目的 构建首发脑出血患者并发卒中相关性肺炎的风险预测模型并验证模型的预测性能。方法 回顾性分析2012年1月—2022年12月广州市第一人民医院治的419例首发脑出血患者的临床资料，按照7︰3比例随机化分为训练列（293例）和验证队列（126例）。统计基于开发队列数据，采用Logistic回归模型分析首发脑出血患者并发卒中相关性肺炎的影响因素，并构建风险预测模型。基于开发队列和验证队列数据，采用校准曲线、受试者操作特征（ROC）曲线下面积和决策曲线分析模型的预测性能。结果 419例首发脑出血患者中有113例发生卒中相关性肺炎，发生率为26.97%。美国国立卫生研究院卒中量表（NIHSS）评分、吞咽困难、初始血肿体积、中性粒细胞百分比与白蛋白比值（NPAR）、中性粒细胞计数与淋巴细胞计数比值（NLR）、手术治疗、气管插管、留置胃管均是首发脑出血患者并发卒中相关性肺炎的影响因素（P＜0.05）。基于上述影响因素构建了首发脑出血患者并发卒中相关性肺炎的风险预警模型，校准曲线显示模型在开发队列和验证队列中预测卒中相关性肺炎发生率均与实际发生率相近；ROC曲线显示此模型在开发队列、验证队列中预测的曲线下面积分别为0.906（95%CI：0.867~0.937）、0.884（95%CI：0.815~0.934）；决策曲线分析显示当开发队列阈概率在3%~80%内、验证队列阈概率在2%~76%内使用此模型干预比全/无干预更有临床价值。结论 基于NIHSS评分、吞咽困难、初始血肿体积、NPAR、NLR、手术治疗、气管插管、留置胃管构建的首发脑出血患者并发卒中相关性肺炎的风险预测模型具有良好预测性能和临床应用价值。
Objective To construct a risk prediction model for stroke associated pneumonia in patients with initial cerebral hemorrhage（ICH）and validate the predictive performance of the model．Methods A retrospective analysis was conducted on the clinical data of 419 patients with ICH admitted to our hospital from January 2012 to December 2022．They were randomly divided into a development cohort（293 cases）and a validation cohort（126 cases）according to a 7∶3 ratio．The Logistic regression model was used to analyze the influencing factors of stroke related pneumonia in patients with ICH based on the development cohort data，and a risk prediction model was constructed．Based on the development cohort data and validation cohort data，the predictive performance of the model was analyzed using calibration curves，receiver operating characteristic（ROC）curve，and decision curve analysis．Results Among 419 patients，113 developed stroke associated pneumonia，with a rate of 26.97%．The National Institutes of Health Stroke Scale（NIHSS）score，swallowing difficulties，initial hematoma volume，neutrophil percentage to albumin ratio（NPAR），neutrophil count to lymphocyte count ratio（NLR），surgical treatment，endotracheal intubation，and indwelling gastric tube were all independent influencing factors for stroke associated pneumonia in patients with ICH（P＜0.05）．Based on the above influencing factors，a risk prediction model for stroke associated pneumonia in patients with ICH was constructed．The calibration curve showed that the predicted incidence of stroke associated pneumonia by the model in both the development and validation cohorts was close to the actual incidence．The ROC curve showed that the predicted area under the curve for this model in the development cohort and validation cohort was 0.906（95%CI：0.867-0.937）and 0.884（95%CI：0.815-0.934），respectively．The decision curve analysis showed that when the threshold probability of the development cohort was between 3%-80%，and the threshold probability of the validation cohort was between 2%-76%，the intervention using this model was more clinically valuable than all/no intervention．Conclusions The risk prediction model for stroke associated pneumonia in patients with ICH based on NIHSS score，swallowing difficulties，initial hematoma volume，NPAR，NLR，surgical treatment，tracheal intubation，and indwelling gastric tube has good predictive performance and clinical application value．
[摘要] 目的 验证医院在用冷藏药品库（以下简称冷库）相关设施、设备的性能是否符合规定的设计标准和使用要求，为药品冷链管理提供依据，保证药品质量安全。方法 以《药品经营质量管理规范》《医药产品冷链物流温控设施设备验证性能确认技术规范》为指导，于2021年10月26日-10月30日对冷库进行温度分布特性测试、自动温湿度监测系统准确度测试，开门测试及断电测试，记录、分析测试数据。结果 测试数据显示，冷库各测试点的温度均在2~8 ℃范围内波动，温度均匀度、温度波动度及温度偏差均不高于±3℃；开门7min后，冷库达到温度警戒值，开门后冷库温度恢复时间分别为17min和13min；两次断电测试中，分别于106min和92min后冷库到达温度警戒值。结论：冷库运作正常，制冷设备参数设置合理，温度均匀度、波动度能满足冷藏药品的存储要求；建议开门作业时间不能超过7min，断电时最大应急时间为90min。
目的：运用网络药理学和分子对接技术研究黄芪甲苷（AstragalosideIV，AS-IV）治疗突发性聋的作用机制及潜在靶点，并进行体外实验验证。方法：通过中药药理学分析平台（TCMSP）获取到AS-IV活性成分，从Genecard获得AS-IV对应的靶点及与突发性聋相关的靶点。疾病靶点蛋白和蛋白之间的交互数据是通过检索String数据库得到的。使用 Cytoscape3.7.1 构建成分-靶点-疾病网络，用 R4.0.3，安装ClusterProfiler 包，然后进行 GO 分析和 KEGG 路径分析。利用 Pymol 软件来优化靶点，利用 AutoDockTools 进行加氢和电荷处理，将关键靶点作为受体，其对应的有效成分作为配体，再利用 Pyrx 软件内部的 Vina 进行分子对接，计算结合能量。建议听觉细胞HEI-OC1的结果：利用软件Venny 2.1，得到89个共有靶点，通路分析排名前七的关键靶点是ALB、AKT1、CTNNB1、IL-6、VEGFA，EGFR，CASP3。分子对接结合活性由高到低分别是IL-6、Caspase3、AKT1、MAPK1、ALB。体外实验qPCR结果显示AS-IV干预前后mRNA存在差异。结论：初步揭示了黄芪甲苷通过多成分、靶点、通路起到了激活自噬抑制凋亡等作用，为突发性聋的临床治疗提供了新的思路。
[摘要] 目的 验证医院在用冷藏药品库（以下简称冷库）相关设施、设备的性能是否符合规定的设计标准和使用要求，为药品冷链管理提供依据，保证药品质量安全。方法 以《药品经营质量管理规范》《医药产品冷链物流温控设施设备验证性能确认技术规范》为指导，于2021年10月26日-10月30日对冷库进行温度分布特性测试、自动温湿度监测系统准确度测试，开门测试及断电测试，记录、分析测试数据。结果 测试数据显示，冷库各测试点的温度均在2~8 ℃范围内波动，温度均匀度、温度波动度及温度偏差均不高于±3℃；开门7min后，冷库达到温度警戒值，开门后冷库温度恢复时间分别为17min和13min；两次断电测试中，分别于106min和92min后冷库到达温度警戒值。结论：冷库运作正常，制冷设备参数设置合理，温度均匀度、波动度能满足冷藏药品的存储要求；建议开门作业时间不能超过7min，断电时最大应急时间为90min。
目的 基于结构方程模型（SEM）验证早产儿母亲育儿胜任感的多路径作用机制。方法 采用便利抽样法选取2024年6月—2025年6月在莆田学院附属医院分娩的早产儿母亲250例作为研究对象。采用一般资料调查表、中文版育儿胜任感量表（C-PSOC）、婴儿母亲育儿支持问卷（PSM）、角色适应问卷、简式亲职压力量表收集数据。通过单因素分析及多元线性回归分析母亲育儿胜任感的影响因素，使用AMOS软件构建结构方程模型，分析早产儿分娩后母亲育儿胜任感的作用路径。结果 250例早产儿母亲的C-PSOC得分为（61.93±6.02）分，多元线性回归分析结果显示，早产儿母亲育儿胜任感的影响因素包括产次、育儿支持、角色适应、亲职压力（均P＜0.05）。结构方程模型拟合良好（χ 2 /df=1.026，GFI=0.987，AGFI=0.978，NFI=0.987，CFI=1.000，RMSEA=0.010），其中角色适应正向预测育儿胜任感（β=0.344），育儿支持（β=-0.477）与亲职压力（β=-0.283）负向预测（均P＜0.05），并且角色适应通过育儿支持、亲职压力间接提升育儿胜任感（效应值0.467）；产次经角色适应间接降低压力源影响（效应值0.529）。结论 早产儿母亲育儿胜任感受多路径机制调控，临床需针对角色适应、育儿支持及亲职压力设计级联干预策略。
Objective To verify the multi-pathway mechanism of parenting competence of premature infant mothers based on structural equation modeling（SEM）．Methods A convenience sampling method was used to select 250 mothers of preterm infants who delivered in Affiliated Hospital of Putian University between June 2024 and June 2025 as the study subjects．Data was collected using a general information survey，the Chinese version of the Parenting Sence of Competence Scale（C-PSOC），the Parenting Support Questionnaire for Infant Mothers（PSM），the Role Adaptation Questionnaire，and the Simplified Parenting Stress Scale．By conducting single factor analysis and multiple linear regression analysis on the influencing factors of maternal parenting competence，a structural equation model was constructed using AMOS software to analyze the pathway of maternal parenting competence after premature birth．Results The C-PSOC score of 250 mothers of premature infants was（61.93±6.02）．Multiple linear regression analysis showed that the influencing factors of parenting competence among mothers of premature infants included parity，parenting support，role adaptation，and parental pressure（all P＜0.05）．The structural equation model fits well（2/df=1.026，GFI=0.987，AGFI=0.978，NFI=0.987，CFI=1.000，RMSEA=0.010），which role adaptation positively predicted parenting competence（β=0.344），parenting support（β=-0.477）and parenting stress（β=-0.283）negatively predicted（all P＜0.05），and role adaptation indirectly enhanced parenting competence through parenting support and parenting stress（effect value 0.467）．The adaptation of roles during childbirth indirectly reduced the impact of stressors（effect value 0.529）．Conclusions The multi-pathway mechanism of parental competence perception regulation in premature infant mothers requires the design of cascading intervention strategies targeting role adaptation，parenting support，and parental stress in clinical practice．
目的 分析儿童大环内酯类耐药重症肺炎支原体肺炎（SMPP）的危险因素,构建列线图预测模型。 方法 回顾性收集2023年1月—2024年9月在广州医科大学附属番禺中心医院儿科住院治疗的1 121例大环内酯类耐药肺炎支原体肺炎患儿入院初期的临床资料。按7∶3比例将患儿资料随机分为训练集（784例）和验证集（337例）。采用R4.4.1软件使用10重交叉验证最小绝对收缩与选择算法（LASSO）回归分析进行单因素变量筛选,采用Logistics回归分析建立预测模型, 绘制可视化列线图。使用受试者操作特征曲线（ROC）, 校准曲线、Hosmer-Lemeshow（HL）检验及临床决策曲线（DCA）分别评估模型的区分度、校准度和临床使用价值。 结果 在训练集中, LASSO回归结合Logistics回归分析结果显示,院前发热时间>5.5 d、谷丙转氨酶>14.5 U/L、乳酸脱氢酶>287.5 U/L、C反应蛋白>18.65 mg/L、肺实变、合并病毒感染是大环内酯类耐药SMPP发生的危险因素（P<0.05）, 根据上述危险因素构建列线图预测模型。训练集和验证集ROC曲线下面积分别为0.847和0.822; 校准曲线和HL检验显示模型具有良好的校准度; DCA显示预测模型在风险阈值为0.05~0.95时预测性能最优。 结论 院前发热时间、谷丙转氨酶、乳酸脱氢酶、C反应蛋白、肺实变、合并病毒感染是大环内酯类耐药SMPP发生的影响因素, 基于以上因素构建的列线图模型具有较好的预测效能, 有利于早期识别耐药重症病例, 及早采取有效干预,改善患者预后。
Objective To explore the risk factors and to construct a nomogram prediction model for severe macrolide-resistant Mycoplasma pneumoniae pneumonia（MPP）in children．Methods The clinical data during the initial admission period of 1 121 children with macrolide-resistant MPP who were hospitalized in the Department of Pediatrics of the Affiliated Panyu Central Hospital of Guangzhou Medical University from January 2023 to September 2024 were retrospectively collected．The children data were randomly divided into a training set（n=784）and a validation set（n=337）at a ratio of 7∶3．With R language software（version 4.4.1）, least absolute shrinkage and selection operator（LASSO）regression analysis with tenfold cross-validation was used to screen risk factors, Logistics regression analysis was used to establish prediction model, and a visualization of the risk variables was created using a nomogram．The receiver operating characteristic（ROC）curves, calibration curves, Hosmer-Lemeshow（HL）test and clinical decision curve analysis（DCA）were used to evaluate the discrimination, calibration and clinical application value of the model．Results In the training set, LASSO regression analysis combined with Logistics regression analysis showed that prehospital fever duration > 5.5 days, alanine aminotransferase level> 14.5 U/L, lactate dehydrogenase level> 287.5 U/L, C-reactive protein > 18.65 mg/L, lung consolidation, and co-infection with virus were risk factors for severe macrolide-resistant MPP（P<0.05）．A nomogram prediction model was constructed based on the above risk factors．The area under the ROC curves of the training set and the validation set were 0.847 and 0.822, respectively．The calibration curves and HL test showed that the model had good calibration． The DCA curves showed that the prediction model had the best prediction performance when the risk threshold was between 0.05-0.95．Conclusions Prehospital fever duration, alanine aminotransferase level, lactate dehydrogenase level, C-reactive protein level, lung consolidation and co-infection with virus were risk factors for prediction of severe macrolide-resistant MPP．The nomogram model based on the above factors had a good prediction efficiency, which was conducive to early identification of severe cases with macrolide-resistant, and taking early effective interventions to improve the prognosis．
目的 基于SEER数据库分析三阴性乳腺癌（TNBC）的预后,并建立Cox回归临床预测模型且进行内部验证。方法 使用SEER*Stat软件（8.4.2版）筛选2010—2015年诊断为TNBC的病例,进行单因素和Cox多因素回归以及向后逐步回归分析,明确与生存相关的独立危险因素,构建预测TNBC患者3年和5年癌症特异生存（CSS）率的Nomogram图,并用受试者工作特征曲线,Harrell’s一致性指数,临床预测模型校准曲线以及决策曲线对该模型进行评估及内部验证,以评估该模型的临床预测效能。结果 共筛选出符合纳入标准的TNBC患者5 564例,按照7∶3的比例随机拆分为训练集（n=3 894）和验证集（n=1 670）。通过单因素,多因素分析显示TNM分期、放射治疗、化学治疗以及手术和其他治疗的先后顺序是与TNBC患者CSS显著相关的独立危险因素（P<0.05）。利用上述预后相关因素建立Nomogram图模型。训练集的C-index为0.731（95%CI：0.712~0.749）,验证集的C-index为0.719（95%CI：0.688~0.749）,训练集和验证集3年和5年生存ROC曲线的曲线下面积均>0.7,区分度较好,且校准曲线拟合良好。结论 TNM分期、放射治疗、化学治疗以及手术和其他治疗的先后顺序是TNBC的独立预后因素,基于此建立的Nomogram图临床预测模型区分度、准确度以及临床适用性较好,能较好地预测TNBC患者的生存预后。
Objective To analyze the prognosis of triple negative breast cancer（TNBC）based on the SEER database,and to establish a Cox regression clinical prediction model with internal validation．Methods Cases diagnosed with TNBC from 2010 to 2015 were screened using SEER*Stat software（version 8.4.2）,and univariate and Cox multifactorial regression as well as backward stepwise regression analyses were performed to identify the independent risk factors associated with survival,and to construct a clinical prediction model for predicting the three- and five-year cancer specific survival（CSV）of TNBC patients．Survival（CSS）rates of TNBC patients at 3 and 5 years,and the model was evaluated and internally validated using the ROC curve,Harrell’s consistency index（C-index）,clinical prediction model calibration curve,and decision-making curve（DCA curve）to assess the predictive efficacy of the model for clinical prediction．Results A total of 5 564 TNBC patients meeting the inclusion criteria were screened and randomly split into a training set（n=3 894）and a validation set（n=1 670）according to a 7∶3 ratio．By univariate,multivariate analysis showed that T-stage,N-stage,M-stage,radiotherapy,chemotherapy,and the sequence of surgery and other treatments were independent risk factors significantly associated with CSS in TNBC patients．The above prognostic-related factors were utilized to build a Nomogram plot model．The C-index was 0.731（95%CI：0.712-0.749）for the training set and 0.719（95%CI：0.688-0.749）for the validation set,and the areas under the curves of the 3- and 5-year survival ROC curves of both the training and validation sets were >0.7,which was a good differentiation,and the calibration curves were well-fitted．Conclusions T-stage,N-stage,M-stage,radiotherapy,chemotherapy,and the sequence of surgery and other treatments are independent prognostic factors for TNBC,and the Nomogram clinical prediction model based on this has good differentiation,accuracy,and clinical utility,and can better predict the survival prognosis of TNBC patients．
目的 构建并验证机械通气患儿肠内营养支持发生误吸的风险预测模型。方法 回顾性分析中山市博爱医院2021年3月—2023年3月儿童重症监护病房330例行机械通气并进行肠内营养的患儿临床资料,通过二元Logistic回归,获取机械通气患儿肠内营养支持发生误吸的预测因素,绘制列线图模型,并进行模型评价及验证。结果 330例机械通气患儿中,104例患儿发生误吸、226例未发生误吸。两组患儿在意识状态、机械通气方式、管饲量、胃残留量、胃管置入深度、促胃动力药、镇静剂等方面对比差异具有统计学意义（P<0.05）。二元Logistic结果显示,胃残留量、机械通气方式、管饲量、意识状态、胃管置入深度、促胃动力药、镇静剂是机械通气患儿肠内营养支持发生误吸的影响因素（P<0.05）。建模组AUC为0.810（95%CI：0.760~0.860）,Hosmer-Lemesh结果显示,χ2=3.245,P=0.846;外部验证组AUC为0.873（95%CI：0.831~0.914）,Hosmer-Lemesh结果显示,χ2=3.567,P=0.875。建模组和训练组DCA曲线大部分落于Y=0上方。建模组与外部验证组校准曲线均与参考曲线高度贴合,预测概率与实际概率接近,校准度良好。结论 基于胃残留量、机械通气方式、管饲量、意识状态、胃管置入深度、促胃动力药、镇静剂等7项指标构建的风险预测模型具有一定的临床价值,可作为医护人员识别肠内营养机械通气误吸高危患儿的工具。
Objective To establish and verify the risk prediction model of enteral nutritional aspiration in children with mechanical ventilation．Methods The clinical data of 330 children who underwent mechanical ventilation and enteral nutrition in the PICU of Zhongshan Boai Hospital from March 2021 to March 2023 were retrospectively analyzed．The independent predictive factors of enteral nutrition support aspiration in children with mechanical ventilation were obtained by binary Logistic regression,and the nomographic model was drawn,and the model was evaluated and verified. Results Among 330 children with mechanical ventilation,104 had aspiration and 226 did not．There were statistically significant differences between the two groups in consciousness state,mechanical ventilation mode,tube feeding amount,gastric residual amount,gastric tube insertion depth,gastric motivity drugs,sedatives,etc.（P<0.05）．Binary Logistic results showed that gastric residual amount,mechanical ventilation mode,tube feeding amount,state of consciousness,depth of gastric tube insertion,gastric motonics and sedatives were the influential factors of enteral nutritional aspiration in children with mechanical ventilation（P<0.05）．The AUC of the modeling group was 0.810（95%CI：0.760-0.860）,and the Hosmer-Lemesh result showed that χ2=3.245,P=0.846．The AUC of the external verification group was 0.873（95%CI：0.831-0.914）,and the Hosmer-Lemesh result showed that χ2=3.567,P=0.875．The DCA curves of modeling group and training group mostly were above Y=0．The calibration curves of the modeling group and the external verification group are highly fit to the reference curves,and the prediction probability was close to the actual probability,and the calibration degree was good．Conclusion sThe risk prediction model based on 7 indexes,including stomach residual amount,mechanical ventilation mode,tube feeding amount,state of consciousness,depth of gastric tube insertion,gastric motivity drug and sedative,with certain clinical value,and can be used as a tool for medical staff to identify children at high risk of enteral nutritional mechanical aspiration．
目的 利用网络药理学技术,分析黄甲软肝颗粒治疗肝纤维化的作用网络,以及黄甲软肝颗粒治疗肝纤维化的潜在作用机制,并在体内动物实验进行初步验证。方法 采用中药系统药理学分析平台中寻找黄甲软肝颗粒中10味中药相关的化学成分和作用靶点,通过GeneCards等数据库筛选肝纤维化疾病相关的靶标;对药物与疾病靶点相映射得到黄甲软肝颗粒治疗肝纤维化的作用靶点,运用cytoscape将疾病靶点与复方活性成分靶点的交集-交集部分对应的活性成分”构建“C(成分)-T(靶点)”作用网络。将交集靶点利用 DAVID数据库进行GO富集分析和KEGG富集分析,以获得其潜在作用机制。最后,通过黄甲软肝颗粒防治CCl4导致SD大鼠肝纤维化的体内实验进行初步验证,考察末次给药后大鼠体质量和肝脏指数,采用微板法检测SD大鼠血清中天冬氨酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)水平,苏木精-伊红染色观察肝脏病理学变化。结果 预测筛选得到黄甲软肝颗粒共有117个潜在活性成分,266个活性成分对应靶点,161个交集靶点,关键成分有槲皮素、山奈酚、丹参酮IIA、芒柄花黄素等,关键靶点有PTGS2、PTGS1、NCOA1、ACHE、HTR、RXRA、ADRB2、IL1B等。GO 分析共包含 960条富集结果,其中生物过程845 条,分子功能 63条,细胞组成 52 条;KEGG 分析共得出68条通路,与本次研究较相关的通路主要包括TNF信号通路、Toll样受体信号通路、Rap1信号通路、胞质DNA传感途径、ErbB信号通路、VEGF信号通路等。体内动物实验研究表明,黄甲软肝颗粒能显著降低大鼠的肝脏指数和血清ALT、AST,改善肝组织病理学指标。结论 黄甲软肝颗粒可通过多成分、多途径、多靶点协同发挥治疗肝纤维化的作用,本研究为黄甲软肝颗粒治疗肝纤维化疾病的物质基础、作用机制及临床应用的进一步研究奠定基础。
Objective To analyze the effective network of Huangjia Ruangan Granules in treating liver fibrosis and its potential mechanism by using network pharmacology, and preliminary verify by animal in vivo experiments. Methods From the Chinese Medicine System Pharmacology Analysis Platform, we searched for the chemical constituents and targets of 10 Chinese herbs in Huangjia Ruangan Granules, and screened the targets related to liver fibrosis diseases through GeneCards and other databases. The drug and disease target were mapped to the target of Huangjia Ruangan Granules for the treatment of liver fibrosis, and the active component corresponding to the intersection of the disease target and the compound active component target was constructed using cytoscape “C (component)-T (target)” action network. The intersection target was used for GO enrichment analysis and KEGG enrichment analysis with DAVID database to obtain its potential mechanism of action. Finally, through the in vivo experiment of using Huangjia Ruangan Granules to prevent and treat CCl4 leaded liver fibrosis in SD rats, the rats' body weight and liver index after the last dose were recorded, and the levels of aminotransferase (AST) and alanine aminotransferase (ALT) in the serum of SD rats were detected by the microplate method, hematoxylin-eosin staining were used to observe liver pathological changes. Results Predictive screening showed that Huangjia Ruangan Granules had 117 potential active ingredients, 266 active ingredients corresponded to targets, and 161 intersection targets. The key ingredients was quercetin, kaempferol, tanshinone IIA, formononetin, etc. The key targets were PTGS2, PTGS1 NCOA1, ACHE, HTR, RXRA, ADRB2, IL1B, etc. GO analysis showed a total of 960 enrichment results, including 845 biological processes, 63 molecular functions, and 52 cell compositions; KEGG analysis revealed a total of 68 pathways, the related pathways included TNF signaling pathway, Toll-like receptor signaling pathway, Rap1 signaling pathway, cytoplasmic DNA sensing pathway, ErbB signaling pathway and VEGF signaling pathway, etc. In vivo animal experiments had shown that Huangjia Ruangan Granules could significantly reduce the liver index and serum ALT and AST levels of rats, and improve liver histopathological indicators. Conclusions Huangjia Ruangan Granules treated liver fibrosis through multi-component, multi-pathway and multi-target synergy. This research laid the groundwork for the material basis, mechanism and clinical application of Huangjia Ruangan Granules in treating liver fibrosis diseases.
目的 对ChiTaS BSS1200血液核酸检测系统(简称“ChiTaS ”)主要分析性能进行验证,确定该系统是否稳定、准确、可靠。方法 参照美国临床实验室标准化协会(CLSI)相关文件要求,对在ChiTaS上开展的HBV-DNA、HCV-RNA、HIV-RNA项目进行检出限、精密度、准确度及抗干扰等方面验证。结果 ChiTaS 分析系统HBV-DNA、HCV-RNA、HIV-RNA最低检出限分别为3.63(3.16～6.26)IU/mL、12.71(10.37～21.63)U/mL、25.49(21.43～37.48)IU/mL;HBV-DNA、HCV-RNA、HIV-RNA阳性样本总变异系数分别为2.56%、1.03%、3.36%;22个阴性样本和10个阳性样本进行8混样模式检测结果为反应性,拆分检测结果:阳性样本符合率100%、阴性样本符合率100%;溶血血浆(血红蛋白含量为5 g/L)、脂肪血浆(甘油三酯大于6.3 mmol/L)对低浓度HBV(6.3 IU/mL)、HCV(23.3 IU/mL)、HIV(47.6 IU/mL)样本检出无显著影响。结论 ChiTaS检出限、精密度、准确度等均达到生产商的检测性能的要求,实验室该系统的检测能力可以满足本血站对无偿献血者样本的常规核酸检测要求。
