Kobayashi N, Kamada Y, Tomiya Y
… +5 more, Kikuchi Y, Omokawa A, Saga T, Ueki S, Hirokawa M
Rinsho Byori
· 2016 Jan · PMID 27192803
With the development of medicine, the field of clinical laboratory medicine evolves rapidly, and it will be more specialized in the near future. Medical technologists are required to hone their skills and knowledge, in o...With the development of medicine, the field of clinical laboratory medicine evolves rapidly, and it will be more specialized in the near future. Medical technologists are required to hone their skills and knowledge, in order to keep up with the evolution. In recent years, board certifications by several medical societies are considered to indicate the skills of medical technologists. The number of board-certified medical technologists in populated areas such as Tokyo, Kanagawa, Osaka, and Fukuoka is greater than in less populated areas such as Kyusyu and Tohoku. The rate of certified medical technologists among prefectures is the highest in Mie (10.1%), followed by Nagasaki (8.8%). Tokyo, Ishikawa, Kyoto, and Osaka have acquisition rates greater than 7%. In contrast, prefectures of Miyazaki, Kumamoto, Yamanashi, and Akita have low acquisition rates of less than 4%. Being certified is not only an opportunity for personal career advancement, but also a chance to improve the laboratory. More technologists are being certified in our laboratory, and we are encouraging a future increase in their number. However, there are some problems to be overcome. Assignment of competent staff and long-term and premeditated rotation are considered to be important for staff to find the work rewarding, and the laboratory to be trusted by physicians.
Sato A, Shimura H, Hakoiwa T
… +8 more, Sakagami T, Ohishi M, Sato Y, Sakuma N, Midorikawa S, Suzuki S, Ohtsuru A, Suzuki S
Rinsho Byori
· 2016 Jan · PMID 27192802
As a response to the health effects associated with the Fukushima Daiichi Nuclear Power Plant accident that occurred after the Great East Japan Earthquake, the Thyroid Ultrasound Examination program as a part of the Fuku...As a response to the health effects associated with the Fukushima Daiichi Nuclear Power Plant accident that occurred after the Great East Japan Earthquake, the Thyroid Ultrasound Examination program as a part of the Fukushima Health Management Survey was started on Oct. 9th, 2011. Since this project required a large-scale cohort comprising all residents aged ≤ 18 years living in Fukushima when the earthquake happened, the nurturing of many ultrasound examiners was a matter of great urgency. Moreover, the standardization of examination procedures and skills of examiners were also important issues. Therefore, educational projects were established to develop ultrasound skills for medical doctors and technicians in Fukushima Prefecture. Marked efforts for this project resulted in increases in ultrasound examiners and institutions taking part in the Thyroid Ultrasound Examination project. Medical technicians specialized in ultrasound examinations are actively involved in these educational projects. We report the details of human resource development projects from the point of view of such medical technicians.
In order to promote further advances of medical systems in the Tohoku region where the Great East Japan Earthquake and the subsequent accident at the Fukushima Dai-ichi Nuclear Power Plant occurred, the requirement of hu...In order to promote further advances of medical systems in the Tohoku region where the Great East Japan Earthquake and the subsequent accident at the Fukushima Dai-ichi Nuclear Power Plant occurred, the requirement of human resources in clinical laboratory medicine has increased. Therefore, the symposium entitled "Human resource development for Tohoku region after Great East Japan Earthquake" was held in The 47th Tohoku Regional Congress of Japanese Society of Laboratory Medicine. In Fukushima Prefecture, the Thyroid Ultrasound Examination program has been conducted since Oct. 2011. Educational courses and certification programs for thyroid ultrasound examiners were established for medical doctors and technologists in Fukushima. The need for certified sonographers has also increased because deep venous thrombosis is also one of the health problems in the earthquake-hit area. Human resource development of sonographers was discussed in this symposium. In addition, further advances in clinical laboratory medicine are dependent on the development of specified medical technologists and certified physicians. Projects of human resource development currently performed in the Tohoku region were introduced and future actions were discussed.
Similar to other systems, the endocrine system is affected by aging. Thyroid hormone, the action of which is affected by many factors, has been shown to be associated with longevity. The most useful marker for assessment...Similar to other systems, the endocrine system is affected by aging. Thyroid hormone, the action of which is affected by many factors, has been shown to be associated with longevity. The most useful marker for assessment of the thyroid hormone action is the TSH level. Although age and sex are believed to modify the pituitary set point or response to the free thyroid hormone concentration, the precise age- and sex-dependent responses to thyroid hormone have yet to be reported. In this lecture, molecular aspects of resistance to thyroid hormone are initially overviewed. After presentation of the evidence that the TSH-thyroid hormone axis is evolutionarily modified, and that negative feedback mechanisms may start to play roles in homeostatic regulation at the time of delivery, the rationale of age-dependent thyroid hormone resistance is introduced. To assess the age- and sex-dependent resistance to thyroid hormone, the index is provided by the formula based on the relationship between thyroid hormone and TSH levels. The index is calculated by the results of thyroid function tests obtained from the two individual clinical groups. From the results, there were negative relationships between the free T3 resistance index and age in males of both groups, while there were no apparent relationships in females. These findings indicate that there is a male-specific response to thyroid hormone with aging. Furthermore, the specific features of the response may not be affected by environmental factors such as the presence of disorders or medical treatments.
Along with the established evidence on the association between a low HDL cholesterol level and arterial thrombosis, several limited studies have suggested that low HDL cholesterol is also a risk factor for venous thrombo...Along with the established evidence on the association between a low HDL cholesterol level and arterial thrombosis, several limited studies have suggested that low HDL cholesterol is also a risk factor for venous thrombosis, such as deep vein thrombosis and pulmonary embolism. As well as emerging evidence from clinical studies, basic research has proposed the interaction between HDL and key molecules in the field of thrombosis and hemostasis; HDL interacts with megakaryocytes to affect the production of platelets, suppresses the aggregation of platelets, protects against the injury of endothelial cells, and inhibits coagulation and fibrinolysis cascades. Considering these reports together, HDL can possess anti-thrombotic properties as one of its pleiotropic effects other than its role in the reverse transport system of cholesterol. Further study on the basic mechanism of this property of HDL and medical applications are expected to lead to the development of novel anti-thrombotic reagents and new laboratory tests for thrombosis and hemostasis in the future.
Low plasma levels of HDL-cholesterol (HDL-C) have been consistently associated with an increased risk of atherosclerotic cardiovascular diseases (CVD), and it is thus considered to be an anti-atherogenic lipoprotein. The...Low plasma levels of HDL-cholesterol (HDL-C) have been consistently associated with an increased risk of atherosclerotic cardiovascular diseases (CVD), and it is thus considered to be an anti-atherogenic lipoprotein. The development of novel therapies to enhance the atheroprotective properties of HDL may have the potential to further reduce the residual risk. Reverse cholesterol transport (RCT) is believed to be a primary atheroprotective property of HDL and its major protein, apolipoprotein A-I(apoA-I). HDL and apoA-I have been shown to promote the efflux of excess cholesterol from macrophage-derived foam cells via the cholesterol transporters, ATP-binding cassette transporter A1 (ABCA1), ABCG1, and scavenger receptor class B, type I (SR-BI), and then transport it back to the liver for excretion into bile and eventually into the feces. In this regard, a validated murine assay that quantifies macrophage RCT may be a better predictor of atherosclerosis than the steady-state plasma concentration of HDL-C. Indeed, a recent clinical study demonstrated that the ability of serum HDL to mediate cholesterol efflux from macrophages was independently and negatively associated with the CVD risk even after adjustment for HDL-C levels, suggesting that HDL functionality is more important than its quantity. Therefore, the future development of HDL-targeted therapy should take both aspects into consideration to further reduce the residual risk.
Plasma concentrations of high-density lipoprotein cholesterol (HDL-C) are inversely correlated with the risk of coronary artery disease (CAD). The cardioprotective effect of HDL is attributable to its reverse cholesterol...Plasma concentrations of high-density lipoprotein cholesterol (HDL-C) are inversely correlated with the risk of coronary artery disease (CAD). The cardioprotective effect of HDL is attributable to its reverse cholesterol transport capacity from peripheral cells to the liver. HDL has a variety of anti-inflammatory, anti-oxidative, and anti-apoptotic properties. However, recent interventional therapies using CETP inhibitors or niacin did not prove to be of benefit in the reduction of cardiovascular risks. This discrepancy is often explained by the quality of HDL particles. HDL particles undergo oxidation, chloralization, nitration, and calbamilation, under conditions due to inflammatory or metabolic disorders. HDL particles with these modifications may lose their atheroprotective effects and promote inflammatory processes, being referred to as dysfunctional HDL. HDL consists of a variety of phospholipids and proteins such as apolipoprotein A-I and paraoxonase-1. Because these components in the HDL particle regulate anti-atherosclerotic effects, the significance of HDL should be evaluated based on the HDL function. Reliable assays and surrogate markers of HDL function will be useful for evaluating the efficacy of HDL-targeted interventions against atherosclerosis. In this review, we summarized the mechanism of anti-inflammatory effects on HDL and assays for evaluating HDL functions.
High-density lipoprotein(HDL) particles play a role in anti-oxidative stress, and this action is partially involved in the anti-atherosclerotic processes. Indeed, a decreased level of anti-oxidative stress in HDL has bee...High-density lipoprotein(HDL) particles play a role in anti-oxidative stress, and this action is partially involved in the anti-atherosclerotic processes. Indeed, a decreased level of anti-oxidative stress in HDL has been reported in oxidative stress-related pathologies. As typical HDL-containing protein molecules, apolipoprotein A-I (apoA-I), paraoxonase-1 (PON1), and lipoprotein-associated phospholipase A2 (Lp-PLA2) are mainly described in the present review. Numerous studies have demonstrated that a low apoA-I level and the oxidative modification of apoA-I is associated with a dysfunction of anti-oxidative stress in HDL. A low PON1 level also plays a significant role in the dysfunction of anti-oxidative stress in HDL. Several studies have shown Lp-PLA2 to have an anti-atherosclerotic ability, while there have also been clinical studies showing a positive association between the Lp-PLA2 level and atherosclerotic manifestations. There are other HDL-containing protein molecules related to the anti-oxidative stress system in HDL, and all of these should be further investigated. The treatment of oxidative stress-related pathologies can lead to an improvement or even a full recovery of the anti-oxidative stress function in HDL. Given the multiple functions of HDL particles and the limitations associated with only HDL-cholesterol measurements, a comprehensive assessment of HDL particles, which includes the role of anti-oxidative stress in HDL, is thus considered to be necessary in future practice.
It is well-known that plasma HDL-C shows a negative correlation with the incidence of coronary artery disease, which was confirmed by the Framingham Study, a famous prospective cohort study, in 1977. At first, HDL-C was...It is well-known that plasma HDL-C shows a negative correlation with the incidence of coronary artery disease, which was confirmed by the Framingham Study, a famous prospective cohort study, in 1977. At first, HDL-C was determined by the precipitation method, and then the homogeneous method of HDL-C determination was developed in the 1990's in Japan. This method enabled HDL-C measurement in a short time for many samples. HDL removes free cholesterol from somatic cells by accepting cell cholesterol via ATP-binding cassette transporter A1. Cholesterol ester in HDL is transferred to VLDL and LDL by the action of cholesterol ester transfer protein or is incorporated into the liver via SR-BI. This pathway is called reverse cholesterol transport, which can regress atheromatous plaques. On the other hand, some CETP inhibitors, which can increase the HDL-C level have been developed in the world. However, the development of all candidate drugs was stopped because of side or insufficient effects. In addition, patients with CETP deficiency, whose HDL-C levels are markedly high, sometimes show the findings of coronary artery disease. These observations indicate that elevating HDL-C levels alone may not lower the cardiovascular disease risk. Recently, it was reported that HDL has pleiotropic functions other than reverse cholesterol transport. Actually, HDL inhibits lipid oxidation, impairs leukocyte adhesion and monocyte activation, promotes nitric oxide production, and inhibits the activation of platelets and the coagulation cascade. Functional characterization of HDL is, therefore, necessary for precise assessment of the cardiovascular risk and effectiveness of risk reduction.
OBJECTIVE: Clinical utility of a new marker for sepsis, presepsin, was evaluated by use of a case-control study design. METHOD: Enrolled in the study were seventy-one consecutive cases for whom blood culture was ordered...OBJECTIVE: Clinical utility of a new marker for sepsis, presepsin, was evaluated by use of a case-control study design. METHOD: Enrolled in the study were seventy-one consecutive cases for whom blood culture was ordered in suspicion of sepsis. After the culture, 36 subjects were diagnosed as having a state of sepsis (S group) and 35 were denied of sepsis (NS group). The serum level of presepsin was measured together with basic chemistry tests and complete blood counts at the time of diagnosis. RESULTS: Median serum presepsin for the two groups were 1,602 and 586 pg/mL, respectively. The difference was significant by Mann-Whitney test (P < 0.001). Logistic regression analysis was performed to evaluate contribution of presepsin in diagnosing sepsis in comparison with other markers for septic state. The result showed that presepsin was most powerful in predicting sepsis together with monocyte count percent (Mo). The diagnostic accuracy by use of logistic equation including both presepsin and Mo was 0.86 in terms of area under ROC curve (AUC), whereas AUC by use of an equation with presepsin alone was 0.80. Additionally, multiple regression analysis was performed to evaluate sources of variation of presepsin. It revealed that serum albumin and eGFR were negatively associated with serum level of presepsin. CONCLUSION: It is recommended to look at Mo together with presepsin in the diagnosis of sepsis. Serum level of presepsin is raised in the presence of renal dysfunction and/or hypoalbuminemia.
Nanbu Y, Nakata M, Nagasawa T
… +5 more, Ohe H, Nagahara M, Sakai Y, Minabe Y, Wada T
Rinsho Byori
· 2016 Jan · PMID 27192793
There have been a number of inconsistent previous reports indicating that mood disorder patients are relatively sensitive or conversely insensitive to physical pain. However, there have been few such studies examining pa...There have been a number of inconsistent previous reports indicating that mood disorder patients are relatively sensitive or conversely insensitive to physical pain. However, there have been few such studies examining pain using neurophysiological techniques. The present study was performed to investigate the differences in tactile sense recognition between mood disorder patients and control subjects using a tactile sense recognition P300 measuring system. Tactile stimuli were delivered to the index finger as frequent stimuli and to the ring finger as infrequent stimuli. Subjects were requested to press a button promptly and accurately in response to infrequent stimuli. N140 and P300 were measured in the event-related potential to infrequent stimulus paradigm. The subjects evaluated stimuli on a visual analog scale (VAS). The amplitudes of P300 were smaller for the mood disorder patients than for control subjects. The VAS scores of mood disorder patients were significantly higher than those of control subjects. In mood disorder patients, the amplitude of P300 was negatively correlated with the HAM-D score. These results suggest dysfunction of tactile sense recognition in mood disorder patients. In addition, the amplitude of P300 may be useful as a biological marker for psychological conditions in mood disorder patients.
Isono S, Okamur A, Iwamoto M
… +8 more, ImaiJunko IMAI, Nagata K, Akishino T, Okamura A, Kawamoto S, Kono M, Sugimoto T, Saigo K
Rinsho Byori
· 2016 Jan · PMID 27192792
Morphological abnormalities of blood cells are the typical characteristics of myelodysplastic syndromes (MDS). Recently, the usefulness of multiparameter automatic hematology analyzer XE-2100 for detecting neutrophil dys...Morphological abnormalities of blood cells are the typical characteristics of myelodysplastic syndromes (MDS). Recently, the usefulness of multiparameter automatic hematology analyzer XE-2100 for detecting neutrophil dysplasia has been reported by using parameters of NEUT-X and NEUT-Y, reflecting neutrophil cytoplasmic granularity and the cellular content of nucleic acid and protein, respectively. We evaluated the utility of these parameters by analyzing the blood samples of fifty MDS patients consulting Kakogawa West Municipal Hospital between Jan, 2010 and Jun, 2014, as well as 100 persons undergoing medical examinations during the same period as controls. Neutrophil granulation level was classified as normal, hypo-granular, or agranular under microscopic observation, and degranulation index was calculated using the following formula. The relationship between NEUT-X, NEUT-Y values and degranulation index was studied as below. Degranulation index = agranular (%) x 2+ hypo-granular (%) x 1 + normal (%) x 0 Neut-X values of MDS patients were 1,350 (mean), 1,345 (median), and NEUT-Y values, 430 (mean) and 432 (median). The NEUT-X and NEUT-Y values of control patients were 1,350, 1,349, 446 and 445, respectively. Correlation efficiency between degranulation index and NEUT-X or NEUT-Y were r = 0.62 or 0.52, respectively. Relationship between NEUT-X and NEUT-Y for all patients was r = 0.90. All the 10 patients showing NEUT-X lower than 1,315 and NEUT-Y lower than 400 simultaneously were MDS. Hence, we conclude that NEUT-X and NEUT-Y information is useful for quantitative evaluation of neutrophil morphological abnormalities.
A case of acute kidney injury (AKI) strongly suspected to be drug-induced (oxaliplatin and non-steroidal anti-inflammatory drug) is discussed regarding the mechanism of a reduced glomerular filtration rate responsible fo...A case of acute kidney injury (AKI) strongly suspected to be drug-induced (oxaliplatin and non-steroidal anti-inflammatory drug) is discussed regarding the mechanism of a reduced glomerular filtration rate responsible for the development of AKI. Urinary biochemical tests are useful for the differential diagnosis of pre- renal (functional) AKI and intrinsic (structural) AKI(so-called acute tubular necrosis). In this case, although a comprehensive differential diagnosis using these parameters supported intrinsic AKI, only one pa- rameter, fractional excretion of urea (FEurea), indicated the existence of prerenal AKI. As a result of treatment with the appropriate management of body fluid in addition to avoiding nephrotoxic medications, AKI rapidly improved. FEurea revealed the underlying mechanism of AKI. [Review].
In daily laboratory services, there are various factors associated with errors, such as those related to the principles of measurement, blood sampling procedure, or pathological condition. If medical technologists do not...In daily laboratory services, there are various factors associated with errors, such as those related to the principles of measurement, blood sampling procedure, or pathological condition. If medical technologists do not understand these factors, or adopt appropriate measures, they may face pitfalls. This paper outlines blood tests to develop basic knowledge of this area, and present examples of possible daily pitfalls and coun- termeasures against them. Regarding the blood count, it explains the mechanisms of automatic blood count devices and methods to manage erythrocyte aggregation, giant platelets, schizocytes, and platelet aggregation. Focusing on blood smears, it also examines the influences of excessive EDTA on blood cells, while discussing the mechanisms of automatic blood coagulation analyzers, as well as the influences of chyle and hematocrit levels on coagulation tests. Furthermore, in relation to the erythrocyte sedimentation rate, it confirms the principles of the international standard Westergren method and capillary photometry, and the influences of hematocrit levels. In order to avoid unexpected pitfalls, it may be important for medical technologists engaged in blood tests to implement their daily duties while fully understanding the necessity of: carefully observing individual spec- imens; clarifying related items (such as the patient's age, sex, and disease); and accurately recognizing the characteristics of individual test methods and reagents used within the facility, in addition to the principles of their measurement. [Review].
Biochemical tests are used to analyze a variety of blood components, and in the diagnosis and post- treatment follow-up of diseases. Diagnosis is often performed with an integrated approach using a number of clinical tes...Biochemical tests are used to analyze a variety of blood components, and in the diagnosis and post- treatment follow-up of diseases. Diagnosis is often performed with an integrated approach using a number of clinical test items. It is necessary for the sound interpretation of measurement results to consider the mechanisms and pathogenesis, in addition to technical knowledge. Furthermore, some new pitfalls must be considered when introducing automatic analyzers. When considering re-examination, it is necessary to as- sess data of related test items, sample conditions, and all the possibilities of clinical backgrounds. Determin- ing data authenticity by the combination of pitfalls.of laboratory testing with clinical testing backgrounds may allow the work of clinical laboratory technologists to be more meaningful. [Review].
Immunological tests based on antigen-antibody reactions are widely used to detect and quantify tumor markers, hormones, infections, and other targets. The detection sensitivity and specificity of these tests have recentl...Immunological tests based on antigen-antibody reactions are widely used to detect and quantify tumor markers, hormones, infections, and other targets. The detection sensitivity and specificity of these tests have recently improved markedly as a result of technical advances in antibody preparation and optical meas- urement. Despite these technical innovations however, it remains impossible to completely prevent non- specific reactions. In this paper, we describe the causes of such non-specific reactions as obstacles to im- munological testing, mainly in automated testing; special reference is given to some cases of interference by cross-reactions, heterophile antibodies, and autoantibodies that we encountered while measuring carcinoem- bryonic antigens (CEAs). Since not only non-specific reactions but also exogenous factors, such as sample processing, can cause abnormal data, noteworthy points in actual test settings are also described. To cope with the abnormal data, it is necessary to raise risk awareness among technicians who perform immunological tests, and establish an information-sharing system that allows queries from physicians to be quickly relayed to staff in the actual test setting. [Review].
The promotion of self-medication was announced in the "strategy for the reconstruction of Japan", which was approved in June 2013 by the cabinet, with the concepts of "extending healthy life expectancy" and estab- lishin...The promotion of self-medication was announced in the "strategy for the reconstruction of Japan", which was approved in June 2013 by the cabinet, with the concepts of "extending healthy life expectancy" and estab- lishing "pharmacy-based laboratory testing services". In April 2014, the "guideline for pharmacy-based laboratory testing" was published, and approximately 1,000 pharmacies were registered as service providers as of the end of May 2015. Issues of providing pharmacy-based laboratory testing services were as follows: 1) appropriate techniques for fingertip blood sampling, 2) quality control including the maintenance and management of devices and reagents, 3) infection prevention, and 4) provision of information on examination results and factors affecting the examination to examinees. The improvement of health screening rates remains to be resolved in order to achieve "extension of healthy life expectancy" and reduce medical costs. The involvement of clinical testing specialists is essen- tial to resolve the above issues for the appropriate management of pharmacy-based laboratory testing ser- vices. [Review].
Type 2 diabetes and prediabetes are highly prevalent in Japan, affecting nearly 25% of the population. Recent advances in the development of POCT analyzers now enable us to screen for undiagnosed diabetes using easy fing...Type 2 diabetes and prediabetes are highly prevalent in Japan, affecting nearly 25% of the population. Recent advances in the development of POCT analyzers now enable us to screen for undiagnosed diabetes using easy fingertip self-testing of blood hemoglobin A1c (HbA1c) in such public places as community phar- macies. Using this method in 20 pharmacies in Adachi Ward, Tokyo and in Tokushima Prefecture, we screened more than 4,700 people who were not under treatment at hospital in our study, named "Diabetes Screening Revolution." As a result, we identified more than 500 (app. 11%) diabetic and 670 (app. 14%) prediabetic people who were not under treatment. This result demonstrates that fingertip screening using the POCT HbAlc analyzer at pharmacies is effective for the early recognition of diabetes and prediabetes. Moreover, in response to our research results, Japan's government has revised the legislation governing la- boratory medical technologists to allow fingertip self-testing in such public places as community pharmacies, with such a site being referred to as a "Specimen measurement office" in the new legal system. Collectively, we established a new scheme of self-screening for diabetes in Japan. [Review].
Matsuura T, Mezaki Y, Masaki T
… +6 more, Matsumoto Y, Maehashi H, Nakamura M, Nakada K, Park JH, Yokoyama H
Rinsho Byori
· 2016 May · PMID 30695368
The urea breath test was developed for the diagnosis of Helicobacter pylori infection. In this test, we measure exhaled ¹³CO₂ using POCone developed in Japan, which is an infrared spectrometry photometer. Based on the ur...The urea breath test was developed for the diagnosis of Helicobacter pylori infection. In this test, we measure exhaled ¹³CO₂ using POCone developed in Japan, which is an infrared spectrometry photometer. Based on the urea breath test, we subsequently developed the in vitro ¹³C-glucose exhaling test. In this test, ¹³C-glucose is added in the circulation culture medium, and ¹³CO₂ generated with a bioartificial liver is measured by the POCone. The quantity of discharged ¹³CO₂ reflects the energy-producing ability of the bioartifi- cial liver. Therefore, we can simply and easily observe the viability of a bioartificial liver and the effect of drugs on carbohydrate metabolism in the bioartificial liver in real time. According to the results of a bioartificial liver study, we developed the fasting ¹³C-glucose breath test, which can quickly determine hepatic insu- lin resistance in humans with marked sensitivity. The bioartificial liver study unexpectedly led to the development of a new stable isotope breath test. [Review].
Laboratory data are used to check patient eligibility, judge a change in medication, and evaluate the efficacy and safety of a test drug, and they comprise an important part of clinical trial data. Although a central lab...Laboratory data are used to check patient eligibility, judge a change in medication, and evaluate the efficacy and safety of a test drug, and they comprise an important part of clinical trial data. Although a central labora- tory model has been adopted since the early 1990s to minimize inter-site variability, local laboratories are still important and often necessary for many reasons. Because it is not rare for many countries to participate in multi-regional clinical trials, "whether data from different countries or different sites could be handled as if those data were obtained from a single site" is a challenge in such clinical trials. Here, it is very important for sites to be ready to state that their laboratory has no problems with pre-analysis, analysis, or record stor- age to-a third party. [Review].