Objective To establish a quality control mechanism based on the Poisson distribution for monitoring con-tamination in nucleic acid testing(NAT)laboratories.Methods The study collected NAT single-reactivity rates and dis-criminatory test reactivity rates from the Grifols Panther NAT system from 2022 to 2023.The Poisson distribution probability method was used to calculate the daily probability of nucleic acid single reactivity.Sensitivity and specificity of the quality control model were further validated using single-reactivity rates,discriminatory reactivity rates and ROC curve analysis,fol-lowed by proposing corresponding multi-rule quality control strategies.Results Using P=0.05 as the threshold for out-of-control,the Poisson distribution probability quality control model identified 40 out-of-control points with P<0.05.After man-ual verification using discriminatory reactivity rates,20 out-of-control points were confirmed.The sensitivity of determining out-of-control was 60.0%,and the specificity was 95.6%.Due to the high number of out-of-control points,it is recommen-ded to combine discriminatory reactivity rates and employ multi-rule quality control methods for quality monitoring.Under the multi-rule quality control,there were 18 warning points and 2 out-of-control points for NAT single reactivity from 2022 to 2023.Conclusion The multi-rule NAT single-reactivity monitoring mechanism based on the Poisson distribution probability is more suitable for nucleic acid laboratories to monitor and warn of laboratory contamination,thereby enhancing the manage-ment capabilities and detection quality of nucleic acid laboratories.

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.

艾滋病,即获得性免疫缺陷综合征(acquired immun-odeficiency syndrome,AIDS),患者机体免疫力降低引起中枢神经系统机会性感染增多,乳头多瘤空泡病毒(JC poly-omavirus,JCV)就是其中的一种,该病毒感染中枢神经系统引起进行性多灶性白质脑病(progressive multifocal leukoen-cephalopathy,PML),预后差,死亡率高.随着AIDS 发病率逐年增多,PML在艾滋病患者中也日益增多,自2002 年至今近 18 年来国内文献相继个别报告[1-2],但有关 AIDS 合并PML 行脑组织病理活检国内报告较罕见,现报告1 例该病患者并结合文献进行分析讨论.

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 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.

Background With the widespread use of integrase strand transfer inhibitors (INSTIs) in the clinical setting, transmission of INSTIs-resistance mutations may increase. Data regarding transmitted drug resistance mutations (TDRM) to INSTIs in Chinese HIV patients are limited. The aim of this study was to summarize the INSTIs TDRM, including the frequency of protease inhibitors (PIs) and reverse transcriptase (RT) inhibitors (RTIs) mutations in treatment-naïve patients in Southeast China. Methods HIV-1 positive patients were retrospectively selected between April 2018 and October 2020 from the Mengchao Hepatobiliary Hospital of Fujian Medical University, the largest designated HIV/AIDS care hospital in Southeast China. Individuals who were antiretroviral therapy-naïve and received antiretroviral drug resistance testing at baseline were included. Clinical data including demographic data, CD4 counts, HIV-RNA loads, and drug resistance mutations were collected. Results A total of 147 patients were enrolled. INSTIs TDRM was rare, with only one primary integrase mutation E138K observed in one sample and one secondary mutation E157Q detected in another sample. The overall prevalence of INSTIs TDRM was 1.36%. A substantial proportion of patients harbored common INSTIs-associated polymorphic variants. Two samples harbored the T215S, M184V and K70E mutations related to nucleoside RTIs (NRTIs). Twelve patients carried nonnucleoside RTIs (NNRTIs)-resistance mutations. Two individuals harbored PIs-resistance mutations: Q58E in one patient and M46I, I54V, V82A, L10F, and Q58E mutations in another patient. The total TDRM rate for RTIs and PIs was 10.20% (15/147), but only 0.68% (1/147) was according to the WHO recommendations on TDRM. Conclusion The rate of INSTIs TDRM was low among therapy-naïve HIV patients in Southeast China. INSTIs as a first-line regimen are suitable for untreated HIV-1 patients in Southeast China. But special attention must be still paid to INSTIs TDRM in clinical practice.

目的 分析无偿献血者血液检测结果中丙氨酸氨基转移酶(ALT)异常与乙型肝炎表面抗原(HBsAg)和丙型肝炎病毒抗体(抗-HCV)阳性结果的关系,并讨论ALT作为血液筛查计划的必要性.方法 回顾性分析373543例无偿献血者血液样本资料,比较HBsAg、抗-HCV阳性、阴性献血者的ALT异常率,HBsAg、抗-HCV阳性结果 以及乙肝病毒的脱氧核糖核酸(HBV-DNA)、HCV-RNA反应性在ALT正常及异常献血者中的分布情况.结果373543名献血者中HBsAg、抗-HCV阳性者共2814例,其中ALT异常者44例,ALT异常率为1.82%;HBsAg、抗-HCV阴性者370729例,其中ALT异常4260例,ALT异常率1.15％.HBsAg、抗-HCV阳性者ALT异常率1.56％高于阴性者的1.15％,差异具有统计学意义(P<0.05).ALT正常及异常献血者HBsAg、抗-HCV阳性占比以及HBV-DNA、HCV-RNA反应性结果比较,差异均无统计学意义(P>0.05).结论 HBsAg与抗-HCV阳性结果和ALT异常结果之间存在相关性,但ALT异常与乙型和丙型肝炎病毒感染之间无关联,无偿献血者ALT异常的主要原因并非是HBV和HCV感染.

目的 比较双抗原夹心法和间接法检测丙型肝炎病毒抗体的结果.方法 以血站进行无偿献血的人次作为研究对象,其中28982份标本使用双抗原夹心法检测作为实验组,27603份标本使用间接法检测作为对照组.比较两组的阳性检出率、复检率以及复检合格率,分析两种试剂的临床检测结果 .结果 实验组标本中检测出16份双试剂阳性标本,27份单试剂阳性可疑标本,对27份可疑标本进行复检后,有26份合格,1份不合格;对照组标本中检测出14份双试剂阳性标本,42份单试剂阳性可疑标本,对42份可疑标本进行复检后,有22份合格,20份不合格.实验组复检率为0.09％,复检合格率为96.30％;对照组复检率为0.15％,复检合格率为52.4％.实验组复检率低于对照组,复检合格率高于对照组,差异均具有统计学意义(P<0.05).实验组双试剂阳性率为0.06％,对照组双试剂阳性率为0.05％,比较差异无统计学意义(P>0.05).结论 在血站对无偿献血人群进行检测时,可以选择双抗原夹心法对丙型肝炎病毒抗体进行检测,检测有效率要高于间接检测方法,降低了假阳性结果的出现几率,避免了血液浪费的现象出现,也减少了献血者淘汰的几率,值得在今后血站进行推广使用.

目的 探究核酸检测(NAT)在献血者标本内乙型肝炎(乙肝)病毒(HBV)检测中的应用价值.方法 51份献血者乙肝检验可疑标本,所有标本均分别施以电化学发光免疫分析(ECLIA)、酶联免疫吸附测定法(ELISA)以及NAT检测.以ECLIA检测结果作为金标准,对比其余两种检测方法对HBV检测的准确率、灵敏度和特异度.结果 ECLIA检测结果显示,51份献血者乙肝检验可疑标本中HBV检测阳性17例,阴性34例,HBV阳性检出率为33.33％.NAT对HBV检测的准确率、灵敏度、特异度依次为98.04％、100.00％、97.06％,ELISA对HBV检测的准确率、灵敏度、特异性依次为76.47％、70.59％、79.41％,NAT对HBV检测的准确率、灵敏度、特异度均明显高于ELISA,差异具有统计学意义(P<0.05).结论 乙肝患者HBV检测中采用NAT可有效提高检测特异度、敏感度和准确率,减少窗口期,提高检测安全性,值得临床信赖和进一步推广.

目的 探讨分析无偿献血者血液抗-HIV筛查与确证情况.方法选取2016年1月～2019年7月本中心进行无偿献血的1071489例志愿者的血液样本为实验材料,先使用酶联免疫吸附实验(ELISA)对血液样本进行抗-HIV检查,使用ELISA试剂盒对样本进行检验,如有试剂显示为阳性则将此样本记录为筛查结果为抗-HIV为阳性的样本,再使用蛋白免疫印迹试验(WB法)对筛查结果为阳性的样本进行确证. 结果 在1071489份样本中有266份样本被初次筛选为抗-HIV阳性,通过确认检查其中有250例确认为抗-HIV阳性,筛查为抗-HIV阳性的概率为0.025％(266/1071489),确证为抗-HIV阳性的概率为0.023％(250/1071489).这250例HIV感染者对自己的感染情况未知,后续调查分析这250例感染者中有174例为异性传播,76例为同性传播.结论 血站应该建立完善的抗-HIV筛查与确证机制,提高筛选的准确率,提高血液的质量,加强对公众的预防艾滋病的宣传力度,增加民众对艾滋病的检查意识.

BACKGROUND:Talaromyces marneffei (TM) is an emerging pathogenic fungus that can cause a fatal systemic mycosis in patients infected with human immunodeficiency virus (HIV). Although global awareness regarding HIV/TM coinfection is increasing little is known about the mechanism that mediates the rapid progression to HIV/AIDS disease in coinfected individuals. The aim of this study was to analyze the serum proteome of HIV/TM coinfected patients and to identify the associated protein biomarkers for TM in patients with HIV/AIDS.METHODS:We systematically used multiplexed isobaric tandem mass tag labeling combined with liquid chromatography mass spectrometry (LC-MS/MS) to screen for differentially expressed proteins in the serum samples from HIV/TM-coinfected patients.RESULTS:Of a total data set that included 1099 identified proteins, approximately 86% of the identified proteins were quantified. Among them, 123 proteins were at least 1.5-fold up-or downregulated in the serum between HIV/TM-coinfected and HIV-mono-infected patients. Furthermore, our results indicate that two selected proteins (IL1RL1 and THBS1) are potential biomarkers for distinguishing HIV/TM-coinfected patients.CONCLUSIONS:This is the first report to provide a global proteomic profile of serum samples from HIV/TM-coinfected patients. Our data provide insights into the proteins that are involved as host response factors during infection. These data shed new light on the molecular mechanisms that are dysregulated and contribute to the pathogenesis of HIV/TM coinfection. IL1RL1 and THBS1 are promising diagnostic markers for HIV/TM-coinfected patients although further large-scale studies are needed. Thus, quantitative proteomic analysis revealed molecular differences between the HIV/TM-coinfected and HIV-mono-infected individuals, and might provide fundamental information for further detailed investigations.

Objective It is to analyze the distribution of NK cell subsets and cytokine expression in ADIS patients with fungal infection. Methods After the peripheral blood was collected from 61 ADIS patients with fungal infection (Viral RNA was positive,HIV + IFI group),30 ADIS patients with antiretroviral therapy (Viral RNA was negative,HIV + Non-IFI group),and 26 cases of healthy controls (control group),mononuclear cells and serum / plasma were separated from these blood samples. The distribution of NK cell subsets was detected by Flow cytometry,and the expression of IL-6,IL-8,IL-10, TNF-α was measured by suspension chip technology. The relationship between CD4 +,CD8 +,CD4 + / CD8 +,the distribution of NK cell subsets and the expression of HIV-1,RNA and cytokines was analyzed. Results Compared with HIV + Non - IFI group and control group,the total number of NK cells and the number of subgroup of NK cells were significantly decreased (all P < 0. 05),and the CD56dim NK proportion of the total number of NK cells was dramatically down-regulated (P < 0. 05),but the CD56 - CD16 + NK proportion of the total number of NK cells was obviously increased (P < 0. 05). HIV - 1 RNA load was negatively correlated with CD4 + T cell,CD4 + / CD8 +,CD56dim NK proportion and NK cells number (all P < 0. 05),and had no correlation with CD8 + T cell,CD56bright NK,CD56 - CD16 + NK proportion (all P > 0. 05). The level of TNF-α was negatively correlated with CD56 bright NK and CD56dim NK (P < 0. 05). The levels of IL-10 and IL-6 were negatively correlated with CD4 + T cells,CD56 bright NK and CD56dim NK (all P < 0. 05),meanwhile IL-8 was positively correlated with CD56 -CD16 + NK (P < 0. 05). Conclusion The distribution of NK cell subsets is changed by HIV merged fungal infection,which further regulate the cytokine response in ADIS patients with fungal infection.

Human immunodeficiency virus causes a severe disease in humans, referred to as immune deficiency syndrome. Studies on the interaction between host genetic factors and the virus have revealed dozens of genes that impact diverse processes in the AIDS disease. To resolve more genetic factors related to AIDS, a canonical correlation analysis was used to determine the correlation between AIDS restriction and metabolic pathway gene expression. The results show that HIV-1 postentry cellular viral cofactors from AIDS restriction genes are coexpressed in human transcriptome microarray datasets. Further, the purine metabolism pathway comprises novel host factors that are coexpressed with AIDS restriction genes. Using a canonical correlation analysis for expression is a reliable approach to exploring the mechanism underlying AIDS.

人类免疫缺陷病毒(HIV)侵人人体,选择性攻击免疫系统,包括CD4+T淋巴细胞、巨噬细胞和树突细胞等,其主要表现为CD4+T淋巴细胞数量不断减少,最终导致人体细胞免疫功能缺陷,引起各种机会性感染和肿瘤的发生,此综合征称为获得性免疫缺陷综合征(AIDS).由于无症状感染期持续时间长(数月至十多年不等,平均约8 a),病毒变异性强,因此在防治AIDS方面面临较大压力.

Objective:To analyze the causes of the loss of nucleic acid laboratory reagent,analyze the problems and improve the reagent,so as to achieve the purpose of reducing loss,and reduce the detection cost.Method:334 492 reagents for nucleic acids detection report number and reagent loss number in the Guangzhou blood center in 2014 were counted,reagent loss factors were analyzed,the measures to reduce the loss of reagent were explored.Result:In 2014,334 492 nucleic acid reagents were consumed,the number of effective test report was 294 465,the utilization rate of the reagent was 88.03%,the total consumption rate was 11.97%,including the consumption of the daily quality control rate 9.32%,the system failure rate 1.89%,the identification of the experimental use rate 0.74% and other loss rate 0.02%.Conclusion:The cause of the reagent loss has the consumption of daily quality control,the hardware and software of the system,the fault of the software,the identification of the experimental use,the human error and other factors.The consumption of the daily quality control,the hardware and software of the system are the main factors.

Background. Persons living with human immunodeficiency virus (HIV) are at increased risk of developing cardiovascular disease. Few studies have focused on echocardiographic abnormalities in this population.Methods. China AIDS Clinical Trial 0810 is a prospective, multicenter cohort study of persons living with HIV (PLWH). We performed an echocardiography substudy of 325 PLWH. We examined the prevalence of left ventricular systolic dysfunction (LVSD), diastolic dysfunction (DD), pulmonary arterial hypertension (PAH), and increased left ventricular mass (ILVM) in antiretroviral therapy (ART)-naive PLWH at baseline and week 48 after initiation of ART.Results. Compared with age- and sex-matched healthy controls, PLWH had a higher prevalence of DD (16.5% vs 7.2%, P < .027) and a marginally significant higher prevalence of LVSD (7.3% vs 2.1%, P = .056). The increase in the prevalence of DD from baseline to week 48 in PLWH was marginally significant (P = .056). No significant difference was observed in the prevalence of LVSD, PAH, or ILVM at baseline and week 48 in PLWH. In logistic regression analysis of all participants, age was significantly associated with LVSD; HIV infection, age, and hypertension were associated with DD whereas HIV infection and hypertension were associated with ILVM at baseline. Logistic regression analysis of PLWH showed that only age was significantly associated with LVSD and DD.Conclusions. The prevalence of echocardiographic abnormalities was significantly higher in ART-naive PLWH than in controls. HIV infection was significantly associated with cardiac abnormalities. No significant change in echocardiographic abnormalities was observed after 48 weeks of ART. Longer-term prospective studies are warranted.

Background An zidovudine (AZT)-substitution regimen containing 24-week stavudine (d4T) followed by long-term AZT for HIV therapy is potential to trade off short-term AZT-related anemia and long-term risks associated with d4T in resourcelimited settings. However, evidence is scarce. This study aims to assess the efficacy and safety of AZT-substitution regimen, aiming to find a regimen with better efficacy, less adverse events, and more affordability in resource-limited settings. Methods This prospective, multicenter study enrolled 499 (190 on d4T regimen, 172 on AZT regimen, and 137 on AZTsubstitution regimen) HIV-1-infected subjects who initiated combined antiretroviral therapy and attended follow-up visits over 96 weeks from 2009 to 2011. Lamivudine (3TC) and either nevirapine (NVP) or efavirenz (EFV) were the other two drugs in the antiretroviral regimens. Virologic and immunologic responses and adverse events were monitored at baseline and at weeks 4, 12, 24, 36, 48, 60, 72, 84, and 96. Results In terms of hematological adverse effects, AZT-substitution group had similar safety profiles to d4T group and was superior to AZT group. In comparison with AZT-substitution group, AZT group was associated with higher risk of developing anemia (adjusted hazard ratio (aHR) for anemia ≥ grade II, 8.44, 95% CI 1.81–39.46) and neutropenia (aHR for neutropenia ≥ grade II, 1.86, 95% CI 1.19–2.93). The prevalence of lipodystrophy in d4T group was 19.5%, while that in AZT-substitution group was zero. As to antiretroviral efficacy, these three groups showed no differences. Conclusion AZT-substitution regimen provides a relatively safe and effective first-line antiretroviral strategy in resource-limited settings.

<正>优化和简化治疗策略优化和简化治疗策略在过去的30年间对抗反转录病毒治疗(ART)取得了极大的成功,有效的治疗延长了人类免疫缺陷病毒(HIV)感染者及获得性免疫缺陷综合征(AIDS)患者的生命。

Objective To investigate the effectiveness and necessity of nucleic acid test for blood screening. Methods Novartis Procleix TIGRIS automatic nucleic acid test and analysis system and PROCLEIX ULTRIO assay were performed to jointly detect HBV,HCV and HIV-1 in 616 705 blood donors. Moreover,nucleic acid identification test was used to identify NAT positive alone samples. Furthermore,HBsAg,anti-HCV, anti-HIV,anti-TP and ALT were test by serological reagent. Results Of 616 705 blood donors samples,1. 62 %( 10 048 / 616 705) were EIA positive and 0. 95%( 5 874 /616 705) were NAT positive. There was a significant difference between EIA positive and NAT positive. Of 594 325 ELISA negative blood donors,0. 22 %( 1 365 /594 325) were NAT positive. Of 1365 only NAT positive blood donors,including 143 HBV DNA positive,1 HCV positive and 1 HIV positive,30. 4%( 415 /1 365) were nucleic acid identification test positive. Of 5 510 two EIA reagent positive blood donors,75. 28% were NAT positive. But only 2. 27%( 103 /4 538) NAT positive was found in one EIA reagent positive blood donors. 14 554 cases of ALT double reagent unqualified samples,NAT positive rate was 2. 31%( 336 /14 554). Among them,14 080 cases of single ALT detection of unqualified specimen,nucleic acid were detected in 2 cases,the positive rate is 0. 01%,and after six months follow-up of donors,NAT test were negative. Conclusion The present risk of transfusion transmitted disease mainly was HBV infection. Nucleic acid test technique was used for blood screening,which will help to shorten the window period of blood transfusion infection and further improve blood safety.