Electrochemical biosensors for point-of-care testing

Point-of-care testing(POCT)is the practice of diagnosing and monitoring diseases where the patient is located,as opposed to traditional treatment conducted solely in a medical laboratory or other clinical setting.POCT has been less common in the recent past due to a lack of portable medical devices capable of facilitating effective medical testing.However,recent growth has occurred in this field due to advances in diagnostic technologies,device miniaturization,and progress in wearable electronics.Among these developments,electrochemical sensors have attracted interest in the POCT field due to their high sensitivity,compact size,and affordability.They are used in various applications,from disease diagnosis to health status monitoring.In this paper we explore recent advancements in electrochemical sensors,the methods of fabricating them,and the various types of sensing mechanisms that can be used.Furthermore,we delve into methods for immobilizing specific biorecognition elements,including enzymes,antibodies,and aptamers,onto electrode surfaces and how these sensors are used in real-world POCT settings.

Point-of-Care Testing vs. Laboratory Testing during High Patient Volume Situations

Introduction: Our aim was to determine what patient volume, if any, in-laboratory testing provides results faster than Point-of-Care-Testing (POCT). Methods: To evaluate POCT effectiveness during high volume situations, POCT was compared to in-laboratory testing during busy periods with large numbers of patients. Our setting was an urban level 1 trauma center with an academic emergency medicine department (ED) and annual patient volume of 70,000. Patients seen requiring laboratory testing during peak volume between 11 a.m. and 7 p.m. were enrolled over a five-week period. One tube of blood was sent to the laboratory and the other tube was run in the ED using POCT. Turnaround time was recorded as time from when the tube was received to when the result was available. We also completed a time-motion study to assess the number of POCT machines that would be needed to process the entire average hourly hospital laboratory volume. Results: We collected 539 hematology and chemistry specimens. The POCT group was significantly faster than in-laboratory testing, with mean POCT [complete blood count (CBC) and chemistry] 3.5 minutes compared to in-laboratory CBC test time of 30.9 minutes and chemistry test time of 55 minutes. As the volume of samples peaked, there was a slight but insignificant decrease in POCT turnaround time. If POCT was used to process the entire average hospital laboratory volume which approached 54 samples an hour, 3 POCT machines would be necessary to maintain turnaround times. Conclusion: Even during ED high volume situations, POCT provided results significantly faster than in-laboratory testing.

Point-of-Care Testing Using Three Dimensional Optical Biosensor Based on Microfluidic Technology

We have presented a three dimensional optical protein chip that fulfills the demanding for point-of-care diagnostics in terms of ease-of-use (one step assay), miniaturization (5 μl). The artful combination of magnetic nanoparticles on chip and total internal reflection imaging (TIRI) technology permits the sensitive and rapid detection of hs-CRP (high-sensitivity C-reactive protein). The whole test was complete within 10 min using “all in one step” assay with a limit of detection of 0.1 ng/mL hs-CRP. The measuring range for hs-CRP could be extended to 10 ng/mL. The chip can also be used to detect more parameters in blood samples.

Testing the Emergin Senior Care Market

There is a strong demand in the market for elderly care coupled with robust on-site medical facilities.A European senior care company has entered the market to explore the possibilities.IN recent years,senior care providers from overseas have begun to dig into the Chinese market.Among them,French company Orpea has achieved remarkable results:the occupancy rate of its first senior care

Process of Designing Robust, Dependable, Safe and Secure Software for Medical Devices: Point of Care Testing Device as a Case Study

This paper presents a holistic methodology for the design of medical device software, which encompasses of a new way of eliciting requirements, system design process, security design guideline, cloud architecture design, combinatorial testing process and agile project management. The paper uses point of care diagnostics as a case study where the software and hardware must be robust, reliable to provide accurate diagnosis of diseases. As software and software intensive systems are becoming increasingly complex, the impact of failures can lead to significant property damage, or damage to the environment. Within the medical diagnostic device software domain such failures can result in misdiagnosis leading to clinical complications and in some cases death. Software faults can arise due to the interaction among the software, the hardware, third party software and the operating environment. Unanticipated environmental changes and latent coding errors lead to operation faults despite of the fact that usually a significant effort has been expended in the design, verification and validation of the software system. It is becoming increasingly more apparent that one needs to adopt different approaches, which will guarantee that a complex software system meets all safety, security, and reliability requirements, in addition to complying with standards such as IEC 62304. There are many initiatives taken to develop safety and security critical systems, at different development phases and in different contexts, ranging from infrastructure design to device design. Different approaches are implemented to design error free software for safety critical systems. By adopting the strategies and processes presented in this paper one can overcome the challenges in developing error free software for medical devices (or safety critical systems).

Evaluation of a Plasma hCG Method for Point of Care Testing with the Aim of Shortening Test-Turnaround-Times

Objective: To examine the correlation between plasma hCG results obtained with the new i-STAT&reg hCG point of care test with those concomitantly obtained from the central hospital laboratory utilizing the same patient samples. Methods: Prospective cross-sectional laboratory test evaluation. We compared plasma hCG results obtained with the i-STAT&reg hCG test (Abbott Point of Care, Princeton, NJ, USA) with Architect Ci8200 (Abbott Laboratories, Abbott Park, IL, USA). We also calculated the total coefficient of variation (CV) for the i-STAT&reg method. Results: The two methods showed a good linear correlation (R2 = 0.994;slope 1.03) and CV for the i-STAT&reg method was 2.1% - 5.2%. Conclusion: We suggest that the i-STAT&reg hCG blood assay could be used as a complement to urine hCG assays in clinical situations when rapid test results are needed and urine is not available.

A Point-of-Care Test System for Biochemical Blood Analysis Based on ADUC824

A point-of-care test system has been studied in this paper.It was used to determine substances in blood such as Hemoglobin (HB),Aspartate Aminotransferase (AST),Creatine Kinase (CK) and so on.Based on the principle of amperometric determination,the research on detecting weak current signals was carried on.At the same time as to the weak signals (nA level),magnifying,sampling and processing the signals were also studied.Controlled by ADUC824 and assisted by other units, every substance could be determined automatically and rapidly integrated with the corresponding biosensor.In the experiment, the minimum detectable current of the instrument (YT2005-1) is 0.2 nA.With regard to the 1 nA which the experiment demanded,it could be up to the mustard.And the system can provide results in 180 s with a long term stability.

Point-of-care ultrasound for critically-ill patients: A mini-review of key diagnostic features and protocols

Point-of-care ultrasonography(POCUS)for managing critically ill patients is increasingly performed by intensivists or emergency physicians.Results of needs surveys among intensivists reveal emphasis on basic cardiac,lung and abdominal ultrasound,which are the commonest POCUS modalities in the intensive care unit.We therefore aim to describe the key diagnostic features of basic cardiac,lung and abdominal ultrasound as practised by intensivists or emergency physicians in terms of accuracy(sensitivity,specificity),clinical utility and limitations.We also aim to explore POCUS protocols that integrate basic cardiac,lung and abdominal ultrasound,and highlight areas for future research.

Assessment of platelet function: Laboratory and point-of-care methods

In the event of blood vessel damage, human platelets are promptly recruited on the site of injury and, after their adhesion, activation and aggregation, prevent blood loss with the formation of a clot. The consequence of abnormal regulation can be either hemorrhage or the development of thrombosis. Qualitative and/or quantitative defects in platelets promote bleeding, whereas the residual reactivity of platelets, despite antiplatelet therapies, play an important role in promoting arterial thrombotic complications. Platelet function is traditionally assessed to investigate the origin of a bleeding syndrome, to predict the risk of bleeding prior surgery or during pregnancy or to monitor the efficacy of antiplatelet therapy in thrombotic syndromes that, now, can be considered a new discipline. "Old" platelet function laboratory tests such as the evaluation of bleeding time and the platelet aggregation analysis inplatelet-rich plasma are traditionally utilized to aid in the diagnosis and management of patients with platelet and hemostatic disorders and used as diagnostic tools both in bleeding and thrombotic diathesis in specialized laboratories. Now, new and renewed automated systems have been introduced to provide a simple, rapid assessment of platelet function including point of care methods. These new methodologies are also suitable for being used in non-specialized laboratories and in critical area for assessing platelet function in whole blood without the requirement of sample processing. Some of these methods are also beginning to be incorporated into routine clinical use and can be utilized as not only as first panel for the diagnosis of platelet dysfunction, but also for monitoring anti-platelet therapy and to potentially assess risk of both bleeding and/or thrombosis.

Security Framework for Managing Data Security within Point of Care Tests

Point of Care (PoC) devices and systems can be categorized into three broad classes (CAT 1, CAT 2, and CAT 3) based on the context of operation and usage. In this paper, the categories are defined to address certain usage models of the PoC device. PoC devices that are used for PoC testing and diagnostic applications are defined CAT 1 devices;PoC devices that are used for patient monitoring are defined as CAT 2 devices (PoCM);PoC devices that are used for as interfacing with other devices are defined as CAT 3 devices (PoCI). The PoCI devices provide an interface gateway for collecting and aggregating data from other medical devices. In all categories, data security is an important aspect. This paper presents a security framework concept, which is applicable for all of the classes of PoC operation. It outlines the concepts and security framework for preventing security challenges in unauthorized access to data, unintended data flow, and data tampering during communication between system entities, the user, and the PoC system. The security framework includes secure layering of basic PoC system architecture, protection of PoC devices in the context of application and network. Developing the security framework is taken into account of a thread model of the PoC system. A proposal for a low-level protocol is discussed. This protocol is independent of communications technologies, and it is elaborated in relation to providing security. An algorithm that can be used to overcome the threat challenges has been shown using the elements in the protocol. The paper further discusses the vulnerability scanning process for the PoC system interconnected network. The paper also presents a four-step process of authentication and authorization framework for providing the security for the PoC system. Finally, the paper concludes with the machine to machine (M2M) security viewpoint and discusses the key stakeholders within an actual deployment of the PoC system and its security challenges.

Correlation of rapid point-of-care vs send-out fecal calprotectin monitoring in pediatric inflammatory bowel disease

AIM To assess the correlation between the send-out enzymelinked immuno sorbent assay(ELISA) and the point-ofcare(POC) calprotectin test in pediatric inflammatory bowel disease(IBD) patients.METHODS We prospectively collected stool samples in pediatric IBD patients for concomitant send-out ELISA analysis and POC calprotectin testing using the Quantum Blue?(QB) Extended immunoassay. Continuous results between 17 to 1000 μg/g were considered for comparison. Agreement between the two tests was measured by a Bland-Altman plot and statistical significance was determined using Pitman's test.RESULTS Forty-nine stool samples were collected from 31 pediatric IBD patients. The overall means for the rapid and ELISA tests were 580.5 and 522.87 μg/g respectively. Among the 49 samples, 18(37.5%) had POC calprotectin levelsof ≤ 250 μg/g and 31(62.5%) had levels > 250 μg/g.Calprotectin levels ≤ 250 μg/g show good correlation between the two assays. Less correlation was observed at quantitatively higher calprotectin levels. CONCLUSION In pediatric IBD patients, there is better correlation of between ELISA and POC calprotectin measurements at clinically meaningful, low-range levels. Future adoption of POC calprotectin testing in the United States may have utility for guiding clinical decision making in real time.

Validation of the Trail Making Test B for the Cognitive Assessment of Patients with Cancer in Palliative Care

Introduction: Cognitive impairment is common in patients with cancer;however, studies examining the adaptation and validation of instruments for use in patients with cancer are scarce. Purpose: The purpose of this study was to validate the Trail Making Test B (TMT-B) for use in patients with cancer. Methods: Ninety-four outpatients receiving palliative treatment and 39 healthy companions were assessed. Patients were tested with the TMT-B and answered questions regarding the presence and intensity of pain, fatigue, quality of sleep, anxiety, and depression, at two time points with a 7-day inter-assessment interval. Results: The instrument discriminated between patients, who were slower, and healthy companions with respect to the time required to complete the test, but not in terms of the number of errors. The test was stable for the healthy companions across the two assessments in terms of time to complete the TMT-B and the number of errors;for patients, the instrument was stable only for the number of errors. Performance on the TMT-B did not correlate with pain, fatigue, depression, anxiety, or sensation of rest. Conclusions: TMT-B cannot be considered fully validated. Further studies incorporating and comparing other instruments evaluating executive function and mental flexibility are needed.

Antibiotics and near-patient testing: Differences in habits between physicians completing or discontinuing a medical audit

Background and Aim: Respiratory tract infection (RTI) is a common reason for consulting primary health care. Antibiotic prescribing for RTIs varies among physicians indicating that national guidelines are not always adhered to. The aim was to study if antibiotic prescribing and use of near-patient tests were different among physicians who complete an audit registration and those who discontinue their participation. Method: A prospective cohort study where physicians participated in an APO (Audit Project Odense) process, making an audit registration for every appointment with a patient who had a respiratory tract infection during 4 weeks in 2008 and 4 weeks in 2009. Between the registrations, a limited educationally oriented intervention was made. 18 Primary Health Care Centres located in three counties in southern of Sweden with 77 primary health care physicians participated. When comparing proportions the Chisquare test was used. Mann Whitney U-test was used when comparing independent groups and Wilcoxon’s signed-rank test was used when comparing dependent groups. Results: Of the 77 physicians, 38 participated only at baseline (group 1) and 39 participated in both registrations (group 2). The overall use of CRP near-patient tests was 37% in group 1 and 28% in group 2 (Chisquare p < 0.001), and the overall use of Strep-A near-patient tests was 31% and 20%, respectively (Chisquare p < 0.001). When the Strep-A near-patient test was negative in pharyngitis/tonsillitis, antibiotics were prescribed to 45% in group 1 and to 12% by group 2 (Chisquare 0.003). Conclusion: In conclusion, this study showed that physicians, who were more inclined to complete audit participation, used near-patient tests and prescribed antibiotics more correctly, according to the national guidelines for respiratory tract infections, than physicians who discontinued the participation. To achieve a rational use of antibiotics, near-patient tests and prescription of antibiotics must be used according to guidelines.

Assessing the Acceptability and Willingness to Use HIV Self-Testing among Student Nurses in a Private Nursing College, Gauteng Province, South Africa

Globally, there is increasing evidence that HIV self-testing (HIVST) is commonly practiced among health care workers (HCWs). Although HIVST kits are available in South Africa, their distribution and use remain unregulated and its acceptability, undocumented. The aim of the study was to explore the acceptability of HIV self-testing among student nurses, examine their willingness to use self-testing, and evaluate their views on the implementation of a regulated HIV self-testing programme. This was a qualitative explorative study, and six focus group discussions were conducted with 67 student nurses recruited from a private nursing college, in Pretoria, South Africa. Thematic analysis and NVivo10 qualitative software were used for data analysis. The nurses perceived HIVST as an acceptable option for HIV testing and most were willing to self-test. Self-testing will provide confidential and accessible HIV testing services, reduce the stigma associated with the condition, and increase partner testing and disclosure. HIVST is more likely to be practised if self-testing kits are easily accessible and affordable, and there are strategies to educate people before the adoption of HIVST. The lack of pre- and post-test counselling, the risk of inaccurate test results, and lack of strategies for the confirmation of self-testing results were the main arguments against HIVST. The high acceptance of HIVST among nurses suggests that HIVST is a feasible option to increase the uptake of HIV-testing among HCWs. However, pre- and post-test counselling should be considered important components in the implementation of self-testing services. Educational and awareness campaigns should precede the roll-out of the self-testing programs.

应用于食品检测领域的分子即时检测技术研究进展

食品安全问题关系人类民生。为有效预防和控制食品安全风险,减少食品安全经济损失,迫切需要开发出针对食源性病原体、食物掺假、转基因作物的高特异性、高敏感性、快速的核酸检测技术。即时检测(point-of-care testing,POCT)作为一种新兴的快速检测手段,由于其检测速度快、操作简单、现场检查等特点,在食品检测领域应用广泛。本文首先介绍了POCT技术的发展历史,而后根据食品安全事件的特点,从食源性致病菌、食物掺假、转基因作物3个方向分析了食品检测的主要对象,阐述了分子POCT技术在食品检测领域的应用现状,最后对应用于食品检测领域的分子POCT技术存在的问题和解决办法进行了分析总结,对食品检测分子POCT技术的发展方向进行了展望。本文有助于进一步了解分子POCT技术在食品检测中的应用,并为分子POCT技术在食品快速检测中的研究和应用提供参考。

14台POCT血气分析仪与中心实验室检测结果的一致性分析

目的分析14台床旁检测(POCT)血气分析仪和中心实验室血气分析仪检测结果的一致性。方法采用中心实验室血气分析仪及14台POCT血气分析仪分别检测3个浓度水平质控品,每天检测2次,连续检测4 d,共24次,根据检测结果计算pH、动脉血二氧化碳分压(PCO_(2))、动脉血氧分压(PO_(2))、K^(+)、Na^(+)、Cl^(-)、Ca^(2+)的均值、标准差和变异系数等;计算14台POCT血气分析仪检测结果与中心实验室检测结果的偏倚及偏倚率;应用ANOVA检验、Passing-Bablok回归分析对14台POCT血气分析仪与中心实验室检测结果一致性进行分析评价。结果14台POCT血气分析仪各比对项目检测结果的变异系数均小于生产商声明的性能范围。14台POCT血气分析各比对项目的检测结果与中心实验室的偏倚均小于国家卫生健康委员会临床检验中心室间质量评价标准。14台POCT台血气分析各比对项目的检测结果比较,差异均无统计学意义(P>0.05)。14台POCT血气分析仪检测结果与中心实验室pH值、PCO_(2)、PO_(2)、K^(+)、Na^(+)、Cl^(-)、Ca^(2+)检测结果模拟回归方程的截距和斜率均在95%置信区间,且P>0.05,与中心实验室检测结果具有高度的一致性。结论14台POCT血气分析仪具有良好的精密度,且14台POCT血气分析仪之间及与中心实验室间均具有较好的一致性。

利用临床药师工作站解读药敏试验结果的工作模式探讨

目的 探讨利用临床药师工作站解读药敏试验结果工作模式的意义。方法 介绍利用临床药师工作站解读药敏试验的工作流程、工作开展情况。结果 我院将常规药敏试验解读工作形成标准化系统板块嵌入临床药师工作站中,医生站以及检验科LIS系统与其智能化链接,使得报告的查收、发送以及接收均在线上完成,减少了中间环节,医生可在查收药敏试验结果的同时,更清晰地查看临床药师的用药建议。结论 利用临床药师工作站解读药敏试验结果的工作模式充分利用了信息化优势,提高了临床药师的临床参与度。该工作模式可量化,且覆盖科室范围较广,获得了临床的认可。

胸痛发作时床边即时检测心肌钙蛋白T诊断急性心肌梗死的价值

目的确定胸痛症状发作后不同时间间隔内,床边心肌肌钙蛋白T(point of care troponin-T testing,POCT-cTnT)对急性心肌梗死(acute myocardial infarction,AMI)的诊断性能,了解其在快速排除AMI方面的意义。方法这项回顾性研究包括了2019年1月至2022年12月期间出现胸痛症状的6024例患者。在入院时测量了POCT-cTnT和中心实验室cTnI水平。通过按时间窗口划分的受试者工作特征(receiver operating characteristics,ROC)分析,评估POCT-cTnT在诊断AMI时的准确性。结果总体而言,POCT-cTnT诊断AMI的AUC为0.826(95%CI:0.816~0.836),灵敏度和特异度分别为72.81%和86.26%。根据胸痛发作的时间进行区间分组(<3 h、3~6 h、6~12 h、12~24 h、24~72 h和≥72 h),6~12 h以后的分组AUC值分别为0.918、0.928、0.920和0.908,差异无统计学意义(P>0.05),均要高于6 h时以内的组(P<0.001);根据胸痛发作时间点进行分组,≥8 h组的AUC为0.921,阴性预测值(negative predictive value,NPV)98.1%和阴性似然比(negative likelihood ratio,-LR)0.11,其AUC高于≥3 h、≥2 h、≥1 h和overall组(P<0.05),而与≥4 h以后的各时间组相比,差异无统计学意义(P>0.05)。结论胸痛发作时间对单次检测POCT-cTnT诊断AMI的性能存在一定的影响,结合胸痛发作至就诊时间,可能提高其诊断或排除AMI的可靠性。在胸痛发作4 h后,单次POCT-cTnT检测能可靠地诊断或排除AMI;当胸痛发作8 h后,其诊断或排除AMI方面具有更高的可靠性。

即时检测仪器与电化学发光仪检测心脏标志物的对比研究

目的:对比分析两种即时检测(POCT)仪器与Roche电化学发光仪检测心脏标志物的相关关系,为临床检验选择POCT仪器提供参考。方法:选取2020年11月在中国中医科学院西苑医院就诊的20例患者血液样本,其浓度范围覆盖检测结果可报告范围,使用两种POCT仪器(分别命名为仪器A和仪器B)检测血浆肌红蛋白(Myo)、肌酸激酶同工酶质量(CKMB mass)、心肌钙蛋白I(cTnI)、氨基末端脑钠肽前体(NT-proBNP)/B型钠尿肽(BNP)的浓度水平,以电化学分析仪检测结果为参考,分别采用pearson相关分析和Kappa检验评价两种POCT仪器与Roche电化学发光仪检测结果的相关性和一致性。结果:仪器A和仪器B检测结果与Roche电化学发光仪检测Myo、CK-MB mass、cTnI、NT-proBNP/BNP结果均有较好的相关性(r_(仪器A)=O.994、0.989、0.917、0.996,r_(仪器B)=0.928、0.934、0.883、0.977,P<0.05)。在一致性比较中,仪器A检测Myo、CK-MB mass、cTnI、NT-proBNP与电化学分析仪的符合率分别为90%、100%、70%和100%;仪器B检测结果的符合率分别为90%、95%、70%和100%,两种POCT仪器与Roche电化学发光仪均具有较好的一致性(Kappa_(仪器A)=0.798、1.00、0.429、1.00,Kappa_(仪器B)=0.794、0.886、0.429、1.00)。两种仪器的精密度均<10%。结论:两种POCT仪器均能满足临床检测要求,在检测心脏标志物时与电化学发光仪有较好的相关性。