Point-of-Care-Testing – das Intensivlaboratorium

After successful centralization of laboratory analyses since more than 30 years, advances in biosensors, microprocessors, measurement of undiluted whole blood and miniaturization of laboratory analyzers are leading nowadays more and more to a re-decentralization in the laboratory medicine. Point-of-care-testing (POCT), which is defined as any laboratory test performed outside central or decentralized laboratories, is becoming more and more popular. The theoretical advantages of POCT are faster turn-around-times (TAT), more rapid medical decisions, avoidance of sample identification and sample transport problems and the need of only small specimen volumes. These advantages are frequently mentioned, but are not associated with a clear clinical benefit. The disadvantages of POCT such as incorrect handling and/or maintenance of the analyzers by nontrained clinical staff, inadequate or even absent calibrations and/or quality controls, lack of cost-effectiveness because of an increased number of analyzers and more expensive reagents, insufficient documentation and difficult comparability of the obtained POCT-results with routine laboratory results, are strongly evident. According to the authors' opinion the decision for the establishing of POCT has only to be made in a close co-operation between physicians and laboratorians in order to vouch for necessity and high quality of the analyses. Taking the local situation into consideration (24-h-central laboratory, etc.) the spectrum of parameters measured by means of POCT should be rigorously restricted to the vital functions. Such analytes should be: hemoglobin or hematocrit, activated whole blood clotting time, blood gases, sodium, potassium, ionized calcium, glucose, creatinine, ammonia and lactate.     

The effect of disinfecting procedure on the glucose concentration using a personal glucose meter

BackgroundPersonal glucose meters, primarily designed for self-control of glucose concentration in patients with diabetes, are frequently used in clinical practice as point-of-care equipment. The procedure of washing hands with water and soap before testing, as recommended by the manufacturer of personal glucose meters, in hospital wards is often difficult to fulfil and is replaced by disinfecting the place of blood sampling with isopropyl alcohol.AimThe purpose of the research was to evaluate the effect of different disinfecting procedures on glycemia measurement in capillary blood using personal glucose meters.Materials and methodsFour measurements of glycemia were taken in each of 50-volunteer group using Accu-Check Performa (Roche, Swiss) glucose meter using different procedures: washing hands with soap and drying them (1), disinfection with isopropyl alcohol and waiting for the disinfectant to evaporate (2) and the immediate puncture after disinfection. In the latter case two kind of single-use lancets were use – typical for adult (3) and smaller preferred by diabetics or children (4).ResultsPaired T-student test showed no statistically significant difference between measurements 1st and 2nd 95% CI (−4.282 to 0.322), p = 0.09. However, the comparison between 1st/3rd and 1st/4th showed statistically significant difference, 95% CI (−4.964 to −0.796), p = 0,0077 (p < 0,01) and 95% CI (−7.842 to −2.917), p = 0.00006 (p < 0.001).ConclusionsThe procedure of disinfection when fluid completely evaporates has no effect on glucose measurements. Sampling the wet finger influences results of glucose measurement but observed changes were clinically irrelevant.     

即时检验血糖仪检测指尖血及静脉全血血糖的临床分析

目的：探讨即时检验血糖仪检测指尖血及静脉全血血糖检验结果的临床可行性。方法随机选取该院2011年6月—2012年7月所接收治疗的50例糖尿病患者,采取静脉血和指尖血,采用即时检验血糖仪检测所有患者的血糖数值,同时,还在生化分析仪上进行检测血浆葡萄糖,对比分析两部位生化分析仪检测结果和血样检测结果的偏倚程度。结果即时检验血糖仪指尖血血糖为（9.38±4.28）mmol/L,静脉全血血糖为（9.17±4.05）mmol/L,生化仪测定血浆葡萄糖为（9.96±5.01）mmol/L,三者之间进行统计学分析,差异有统计学意义（P＜0.05）,两部位生化分析仪检测结果和血样检测结果的偏移程度都是负偏倚,其中,偏倚范围最高是13.8%,最低为1.4%,都没有超过20%。静脉全血血糖偏倚显著高于指尖血血糖偏倚,差异具备统计学意义（P＜0.05）。结论对于即时检验血糖仪检测指尖血及静脉全血血糖检验结果的临床可行性,不管是采用静脉采血,还是指尖采血,即时检验血糖的数值都在接受范围内,但是采取指尖血样,检测结果更加接近血浆葡萄糖。     

Field applicable detection of hepatitis B virus using internal controlled duplex recombinase-aided amplification assay and lateral flow dipstick assay

Hepatitis B virus (HBV) is a widespread blood-borne pathogen associated with the complication of liver cirrhosis and hepatocellular carcinoma, particularly in south-east Asian and African countries where HBV is highly endemic and the budget and resources are limited. Therefore, simple, rapid, and portable field detection methods are crucial to efficiently control HBV infection. In this study, using heat-treated DNA, we developed two-field applicable detection assays for HBV based on recombinase-aided amplification (RAA). One was an internal controlled duplex RAA assay using a portable real-time fluorescence detection device, another was an instrument-free visual observation assay using lateral flow dipsticks. The entire experimental time was greatly shortened to less than 40 minutes at 39.0°C. The sensitivities, specificities, and clinical performance of both assays were evaluated. Compared with quantitative polymerase chain reaction assay as a reference, our results demonstrated that the two RAA-based assay obtained 97.18% and 95.77% of sensitivity, respectively, and the specificity was 100%, by testing a total of 157 serum samples with HBsAg positive. We conclude that the advantages of rapidity, simplicity, portability, and visualization of proposed two assays make them great potentials in point-of-care testing of HBV infection by untrained people in resource-limited situations.     

POCT在采供血机构的应用和质量管理

POCT(point of care testing)是检验医学的新领域,采供血机构越来越多的使用了POCT技术用于献血者和相关人员的快速检潮.目前采供血机构对POCT的应用和管理并没有相关标准和要求,其质量管理也处于初级阶段.采用体系化管理模式将POCT管理纳入采供血机构质量管理体系的范畴是POCT发展的最佳途径,也是保障献血者和血液安全的前提条件.     

POCT的研究进展

POCT(point of caretesting)作为检验医学中最具革命性的新领域越来越受到人们的关注和重视。本文简要介绍了POCT的产生背景、特点、技术、应用、管理、控制及发展前景。     

便携式血糖仪与生化仪检测血糖的比较

目的探讨便携式血糖仪检测血糖的准确性及存在问题。方法抽取患者静脉血,以氟化钠抗凝,以快速血糖仪检测全血血糖,分离血浆,以生化仪检测血浆葡萄糖,对结果进行统计分析。结果便携式血糖仪检测全血血糖7.50±4.89mmol/L,生化仪检测血浆葡萄糖8.33±5.49mmol/L,两种方法均值比较的t检验无显著性差异;配对资料的t检验有显著性差异;两种方法具有良好的相关性。结论便携式血糖仪与生化仪的差别在卫生部规范允许的可接受范围内,可以用作糖尿病患者监测使用;应定期将本单位的便携式血糖仪与生化仪进行对比、校正,以满足临床需要;使用便携式血糖仪作监测时,应考虑到便携式血糖仪检验结果有可能偏低的情况,做出合理判断。     

POCT血糖仪与全自动生化分析仪血糖检测结果比对

目的了解病区POCT血糖仪的使用情况,将POCT血糖仪与实验室全自动生化分析仪血糖检测结果进行比对分析,确保POCT血糖仪检测结果的准确性。方法配制高、中、低50份不同血糖浓度(EDTA-K2抗凝)的全血标本,同时用POCT血糖仪与全自动生化分析仪检测血糖并与结果进行比对分析。结果调查的8台POCT血糖仪与全自动生化分析仪结果比对,7台符合国家要求,比对合格;其中1台在检测低浓度样本(<2.8mmol/L)时结果误差较大,测定值超出国家控制标准,比对不合格。结论 POCT血糖仪检测结果可靠,方便快捷,可以作为急诊、快速筛查等临床应用,但应定期对POCT血糖仪与实验室全自动生化分析仪血糖检测结果进行对比,确保检测结果的准确性。     

床旁快速检测对急性冠脉综合征的诊断和预后的影响

目的 对比床旁快速检测与传统实验室方法检测心肌损伤标志物对急性冠脉综合征(ACS)的诊断及预后的影响.方法 回顾性分析2006年1月1日至2010年6月30日首都医科大学附属北京朝阳医院急诊科收治已确诊的3467例急性冠脉综合征的患者,记录患者的年龄、性别、既往病史和吸烟史等基本人口资料,以及心肌损伤标志物(CTNI CKMB MYO)、D二聚体、NTproBNP、心脏彩超EF等实验室指标,采用统计学方法比较应用床旁快速检测与实验室检测心肌损伤标志物的患者,在急诊滞留时间(急诊就诊到接受介入或保守治疗之间用时)、入院到住院期间的心血管事件(心衰、室颤、脑血管病)的发生率和28 d病死率的不同.结果 床旁快速检测组的急诊滞留时间、心血管事件发生率和28 d病死率均低于常规实验室检测组(p=0.000),且急诊滞留时间越长,早期肌红蛋白和D二聚体测定值越高,EF测定值越低,28 d死亡风险越高.结论 床旁快速检测比常规实验室检测能缩短ACS患者的急诊滞留时间,降低心血管事件发生率并能明显改善预后.