Current status of POCT and its future challenges

Point of care testing (POCT) is a real-time examination with a portable analyzer and a rapid diagnostic kit in medical practice, and it includes all clinical tests carried out at the places other than laboratories in the hospital and outsourced clinical laboratory centers. Achieving "quickly at any place, any time", a basis for clinical laboratory testing, is expected for POCT and POCT has realized "a laboratory at any place, any time". Therefore, a wide range and a variety of places and methods to use it is expected. POCT, a realt-time examination in clinical practice, is indispensable for today's medical practice. Although POCT is an easy rapid test, data may be influenced unless its usage and maintenance methods are fully understood. Considering the situation that tests are done without the attendance of laboratory experts, construction of the management system of POCT by the laboratory and fostering POC coordinators responsible for its management and operation are important issues.     

Considering what clinical laboratories should become in the future--POCT, mail testing and OTC test

Medical staff working in laboratories have shown little or no interest in POCT, mail testing and OTC test. POCT and mail testing are laboratory systems that respectively involve a series of laboratory processes (advice on sampling, interpretation of data, referral to a doctor, etc.). However, the usefulness of data in the two systems differs. Data in POCT are directly used for medical treatment and those in mail testing are used as screening for health control or self-medication. OTC test is different from POCT and mail testing. People buy materials for OTC test at a drug store, then perform it and interpret the data by themselves. There are several factors in the development of POCT, mail testing and OTC test, for example the awareness of people about participation and responsibility for their own medical care, control of lifestyle-related diseases, relaxation of governmental regulation and development of technologies. These laboratories will grow gradually and influence clinical laboratories in medical facilities as well as commercial laboratories. Medical technologists and laboratory physicians should contribute to the sound development of these laboratories. As things are being changing so rapidly, medical technologists and laboratory physicians are forced to realign.     

POCT and system

POCT refers to a medical test which is carried out at sites other than a central laboratory. It includes a simple test that medical service staff carry out at the scene of a medical treatment and self-care tests that patients can perform by themselves at home. This concept has been established in the U.S. since the late 1980's. In recent years, doctor's offices and clinics have been leaders in primary care and are now paying close attention to immediate testing facilities inside their hospitals to provide better service to patients. Now, we can see more and more POCT equipment being introduced to such places. Since it is unlikely that specially trained technicians can staff the hospital around the clock, physicians or nurses have must operate the POCT instrument themselves. Based on this fact, easily accessible instruments that produce reliable data are strongly required. ARKRAY introduces the "CARE LAB" system that combines special data management software "MEQNET" with various POCT devices. These systems facilitate establishing an "in-clinic inspection station" in a general practitioner or clinic. This article presents detailed information on various POCT products and the "MEQNET" program that make up the "CARE LAB" System.     

From the perspective of the Japan Association of Clinical Reagents Industries

Simple testing conducted in the hospital laboratory and the Commercial Lab is not considered "time-consuming testing" but prompt testing that enables obtaining data near the patient. In the field of medical care, the need for POCT(Point-of-Care Testing) which can test in prompt and minimally invasive ways has been increasing. In a related move, new techniques are being developing one after another to meet those needs. In the future, we will need to appropriately provide intensive service at the central laboratory and prompt service at the bedside while increasing economic efficiency. Because the 21st century is being promoted as the age of self-responsibility, we need to create systems and an environment for patients to manage their own health. In terms of the reduction of medical service fees, it seems that the method of payment directs forward like DRG definitely. Therefore, cooperation among industry and academia is needed to promote OTC test agents as testing before getting a disease and take an active part enlightening the importance of home testing. Currently, long-term medication is administered for an increasing number of chronic ailments going with the aging population. It seems desirable to develop and popularize easy home tests for monitoring chronic ailment and easy test agents for the checking side effects by drug.     

Point of care testing from clinical laboratory

The point of care testing(POCT) becomes popular in the Japanese medical scenes. POCT has its unique technologies which makes convenient and fast turn around time(TAT) test available to the physicians. Can clinical laboratories challenge to this new technologies? The licensed medical technologists and clinical laboratory analyzers with advanced user interface improve TAT, and the well established technology can provide the best solution today, and. The synergy of the clinical laboratory tests and POCT will increase the productivity of patient care in the future.     

Usefulness of POCT in critical care medicine

The need for speedy and accurate test results is becoming increasingly urgent in the areas of emergency medicine and ICU. The form of emergency testing is changing from conventional testing conducted by laboratory technicians to point-of-care testing (POCT) performed by the doctor or nurse. Therefore, the skill and time of the technician, which used to be expended for emergency testing, is now utilized for maintenance and precision control of POCT equipment so that the doctors and nurses can conduct POCT with confidence at all times. We also attempted point of prehospital care testing (POPCT), comprised of prehospital care and POCT. Here, the laboratory technician rides with the doctor to provide patient information to the clinicians from the perspective of a laboratory technician in the field to support emergency treatment. This has not yet been made fully practical, but the usefulness of POCT in critical care medicine seems to be essential to the forthcoming advanced emergency medicine, considering its usefulness outside the hospital environment.     

The relevance of a simultaneous measurement of WBC and CRP as a POCT(point of care testing) of the inflammatory markers running title: the POCT(point of care testing) of WBC and CRP

The POCT(point of care testing) is not enough popular as the term in Japan, but many tests are actually performed as POCT. We have developed POCT analyzer to measure WBC and CRP simultaneously from whole blood, and one of its key technologies is Hct correction of CRP concentration from whole blood to plasma. After its launch, the users are discussing some findings, one of what is a transition phase of WBC and CRP found by frequent measurement of both. In case of acute infectious inflammation, the CRP peak follows the WBC peak after 1 or 2 days. Needless to say, this finding makes haste to foresee a remission by both doctor and patient family. Thus, the POCT has a possibility to give additional and/or another advanced medical relevance even if it is alternative.     

Katrina, the tsunami, and point-of-care testing: optimizing rapid response diagnosis in disasters

We assessed how point-of-care testing (POCT), diagnostic testing at or near the site of patient care, can optimize diagnosis, triage, and patient monitoring during disasters. We surveyed 4 primary care units (PCUs) and 10 hospitals in provinces hit hardest by the tsunami in Thailand and 22 hospitals in Katrina-affected areas. We assessed POCT, critical care testing, critical values notification, demographics, and disaster responses. Limited availability and poor organization severely limited POCT use. The tsunami impacted 48 PCUs plus island and province hospitals, which lacked adequate diagnostic instruments. Sudden overload of critical victims and transportation failures caused excessive mortality. In New Orleans, LA, flooding hindered rescue teams that could have been POCT-equipped. US sea, land, and airborne rescue brought POCT instruments closer to flooded areas. Katrina demonstrated POCT value in disaster responses. We recommend handheld POCT, airborne critical care testing, and disaster-specific mobile medical units in small-world networks worldwide.     

Analytical performance of a platform for point-of-care CRP testing in adults consulting for lower respiratory tract infection in primary care

C-reactive protein (CRP) is a biomarker widely used for disease severity assessment and treatment of inflammatory conditions. Point-of-care testing (POCT) devices should ideally be rapid and provide similar results to standard tests done in laboratories. Two thousand nine hundred twenty-two serum samples were obtained from adult patients presenting to primary care with symptoms of lower respiratory infection in a European diagnostic study. The analytic performance of the CRP QuikRead POCT device (Orion Diagnostica) was evaluated by comparing results with a central laboratory method (Dimension Vista, Siemens), with both tests performed in a laboratory setting. For a CRP cut-off concentration of ≥?30 mg/L, the QuikRead test had a sensitivity of 92.2%, and specificity of 99.4%. The mean difference between the QuikRead and the central lab test was 0.4 mg/L. The slope of the Passing-Bablok regression was 0.94 (95% CI 0.93–0.95) indicating an underestimation of CRP levels of 6% by QuikRead. CRP estimates obtained from the QuikRead test correlate well with a central laboratory assay and the measurement displays low inter-assay variation. Therefore, the QuikRead test is a good candidate for CRP testing in primary care.     

What's Old Is New Again: Laboratory Oversight of Point of Care Testing—Guidelines,Challenges, and Practical Strategies

Laboratory medicine has evolved significantly over the past 45 years. Collaboration with other health care workers has always been important; today, it is even more important when developing new services, such as point-of-care testing (POCT) performed by non-laboratory staff with governance and oversight by laboratory personnel. POCT implies near-patient testing with the objective of generating rapid results for immediate management and treatment decisions. Although POCT dates back many years, what is old is now new again. We have seen a significant increase in POCT in the past 20-plus years, with predictions for even more testing with the advent of new technology. This article provides an overview of common challenges and practical examples for addressing POCT in daily clinical practice.     

Future of POCT--connection to computer network of a hospital

Point-of-care testing[POCT] has many advantages and disadvantages. Rapid availability of the results facilitates immediate decision making, which is a most important advantage. However, the results get lost occasionally and solving this problem is essential for the successful use of POCT. We linked a portable blood gas analyzers to the computer network system in our hospital. At the same time we created a new program to automatically save results and create test orders. Thereafter, there has been no loss of results and the results can be checked quickly at any computer display in our hospital. Surveying past results has also become very easy. This rapid sharing and easy survey of results has enhanced the value of POCT by facilitating more immediate clinical decision making and improving the quality of hospital service. In the near future, POCT will have a much greater menu and be used more widely. Many types of echographic studies will be done at bed side as well. Linking POCT to computer network system and automatically saving the results are critical points to providing quality service in hospitals of the new era.     

Point care testing in blood gas and electrolyte analysis : examples of implementation and cost analysis

An increasing proportion of laboratories manage and organize point of care testing (POCT). The purpose of this article is to describe the implementation made at Lariboisière hospital for three remote blood gas analysers. The most important aspect in this achievement is the comprehensive computerization, making possible real time management of POCT in agreement with the Point of Care unit Management team. In addition, we present a running cost analysis, comparing three Blood gas systems (Rapidlab860, Rapidpoint 400--Bayer Diagnostics and i-Stat Abbott Diagnostics). This study indicates that cost per test hugely varies based on the daily sample demand. In addition to analytical and organizational items, the clinical chemist should consider the testing demand as a key factor in choosing an analyser for POCT.     

Human germline genetic tests

A guideline for genetic testing by 10 scientific societies was published recently. This can be summarized as follows. 1) Generalized medical care for genetic medicine is necessary when genetic testing is considered. 2) Analytical validity, clinical validity and clinical usefulness must be proven when genetic testing is applied to clinical medicine. 3) Informed consent must be given by the client before genetic testing is performed. 4) Information on an individual's genetic test must be protected tightly and should not be disclosed to others without permission from the client. 5) Genetic counseling must be performed before genetic testing is performed. 6) The purposes of genetic test performed to prepositus ((i) for definite diagnosis of the patient and (ii) for obtaining information by predictive tests for family members) should be clearly distinguished. 7) Genetic tests for detection of carrier status of specific genetic conditions should be carefully performed, because they do not affect the health condition themselves, but can be a cause of discrimination. 8) Predictive genetic tests must be performed very carefully, especially when no procedures of treatment/prevention are available. 9) In general, genetic testing of children should be considered when such tests provide clinical benefits to the children themselves.     

3款床旁糖化血红蛋白检测系统社区人群适用性研究

目的 研究3款血红蛋白(HbA1c)床旁检测(Point of care testing, POCT)系统在社区医疗机构的适用性.方法 收集658例社区临床机构EDTA抗凝全血标本,借助可溯源的二级参考测量程序(SRMP)结果将人群进行分组比较,得出3款POCT HbA1c检测系统在临床检测的一致性.并采用受试者工作曲线(ROC)评价各检测系统在临床诊断关键点的灵敏度和特异性.结果 POCT HbA1c-1、2、3 与溯源到IFCC参考方法的SRMP检测结果Kappa一致性分析结果为,κPOCT-1=0.828、κPOCT-2=0.794、κPOCT-3=0.756;ROC曲线下面积(AUC)分别为0.900、0.901、0.898;在临床诊断切点6.5%处,灵敏度分别为87.0%、83.8%、84.8%,特异性分别为78.8%、81.9%、81.0%;结论 3款POCT HbA1c检测系统在社区人群检测中,均具有良好的灵敏度、特异性和检测一致性,适用于临床使用.     

Evidence based practice: clinicians' use and attitudes to near patient testing in hospitals.

AIM: To survey the use made of laboratory services for urgent tests and clinicians' attitudes to near patient testing. METHODS: A questionnaire was sent to clinicians working in acute hospitals within Trent and North West Thames Regions. RESULTS: 197 replies were received. Most demand came from intensive care units. Overall, clinicians requested a median of six urgent tests a day. Blood glucose and dip stick urine testing were the most commonly performed bedside tests, but 41% of clinicians did not use ward testing. The most frequently cited indication for bedside testing was the need for speed. 85% of clinicians trusted results obtained in their central hospital laboratory, but there was an almost equal division between those who did (34%) and those who did not (38%) trust the results from near patient testing. A slightly larger proportion indicated they would accept responsibility (44%) for results obtained on the ward than would not (35%). Most staff indicated that better transport to the laboratory would remove the need for near patient testing. CONCLUSIONS: Clinicians have demonstrated an apparent need for rapid response testing but there is a strong preference for rapid transport systems and central laboratory analysis rather than bedside testing as a solution to this problem. There is a need to investigate the clinical and cost-effectiveness of near patient testing as a solution to rapid response testing.     

An in-line microfluidic blood sampling interface between patients and saline infusion systems

This work seeks to extend the utility of microfluidics to conventional blood sampling aperati. Daily medical care of hospitalized patients demands repeated needle punctures or interfacing with a catheter to collect blood samples. Large, research grade systems can autonomously sample blood from laboratory animals; however, a disposable aperatus that can be used to repeatedly sample blood from hospitalized patients does not exist. We have designed, fabricated and demonstrated a 3-layered rigid polymer microfluidic blood sampling device with integrated polymer pinch valves for placement in-line between a patient and a saline infusion system. The blood sampler we designed seeks to mitigate sample cross contamination, reduce risks of microbial contamination associated with invasive blood sampling and improve technical ease of blood sampling. Clinical laboratory tests and microfluidic devices for rapid point-of-care-testing (POCT) of patient samples require human sampling procedures for collection of a patient sample at defined time points. The microfluidic sampling device is designed ultimately to be backwards compatible with existing clinical saline infusion protocols and function as a universal front-end blood sampling unit for the variety of microfluidic lab chips and POCT devices.     

Recent blood gas analysis as emergency testing

Laboratory specimen tests, histological exams, physiological tests and image diagnoses are routinely conducted on medical premises. These include emergency specimen testing such as hematological exams, partial biochemical exams and partial immunology exams. Emergency tests, especially those carried out by doctors and nurses in the operating theatre, nurse's station and bedside are called Point Of Care Tests or Near Patient Tests. The purpose is to facilitate quick, accurate diagnosis, thereby increasing the effectiveness of critical care. POCT/NPT was started due to an increasing requirement in the USA for faster turnaround times, and made possible with the development of high quality portable medical devices with sensor technology. In this article, the history and most recent information, diagnosis and treatment using Blood Gas Analysis, a mandatory test for critically ill patients, is described.     

Evolving strategy for HCV testing in an Italian tertiary care hospital

BackgroundDiagnostic tests for hepatitis C virus (HCV) infection should be adapted according to the clinical status of the patient.ObjectivesWe exploited the application of different HCV diagnostic algorithms in a tertiary care hospital practice.Study designThe laboratory clinical reports to the medical orders for HCV testing during three years were clustered by different combinations of assays for anti-HCV antibodies (HCV Ab) (screening and confirmatory), HCV nucleic acid (HCV-RNA), HCV core antigen (HCV Ag). The latter was the first-line assay in acute HCV infections requiring a rapid assessment of the infectious state.ResultsThe majority (91.9%) of the 2726 subjects whose samples were analyzed were inpatients. Most of the patients/subjects were tested for clinical suspicion of viral hepatitis (49.2%), or occupational accident to health care professionals (20.0%). On 66% of samples HCV Ag test alone was performed and resulted positive in 116 cases (6%), while it was detected in 50.3% of anti-HCV positive samples. The agreement between HCV Ag and HCV-RNA was very high (k = 0.97); HCV Ag positivity rates increased according to the signal of the HCV Ab screening test.ConclusionsThe use of different testing strategies according to the patients’ history and clinical status allowed a significant reduction of the number of tests performed and the time needed to provide a diagnostic response useful for patients’ management without compromising the overall diagnostic accuracy for HCV infection.     

Is the international normalised ratio (INR) reliable? A trial of comparative measurements in hospital laboratory and primary care settings.

AIM: To determine the reliability of international normalised ratio (INR) measurement in primary care by practice nurses using near patient testing (NPT), in comparison with results obtained within hospital laboratories by varied methods. METHODS: As part of an MRC funded study into primary care oral anticoagulation management, INR measurements obtained in general practice were validated against values on the same samples obtained in hospital laboratories. A prospective comparative trial was undertaken between three hospital laboratories and nine general practices. All patients attending general practice based anticoagulant clinics had parallel INR estimations performed in general practice and in a hospital laboratory. RESULTS: 405 tests were performed. Comparison between results obtained in the practices and those in the reference hospital laboratory (gold standard), which used the same method of testing for INR, showed a correlation coefficient of 0.96. Correlation coefficients comparing the results with the various standard laboratory techniques ranged from 0.86 to 0.92. It was estimated that up to 53% of tests would have resulted in clinically significant differences (change in warfarin dose) depending upon the site and method of testing. The practice derived results showed a positive bias ranging from 0.28 to 1.55, depending upon the site and method of testing. CONCLUSIONS: No technical problems associated with INR testing within primary care were uncovered. Discrepant INR results are as problematic in hospital settings as they are in primary care. These data highlight the failings of the INR to standardise when different techniques and reagents are used, an issue which needs to be resolved. For primary care to become more involved in therapeutic oral anticoagulation monitoring, close links are needed between hospital laboratories and practices, particularly with regard to training and quality assurance.