Potential of Next-generation POCT in Infectious Disease Rapid Test.

Real-time test results are necessary for early diagnosis and in determining treatment orientation in medical practice. Point of Care Testing (POCT) is a testing system that provides beneficial and helpful information for diagnosis and treatment through real-time testing at the bedside. Therefore, POCT has high utility value in the field of infectious diseases as a rapid test that provides, within the consultation hours, useful information for initial treatment.Infectious disease rapid test kits are commercially available for a wide variety of prophlogistic pathogen targets, including bacterial, viral, fungal, protozoal, and other disease agents. One of these kits is immunochromatography assay (ICA), a measuring method used as POCT that is easy to operate, wherein even physicians and nurses can conduct the test.Serodiagnostic method has been adjunctively used in medical practice in Japan for early clinical diagnosis of deep mycosis as a means to determine treatments. However, this method is complicated and is considered a full-scale clinical examination; therefore, it is not included in the category of POCT. Recently, Loop-Mediated Isothermal Amplification (LAMP) method has been tested as a POCT for diagnosis of fungal infection in the US. Development of a laboratory procedure using simple and highly accurate POCT for early diagnosis of deep mycosis is expected in the near future.

[Laboratory Medicine Support for Disaster-Affected Region].

As natural disasters have been occurring more frequently in recent years, the need to prepare for a future disaster is growing. Based on the experience of the Great Hanshin earthquake occurred in 1995, we pre- dicted that laboratory test demand will be increased one week post-disaster. Also, the provision of medical and health care services is indispensable in areas affected by disasters for not only acute-phase patients, but also for those with diabetes, hypertension, and chronic diseases. This study summarized how laboratory medicine supplies were provided to the region affected by the Great East Japan earthquake occurred in 2011. In order to provide laboratory medicine supplies in the affected region, the Japanese Society of Laboratory Medicine set up a committee to respond to the Great East Japan earthquake as a temporary measure. Since electric power and water supplies are cut after a disaster, we decided to provide support using Point-Of-Care Testing (POCT) devices and disposable In-Vitro Diagnostic (IVD) reagents. A total of 40 companies agreed to provide support, and more than 100 IVD reagents were prepared. We posted the above information on our website, and updated it immediately when additional support requests were made. In addition, volunteer clinical technologists were sent to the affected region for 8 weeks, in order to support laboratory tests per- formed in temporary clinics or first aid stations. This experience was immediately applied to medical sup- port activities performed after the 2016 Kumamoto earthquake. This study identified the usefulness of la- boratory tests and clinical technologists in disaster-affected regions. [Review].

[Post-graduate Education of Clinical Laboratory Physicians and Medical Technologists (Biomedical Laboratory Scientist) -Chairpersons' Introductory Remarks -].

The symposium was cosponsored by the College of Laboratory Medicine of Japan (CLMJ). Two main top- ics were discussed in it. One was for clinical laboratory physicians, and the other was for medical technolo- gists. Regarding the former theme, a lecture was held about the medical specialist system beginning in the 2017 fiscal year, and the educational steps for becoming a clinical laboratory physician in the system. Re- garding the latter, four lectures were held, 1. Post-graduate education for medical technologists and the role of the Japanese Association of Medical Technologists, 2. Certification examinations by CJMJ, 3. Certification examinations by the College of Molecular Analysis, 4. Certification systems in foreign countries. We hope that this symposium can promote understanding of post-graduate education for clinical laboratory physicians and medical technologists, leading to career improvement. [Review].

[Circulatory Function Tests for Home & Community Use.]

Currently, the main circulatory function-testing tools for home use are blood pressure monitors and elec- trocardiography devices. Just like blood pressure monitors that are already widespread for home use, some devices with an electrocardiographic function have recently become available for purchase for personal use by the general public. On the other hand, clinic equipment on loan from doctors to patients in need can perform circulatory function tests like 24-hour ambulatory blood pressure monitoring (ABPM), Holter monitoring, and real-time electrocardiography. We introduce the actual clinical usage of ABPM and real-time electro- cardiography, and discuss the usefulness of these procedures. ABPM uses a blood pressure measurement device worn on the body for 24 hours a day to measure blood pressure at regular intervals. This makes it possible to check blood pressure changes throughout the day in a way in which conventional home-use blood pressure monitors cannot, like during sleep. This method al- lows the identification of masked hypertension like early-morning and nocturnal hypertension, stress hyper- tension including workplace hypertension, and white coat hypertension that only occurs in the doctor's office. Under routine care, there are few opportunities to perform electrocardiography at the time a patient is experiencing symptoms. Now, real-time electrocardiography has begun to be used in routine care, and pa- tients can record an electrocardiogram by themselves anytime, anywhere, and send the data by telephone or the Internet for analysis and diagnosis. Transmission-capable electrocardiography devices can play an im- portant role in the event of dangerous symptoms like arrhythmia, angina, or acute myocardial infarction. The spread of ABPM and event heart monitors is likely to make the early treatment and prevention of stroke and heart disease possible. We are expecting rapid development in this field in the future.

[The Significance and Efforts to Promote External Quality Control Surveys and Skills Tests--Chairmen's Introductory Remarks].

Not only is the role of "clinical testing" becoming increasingly important in diagnosis, but also the accurate management of clinical testing is growing in significance in order to examine "the reliability of data" obtained from such testing. For the purpose of assuring the reliability of data based on international conformity associated with an increase in global clinical trials, the Ministry of Health, Labour and Welfare advocates appropriate accuracy management, involving certification by a third party. Regardless of clinical trials, the Ministry of Health, Labour and Welfare states that the accurate management of a standard laboratory test is also a critically important issue. The value of clinical testing is fundamental to offering reliable clinical test data for clinical practice, and the mission of a clinical test department is to embody the principal of accuracy assurance and reflect it in routine clinical testing. Concerning external quality control surveys and skills tests in Japan, we asked both test sponsors and examinees to provide opinions on survey efforts, the purpose of participation, etc.

[The Establishment and Reality of a Quality Management System--Chairmen's Introductory Remarks].

Compared with clinical test data, the main ditterence from other forms of medical information is the objectivity of clinical test data. The value of clinical testing is basically to offer objective and reliable clinical test data for clinical practice both timely and promptly. A quality management system supports those practices, and the mission of a clinical test department is to embody the principle of accuracy assurance and reflect it in routine clinical testing. Accuracy management was previously a system to maintain and manage accurate reading, but it has developed into a system to assure data quality. It is considered necessary to use knowledge and skills on accuracy assurance and actively ensure the reliability of data. We therefore suggest the need for "a shift from accuracy assurance to quality management".

[Management of Personal Information in Clinical Laboratory Medicine:--Chairmen's Introductory Remarks].

The Japanese Society of Laboratory Medicine has been running its own Medical Safety Committee, and holding a symposium on medical safety during the annual meeting. The medical world is filled with a considerable amount of personal information, including genetic information, the ultimate personal information. We, as medical staff, have to manage such personal information not only in times of peace but also during disasters or emergency situations. In Japan, the Act on the Protection of Personal Information is currently being implemented, but a number of problems remain. Human beings have entered the information technology era, including electrical medical record systems, which is useful for research and education besides medical practice. This is why personal information must be more effectively protected from leakage, misconception, and abuse. We should create a sound system to manage personal information, with the spirit of protecting patient information that originated from the Oath of Hippocrates.

[Countermeasures against patient misidentification in laboratory study--chairmen's introductory remarks].

Since the launch of the "National Joint Action of Risk Management" back in May, 2008, as a participating organization, The Japanese Society of Laboratory Medicine has been running a Medical Safety Committee of our own. As part of our awareness education activities, our society has been holding symposia on medical safety at our annual meetings. In clinical practice, misidentification of patients is directly connected to serious medical mistakes. Although clinical practice itself must be safe for all, the actual clinical setting poses many hazards that could lead to medical professionals making errors. Since misidentification of patients regarding obtained specimens such as blood or physical function exams and misinterpretation of the exams itself can result in a serious outcome, every institute is using ingenious ways to keep close checks to prevent such misidentifications from happening. In this symposium, lectures were presented in the following subjects: A review on countermeasures against specimen misidentification in pathological exams in hospitals using electronic patient verification systems to prevent misidentification of patient blood samples, and hospitals where such systems are not employed; an introduction of countermeasures against specimen misidentification in pathological exams; and lastly, characteristics and limitations of human abilities, and process management, entitled "Human Factor Approaches to Medical Safety".

[Medical safety in infectious disease--chairmen's introductory remarks].

"The National Joint Action of Risk Management" was started in May 2008. The Japanese Society of Laboratory Medicine took this opportunity to set up a Medical Safety Committee as a participant in this Action. The Society holds symposia concerning medical safety to educate the Society members. Nosocomial infections are medical accidents. Whereas community-acquired infections are likely to develop depending on a balance between pathogens and hosts, nosocomial infections are implicated with medical practices, so they develop depending on the interrelationship among pathogens, hosts, and medical practices. Medical practices are mostly indispensable for providing medical services; therefore, activities against nosocomial infections are critical for establishing medical safety, freedom from anxiety, and reliability. Hence, this symposium deals with five themes: Countermeasures against and the management of needle-stick and cut accidents, collaboration between the infection control team (ICT) and the bacteriology laboratory, information transmission from the clinical laboratory department to physicians engaged in infectious disease treatment, utilization of laboratory data for infection control, and medical safety against tuberculosis infection.

[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.

[Activities for laboratory medicine support after the Great East Japan Earthquake by the Japanese Society of Laboratory Medicine].

The Great East Japan Earthquake caused a tragic tsunami and resulted in serious damage to north region of Japan on March 11, 2011. The Japanese Society of Laboratory Medicine, JSLM launched an ad hoc Committee to support Laboratory Medicine affairs in the affected area. We expected that laboratory testing demands would increase during the weeks following the disaster. We decided to support the use of Point-of-Care Testing. Many POCT devices use battery-powered analyzers. This is definite advantage for their use in areas with limited access to power and water supplies. We contacted many companies about the possibility of providing POCT devices, IVD reagents and/or any laboratory supplies including disposable materials. Finally, forty companies agreed to support this project and we received list of reagents materials for more than one hundred IVD tests. We entered this information on our web site and continued to update it as additional support was received. Once a request of support was received, communication were made to confirm the amount of material, the method of shipping/receipt and if any specific training that would be required for its use at the testing site. Also, we dispatched volunteer Medical Technologists for eight weeks to assist in the laboratory work. Some of the crucial points in recruiting volunteer laboratory professions are expenses and accommodations. We prepared not only accommodations but also transportation methods and covered all expenses including insurance and meals. Our relief activities have shown that Laboratory Medicine and Medical Technologists are useful in disaster-affected area.

[Education and enlightenment on point of care testing (POCT) and trainee physicians' wishes in handy blood glucose monitors: based on a questionnaire survey].

Devices for point of care testing (POCT) and self-monitoring of blood glucose (SMBG) have their own characteristics and understanding them is desirable for appropriate use. However, it is hard to say that all medical care prodivers, who measure blood glucose levels with them, understand the characteristics today. The POCT guidelines recommended education and enlightenment of physicians for appropriate use of POCT devices and documented that it was important to educate and enlighten trainee physicians in particular, who would be instructor doctors in the future. All first-year trainee physicians (72 physicians), who worked at the clinical laboratory in our hospital in 2005 and 2006 as rotator physicians in training, were asked to measure blood glucose with a POCT-compatible blood glucose monitor and a questionnaire survey was carried out. The necessity and the importance of the inspection were experienced, and the understanding level of POCT of the trainee physicians who finished clinical training in an indispensable department was higher than that of an inexperienced trainee physicians for clinical training.

Evaluation of atherosclerosis using data on serum lipids, serum adiponectin, carotid ultrasonography, and pulse wave velocity: implications for preventive medical care.

A database was constructed facilitating the earlier detection and treatment of atherosclerosis on the basis of data from clinical examinations. Carotid ultrasonography and measurement of the pulse wave velocity (PWV) were performed in patients with hyperlipidemia or type 2 diabetes and in those with both diseases together compared with normal healthy controls. The study excluded patients with a severe medical condition but included hyperlipidemic patients with total cholesterol <300 mg/dl or triglycerides <300 mg/dl, and type 2 diabetic patients with fasting blood glucose levels <200 mg/dl. Serum levels of total cholesterol (TC), triglycerides (TG), HDL-cholesterol (HDL-C), and LDL-cholesterol (LDL-C), the fasting blood glucose level, hemoglobin Alc (HbA1c) values, adiponectin levels, findings obtained from carotid ultrasonography (IMT and measurement of blood flow velocity), and PWV values were collated. None of the healthy control group had an intima-media complex thickness (IMT) > 1.1 mm, but 48% of the hyperlipidemic patients and 40% of type 2 diabetic patients did, and 33% of patients with both syndromes showed an increased IMT. Patients with both diseases also had the highest PWV of 1896 cm/s. There was no significant correlation between IMT values and serum lipids (neither total cholesterol, triglycerides, HDL-cholesterol, nor LDL-cholesterol), fasting blood glucose levels, or adiponectin levels. We conclude that not only the blood tests routinely conducted at present, but also functional tests such as ultrasonographic examination and measurement of the pulse wave velocity are necessary as screening tests.

Innovative instrumental analysis of heartbeat signals and its clinical application.

A new apparatus has been built that annexes a normal electrocardiograph, ECG, with the aim to enhance its capacity. It adds the normal ECG power to superpose multiple records of ECG altogether and averages out them and, further, makes sophisticated analysis, such as normalizing the peak heights, evaluating the half-line widths of the peaks, or that of the standard deviations of measurements like the inter peak distances. The results of the said calculations have not been obtainable using the former instruments, and are expected to be useful for clinicians.

[Controversies in the determination of serum albumin concentration in chronic liver diseases].

OBJECTIVE: It is known that there is quantitative alteration in serum albumin in the patients with chronic liver diseases. To clarity the quantitative alteration of serum albumin, serum albumin levels were measured by the Bromcresol green (BCG) method, the modified Bromcresol purple (BCP) method and immunoassay. METHODS: We enrolled 313 patients with chronic hepatitis, 74 cirrhotic patients and 36 healthy subjects. Serum albumin levels were measured by immunoassay, the BCG method and the modified BCP methods. RESULTS: The measurement of immunoassay showed a significant correlation in the measurement of the modified BCP method in the patients with chronic liver diseases. With the progress of chronic liver diseases, the serum albumin levels by the BCG method and electrophoresis were higher than the levels by the modified BCP method. In other hands, it was 0.07 g/dl higher level in chronic hepatitis and 0.18 g/dl higher in liver cirrhosis. And the serum albumin levels by the BCG method and electrophoresis were higher than the levels by the new BCP method in the patients with leg edema and ascites. In the malnourished patients Subjective global assessment (SGA-B), the serum albumin levels by the BCG method and electrophoresis were higher than the levels by the modified BCP method. CONCLUSIONS: Serum albumin levels were different by the method for measurements. The clinical implications of quantitative changes in albumin should be investigated in consideration of the microheterogeneity of albumin. The modified BCP method is superior method to evaluate the serum albumin levels.

[The current status of home medical treatment and its development in the future].

In this aging society, life-style diseases, chronic diseases, and disorders related to aging comprise a considerable share of the diseases treated medically. The importance of home treatment has consequently increased. Compared to patients treated in the hospital, those treated at home usually cannot receive sufficient treatment at present, and may impose a burden of care on family members. However, the cost of treatment at home including medical expenses is generally smaller than that in the hospital. In addition, treatment at home has the advantage that patients can be treated and cared for without reservation by their family members in the dwelling where they have used to living their lives. In Japan, home treatment has been performed by general practitioners making home visits. In response to the increased and diversified needs of community residents, new types of home treatment have also been explored recently, and even clinics specialized in home treatment have been opened. Not only medical doctors but also various medical workers, such as nurses, pharmacists, and physical therapists participate in home treatment at present, and medical instruments and methods of telecommunication have been developed. These circumstances are expected to improve the quality of medical treatment at home. In particular, recent advances in techniques and deregulation have exceeded previous expectations as exemplified by the increased number of downsized mobile and portable medical instruments and by the development of devices that allow diagnostic imaging to be performed at home.