point-of-care test

即时测试
  • 文章类型: Journal Article
    在资源丰富的地区每天使用即时测试(POCT),然而,在全球南部是有限的,特别是在院前设置。关于社区卫生工作者(CHW)使用非疟疾性POCT的研究很少。此范围审查的目的是描述院前环境中评估的POCT的当前多样性和广度。
    由经验丰富的医学图书馆员对已知关键文章进行医学主题标题(MeSH)分析,并在每个数据库中进行范围搜索,以捕获“护理点测试”和“社区卫生工作者”。“这项审查是由PRISMA扩展进行范围审查的指导。
    返回了2735个出版物,185人被提名进行全文审查,110项研究被证实符合研究标准.大多数人关注疟疾(74/110;67%)或HIV(25/110;23%);9/110(8%)描述了其他测试。这篇综述的结果表明,地理范围很广,当地CHW的术语具有显著的异质性。
    新POCT的使用正在增加,并且可能会在有限的资源环境中改善早期风险分层。来自数十年疟疾POCT的当前证据可以指导未来的实施战略。
    Point-of-Care Tests (POCTs) are utilized daily in resource abundant regions, however, are limited in the global south, particularly in the prehospital setting. Few studies exist on the use of non-malarial POCTs by Community Health Workers (CHWs). The purpose of this scoping review is to delineate the current diversity in and breadth of POCTs evaluated in the prehospital setting.
    A medical subject heading (MeSH) analysis of known key articles was done by an experienced medical librarian and scoping searches were performed in each database to capture \"point of care testing\" and \"community health workers.\" This review was guided by the PRISMA Extension for scoping reviews.
    2735 publications were returned, 185 were nominated for full-text review, and 110 studies were confirmed to meet study criteria. Majority focused on malaria (74/110; 67%) or HIV (25/110; 23%); 9/110 (8%) described other tests administered. Results from this review demonstrate a broad geographic range with significant heterogeneity in terminology for local CHWs.
    The use of new POCTs is on the rise and may improve early risk stratification in limited resource settings. Current evidence from decades of malaria POCTs can guide future implementation strategies.
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  • 文章类型: Journal Article
    分子点护理(POC)测试提供高灵敏度,快速的周转时间,相对易用性,以及在没有正式实验室空间和设备的情况下进行实验室级测试的便利性,使它们成为在资源有限的环境中进行传染病诊断的有吸引力的选择。在这次审查中,我们讨论了分子POC测试在资源有限的环境中的作用和潜力及其相关的后勤挑战。我们讨论美国食品和药物管理局的批准,临床实验室改进修正案复杂性水平,和REASSURED标准作为评估目前在美国国内外可用的选项的起点。然后,我们介绍了目前处于研究和开发阶段的POC测试,这些测试具有在资源有限的环境中商业化和实施的潜力。最后,我们回顾了已发表的研究,这些研究评估了分子POC检测在有限和中等资源环境中的临床影响.
    Molecular point-of-care (POC) tests offer high sensitivity, rapid turnaround times, relative ease of use, and the convenience of laboratory-grade testing in the absence of formal laboratory spaces and equipment, making them appealing options for infectious disease diagnosis in resource-limited settings. In this review, we discuss the role and potential of molecular POC tests in resource-limited settings and their associated logistical challenges. We discuss U.S. Food and Drug Administration approval, Clinical Laboratory Improvement Amendments complexity levels, and the REASSURED criteria as a starting point for assessing options currently available inside and outside of the United States. We then present POC tests currently in research and development phases that have potential for commercialization and implementation in limited-resource settings. Finally, we review published studies that have assessed the clinical impact of molecular POC testing in limited- and moderate-resource settings.
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  • 文章类型: Journal Article
    背景:种植体周围和牙周的诊断主要依赖于一套临床措施和X线图像的评估。然而,这些临床设置本身不足以确定,更不用说预测了,种植体周围骨丢失或未来种植体失败。通过生物标志物评估,可以早期诊断植入物周围疾病及其进展速度。一旦确定,种植体周围和牙周组织破坏的生物标志物可以在临床症状出现之前提醒临床医生。因此,重要的是要考虑开发对特定生物标志物具有特异性的椅子侧诊断测试,表明疾病的当前活动。
    方法:在Pubmed和WebofScience上创建了一个搜索策略,以回答以下问题:“当前可用的分子护理点测试如何帮助早期发现植入物周围疾病并揭示护理点诊断设备的改进?”
    结果:PerioSafe®PRODRS(dentognoGstics,耶拿)和ImplantSafe®DR(dentognosticsGmbH,JenaORALyzer®测试套件,已经在临床上使用,可以成为提高牙周/种植体周围疾病的诊断和预后的辅助工具。随着传感器技术的进步,生物传感器可以对牙科植入物或牙周疾病进行日常监测,为个人医疗保健做出贡献,改善健康管理和人类健康的现状。
    结论:根据调查结果,更多的重点是生物标志物在诊断和监测牙周和种植体周围疾病中的作用。通过将这些策略与传统协议相结合,专业人员可以提高早期发现种植体周围和牙周病的准确性,预测疾病进展,并监测治疗结果。
    The diagnosis of peri-implantar and periodontal relies mainly on a set of clinical measures and the evaluation of radiographic images. However, these clinical settings alone are not sufficient to determine, much less predict, periimplant bone loss or future implant failure. Early diagnosis of periimplant diseases and its rate of progress may be possible through biomarkers assessment. Once identified, biomarkers of peri-implant and periodontal tissue destruction may alert the clinicians before clinical signs show up. Therefore, it is important to consider developing chair-side diagnostic tests with specificity for a particular biomarker, indicating the current activity of the disease.
    A search strategy was created at Pubmed and Web of Science to answer the question: \"How the molecular point-of-care tests currently available can help in the early detection of peri-implant diseases and throws light on improvements in point of care diagnostics devices?\"
    The PerioSafe® PRO DRS (dentognostics GmbH, Jena) and ImplantSafe® DR (dentognostics GmbH, Jena ORALyzer® test kits, already used clinically, can be a helpful adjunct tool in enhancing the diagnosis and prognosis of periodontal/peri-implantar diseases. With the advances of sensor technology, the biosensors can perform daily monitoring of dental implants or periodontal diseases, making contributions to personal healthcare and improve the current status quo of health management and human health.
    Based on the findings, more emphasis is given to the role of biomarkers in diagnosing and monitoring periodontal and peri-implant diseases. By combining these strategies with traditional protocols, professionals could increase the accuracy of early detection of peri-implant and periodontal diseases, predicting disease progression, and monitoring of treatment outcomes.
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  • 文章类型: Meta-Analysis
    背景:分子和抗原即时检测(POCT)增强了我们快速识别和管理SARS-CoV-2感染的能力。然而,他们的临床表现在各个研究中有所不同。
    目的:对基于分子和抗原的POCT的性能进行评估,怀疑,或可能的COVID-19病例与现实生活中基于实验室的RT-PCR相比。
    方法:MEDLINE/PubMed,Scopus,Embase,WebofScience,科克伦图书馆,CochraneCOVID-19研究登记册,和来自伯尔尼大学的COVID-19生活证据数据库。
    方法:同行评审或预印观察性研究或随机对照试验,评估了SARS-CoV-2的任何类型的市售抗原和/或分子POCT,包括多重PCR小组,由美国食品和药物管理局批准,具有紧急使用授权,和/或标有欧洲委员会/欧洲联盟的“符合欧洲标准”。
    方法:密切接触者和/或有症状和/或无症状的患者,怀疑,或任何年龄的可能的COVID-19感染。
    未经授权:基于分子和/或抗原的SARS-CoV-2POCT。
    未经鉴定:基于实验室的SARS-CoV-2RT-PCR。
    UNASSIGNED:使用诊断准确性研究2工具对符合条件的研究进行质量控制和偏倚风险评估。
    UNASSIGNED:使用双变量模型估计了其95%CI的总体敏感性和特异性。当至少三项研究告知结果时,进行亚组分析。
    结果:共有123篇合格出版物(评估基于抗原和分子POCT的97项和26项研究,分别)从4674条初始记录中检索。13种基于分子的POCT的合并敏感性和特异性分别为92.8%(95%CI,88.9-95.4%)和97.6%(95%CI,96.6-98.3%),分别。来自138个单独评估的基于抗原的POCT的敏感性大大低于分子POCT;合并的敏感性和特异性分别为70.6%(95%CI,67.2-73.8%)和98.9%(95%CI,98.5-99.2%)。分别。
    结论:需要进一步的研究来评估基于分子和抗原的POCT在代表性不足的患者亚组和不同呼吸道样本中的表现。
    BACKGROUND: Molecular and antigen point-of-care tests (POCTs) have augmented our ability to rapidly identify and manage SARS-CoV-2 infection. However, their clinical performance varies among individual studies.
    OBJECTIVE: The evaluation of the performance of molecular and antigen-based POCTs in confirmed, suspected, or probable COVID-19 cases compared with that of laboratory-based RT-PCR in real-life settings.
    METHODS: MEDLINE/PubMed, Scopus, Embase, Web of Science, Cochrane Library, Cochrane COVID-19 study register, and COVID-19 Living Evidence Database from the University of Bern.
    METHODS: Peer-reviewed or preprint observational studies or randomized controlled trials that evaluated any type of commercially available antigen and/or molecular POCTs for SARS-CoV-2, including multiplex PCR panels, approved by the United States Food and Drug Administration, with Emergency Use Authorization, and/or marked with Conformitè Europëenne from European Commission/European Union.
    METHODS: Close contacts and/or patients with symptomatic and/or asymptomatic confirmed, suspected, or probable COVID-19 infection of any age.
    UNASSIGNED: Molecular and/or antigen-based SARS-CoV-2 POCTs.
    UNASSIGNED: Laboratory-based SARS-CoV-2 RT-PCR.
    UNASSIGNED: Eligible studies were subjected to quality-control and risk-of-bias assessment using the Quality Assessment of Diagnostic Accuracy Studies 2 tool.
    UNASSIGNED: Summary sensitivities and specificities with their 95% CIs were estimated using a bivariate model. Subgroup analysis was performed when at least three studies informed the outcome.
    RESULTS: A total of 123 eligible publications (97 and 26 studies assessing antigen-based and molecular POCTs, respectively) were retrieved from 4674 initial records. The pooled sensitivity and specificity for 13 molecular-based POCTs were 92.8% (95% CI, 88.9-95.4%) and 97.6% (95% CI, 96.6-98.3%), respectively. The sensitivity of antigen-based POCTs pooled from 138 individual evaluations was considerably lower than that of molecular POCTs; the pooled sensitivity and specificity rates were 70.6% (95% CI, 67.2-73.8%) and 98.9% (95% CI, 98.5-99.2%), respectively.
    CONCLUSIONS: Further studies are needed to evaluate the performance of molecular and antigen-based POCTs in underrepresented patient subgroups and different respiratory samples.
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  • 文章类型: Journal Article
    鉴于抗血小板治疗的患病率上升,术前快速识别出血患者的素质是指导血液制品用药的必要条件。这在颅内出血(ICH)的神经外科手术中尤其重要,其中不分青红皂白的输血可能导致进一步的出血性或血栓栓塞性损伤。血小板功能的即时护理(POC)测试是解决这一难题的有希望的解决方案,因为它已被证明在心脏手术中有效。然而,到目前为止,POC在神经外科中的血小板功能检测尚未得到广泛评估。本系统评价了POC血小板功能试验(PFT)在急诊神经外科手术中对患者预后的影响。对四个电子数据库进行了全面搜索(Pubmed,MEDLINE,Embase,和Cochrane)从各自的开始到2022年6月1日为止的相关英语文章。我们纳入了符合以下纳入标准的所有随机对照试验和队列研究:(i)纳入接受ICH神经外科手术的成年患者;(ii)通过POCPFT评估血小板功能;(iii)报告围手术期失血量的变化;和/或(iv)报告与治疗相关的不良事件和死亡率的数据。使用队列研究和病例对照研究的纽卡斯尔渥太华质量评估量表对研究质量进行评估,和JBI关键评估清单案例系列。搜索产生了2,835项研究,其中包含849例患者的7项观察性研究符合本综述的纳入标准.总的来说,有证据表明,使用POCPFT评估出血风险可减少出血事件,血栓栓塞不良结果,以及住院时间。然而,目前没有足够的证据表明使用POCPFT可以改善血液制品的使用,功能结果或死亡率。
    Given the rising prevalence of antiplatelet therapy, rapid preoperative identification of patients with bleeding diathesis is necessary for the guidance of blood product administration. This is especially relevant in neurosurgery for intracranial hemorrhage (ICH), where indiscriminate transfusions may lead to further hemorrhagic or thromboembolic injury. Point-of-care (POC) testing of platelet function is a promising solution to this dilemma, as it has been proven effective in cardiac surgery. However, to date, POC platelet function testing in neurosurgery has not been extensively evaluated. This systematic review appraises the use of POC platelet function test (PFT) in emergency neurosurgery in terms of its impact on patient outcomes.A comprehensive search was conducted on four electronic databases (Pubmed, MEDLINE, Embase, and Cochrane) for relevant English language articles from their respective inceptions until 1 June 2022. We included all randomized controlled trials and cohort studies that met the following inclusion criteria: (i) involved adult patients undergoing neurosurgery for ICH; (ii) evaluated platelet function via POC PFT; (iii) reported a change in perioperative blood loss; and/or (iv) reported data on treatment-related adverse events and mortality. Assessment of study quality was conducted using the Newcastle Ottawa Quality Assessment Scale for Cohort Studies and Case-Control Studies, and the JBI Critical Appraisal Checklist for Case Series.The search yielded 2,835 studies, of which seven observational studies comprising 849 patients met the inclusion criteria for this review. Overall, there is evidence that the use of POC PFT to assess bleeding risk reduced bleeding events, thromboembolic adverse outcomes, and the length of hospitalization. However, there is currently insufficient evidence to suggest that using POC PFT improves blood product use, functional outcomes or mortality.
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  • 文章类型: Journal Article
    The DOAC Dipstick accurately detects the presence or absence of factor Xa (DXI) and thrombin inhibitor (DTI) classes of direct oral anticoagulants (DOACs) in patients\' urine samples on DOAC treatment. The aim of the study was to systematically review the literature and compare the performance of prototype and commercial test strips with a meta-analysis. A systematic literature search of electronic databases PubMed (MEDLINE) and Cochrane Library was performed. Heterogeneity between studies was calculated using the Chi-squared test and the I 2 index. A random effects model was used to pool data to compare the performance of prototype and commercial test strips. Using PRISMA reporting guidelines, four of 1,081 publications were eligible for inclusion in the meta-analysis: three reporting on prototype (DXI n  = 658, DTI n  = 586) and one on commercial test strips (DXI n  = 451, DTI n  = 429). Sensitivity and specificity of DXI and DTI detection did not differ significantly between the prototype and commercial test strips. Odds ratios were 0.718 and 0.365 for sensitivity and 1.211 and 1.072 for specificity of DXI and DTI (p-values between 0.3334 and 1.000), respectively. The pooled sensitivity and specificity values for DXI were 0.968 ( p  = 0.1290, I 2 47.1%) and 0.979 ( p  = 0.1965, I 2 35.9%), and for DTI 0.993 ( p  = 0.1870, I 2 37.5%) and 0.993 ( p  = 0.7380, I 2 0%), respectively. Prototype and commercial DOAC test strips did not differ in their ability to detect DXI and DTI in patient urine samples. This supports the confidence in use of the DOAC Dipstick test, although it needs to be validated in specific patient populations.
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  • 文章类型: Editorial
    Introduction: Visceral leishmaniasis (VL) is a life-threatening infection remaining as one of the most neglected tropical diseases around the world. Despite scientific advances, an accurate diagnosis of VL remains a challenge. Loop-mediated isothermal amplification (LAMP) has emerged as a promising diagnostic tool with the possibility of becoming a point-of-care test to guide VL diagnosis and treatment.Areas covered: We conducted a systematic review assessing LAMP systems for diagnosing VL from 2000 to 2019. We performed structured searches in PubMed, LILACS, Scopus, and Web of Science without language restriction. Two reviewers screened articles, completed the data extraction and assessment of the risk of bias. A qualitative summary of the included studies was performed.Expert opinion: LAMP could be used as a screening test for VL diagnosis, so tissue aspiration could be performed only for those who are LAMP negative. We recommend more studies about the performance of the Loopamp™ Leishmania Detection kit and the Brazilian LAMP assay. Thus, we expect in the future the constitution of an international consortium to share experiences, projects, and other LAMP approaches mainly among researchers and institutions located within VL endemic countries.
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  • 文章类型: Journal Article
    目的:微生物点检测(POCT)有可能彻底改变临床护理。了解从上呼吸道(方便的采样部位)鉴定的微生物的预后价值是了解上呼吸道POCT在协助呼吸道感染(RTIs)的抗菌治疗决策中的潜力的必要的第一步。目的探讨上呼吸道微生物检测与疾病预后的关系,包括抗菌药物使用的影响。
    方法:数据源是MEDLINE和Embase数据库。研究资格标准包括定量研究,报告来自所有年龄段的RTI患者的微生物学和预后数据。向医疗保健或研究机构展示RTI的患者参加。干预措施包括上呼吸道拭子。使用的方法是系统回顾和荟萃分析。
    结果:搜索确定了5156篇文章,其中754项为重复项,4258项为标题或摘要除外。共筛选了144篇全文;保留了21篇文章。研究报告了15种微生物和26种预后措施的数据(390种潜在关联)。对一百一十七个(27%)协会进行了统计调查,其中38人(36%)显著。大多数研究仅报道测试阳性结果的预后价值。Meta分析显示,呼吸道合胞病毒患者的住院时间比腺病毒和流感患者长。但在研究之间观察到显著的异质性。
    结论:已经研究了四分之一的潜在预后关联。其中,第三个是重要的,表明POCT的巨大潜力。未来的研究应该调查阳性和阴性测试的预后价值,以及测试结果之间的相互作用,使用抗菌剂和微生物抗性。
    OBJECTIVE: Microbial point-of-care testing (POCT) has potential to revolutionize clinical care. Understanding the prognostic value of microbes identified from the upper respiratory tract (a convenient sampling site) is a necessary first step to understand potential for upper respiratory tract POCTs in assisting antimicrobial treatment decisions for respiratory infections (RTIs). The aim was to investigate the relationship between upper respiratory tract microbial detection and disease prognosis, including effects of antimicrobial use.
    METHODS: Data sources were the MEDLINE and Embase databases. Study eligibility criteria consisted of quantitative studies reporting microbiological and prognostic data from patients of all age groups presenting with RTI. Patients presenting to healthcare or research settings with RTI participated. Interventions included upper respiratory tract swab. The methods used were systematic review and meta-analysis.
    RESULTS: Searches identified 5156 articles, of which 754 were duplicates and 4258 excluded on title or abstract. A total of 144 full texts were screened; 21 articles were retained. Studies reported data for 15 microbes and 26 prognostic measures (390 potential associations). One hundred and seven (27%) associations were investigated statistically, of which 38 (36%) were significant. Most studies reported only prognostic value of test positive results. Meta-analyses suggested hospitalization duration was longer for patients with respiratory syncytial virus than adenovirus and influenza, but significant heterogeneity was observed between studies.
    CONCLUSIONS: A quarter of potential prognostic associations have been investigated. Of these, a third were significant, suggesting considerable potential for POCT. Future research should investigate prognostic value of positive and negative tests, and interactions between test results, use of antimicrobials and microbial resistance.
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  • 文章类型: Journal Article
    For decades, numerous observations have shown an intimate relationship between von Willebrand factor (VWF) multimer profile and heart valve diseases (HVD). The current knowledge of the unique biophysical properties of VWF helps us to understand the longstanding observations concerning the bleeding complications in patients with severe HVD. Not only does the analysis of the VWF multimer profile provide an excellent evaluation of HVD severity, it is also a strong predictor of clinical events. Also of importance, VWF responds within minutes to any significant change in hemodynamic valve status, making it an accurate marker of the quality of surgical and transcatheter therapeutic interventions. The authors provide in this review a practical, comprehensive, and evidence-based framework of the concept of VWF as a biomarker in HVD, advocating for its implementation into the clinical decision-making process besides usual clinical and imaging evaluation. They also delineate critical knowledge gaps and research priorities to definitely validate this concept.
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  • 文章类型: Journal Article
    OBJECTIVE: To provide a summary of evidence for the diagnostic accuracies of three multiplex PCR systems (mPCRs)-BioFire FilmArray RP (FilmArray), Nanosphere Verigene RV+ test (Verigene RV+) and Hologic Gen-Probe Prodesse assays-on the detection of viral respiratory infections.
    METHODS: A comprehensive search up to 1 July 2017 was conducted on Medline and Embase for studies that utilized FilmArray, Verigene RV+ and Prodesse for diagnosis of viral respiratory infections. A summary of diagnostic accuracies for the following five viruses were calculated: influenza A virus (FluA), influenza B virus, respiratory syncytial virus, human metapneumovirus and adenovirus. Hierarchical summary receiver operating curves were used for estimating the viral detection performance per assay.
    RESULTS: Twenty studies of 5510 patient samples were eligible for analysis. Multiplex PCRs demonstrated high diagnostic accuracy, with area under the receiver operating characteristic curve (AUROC) equal to or more than 0.98 for all the above viruses except for adenovirus (AUROC 0.89). FilmArray, Verigene RV+ and ProFlu+ (the only Prodesse assay with enough data) demonstrated a summary sensitivity for FluA of 0.911 (95% confidence interval, 0.848-0.949), 0.949 (95% confidence interval, 0.882-0.979) and 0.954 (95% confidence interval, 0.871-0.985), respectively. The three mPCRs were comparable in terms of detection of FluA.
    CONCLUSIONS: Point estimates calculated from eligible studies showed that the three mPCRs (FilmArray, Verigene RV+ and ProFlu+) are highly accurate and may provide important diagnostic information for early identification of respiratory virus infections. In patients with low pretest probability for FluA, these three mPCRs can predict a low possibility of infection and may justify withholding empirical antiviral treatments.
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