point of care

护理点
  • 文章类型: Journal Article
    全球近6000万人感染了丙型肝炎病毒(HCV)。一种血液传播的病原体,导致肝硬化并增加肝细胞癌的风险。那些获得医疗资源有限的人,如注射吸毒者和低收入和中等收入国家的人,承担最高的负担。目前的HCV诊断算法是缓慢和昂贵的,导致对HCV高危人群的诊断和治疗存在重大障碍。目前尚无可用的HCV疫苗,感染通常是无症状的,直到发生严重的肝硬化,这使得筛查对于防止肝脏损伤和传播非常重要。最近的调查试图通过改进诊断程序的各个方面来解决这些问题,使用等温扩增技术等方法进行病毒RNA扩增,使用病毒蛋白作为分析物,以及精简的合并,独立的测试系统,以降低管理技能要求。这篇综述全面概述了当前的商业标准和HCV诊断的新改进。以及未来整合这些改进的框架,以开发一步诊断,满足受影响最严重的人的需求。
    Nearly 60 million people worldwide are infected with Hepatitis C Virus (HCV), a bloodborne pathogen which leads to liver cirrhosis and increases the risk of hepatocellular carcinoma. Those with limited access to healthcare resources, such as injection drug users and people in low- and middle-income countries, carry the highest burden. The current diagnostic algorithm for HCV is slow and costly, leading to a significant barrier in diagnosis and treatment for those most at risk from HCV. There remains no available vaccine for HCV, and infection is often asymptomatic until significant cirrhosis has occurred, which makes screening incredibly important to prevent liver damage and transmission. Recent investigation has sought to address these issues through improvements in various aspects of the diagnostic procedure, using methods such as isothermal amplification techniques for viral RNA amplification, the use of viral protein as an analyte, and the incorporation of streamlined, self-contained testing systems to reduce administrative skill requirements. This review provides a comprehensive overview of current commercial standards and novel improvements in HCV diagnostics, as well as a framework for future integration of these improvements to develop a one-step diagnostic that meets the needs of those most affected.
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  • 文章类型: Journal Article
    目的:比较即时凝血分析仪(POCCA)与参考实验室凝血分析仪(LabCA)的准确性,并评估可能改变POCCA性能的混杂因素。
    方法:前瞻性,观察性研究。
    方法:两所大学兽医教学医院。
    方法:在2020年4月至2021年6月期间,有43只客户拥有的狗接受了凝血测试。
    方法:从接受凝血测试的狗中获取样品,作为诊断检查的一部分。在POCCA和LabCA上测量凝血酶原时间(PT)和活化部分凝血活酶时间(aPTT)。PCV,血小板计数,血浆总蛋白,高胆红素血症,溶血,血脂血症,并记录自凝集。
    结果:在POCCA和LabCA之间,PT呈中等相关性,aPTT呈强相关性(PT:0.59,P<0.0001;aPTT:0.71,P<0.0001)。对于38个PT中的30个和37个aPTT中的33个,POCCA结果与正常或低凝样品一致。由LabCA确定。PCV为30%-55%的样本具有中等相关性(PT:0.63,P=0.0004;aPTT:0.63,P=0.0003),但是那些在该范围之外的人更有可能在POCCA上注册错误消息或提供不同的结果。当出现溶血时,PT的POCCA和LabCA之间存在弱相关性(rho:0.38[95%置信区间:0.19-0.76],P=0.18)和aPTT的强相关性(rho:0.86[95%置信区间:0.62-0.95],P<0.0001)。高胆红素血症的样本与PT密切相关(0.97,P=0.002),但与aPTT无关。未观察到血脂和自身凝集。
    结论:PCV患者在制造商推荐的参考范围内存在可接受的相关性;然而,对PCV超出参考范围的样品的测量结果与LabCA不一致。在有凝血病和贫血或其他潜在混杂因素的患者中使用POCCA时应谨慎。
    OBJECTIVE: To compare the accuracy of a point-of-care coagulation analyzer (POCCA) with a reference laboratory coagulation analyzer (LabCA) and to evaluate for confounding factors that could alter the performance of the POCCA.
    METHODS: Prospective, observational study.
    METHODS: Two university veterinary teaching hospitals.
    METHODS: Forty-three client-owned dogs undergoing coagulation testing between April 2020 and June 2021.
    METHODS: Samples were obtained from dogs undergoing coagulation testing as part of a diagnostic workup. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) were measured on the POCCA and on the LabCA. PCV, platelet count, total plasma protein, hyperbilirubinemia, hemolysis, lipemia, and autoagglutination were recorded.
    RESULTS: Moderate correlation was seen for PT and strong correlation was seen for aPTT between the POCCA and the LabCA (PT: 0.59, P < 0.0001; aPTT: 0.71, P < 0.0001). The POCCA results were consistent with normal or hypocoagulable samples for 30 of 38 PT and 33 of 37 aPTT results, as identified by the LabCA. Samples with PCV of 30%-55% were moderately correlated (PT: 0.63, P = 0.0004; aPTT: 0.63, P = 0.0003), but those outside that range were more likely to register an error message on the POCCA or provide disparate results. When hemolysis was present, there was a weak correlation between the POCCA and the LabCA for PT (rho: 0.38 [95% confidence interval: 0.19-0.76], P = 0.18) and a strong correlation for aPTT (rho: 0.86 [95% confidence interval: 0.62-0.95], P < 0.0001). Samples with hyperbilirubinemia were strongly correlated for PT (0.97, P = 0.002) but not for aPTT. Lipemia and autoagglutination were not observed.
    CONCLUSIONS: There was an acceptable correlation in patients with PCV within the manufacturer\'s recommended reference range; however, measurements on samples with PCV outside the reference range were inconsistent with the LabCA. Caution should be used when using the POCCA in patients with coagulopathy and anemia or other potential confounders.
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  • 文章类型: Journal Article
    输血是住院患者常见的治疗干预措施。输血有很多适应症,包括贫血和凝血病,缺乏单一或多种凝血成分,如血小板或凝血因子。然而,危重病人输血的实践一直存在争议,主要是由于缺乏证据,以及需要考虑输血的适当临床背景.Further,输血有许多风险因素,必须与益处相平衡。因此,ICU患者的输血实践不断发展,我们努力在临床试验和专家指南的指导下,对该人群的输血实践进行当代回顾。
    Blood transfusion is a common therapeutic intervention in hospitalized patients. There are numerous indications for transfusion, including anemia and coagulopathy with deficiency of single or multiple coagulation components such as platelets or coagulation factors. Nevertheless, the practice of transfusion in critically ill patients has been controversial mainly due to a lack of evidence and the need to consider the appropriate clinical context for transfusion. Further, transfusion carries many risk factors that must be balanced with benefits. Therefore, transfusion practice in ICU patients has constantly evolved, and we endeavor to present a contemporary review of transfusion practices in this population guided by clinical trials and expert guidelines.
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  • 文章类型: Journal Article
    在社区环境中检测艰难梭菌是耗时的,导致延误诊断和隔离感染者。然而,随着近几十年来半自动设备和改进算法的出现,从无症状携带中辨别CDI感染的能力显著提高.这个,反过来,导致了有效监管的监控系统,进一步降低地方性风险,最近担心医院获得性艰难梭菌感染可能在COVID未能实现后激增。这篇综述重点介绍了在研究和临床环境中用于检测社区获得性艰难梭菌的成熟和新兴技术。
    Clostridioides difficile detection in community settings is time-intensive, resulting in delays in diagnosing and quarantining infected individuals. However, with the advent of semi-automated devices and improved algorithms in recent decades, the ability to discern CDI infection from asymptomatic carriage has significantly improved. This, in turn, has led to efficiently regulated monitoring systems, further reducing endemic risk, with recent concerns regarding a possible surge in hospital-acquired Clostridioides difficile infections post-COVID failing to materialize. This review highlights established and emerging technologies used to detect community-acquired Clostridioides difficile in research and clinical settings.
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  • 文章类型: English Abstract
    这篇综述的重点是描述新的商用POC型分子诊断系统,该系统可以在社区药房中轻松实施,并有可能扩大制药服务的组合,并为改善公共卫生做出重大贡献。对PCR以外的新分子诊断技术的了解相对尚待探索。然而,可用的选择多种多样,并且已经达到了大规模使用的足够技术成熟度。SARS-CoV-2大流行给市场带来了诊断测试,在某些情况下,几十年来一直专门用于研究。等温核酸扩增技术继续发展,很可能在未来几年中,我们将看到其使用呈指数级增长,以及开发新的改进,进一步简化和降低每个测定的成本。此外,我们不能忽视这样一个事实,在新冠肺炎大流行期间,公众已经习惯于通过社区药房等大众分销渠道进行自我诊断。这可以使该部门对其他疾病开放-例如性传播疾病或动物健康-,食物控制,水和空气污染(真菌)或过敏原的存在。对它们的了解是制药部门必不可少的技术监督策略。
    This review focuses on describing new commercially available POC-type molecular diagnostic systems that can be easily implemented in community pharmacies and have the potential to expand the portfolio of pharmaceutical services and make a significant contribution to the improvement of public health.Knowledge of new molecular diagnostic techniques other than PCR is relatively unexplored. However, the available options are diverse and have reached sufficient technological maturity for large-scale use. The SARS-CoV-2 pandemic has brought diagnostic tests to market that, in some cases, have been used exclusively in research for decades.Isothermal nucleic acid amplification technology continues to evolve and it is likely that in the coming years we will witness an exponential increase in its use, as well as the development of new improvements that further simplify and reduce the cost of each assay.Furthermore, we cannot ignore the fact that during the COVID-19 pandemic, the public has become accustomed to self-diagnosing through mass distribution channels such as community pharmacies. Which can open the sector to other diseases - such as sexually transmitted diseases or animal health -, food control, water and air contamination (fungi) or the presence of allergens.Knowledge of them is an essential technological surveillance strategy for the pharmaceutical sector.
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  • 文章类型: Journal Article
    目的:主要目的是确定蛋白尿即时检测(POC)在乌干达感染HIV(YPLHIV)的年轻人中诊断慢性肾脏疾病的诊断性能。
    方法:我们进行了一项横断面研究,比较了微量白蛋白(ErbaLachema,捷克共和国),以实验室测定的白蛋白和肌酐为参考标准的白蛋白尿POC试验。
    方法:这项研究是在坎帕拉的七个艾滋病毒诊所进行的,乌干达向感染艾滋病毒的成人和儿童提供抗逆转录病毒疗法。该研究于2023年4月至8月进行。
    方法:从HIV诊所随机选择了497名年龄在10-24岁之间被诊断为HIV的YPLHIV。排除妊娠YPLHIV。
    方法:参与者提供了点尿液样本,使用POC进行了白蛋白和肌酐测试,并在实验室和蛋白尿中使用尿液试纸进行了测试。敏感性,特异性,阴性和阳性预测值(NPV,计算了POC与实验室测试的PPV),并使用逻辑回归估计与POC检验阳性相关的因素。
    方法:主要结果是诊断为白蛋白尿,定义为白蛋白肌酐比值高于30mg/g。
    结果:在497名参与者中,278名(55.9%)为女性,331名(66.8%)为10-17岁。POC检测的灵敏度为74.5%(95%CI为70.6%~78.4%),特异性为68.1%(95%CI为63.9%~72.3%)。PPV为21.5%(95%CI17.8%至25.1%),净现值为95.8%(95%CI94.0%至97.6%),准确率为68.8%。有强有力的证据表明,阳性POC测试与蛋白尿相关(OR2.82;95%CI1.89至4.22,p<0.001);体重指数<19.5(OR1.6995%CI1.17至2.45,p=0.005)和男性(OR1.48;95%CI1.02至2.14,p=0.04)。
    结论:白蛋白尿POC检测的敏感性和特异性较低。然而,鉴于其高NPV,它可用于排除肾脏疾病。应针对24小时尿排泄率进行验证,以进一步确定其诊断性能。
    OBJECTIVE: The main aim was to determine the diagnostic performance of an albuminuria point-of-care test (POC) for diagnosis of chronic kidney disease among young people living with HIV (YPLHIV) in Uganda.
    METHODS: We conducted a cross-sectional study comparing the diagnostic performance of MicroalbuPHAN (Erba Lachema, Czech Republic), an albuminuria POC test against the laboratory-measured albumin and creatinine as the reference standard.
    METHODS: The study was set in seven HIV clinics in Kampala, Uganda that provide antiretroviral therapy to adults and children living with HIV. The study took place from April to August 2023.
    METHODS: 497 YPLHIV aged 10-24 years who were diagnosed with HIV before 10 years of age were randomly selected from the HIV clinics. Pregnant YPLHIV were excluded.
    METHODS: Participants provided a spot urine sample that was tested for albumin and creatinine using the POC and in the laboratory and proteinuria using urine dipstick. The sensitivity, specificity, negative and positive predictive values (NPV, PPV) of the POC versus the laboratory test were calculated, and factors associated with having a positive POC test were estimated using logistic regression.
    METHODS: The primary outcome was a diagnosis of albuminuria defined as an albumin creatinine ratio above 30 mg/g.
    RESULTS: Of the 497 participants enrolled, 278 (55.9%) were female and 331 (66.8%) were aged 10-17 years. The POC test had a sensitivity of 74.5% (95% CI 70.6% to 78.4%) and specificity of 68.1% (95% CI 63.9% to 72.3%). The PPV was 21.5% (95% CI 17.8% to 25.1%) and the NPV was 95.8% (95% CI 94.0% to 97.6%), with an accuracy of 68.8%. There was strong evidence that a positive POC test was associated with having proteinuria (OR 2.82; 95% CI 1.89 to 4.22, p<0.001); body mass index <19.5 (OR 1.69 95% CI 1.17 to 2.45, p=0.005) and being male (OR 1.48; 95% CI 1.02 to 2.14, p=0.04).
    CONCLUSIONS: The albuminuria POC test had low sensitivity and specificity. However, it can be used to exclude kidney disease given its high NPV. It should be validated against the 24-hour urinary excretion rate to further determine its diagnostic performance.
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  • 文章类型: Journal Article
    背景:在全球范围内,大约有7到20万人被认为患有乙型肝炎病毒(HBV)和丙型肝炎病毒(HCV)的共同感染。环介导等温扩增(LAMP)方法,由Notomi及其同事介绍,作为一种有效的分子工具,已经经历了实质性的进步,可以在单个管中同时分析多个样品。
    方法:本研究使用解链曲线分析多重LAMP(mLAMP)检查了单管中HBV和HCV的同时检测,这是基于独特的熔融峰温度的识别。用于引物设计的选定区域包括HBV的S基因和HCV的UTR基因。引物优化最初通过个体HBV和HCVLAMP分析进行。在优化过程之后,通过优化多重反应混合物来评估mLAMP测定,确定反应时间,并分析检测限(LOD)。还使用横向流动量尺(LFD)分析结果,通过在mLAMP之前将20pmolFITC标记的LF引物添加到反应混合物中,可以目视检测HBV和HCV。
    结果:mLAMP测定的LOD被确定为10拷贝/μl,并且没有检测到与其他微生物的交叉反应性。从患者血浆中获得的检测结果也使用LFD直观显示,并且显示与从实时聚合酶链测定获得的那些显著一致。mLAMP分析显示95%的诊断灵敏度检测HBV,HCV的LOD为90%。mLAMP测定对两种病毒的总体诊断灵敏度为85%。该测定证实了100%的特异性。
    结论:通过在62°C的设定温度内同时检测双重目标HBV和HCV,mLAMP测定显示出分析共感染样品的显着希望,全部在1小时的时间范围内。此外,当与一次性LFD配对时,mLAMP测定能够在几分钟内快速视觉检测测定结果。结果有助于mLAMP分析非常适合共感染筛查,特别是在野外条件下。
    BACKGROUND: Globally, around 7 to 20 million people are believed to be suffering from coinfection with both hepatitis B virus (HBV) and hepatitis C virus (HCV). The loop-mediated isothermal amplification (LAMP) approach, introduced by Notomi and colleagues, has undergone substantial advancements as an effective molecular tool that enables the simultaneous analysis of multiple samples in a single tube.
    METHODS: The present study examined the simultaneous detection of HBV and HCV in a single tube using melt curve analysis multiplex LAMP (mLAMP), which is based on the identification of unique melting peak temperatures. Selected regions for primer design including the S gene of HBV and the UTR gene of HCV. Primer optimization is initially performed through individual HBV and HCV LAMP analysis. Following the optimization process, the mLAMP assay was evaluated by optimizing the multiplex reaction mixture, determining the reaction time, and analyzing the limit of detection (LOD). The results are also analyzed using lateral flow dipsticks (LFD), which enable the visual detection of HBV and HCV by adding 20 pmol FITC-labeled LF primers into the reaction mixture prior the mLAMP.
    RESULTS: The LOD for the mLAMP assay was determined as 10 copies/µl, and no cross-reactivity with other microorganisms was detected. The detection results obtained from patient plasma were also visually demonstrated using LFD, and displayed significant concordance with those obtained from Real-Time Polymerase Chain Assay. The mLAMP assay revealed a diagnostic sensitivity of 95% for detecting the HBV, and LOD is 90% for HCV. The overall diagnostic sensitivity of the mLAMP assay for both viruses was 85%. The assay confirmed a specificity of 100%.
    CONCLUSIONS: The mLAMP assay displays significant promise for analyzing coinfected samples by simultaneously detecting the dual targets HBV and HCV within a set temperature of 62 °C, all within a time frame of 1 h. Additionally, when paired with disposable LFD, the mLAMP assay enables rapid visual detection of assay results in a matter of minutes. The result contributes to the mLAMP assay being highly suitable for coinfection screening, particularly in field conditions.
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  • 文章类型: Journal Article
    目的:创伤性脑损伤(TBI)和出血是所有创伤相关死亡的最大比例。在有出血和TBI风险的多发性创伤患者中,诊断,预后,TBI的管理特征仍然很差。作者试图表征神经胶质纤维酸性蛋白(GFAP)和泛素C末端水解酶L1(UCH-L1)测量在伴有和不伴有TBI的失血性休克患者中的预测能力。
    方法:作者对来自前瞻性观察性队列研究的系列血液样本进行了二次分析,该研究的重点是比较早期全血和成分复苏。使用患者的方便样品,其中在三个时间点收集样品,并且记录通过CT成像存在TBI或没有TBI。使用i-STATAlinity护理点平台对血浆样品进行GFAP和UCH-L1测量。使用分类树递归分区,作者确定了每种生物标志物的测量切点,以最大限度地提高预测TBI诊断的能力,鹿特丹CT影像评分,和6个月格拉斯哥结果扩展量表(GOSE)评分。
    结果:生物标志物比较表明,GFAP和UCH-L1测量值在所有时间点都与TBI的存在有关。分类树分析表明,在患者到达时所取样本的GFAP水平>286pg/ml时,受试者工作特征曲线下面积为0.77,用于预测TBI的存在。分类树结果表明,对于到达的GFAP测量,3094pg/ml的切点对于初始和第二次CT扫描中的鹿特丹评分升高以及扫描之间的TBI进展最具预测性。在UCH-L1的任何最具预测性的切点与鹿特丹CT评分或TBI进展之间均未发现显着关联。UCH-L1的预测能力受到定点护理平台允许的范围的限制。在控制了所有潜在的多发性创伤混杂因素后,到达GFAP临界点仍然是强有力的独立预测因子,包括损伤特征,休克严重程度,和复苏。
    结论:在多创伤和休克患者中,在现场护理设备上早期测量GFAP和UCH-L1与CT诊断的TBI显著相关。早期升高的GFAP测量值与鹿特丹头部CT扫描评分较差相关,TBI进展,更糟糕的GOSE分数,这些关联独立于其他伤害属性,休克严重程度,和早期复苏的特点。
    OBJECTIVE: Traumatic brain injury (TBI) and hemorrhage are responsible for the largest proportion of all trauma-related deaths. In polytrauma patients at risk of hemorrhage and TBI, the diagnosis, prognosis, and management of TBI remain poorly characterized. The authors sought to characterize the predictive capabilities of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1) measurements in patients with hemorrhagic shock with and without concomitant TBI.
    METHODS: The authors performed a secondary analysis on serial blood samples derived from a prospective observational cohort study that focused on comparing early whole-blood and component resuscitation. A convenience sample of patients was used in which samples were collected at three time points and the presence of TBI or no TBI via CT imaging was documented. GFAP and UCH-L1 measurements were performed on plasma samples using the i-STAT Alinity point-of-care platform. Using classification tree recursive partitioning, the authors determined the measurement cut points for each biomarker to maximize the abilities for predicting the diagnosis of TBI, Rotterdam CT imaging scores, and 6-month Glasgow Outcome Scale-Extended (GOSE) scores.
    RESULTS: Biomarker comparisons demonstrated that GFAP and UCH-L1 measurements were associated with the presence of TBI at all time points. Classification tree analyses demonstrated that a GFAP level > 286 pg/ml for the sample taken upon the patient\'s arrival had an area under the receiver operating characteristic curve of 0.77 for predicting the presence of TBI. The classification tree results demonstrated that a cut point of 3094 pg/ml for the arrival GFAP measurement was the most predictive for an elevated Rotterdam score on the initial and second CT scans and for TBI progression between scans. No significant associations between any of the most predictive cut points for UCH-L1 and Rotterdam CT scores or TBI progression were found. The predictive capabilities of UCH-L1 were limited by the range allowed by the point-of-care platform. Arrival GFAP cut points remained strong independent predictors after controlling for all potential polytrauma confounders, including injury characteristics, shock severity, and resuscitation.
    CONCLUSIONS: Early measurements of GFAP and UCH-L1 on a point-of-care device are significantly associated with CT-diagnosed TBI in patients with polytrauma and shock. Early elevated GFAP measurements are associated with worse head CT scan Rotterdam scores, TBI progression, and worse GOSE scores, and these associations are independent of other injury attributes, shock severity, and early resuscitation characteristics.
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  • 文章类型: Journal Article
    泰国的医院面临人满为患,特别是非传染性疾病(NCD)患者,由于医生短缺和人口老龄化。大多数文献显示仅在网络或移动应用程序上实施,以与医生进行远程咨询。相反,在这项工作中,我们开发并实施了一种远程医疗健康亭系统,该系统嵌入了非侵入性生物传感器和时间序列预测因子,以在8个月内改善NCD指标.随机选择两个队列:常规护理的对照组和远程医疗使用组。远程医疗组的平均空腹血糖(148至130mg/dL)和收缩压(152至138mmHg)显着改善。利用Apriori算法进行数据挖掘,揭示疾病之间的相关性,职业,和环境因素,宣传公共卫生政策。信息亭和服务器之间的通信使用LoRa,5G,和IEEE802.11,它们是根据距离和信号可用性选择的。结果支持远程医疗亭对NCD管理有效,显著改善非传染性疾病关键指标,平均血糖,还有血压.
    Thailand\'s hospitals face overcrowding, particularly with non-communicable disease (NCD) patients, due to a doctor shortage and an aging population. Most literature showed implementation merely on web or mobile application to teleconsult with physicians. Instead, in this work, we developed and implemented a telemedicine health kiosk system embedded with non-invasive biosensors and time-series predictors to improve NCD indicators over an eight-month period. Two cohorts were randomly selected: a control group with usual care and a telemedicine-using group. The telemedicine-using group showed significant improvements in average fasting blood glucose (148 to 130 mg/dL) and systolic blood pressure (152 to 138 mmHg). Data mining with the Apriori algorithm revealed correlations between diseases, occupations, and environmental factors, informing public health policies. Communication between kiosks and servers used LoRa, 5G, and IEEE802.11, which are selected based on the distance and signal availability. The results support telemedicine kiosks as effective for NCD management, significantly improving key NCD indicators, average blood glucose, and blood pressure.
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  • 文章类型: Journal Article
    背景:高敏心肌肌钙蛋白I(hs-cTnI)被广泛用于急性冠脉综合征的诊断。hs-cTnI测定的最新建议是0-1小时最终确定的方案,以提高测试的排除准确性。由于减少了周转时间并排除了怀疑患有ACS的患者,因此能够保证这些表现的点护理测试非常有用。特别是使用离心机不需要的生物基质。我们工作的目的是比较使用不同生物基质和抗凝剂获得的hs-cTnI的结果,在Atellica®VTLihs-cTnIPOCT和AccessAccuTnI+3DxI800性能之间获得,以建立直接从这些分析前条件得出的可能偏差。
    方法:锂肝素化池样本主要用于hs-cTnI,Atellica®VTLi作为全血,然后离心并在Atellica®VTLi和DxI800上测试。将K3EDTA池样品离心并在DxI800上测量。根据CLSI_EP-09A2方案进行方法比较。用戴明回归研究了常数误差和比例误差。用BlandAltman试验评价方法之间的偏差。
    结果:比较使用Atellica获得的全血肝素锂与在DxI800上测试的肝素锂和K3EDTA血浆的结果,Deming回归显示出比例误差,而在这两种情况下,BlandAltman都强调了最小的低估。当考虑在Atellica上测试的血浆肝素锂与用DxI800获得的肝素锂和K3EDTA血浆时,发现了相似的性能,证实了相同的低估。考虑到接近截止值的值,没有发现显著差异。
    结论:在实验室,两种不同分析仪的偏差估计至关重要。当使用不同的生物基质和抗凝剂进行分析时,这再次是至关重要的。我们的研究表明,当比较Atellica和DxI800性能时,两个矩阵之间没有显着差异。
    BACKGROUND: high-sensitive cardiac TroponinI (hs-cTnI) is widely used for diagnosis of acute coronary syndromes. The latest recommendation for hs-cTnI determination is the protocol 0-1 h finalized to improve the rule out accuracy of the test. A Point of Care Testing able to guarantee these performances could be very useful due to reducing the turnaround time and ruling out patients suspected of ACS, especially by using biological matrices that are not required for centrifuge. The aim of our work is to compare the results for hs-cTnI obtained using different biological matrices and anticoagulants, obtained between Atellica® VTLi hs-cTnI POCT and Access AccuTnI+3 DxI800 performances, in order to establish a possible bias derived directly from these pre-analytical conditions.
    METHODS: Li-heparinized pool samples were primary employ for hs-cTnI with Atellica® VTLi as whole blood, then centrifuged and tested on Atellica® VTLi and DxI800. K3EDTA pool samples were centrifuged and measured on DxI800 too. A comparison of methods was performed according to CLSI_EP-09A2 protocol. Constant and proportional errors were investigated with Deming regression. Bias between methods was evaluated with the Bland Altman test.
    RESULTS: comparing whole blood lithium heparin results obtained with Atellica versus lithium heparin and K3EDTA plasma tested on DxI 800, the Deming regression revealed a proportional error, whereas in both cases Bland Altman highlighted a minimal underestimation. A similar performance was revealed when considering plasma lithium heparin tested on Atellica versus lithium heparin and K3EDTA plasma obtained with DxI800, confirming the same underestimation. Considering values close to the cut off, no significant differences were found.
    CONCLUSIONS: in the laboratory, the estimation of the bias of two different analyzers is pivotal. Once more this is crucial when different biological matrices and anticoagulants are employed for the analysis. Our study demonstrates that no significant differences among the two matrices are present when comparing Atellica and DxI800 performances.
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