⅥ.3为广州地区汉族人群最常见RhD烫异型类型,其中DⅥ可以通过D-screen等血清学方法得到初步鉴定,其他RhD变异型均需要分子生物学方法才能得到鉴定:＞95％RhD变异型均为C+或E+表型.

目的:探讨本地区献血人群中ALT异常人群特征,为减少因ALT异常报废率以及献血招募提供依据.方法:回顾性分析2015-2018年本中心无偿献血者中ALT异常的人群数据,统计分析ALT与HBsAg、HCV抗体、TP抗体以及在NAT检测中阳性标本的基本情况.结果:1372591例献血者中筛检出12032例(0.88％)ALT异常,2015-2018年ALT异常率呈逐年下降趋势.献血者ALT异常人群中在献血季度、性别、年龄、献血点和献血类型比较,差异均有统计学意义(P<0.05).第三季度(7～9月)异常率最高、第二季度(4～6月)最低,男性比女性高,26～30岁和31～35岁年龄段分别为1.33％、1.25％,流动献血人群较高为1.01％,全血与单采分别是0.98％、0.06％.2017-2018年,ALT正常与异常的HBsAg、HCV抗体、TP抗体、NAT检测结果比较,差异均有统计学意义(P<0.05);而肝炎指标(HBsAg、HCV抗体)抗体阳性标本中,合并ALT异常的只占1.9％(102/5360).结论:本地区献血者ALT异常率男性远高于女性,26～35岁年龄段最高,主要来自献全血人群,流动点人群高于单位团体,而且跟季节有关;献血人群中进行ALT筛查仍然是需要的.

目的 了解献血人群中2种抗-TP ELISA试剂的应用价值.方法 用2种国产抗-TP ELISA试剂检测无偿献血者血浆标本,阳性标本再用梅毒螺旋体明胶颗粒凝集试验(TPPA)确认;绘制抗-TP S/CO值ROC曲线,分析2种试剂灵敏度、特异性、阳性预测值.结果 抗-TP ELISA检测阳性1103例(0.37％),其中TPPA确认阳性738例,阴性353例,不确定12例;ROC曲线显示2种抗-TP ELISA试剂与TPPA确认结果均有较高符合度.A、B试剂在S/CO最佳阈值分别为11.5和9.05,均可预测大于95％确认阳性结果,S/CO值为10～14.99时阳性预测值分别为95.3％、93.2％.结论 2种抗-TP ELISA试剂S/CO值均≥10时,可直接屏蔽这类献血者;单试剂S/CO值≥10或者双试剂S/CO值均<10时,需要TPPA确认.

目的:为血液中心丙型肝炎病毒(HCV)抗体检测试剂由间接法更改为双抗原夹心法提供依据.方法:随机抽取2018-2020年无偿献血者标本,采用酶联免疫吸附试验(ELISA)间接法双试剂(A、B)和双抗原夹心法双试剂(A1、B1)检测抗-HCV抗体,同时进行HCV RNA核酸检测.统计分析4种抗-HCV ELISA试剂盒检测结果,单试剂阳性标本复查阳性符合率.结果:抗-HCV ELISA间接法双试剂、双抗原夹心法双试剂共检测无偿献血116 843、98 903人份,间接法抗-HCV抗体单试剂阳性标本复检阳性率0.088％(102/116 843)与双抗原夹心法抗-HCV抗体单试剂阳性标本复检阳性率0.012％(12/98 903),差异有统计学意义(P＜0.05).单试剂阳性标本均进行双试剂双孔复检,试剂A、B、A1、B1的再检阳性符合率分别为A(61.90％)＞B(54.95％)＞A1(50.00％)、B1(50.00％),4种试剂之间差异无统计学意义(P＞0.05),单试剂阳性标本核酸RNA均为阴性.结论:本地区无偿献血者抗HCV抗体酶免双试剂阳性人群在性别、年龄分布有差异,对日后招募低危献血者人群有指导意义.抗-HCV双抗原夹心法ELISA检测特异性更高,减少假阳性率,保证临床用血安全.

目的 回顾性分析献血者ELISA单试剂检测呈反应性标本的检测结果,为研究献血者检测策略提供指导意义.方法 广州血液中心2017年1月1日—2017年12月31日无偿献血标本共345164例,采用自动酶联免疫检测分析仪对血液标本进行检验,分析标本检验结果.结果 2017年1月1日—2017年12月31日无偿献血标本共345164例,经过ELISA双试剂检测后HBV、HCV、HIV可疑标本数为2956,占样本数0.86％.HBV复检后合格数为1068,占HBV总可疑数的67.5％.HCV复检后合格数为343,占HCV总可疑数的49.8％.HIV复检后合格数为347,占HIV总可疑数的50.7％.复检后HBV和HIV单试剂呈反应性有显著差异(P<0.01),HCV没有差异.HBV试剂2单试剂反应性不合格且核酸阳性标本占了HBV单试剂反应性标本的11.61％,其余试剂均少于1％.结论 只采用1种ELISA检测试剂进行初筛,可能存在漏检的风险,血清学ELISA单试剂检测呈反应性献血者大部分核酸是阴性的.

目的 探讨"取消互助献血"政策对广州地区医疗机构血小板供应的影响.方法 分别统计广州血液中心信息管理系统中2017年4月至2017年12月和2018年4月至2018年12月机采血小板和手工血小板的每月供应袋数,通过SPSS 22.0统计学软件对数据进行正态分布检验和独立样本t检验.结果 与"取消互助献血"实行前(对照组,2017年4月至2017年12月)相比,"取消互助献血"实行后(实验组,2018年4月至2018年12月)机采血小板平均每月的临床供应袋数[(5616±249)vs.(5605±776)]比较差异无统计学意义(P=0.970);手工血小板平均每月的临床供应袋数[(1808±534)vs.(4745±2149)]比较差异有统计学意义(P=0.003).结论 "取消互助献血"政策实行后,机采血小板的临床供应情况与政策实行前持平,手工血小板总体供应量高于政策实行前;"取消互助献血"政策实行后,广州血液中心实施一系列措施确保了广州地区血小板的临床供应,新政策在一定程度上给血小板供应带来正面影响.

目的 探析采血后12-24 h制备的原料血浆经全自动冷沉淀制备仪制备的冷沉淀质量.方法 随机选取95袋于2018年1月21-25日采集规格为400 mL/袋的全血(CPDA保存液)制备的血浆作为原料血浆,以采血到血浆制备的时间分组,12-18 h为新鲜冰冻血浆组(45袋),＞18-24 h为普通冰冻血浆组(50袋);原料血浆经速冻后在-20℃以下保存48 h,再经全自动冷沉淀制备仪制备成冷沉淀,检测原料血浆的FⅧ含量、冷沉淀的FⅧ和FIB含量.计量资料以均数±标准差(x±s)表示,采用单样本t检验,P＜0.05为差异有统计学意义.结果 对照GB18469-2012《全血及成分血质量要求》(来源于400 mL全血的冷沉淀FⅧ含量≥80 IU,FIB含量≥150 mg)和WS/T550-2017《全血和成分血质量监测指南》(冷沉淀标本FⅧ和FIB含量符合率≥75％),FⅧ含量≥0.7 IU/mL的新鲜冰冻血浆组(12-18 h)制备的冷沉淀(FⅧ:121.80 IU,P＜0.01;FIB: 204.33 mg,P＜0.01)和普通冰冻血浆组(＞18-24h)制备的冷沉淀(FⅧ:119.17 IU,P＜0.01;FIB:222.74 mg,P＜0.01)符合质量控制标准且符合率均高于75％;FⅧ含量＜0.7 IU/mL的新鲜冰冻血浆组(12-18 h)制备的冷沉淀FⅧ和FIB含量均值达标(FⅧ:84.81IU,P＞0.05;FIB:187.22 mg,P＜0.05)但FⅧ(53％)符合率低于75％;FⅧ含量＜0.7 IU/mL的普通冰冻血浆组(＞18-24 h)制备的冷沉淀FⅧ(72.37 IU,P＞0.05)含量均值低于标准且符合率(37％)低于75％,FIB(200.82 mg,P＜0.05)含量均值达标但符合率(68％)低于75％.结论 采血后12-24 h制备的原料血浆(FⅧ含量≥0.7 IU/mL)经全自动冷沉淀制备仪制备的冷沉淀质量符合GB18469-2012《全血及成分血质量要求》和WS/T550-2017《全血和成分血质量监测指南》质量控制要求和检查标准,经该制备仪制备冷沉淀的原料血浆不需仅限制于新鲜冰冻血浆.