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).

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.

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 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.

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.

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.

基于Co-MOFs衍生物用于L-Cys的比色和智能手机双模检测

采用室温合成-热解法制备了一种具有类过氧化物酶性质的金属钴有机框架衍生纤维棒状碳材料(Co-DM)。利用SEM、TEM、XRD和XPS对其形貌、结构及元素组成进行了表征。通过活性氧捕获实验研究了其催化机理,Co-DM可催化H2O2使其释放出超氧阴离子自由基(·O_(2)^(-))和羟基自由基(·OH),从而使无色的显色底物3,3’,5,5’-四甲基联苯胺(TMB)氧化成蓝色的氧化态产物(ox TMB),在652 nm处有最大的紫外吸收峰;而L-半胱氨酸(L-Cys)具有抗氧化性,能够还原ox TMB使蓝色褪色。基于此原理建立了一种检测L-Cys的比色检测方法。在pH=4.0、温度为40℃的最优条件下,L-Cys的浓度与652 nm处的吸光度在0.1~15.0μmol/L范围呈线性关系,检出限(LOD)为0.35μmol/L。此外,借助自制的智能手机光学设备和Color Garb软件,通过记录不同浓度L-Cys下溶液在白色(0,0,0)至黑色(255,255,255)范围内颜色变化的特征值R(红)、G(绿)、B(蓝)值,建立了Co-DM的相对活性与颜色特征值的定量关系,检测范围为0.1~70.0μmol/L,LOD为0.27μmol/L。该方法还成功地应用于临床人血清中L-Cys的检测,回收率在94.0%~101.5%之间。

Protocol for the management of oral surgery patients on warfarin utilizing a Point-of-Care In-Office international normalized ratio monitoring device

Purpose: This study was performed to assess the utility and safety of an In-Office INR Monitoring Device and present a safe and efficient protocol for the management of patients on oral anticoagulants and/or antithrombolytics requiring routine office oral and maxillofacial surgery. Patients and Methods: Sixty-one patients requiring “minor” oral and maxillofacial surgery being treated chronically with oral anticoagulation (warfarin) were entered into the study and compared in 2 groups. The control group (n = 29) was managed by discontinuing warfarin and any anti-platelet medication(s) prior to surgery. In the study group (n = 30), the decision to continue or withhold warfarin was determined by a protocol in which patients are 1) stratified based on risk for thromboembolism, and 2) classified as requiring “major” or “minor” surgery. Procedures categorized as “minor” surgery included dental extraction(s), dental implants, soft tissue and bone biopsies, and preprosthetic bone surgery, and incision and drainage. Warfarin and antiplatelet medication were not withheld in these patients, and a Point-of-Care In-Office INR Monitoring Device was used to obtain INR levels on the day of consultation and surgery. Local measures including removal of granulation tissue, packing, suturing, etc. were utilized for hemostasis. Results: The 30 patients in the study group maintained on warfarin readily achieved hemostasis using intraoperative local measures. The mean INR measured by the In-Office INR Monitoring Device was 2.36 with a range from 1.3 to 3.2. Study group patients underwent a total of 131 separate procedures including 108 dental extractions (impactions), placement of dental implants, preprosthetic bony surgery, bone cyst removal, soft tissue biopsies, facial skin cancer repair, and incision and drainage. One patient (3%) required “minor” intervention with removal of a “liver clot” on postop day 2 with repacking and suturing. The 29 patients in the control group discontinued off of war farin underwent a total of 99 procedures. One patient (3%) also required a “minor” intervention (repacking of extraction site). There were no “major” complications in either group. Conclusions: This study supports previous studies that minor oral surgery procedures can be safely performed while maintaining patients on warfarin minimizing the risk of a potentially devastating thromboembolic event. When deciding whether or not to withhold warfarin, this study supports the use of the proposed protocol based on 1) risk stratification for thromboembolism, 2) the need for “minor” versus “major” surgery, 3) and utilization of an In-Office INR Monitoring Device. An In-Office Point-of-Care INR measuring device can be a very effective tool to safely simplify and make the perioperative management of the anticoagulated patient more efficient for the patient and oral and maxillo facial surgeon.

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.

Evaluation of an Innovative Diagnostic Method for Detection of Antibodies and Antigens

Reports manifest a continuing need for the development of rapid and on-site (point of care) assays. Current diagnostic methods commonly used for detection of antibodies and antigens have significant limitations. Scientists at Micro Detect, Inc. have developed an innovative diagnostic device (method) that can be utilized broadly for antibody/antigen interactions including diagnostic assays in the medical, veterinary and food industries. The developed device can be utilized for the detection of antibodies against a single antigen or vice versa. It can also be tailored for specific panels that detect antigens or antibodies for diverse infectious agents, proteins, hormones, tumor markers, autoimmune markers, and allergens. Additionally, it can also be used for detection of toxins, antitoxins, nucleic acids, enzymes, drugs, etc. in both humans and animals. Specimens used in different formats of the device can be tears, saliva, whole blood, serum, plasma, urine, stool, and other bodily discharges. The good intra and inter precisions and acceptable linearity of the device support reliable use of the device. The CV of the device is 1.9% - 2.2%. Likewise, the performance of the device using 92 confirmed negative and positive specimens via a typical assay showed 100% sensitivity, 80% specificity, 96.8% efficacy, 80% positive predictive value, and 100% negative predictive value. The results of our feasibility study suggest reliable utility of a device for rapid, easy-to-use, inexpensive, and on-site (point of care) diagnostic assays. This presents a potential breakthrough in diagnostic methodologies that can be integrated into modern medicine and food industries.

Machine Learning Approach to Enhance the Performance of MNP?Labeled Lateral Flow Immunoassay

The use of magnetic nanoparticle(MNP)-labeled immunochromatography test strips(ICTSs) is very important for point-ofcare testing(POCT). However, common diagnostic methods cannot accurately analyze the weak magnetic signal from ICTSs, limiting the applications of POCT. In this study, an ultrasensitive multiplex biosensor was designed to overcome the limitations of capturing and normalization of the weak magnetic signal from MNPs on ICTSs. A machine learning model for sandwich assays was constructed and used to classify weakly positive and negative samples, which significantly enhanced the specificity and sensitivity. The potential clinical application was evaluated by detecting 50 human chorionic gonadotropin(HCG) samples and 59 myocardial infarction serum samples. The quantitative range for HCG was 1–1000 mIU mL^(-1) and the ideal detection limit was 0.014 mIU mL^(-1), which was well below the clinical threshold. Quantitative detection results of multiplex cardiac markers showed good linear correlations with standard values. The proposed multiplex assay can be readily adapted for identifying other biomolecules and also be used in other applications such as environmental monitoring, food analysis, and national security.

Evaluation of a handheld creatinine measurement device for real-time determination of serum creatinine in radiology departments

AIM: To assess the feasibility/accuracy of a commercial handheld device in the context of increased demand for point-of-care serum creatinine (SCr) determination. METHODS: In this institutional review board-approved, prospective study, 401 patients referred for contrastenhanced computed tomography were included at two centres. Capillary (c)SCr was determined using two devices A+B and venous (v)SCr was determined in the centre's laboratory. Method comparison statistics for both centres and for vSCr<>1.2 mg/dL, receiver operating characteristic analysis, negative predictive values (NPV), sensitivity and specificity were calculated pre-/ post-curve offset correction with vSCr. RESULTS: Pearson's coefficients for cSCr vs vSCr were: centre 1-A:0.93/B:0.92; centre 2-A:0.85/B:0.82 (all P < 0.0001). Overall correlation was better for vSCr > 1.2 mg/dL. The area under the receiver operating characteristic curves showed a high accuracy for cSCr, but the device underestimated SCr, which was confirmed by Bland-Altman plot. Addition of the offset correction factor to the original data from centre 1 resulted in an improvement in sensitivity for detecting patients at risk (> 1.2 mg/dL), whilst maintaining acceptable specificity and improving NPV. CONCLUSION: This study showed the feasibility of SCr determination using the evaluated handheld device in a routine clinical setting. The device showed high sensitivity and high NPV, but may significantly underestimate SCr without offset correction to local laboratories.

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。

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。

基于RPA等温扩增的松材线虫快速检测技术体系建立

利用松材线虫Bursaphelenchus xylophilus基因组分析和等温扩增技术,设计生产松材线虫野外快速检测技术产品并测试其效果。结果表明:比较分析松材线虫和拟松材线虫Bursaphelenchus mucronatus基因组发现松材线虫特异性基因Bx-gene12,以此为基础设计特异性扩增引物和探针,对采集自不同地区的松材线虫、拟松材线虫和松树内其他线虫株系采用研磨颗粒以1500 r/min转速震荡5 min的破碎方法有效释放线虫DNA,40℃等温扩增15 min反应条件下可有效区分松材线虫和其他线虫,检测灵敏度达到100 fg或1条线虫;该快速检测方法在25 min内有效检测出染病黑松Pinus thunbergii和赤松Pinus densiflora松木内的松材线虫。利用RPA等温扩增技术实现25 min内对野外环境下松材线虫的快速检测,可为松材线虫病及时有效防控提供支持。

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。

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。

急性心肌梗死标志物检测方法研究进展

心血管疾病尤其急性心肌梗死(AMI)发病率和病死率逐年上升,及时、准确地检出AMI并尽早给予治疗,对保障患者及患者家庭的生活质量、促进社会稳定发展具有重要意义。AMI相关心肌损伤标志物的检测可为AMI的及时准确诊断和预后评估提供重要依据。该文对与AMI相关特异性酶或蛋白类心肌损伤标志物如肌酸激酶、天冬氨酸转氨酶、乳酸脱氢酶、肌红蛋白、心肌肌钙蛋白等的特点进行了阐述,并对其检测方法(包括免疫层析法、酶联免疫吸附试验、比色法、化学发光分析法、荧光分析法和电化学分析法)的新进展进行了探讨,为AMI标志物早期诊断技术的研究提供参考依据。临床实验室应在优化现有AMI标志物检验方法的基础上,研发更为便捷的AMI标志物生物传感检测方法,发展更为准确且快速的AMI标志物即时检测技术,寻找早期诊断AMI的新型生物标志物,共同助力AMI的精准治疗。

肌钙蛋白即时检验在急性冠状动脉综合征疑似患者院前急救中的应用

目的探讨疑似急性冠状动脉综合征(ACS)在院前急救车上应用即时检验(POCT)检测肌钙蛋白Ⅰ(cTnⅠ)的优势及可行性分析。方法将2019年5月—2020年5月北京急救中心院前接诊的60例疑似急性冠状动脉综合征(ACS)患者,通过现场抽签的方式随机分为试验组30例和对照组30例,对照组常规收集患者病史资料、进行体格检查和心电图测量,试验组在对照组基础上增加POCT检测cTnⅠ,比较两组患者急诊停留时间(EDLOS)、从首次医疗救治(FMC)到接受血运重建时间、出院45 d不良心血管事件发生率。结果试验组EDLOS较对照组更短(P<0.05),试验组从FMC到接受血运重建时间较对照组更短(P<0.05),试验组出院45 d不良心血管事件发生率较对照组更低(P<0.05)。结论院前应用POCT检测cTnⅠ能够缩短疑似ACS患者的EDLOS、缩短从FMC到接受血运重建时间、降低出院45 d不良心血管事件的发生率,对院前疑似ACS患者的早期诊断及预后具有一定的临床参考价值。

尿路感染病原体即时检测微流控系统研制

为了实现现场快速诊断,研制了一种基于离心微流控技术的尿路感染病原体即时检测(POCT)系统。该系统由离心检测芯片、选通阀进样芯片和POCT装置组成。利用比色反应的原理,可在60 min内直接用肉眼观察到检测结果。实验定量结果表明,该系统对一定浓度范围内大肠杆菌富集效率为99.8%,检测限为10~5CFU/mL。最后,通过对大肠杆菌浓度梯度为10~5~10~8 CFU/mL的4组模拟样品进行检测,记录下4组浓度对应的检测结果。将结果制成标准比色卡,便于进一步对检测结果进行分析。该系统成本低、易操作、检测快,具有一定的应用价值。