Point-of-care tests

即时测试
  • 文章类型: Journal Article
    即时测试(POCT)已成为许多全球健康挑战的技术解决方案。本元人种学考察了深入的定性研究揭示的关于POCT的“社会生活”的内容,强调决策者的关键社会考虑因素,资助者,设计中的开发人员和用户,POCT的开发和部署。我们筛选了研究低收入和中等收入国家(LMICs)POCT的定性研究,并选择了13篇论文进行综合。研究结果阐明了五个基于价值的逻辑-技术自主性,care,可扩展性,快速和确定性塑造全球卫生创新生态系统及其与卫生系统的纠缠。我们的元人种学表明,POCT永远不会实现设计和开发过程中经常预期的技术自主性。相反,在实践中,它们既嵌入了构成卫生系统的动态关系,又构成了动态关系。POCT通常被想象为关怀商品;然而,在使用中,这些设备中记载的护理概念在与多种护理理解相关的过程中不断协商和转变。POCT承诺跨规模标准化护理,然而我们的分析表明非标准流程,诊断和治疗途径对“流体技术”至关重要,而不是危险的畸变。POCT的快速性是在多个不同的时间寄存器中构建和协商的,POCT作为时间对象运行,可以加快或减慢诊断和创新的经验。最后,虽然通常被认为是可以消除诊断不确定性的认知工具,这些论文表明,POCT有助于新形式的不确定性。一起,这些论文指出知识实践是多重的,和POCT有助于,而不是减少,多重性。POCT中嵌入的值是不稳定和有争议的,对这些工具可以提供的护理有重要意义。这些发现可以为全球健康创新提供更多的反身方法,考虑到既定的全球健康逻辑的局限性,并认识到卫生系统的社会技术复杂性。
    Point-of-care tests (POCTs) have become technological solutions for many global health challenges. This meta-ethnography examines what has been learned about the \'social lives\' of POCTs from in-depth qualitative research, highlighting key social considerations for policymakers, funders, developers and users in the design, development and deployment of POCTs. We screened qualitative research examining POCTs in low- and middle-income countries and selected 13 papers for synthesis. The findings illuminate five value-based logics-technological autonomy, care, scalability, rapidity and certainty-shaping global health innovation ecosystems and their entanglement with health systems. Our meta-ethnography suggests that POCTs never achieve the technological autonomy often anticipated during design and development processes. Instead, they are both embedded in and constitutive of the dynamic relationships that make up health systems in practice. POCTs are often imagined as caring commodities; however, in use, notions of care inscribed in these devices are constantly negotiated and transformed in relation to multiple understandings of care. POCTs promise to standardize care across scale, yet our analysis indicates nonstandard processes, diagnoses and treatment pathways as essential to \'fluid technologies\' rather than dangerous aberrations. The rapidity of POCTs is constructed and negotiated within multiple distinct temporal registers, and POCTs operate as temporal objects that can either speed up or slow down experiences of diagnosis and innovation. Finally, while often valued as epistemic tools that can dispel diagnostic uncertainty, these papers demonstrate that POCTs contribute to new forms of uncertainty. Together, these papers point to knowledge practices as multiple, and POCTs as contributing to, rather than reducing, this multiplicity. The values embedded in POCTs are fluid and contested, with important implications for the kind of care these tools can deliver. These findings can contribute to more reflexive approaches to global health innovation, which take into account limitations of established global health logics, and recognize the socio-technical complexity of health systems.
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  • 文章类型: Journal Article
    背景:南部非洲国家是全球艾滋病毒和梅毒负担最大的国家,在育龄妇女中患病率很高。虽然产前筛查是护理标准,梅毒筛查通常落后于HIV筛查。我们旨在评估两种商业化的双重HIV/梅毒护理点测试(POCT)的性能和操作特征,以同时进行母体HIV/梅毒筛查。
    方法:在南非和赞比亚的五个初级保健中心(PHCs)对HIV/梅毒双重POCT(SDBioline和Chembio)进行了基于临床的评估。将使用毛细血管指刺血的POCT结果与参考实验室梅毒和HIV血清学测定进行比较。
    结果:招募了三千四百十二名年龄≥18岁的孕妇。螺旋体抗体阳性和HIV感染的患病率为3.7%至9.9%(n=253)和17.8%至21.3%(n=643),分别。与参考测定相比,SDBioline对梅毒的合并敏感性为66.0%(95CI57.7-73.4),Chembio为67.9%(95CI58.2-76.3)。两种POCT对梅毒的集合特异性均高于98%。SDBioline和Chembio测定的灵敏度分别为78.0%(95CI68.6-85.7)和81.0%(95CI71.9-88.2),分别与活性梅毒病例定义的螺旋体试验阳性,血浆反应素快速滴度≥8进行比较。基于两种测定的梅毒的各种患病率估计的阴性预测值(NPV)范围为97%至99%。SDBioline对HIV的合并敏感性为92.1%(95CI89.4-94.2);Chembio为91.5%(95CI88.2-93.9)。SDBioline的HIV合并特异性为97.2%(95CI94.8-98.5),Chembio的合并特异性为96.7%(95CI95.1-97.8)。基于两种测定的HIV的各种患病率估计的NPV约为98%。大多数参与的女性(91%)更喜欢双重POCT,而不是两个单独的POCT,以治疗艾滋病毒和梅毒。医疗保健提供者对两种检测方法在PHC水平的实用性给予了有利的反馈.
    结论:基于提高梅毒产前筛查覆盖率的需要,可将双重HIV/梅毒POCT有效纳入产前检测算法,以加强努力消除这些感染的母婴传播.
    BACKGROUND: Southern African countries have the largest global burden of HIV and syphilis, with a high prevalence among women of reproductive age. Although antenatal screening is standard of care, syphilis screening has generally lagged behind HIV screening. We aimed to evaluate the performance and operational characteristics of two commercial dual HIV/syphilis point-of-care tests (POCTs) for simultaneous maternal HIV/syphilis screening.
    METHODS: A clinic-based evaluation of dual HIV/syphilis POCTs (SD Bioline and Chembio) was conducted at five primary healthcare centres (PHCs) in South Africa and Zambia. POCT results using capillary fingerprick blood were compared to reference laboratory syphilis and HIV serological assays.
    RESULTS: Three thousand four hundred twelve consenting pregnant women aged ≥ 18 years were enrolled. The prevalence of treponemal antibody seropositivity and HIV infection ranged from 3.7 to 9.9% (n = 253) and 17.8 to 21.3% (n = 643), respectively. Pooled sensitivity for syphilis compared to the reference assay was 66.0% (95%CI 57.7-73.4) with SD Bioline and 67.9% (95%CI 58.2-76.3) with Chembio. Pooled specificity for syphilis was above 98% with both POCTs. The sensitivities of SD Bioline and Chembio assays were 78.0% (95%CI 68.6-85.7) and 81.0% (95%CI 71.9-88.2), respectively compared to an active syphilis case definition of treponemal test positive with a rapid plasma reagin titre of ≥ 8. The negative predictive values (NPVs) based on various prevalence estimates for syphilis with both assays ranged from 97 to 99%. The pooled sensitivity for HIV was 92.1% (95%CI 89.4-94.2) with SD Bioline; and 91.5% (95%CI 88.2-93.9) with Chembio. The pooled specificities for HIV were 97.2% (95%CI 94.8-98.5) with SD Bioline and 96.7% (95%CI 95.1-97.8) with Chembio. The NPV based on various prevalence estimates for HIV with both assays was approximately 98%. Most participating women (91%) preferred dual POCTs over two single POCTs for HIV and syphilis, and healthcare providers gave favourable feedback on the utility of both assays at PHC level.
    CONCLUSIONS: Based on the need to improve antenatal screening coverage for syphilis, dual HIV/syphilis POCTs could be effectively incorporated into antenatal testing algorithms to enhance efforts towards elimination of mother-to-child transmission of these infections.
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  • 文章类型: Journal Article
    背景:在初级保健中正确实施C反应蛋白(CRP)的即时护理测试(POCT)可以减少抗生素的不当使用,从而解决日益增长的抗菌素耐药性问题。
    目的:评估了四种POCT-CRP测定法的分析性能和用户友好性:QuikRead变得容易,LumiraDx,cobasb101和Afinion2。
    方法:除了制造商特定的对照材料外,还使用血浆池评估了不精确性。通过验证ERM-DA474/IFCC的可追溯性来评估真实性,同时使用i)回顾性选择的血浆样品(n=100)和ii)前瞻性收集的毛细管全血样品(n=50)与中央实验室CRP方法(cobasc503)进行方法比较。使用问卷检查用户友好性。
    结果:血浆池的日间不精确度从4.5%(LumiraDx)到11.5%(QuikRead)不等。可追踪性验证显示,cobasc503CRP结果与ERM-DA474/IFCC认证值之间没有显着差异。cobasb101和Afinion与中央实验室方法达成了最佳协议。LumiraDx和QuikRead显示出负的平均差异,与LumiraDx违反标准>95%的POCT-CRP-结果在±20%的比较方法。关于用户友好性,Afinion获得了最高的Likert得分。
    结论:POCT-CRP装置的分析性能和用户友好性因制造商而异,强调需要由中央实验室监督的质量保证。
    BACKGROUND: Proper implementation of Point-of-Care testing (POCT) for C-reactive protein (CRP) in primary care can decrease the inappropriate use of antibiotics, thereby tackling the problem of growing antimicrobial resistance.
    OBJECTIVE: The analytical performance and user-friendliness of four POCT-CRP assays were evaluated: QuikRead go easy, LumiraDx, cobas b 101 and Afinion 2.
    METHODS: Imprecision was evaluated using plasma pools in addition to manufacturer-specific control material. Trueness was assessed by verification of traceability to ERM-DA474/IFCC in parallel to method comparison towards the central laboratory CRP method (cobas c 503) using i) retrospectively selected plasma samples (n = 100) and ii) prospectively collected capillary whole blood samples (n = 50). User-friendliness was examined using a questionnaire.
    RESULTS: Between-day imprecision on plasma pools varied from 4.5 % (LumiraDx) to 11.5 % (QuikRead). Traceability verification revealed no significant difference between cobas c 503 CRP results and the ERM-DA474/IFCC certified value. cobas b 101 and Afinion achieved the best agreement with the central laboratory method. LumiraDx and QuikRead revealed a negative mean difference, with LumiraDx violating the criterion of > 95 % of POCT-CRP-results within ± 20 % of the comparison method. Regarding user-friendliness, Afinion obtained the highest Likert-scores.
    CONCLUSIONS: The analytical performance and user-friendliness of POCT-CRP devices varies among manufacturers, emphasizing the need for quality assurance supervised by a central laboratory.
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  • 文章类型: Journal Article
    腹泻是一种影响全球数百万人的普遍疾病。然而,目前的标准诊断方法有许多缺点。这篇综述研究了各种非侵入性护理点(POC)测试和生物标志物,以帮助快速诊断不同原因的腹泻。
    PubMed,PubMedCentral,ScienceDirect,科克伦图书馆,和谷歌学者从2013年开始搜索到目前的相关文献。两名审稿人使用关键评估技能计划(CASP)清单独立评估了研究的质量。
    搜索产生了1453项研究,其中39项纳入筛查和应用资格标准后.聚合酶链反应(PCR)是25项研究中的POC测试,提供一致的灵敏度和特异性。对于生物标志物,C反应蛋白(CRP),粪便钙卫蛋白,降钙素原对急性小儿腹泻等疾病具有很高的敏感性和特异性,显微镜下结肠炎,和炎症性腹泻,分别。
    PCR证明了快速诊断腹泻的理想POC测试,而降钙素原生物标志物有助于区分炎症性和非炎症性腹泻。其他经过审查的工具也证明了有希望的诊断性能,虽然灵敏度提高了,特异性,和可用性仍然需要。
    UNASSIGNED: Diarrhea is a prevalent condition affecting millions worldwide. However, current standard diagnostic methods have many drawbacks. This review examines various non-invasive point-of-care (POC) tests and biomarkers aiding rapid diagnosis of diarrhea from different causes.
    UNASSIGNED: PubMed, PubMed Central, ScienceDirect, Cochrane Library, and Google Scholar were searched from 2013 to present for relevant literature. Two reviewers independently assessed included studies\' quality using the Critical Appraisal Skills Programme (CASP) checklist.
    UNASSIGNED: The search yielded 1453 studies, of which 39 were included after screening and applying eligibility criteria. Polymerase chain reaction (PCR) was the POC test in 25 studies, providing consistent sensitivity and specificity. For biomarkers, C-reactive protein (CRP), fecal calprotectin, and procalcitonin offered high sensitivity and specificity for conditions like acute pediatric diarrhea, microscopic colitis, and inflammatory diarrhea, respectively.
    UNASSIGNED: PCR proved the ideal POC test for rapid diarrhea diagnosis, while the procalcitonin biomarker helps differentiate inflammatory from non-inflammatory diarrhea. Other reviewed tools also demonstrated promising diagnostic performance, though improvements in sensitivity, specificity, and usability are still needed.
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  • 文章类型: Journal Article
    随着COVID-19限制的放松,其他呼吸道病毒,如流感和呼吸道合胞病毒(RSV),由于COVID-19的预防措施,其传播量减少,再次上升。由于相似的临床特征和报告的合并感染,SARS-CoV-2,甲型/乙型流感,和RSV需要使用特定的治疗。该研究评估了使用rRT-PCR进行多重检测的无提取样品制备(在95°C热处理3分钟)。尽管与标准方法相比,观察到的Ct延迟(ΔCt)平均为1.26,可接受的总灵敏度为92%,阴性预测值(NPV)为96%.此外,在微流控芯片上的实现证明了效率,与标准方法保持良好的相关性(R2=0.983)。将这种无提取程序与微流体芯片上的rRT-PCR相结合似乎很有希望,因为它简化了设计并降低了用于SARS-CoV-2,流感A/B多重检测的集成检测的成本和复杂性,RSV
    Following the relaxation of COVID-19 restrictions, other respiratory viruses such as influenza and respiratory syncytial virus (RSV), whose transmission were decreased due to COVID-19 precautions, are rising again. Because of similar clinical features and reported co-infections, multiplex detection of SARS-CoV-2, influenza A/B, and RSV is required to use specific treatments. This study assessed an extraction-free sample preparation (heat treatment at 95°C for 3 minutes) for multiplex detection using rRT-PCR. Despite an observed Ct-delay (∆Ct) averageing 1.26 compared to the standard method, an acceptable total sensitivity of 92 % and a negative predictive value (NPV) of 96 % were obtained. Moreover, Implementation on a microfluidic chip demonstrated efficiency, maintaining an excellent correlation (R2=0.983) with the standard method. Combining this extraction-free procedure with rRT-PCR on a microfluidic chip seems promising, because it simplifies the design and reduces the cost and complexity of the integrated assay for multiplex detection of SARS-CoV-2, influenza A/B, and RSV.
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  • 文章类型: Journal Article
    背景:在欧洲各地的医院中采用C反应蛋白点护理测试(CRPPOCT)。我们旨在了解两个国家不同程度采用CRPPOCT来管理儿童急性感染的因素。
    方法:对荷兰和英国实施CRPPOCT的比较定性分析。这项研究是由非收养者告知的,放弃,传播,扩大规模,和可持续性(NASSS)框架。数据是通过文件分析和与利益攸关方的定性访谈收集的。文件是通过范围界定文献综述确定的,搜索网站,通过利益相关者。利益相关者最初是有目的地抽样的,然后滚雪球。数据进行了主题分析。
    结果:搜索出了41份文献,进行了46次访谈。荷兰的大多数医院医护人员都熟悉CRPPOCT,因为这些测试在初级保健中被广泛使用和信任。此外,尽管两个国家的诊断都是通过类似的诊断相关组报销机制资助的,在英格兰,每家医院的实际资金受到了更多的限制。与初级保健相比,基于实验室的CRP检测通常可在医院使用,并且在两个国家都鼓励使用,因为它们更便宜.然而,CRPPOCT在两个国家的一些医院中被认为是有用的,在这些医院中,实验室无法24/7或在短时间内提供CRP措施,和/或在急诊部门,加快病人护理是重要的。
    结论:CRPPOCT在荷兰的医院中更多,因为荷兰的医护人员更熟悉在他们国家的初级保健中广泛使用的测试,并且因为在英国有更多的资金限制。然而,荷兰和英国的大多数医院没有采用CRPPOCT,因为医院实验室的替代CRP测量在几个小时内就可以获得,而且成本较低.
    BACKGROUND: The adoption of C-reactive protein point-of-care tests (CRP POCTs) in hospitals varies across Europe. We aimed to understand the factors that contribute to different levels of adoption of CRP POCTs for the management of acute childhood infections in two countries.
    METHODS: Comparative qualitative analysis of the implementation of CRP POCTs in the Netherlands and England. The study was informed by the non-adoption, abandonment, spread, scale-up, and sustainability (NASSS) framework. Data were collected through document analysis and qualitative interviews with stakeholders. Documents were identified by a scoping literature review, search of websites, and through the stakeholders. Stakeholders were sampled purposively initially, and then by snowballing. Data were analysed thematically.
    RESULTS: Forty-one documents resulted from the search and 46 interviews were conducted. Most hospital healthcare workers in the Netherlands were familiar with CRP POCTs as the tests were widely used and trusted in primary care. Moreover, although diagnostics were funded through similar Diagnosis Related Group reimbursement mechanisms in both countries, the actual funding for each hospital was more constrained in England. Compared to primary care, laboratory-based CRP tests were usually available in hospitals and their use was encouraged in both countries because they were cheaper. However, CRP POCTs were perceived as useful in some hospitals of the two countries in which the laboratory could not provide CRP measures 24/7 or within a short timeframe, and/or in emergency departments where expediting patient care was important.
    CONCLUSIONS: CRP POCTs are more available in hospitals in the Netherlands because of the greater familiarity of Dutch healthcare workers with the tests which are widely used in primary care in their country and because there are more funding constraints in England. However, most hospitals in the Netherlands and England have not adopted CRP POCTs because the alternative CRP measurements from the hospital laboratory are available in a few hours and at a lower cost.
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  • 文章类型: Journal Article
    背景:现场护理测试(POCT)为社区药剂师参与定向初级患者护理提供了重要的机会。需要对这些服务进行有效管理,以实现其当前未充分利用的利益。目标:评估态度和实践,检查了部署的管理职能,并确定了影响社区药剂师提供POCT的因素。方法:在尼日利亚西南部奥孙州对146名随机选择的社区药剂师进行了问卷调查指导的横断面调查。研究变量在5点Likert量表上测量,加权平均值,用于显示项目表现的中位数分数和排名。计算四分位数范围以对练习分数进行分类。卡方统计量用于检验变量的关联。使用ANOVA和2样本t检验来比较平均值。结果:有效率为94.5%。受访者对提供POCT作为其实践的核心组成部分(MWA4.58)持积极态度(MWA3.75),并有可能对盈利能力做出重大贡献(MWA4.31)。受访者的中位数练习得分为3.01(中度练习),血压筛查(4.77),重量测量(4.45),和血糖筛查(4.18)作为领先的POCT,而宫颈癌筛查(1.09)最少。POCT的管理是公平的(MWA3.33),工作组织是主要领域(MWA3.66)。管理实践与几乎所有人口统计学变量显着相关(p<0.05)。公众对药剂师角色的积极看法(MWA4.31)和他们提高的临床技能(MWA4.01)是主要推动者,而缺乏扶持性政策框架(MWA3.80)和健康信息骨干(MWA3.78)是受访者常规采用POCT的主要挑战。结论:社区药师对POCT的态度积极,实践适度。这些服务的管理是公平的。应利用提高公众对药剂师的认识,同时应提供法律和健康信息系统,以推动POCT的常规采用。
    Background: Point-of-care testing (POCT) provides important opportunity for community pharmacists to participate in oriented primary patient care. Effective management of these services is required to deliver their currently- underexploited benefits. Objectives: Assessed attitudes and practice, examined management functions deployed and identified factors affecting provision of POCTs by community pharmacists. Methods: A questionnaire-guided cross-sectional survey of 146 randomly-selected community pharmacists was conducted in Osun State Southwestern Nigeria. Study variables were measured on 5-point Likert scales with weighted averages, median scores and ranks used to present item performances. Interquartile ranges were computed to categorize practice scores. Chi square statistic was used to examine association of variables. ANOVA and 2-sample t-test were used to compare means. Results: A response rate of 94.5% was achieved. Respondents had a positive attitude (MWA 3.75) towards provision of POCTs as core component of their practice (MWA 4.58) with potential to contribute significantly to profitability (MWA 4.31). Respondents\' median practice score was 3.01(moderate practice) with blood pressure screening (4.77), weight measurement (4.45), and blood glucose screening (4.18) as leading POCTs, while cervical cancer screening (1.09) was least practiced. Management of POCTs was fair (MWA 3.33) with organisation of work as pre-eminent domain (MWA 3.66). Management practices were significantly associated with almost all demographic variables (p< .05). Positive public perception of pharmacists\' roles (MWA 4.31) and their improving clinical skills (MWA 4.01) were the leading enablers while the lack of enabling policy framework (MWA 3.80) and poor health information backbone (MWA 3.78) were major challenges to routine adoption of POCTs by respondents. Conclusion: The community pharmacists had positive attitude and moderate practice of POCTs. Management of these services was fair. Improving public perception of pharmacists should be exploited while enabling legal and health information systems should be provided to drive routine adoption of POCTs.
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  • 文章类型: Meta-Analysis
    目的:评估即时护理(POC)试验对孕妇蛋白尿的诊断准确性。
    方法:系统评价和荟萃分析。
    方法:从开始到2020年11月13日检索了MEDLINE和EMBASE数据库。
    方法:纳入的研究测量了与实验室参考标准相比POC蛋白尿测试的敏感性和特异性(蛋白质-肌酐比率(PCR),24小时尿液收集)。双变量荟萃分析确定了合并的敏感性和特异性。随机效应逆方差模型确定异质性。
    方法:主要结果是总体敏感性和特异性,按POC测试方法和参考标准分层。次要结果是ubgroupstest品牌内的敏感性和特异性,参考标准,和高血压状态。
    结果:确定了1078项研究,包括17项研究,包括23项比较。荟萃分析包括13项研究和19项比较。对PCR的视觉试纸的总体敏感性和特异性为72%(95%CI:56%至84%)和92%(95%CI:76%至98%),分别。对24小时采集的视觉试纸的集合敏感性和特异性为69%(55%至80%)和70%(51%至84%),分别。针对PCR的自动读取器的集合灵敏度和特异性为73%(53%至86%)和91%(83%至95%),分别。自动阅读器对24小时收集的敏感性和特异性分别为65%(42%至83%)和82%(46%至96%),分别。
    结论:视觉试纸具有与自动阅读器相当的准确性,然而,作为蛋白尿的排除测试还不够。进行重复随访测试时,蛋白尿POC测试可能是有益的产前护理。PROSPERO注册号:CRD42021231914。
    OBJECTIVE: To evaluate the diagnostic accuracy of point-of-care (POC) tests for detecting proteinuria in pregnant women.
    METHODS: Systematic review and meta-analysis.
    METHODS: MEDLINE and EMBASE databases were searched from inception to 13 November 2020.
    METHODS: Included studies measured the sensitivity and specificity ofPOC proteinuria testing compared to laboratory reference standards (protein-creatinine ratio (PCR), 24-hour urine collection). Bivariate meta-analyses determined pooled sensitivity and specificity. Random-effects inverse-variance model determinedheterogeneity.
    METHODS: The primary outcome was overall sensitivity and specificity, stratified by method of POC testing and reference standard. Secondary outcomes were sensitivity and specificity within thesubgroupstest brand, reference standard, and hypertension status.
    RESULTS: 1078 studies were identified, 17 studies comprising 23 comparisons were included. The meta-analysis included 13 studies with 19 comparisons. Pooled sensitivity and specificity of visual dipsticks against PCR was 72 % (95 % CI: 56 % to 84 %) and 92 % (95 % CI: 76 % to 98 %), respectively. Pooled sensitivity and specificity of visual dipsticks against 24-hour collection was 69 % (55 % to 80 %) and 70 % (51 % to 84 %), respectively. Pooled sensitivity and specificity for automated readers against PCR was 73 % (53 % to 86 %) and 91 % (83 % to 95 %), respectively. Pooled sensitivity and specificity of automated readers against 24-hour collection was 65 % (42 % to 83 %) and 82 % (46 % to 96 %), respectively.
    CONCLUSIONS: Visual dipsticks have comparable accuracy to automated readers, yet are notadequate as a rule-out test for proteinuria. Proteinuria POC testing maybe beneficial inantenatal care when repeatfollow-up tests are performed. PROSPERO Registration Number: CRD42021231914.
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  • 文章类型: Journal Article
    食品-动物疾病即时检测(POCT)的日益普及为及时诊断提供了机会,促进控制措施的有效实施。然而,新POCT的现场评估尚未标准化。本文讨论了扩大目前在食用动物疾病诊断中评估和验证POCT的方法的机会,强调了主要依赖于估计诊断准确性(敏感性和特异性)的传统实践的局限性。这里,使用称为FIT-REASSURED的协议,一个结合了保证和保证标准的修改框架,建议对POCT进行全面评估。FIT-REASSURED包含关键标准,如适合目的,实时连接,易于收集标本,负担能力,灵敏度,特异性,用户友好性,快速性和鲁棒性,无设备运行,和可交付性。通过合并这些属性,FIT-REASSURED提供了一种可定制的方法来评估准确性,负担能力,和POCT的效用。通过利益相关者之间的合作努力,基于这些FIT-REASSURED标准的标准化记分卡的实施可以提高POCT在食品-动物健康中的可靠性和实用性.
    The growing availability of point-of-care tests (POCTs) for food-animal diseases offers opportunities for timely diagnosis, facilitating the efficient implementation of control measures. However, field assessment of new POCTs are yet to be standardized. This paper discusses the opportunity of expanding the current approach for the evaluation and validation of POCTs in food animal disease diagnosis, highlighting the limitations of traditional practice that primarily relies on estimating diagnostic accuracy (sensitivity and specificity). Here, the use of a protocol referred to as FIT-REASSURED, a modified framework combining the ASSURED and REASSURED criteria, is proposed to comprehensively assess POCTs. FIT-REASSURED encompasses key criteria such as fitness for purpose, real-time connectivity, ease of specimen collection, affordability, sensitivity, specificity, user-friendliness, rapidity and robustness, equipment-free operation, and deliverability. By incorporating these attributes, FIT-REASSURED provides a customizable approach to assess the accuracy, affordability, and utility of POCTs. Through collaborative efforts among stakeholders, the implementation of a standardized scorecard based on these FIT-REASSURED criteria can improve the reliability and practicality of POCTs in food-animal health.
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  • 文章类型: Journal Article
    尽管超过80%的急性咽炎(AP)病例具有病毒性病因,它仍然是不必要的抗生素处方(ABs)的最常见原因之一.一半的患者在一般实践中接受抗生素治疗。现场护理测试(POCT)区分细菌性和病毒性咽炎。这项研究的目的是评估在德国各地的初级保健实践中,使用咽拭子检测咽喉痛/急性咽炎患者中的β-化脓性链球菌A组(链球菌A)感染的POCT的使用。在1257个初级保健实践中进行了一项研究。进行了两份关于频率的问卷,POCT结果和是否开了抗生素。在1257名医生中,60%使用POCT。其中,25%的人在开抗生素之前使用过POCT,在严重喉咙痛的情况下,39%长期咽炎的病例为40%,其他病例为25%。总的来说,83%的人认为在日常实践中采用POCT对于链球菌A的诊断很重要或非常重要,90%的人认为这对于更合理地使用抗生素和预防细菌耐药性很重要或非常重要,80%的人认为这对于证明患者是否需要抗生素很重要或非常重要。583例患者可获得POCT结果和AB处方信息。其中,22.5%的链球菌A检测呈阳性,21.8%被处方抗生素。我们的研究表明,在初级保健实践中对喉咙痛患者使用拭子测试可提高医师的满意度,并可大大减少临床实践中抗生素的滥用。
    Though more than 80% of acute pharyngitis (AP) cases have a viral etiology, it remains one of the most common causes for the unnecessary prescription of antibiotics (ABs). Half of patients receive antibiotics in general practice. Point-of-Care Tests (POCTs) distinguish between bacterial and viral pharyngitis. The objective of this study was to evaluate the use of POCTs using throat swabs to detect β-Streptococcus pyogenes Group A (strep A) infection among patients with sore throat/acute pharyngitis in primary care practices across Germany. A study was conducted in 1257 primary care practices. Two questionnaires were administered concerning frequency, POCT results and whether antibiotics were prescribed. Of the 1257 physicians, 60% used POCTs. Of these, 25% used a POCT before prescribing an antibiotic, 39% in cases of severe sore throat, 40% in cases of long-lasting pharyngitis and 25% in other cases. In total, 83% considered the adoption of POCTs in everyday practice to be important or very important for the diagnosis of strep A, 90% considered it important or very important for achieving a more sensible use of antibiotics and the prevention of bacterial resistance and 80% considered it important or very important for justifying to patients whether or not an antibiotic is needed. POCT results and information on AB prescriptions were available for 583 patients. Of these, 22.5% tested positive for strep A, and 21.8% were prescribed antibiotics. Our study shows that the use of swab tests in patients with sore throat in primary care practices results in high levels of physician satisfaction and can strongly reduce the misuse of antibiotics in clinical practice.
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