Rinsho Byori. The Japanese Journal Of Clinical Pathology[JOURNAL]
Sun
200 papers
[Instruction on Clinical Samples and Ethical Guidelines -How We Should Handle These Matters, Measurements, and Problems in Kyoto Prefectural University Hospital-].
Inaba T
Rinsho Byori · 2016 Jul · PMID 30695470
Since 2013, the institutional review board (IRB) of Kyoto Prefectural University of Medicine has adopted an on-line application system for medical research protocols to shorten the term of examination. In the same year,...
Since 2013, the institutional review board (IRB) of Kyoto Prefectural University of Medicine has adopted an on-line application system for medical research protocols to shorten the term of examination. In the same year, research misconduct regarding valsartan (Diovan®) was disclosed, which prompted our institute to reorganize research ethics especially through the Center for Quality Assurance in Research and Development. Concerning the questions asked by Prof. Tohyama, the answers from the IRB of our institute were as fol- lows: 1) the evaluation of new instruments or reagents should be approved by the IRB if it may be exhibited at an academic meeting or published in a scientific journal, 2) non-invasive non-interventional data collection without prior approval would become a target of verbal warnings by the IRB, and 3) residual samples after laboratory examination could be available for research use if the protocol is explained to the patients with an opt-out guarantee. For research use of residual samples after laboratory examination, we have been able to issue a letter of consent for laboratory examination since 2008. However, unfortunately, this letter does not seem to be convenient for the majority of clinicians in our hospital. A more useful and reasonable method seems neces- sary to assist clinical research using residual samples based on Ethical Guidelines for Medical and Health Research Involving Human Subjects, which was newly published in 2015. [Review].
[How to Treat the Clinical Specimens for Laboratory Testing in Line with Ethical Guidelines - Chairpersons' Remarks -].
Tohyama K, Okubo S
Rinsho Byori · 2016 Jul · PMID 30695469
Clinical laboratory studies utilizing residual specimens after laboratory testing have markedly contributed to the development of medical science. However, according to recent rules regarding ethical aspects, the ethical...
Clinical laboratory studies utilizing residual specimens after laboratory testing have markedly contributed to the development of medical science. However, according to recent rules regarding ethical aspects, the ethical committee of the Japanese Society of Laboratory Medicine (JSLM) developed ethical guidelines for treating residual specimens. In this symposium, several ethical problems concerning the application of such specimens to laboratory investigation were raised and discussed. Concerning whether or not each informed consent should be ob- tained before the secondary use of the residual specimens, this matter itself revealed serious disagreements among institutes. Therefore, the ethical committee of JSLM has to propose uniform and widely acceptable guidelines for the effective utilization of laboratory specimens, aiming at the advancement of laboratory medi- cine. [Review].
[Progress in the Management of NAFLD/NASH].
Aizawa Y
Rinsho Byori · 2016 Jul · PMID 30695468
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases. The con- cept of NAFLD ranges from simple steatosis (NAFL) to non-alcoholic steatohepatitis (NASH) and cirrhosis. The majority o...
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases. The con- cept of NAFLD ranges from simple steatosis (NAFL) to non-alcoholic steatohepatitis (NASH) and cirrhosis. The majority of NAFLD has been recognized as a hepatic manifestation of metabolic syndrome with a close association with insulin resistance. Regarding the development of NAFLD/NASH, adiponectin and TNFa are thought to have key roles. Moreover, the gut microbiota may affect energy metabolism in the context of NAFLD. Genetic susceptibility to NAFLD may be determined by polymorphisms of patatin-like phospho- lipase domain-containing 3 (PNPLA3) and methylenetetrahydrofolate reductase (MTHFR). The diagnosis of NAFLD/NASH is made by liver biopsy. The differential diagnosis between NAFL and NASH has been made according to Matteoni's classification, and the progression of liver fibrosis has been determined by Brunt's staging. For the prevention and treatment of NAFLD, the modification of dietary habits and promo- tion of physical activity including aerobic and resistance training are essential. Although vitamin E, pioglita- zone, or liraglutide is used as a first-line treatment for NAFLD, pharmacotherapy for NAFLD has not been established because of the insufficient pharmacological effects of these agents. Among recently developed drugs, farnesoid X nuclear receptor ligand obeticholic acid is the most promising for first-in-class treatment of NASH. In this review, the details of recent advances in knowledge about the epidemiology, etiology, diag- nosis, and treatment of NAFLD/NASH are described. [Review].
[Liver Cancer].
Yamashita T, Kaneko S
Rinsho Byori · 2016 Jul · PMID 30695467
Liver cancer is classified into primary and metastatic liver cancer. In Japan, hepatocellular carcinoma (HCC) accounts for about 95% and intrahepatic cholangiocarcinoma for about 4% of primary liver cancer. Recently, the...
Liver cancer is classified into primary and metastatic liver cancer. In Japan, hepatocellular carcinoma (HCC) accounts for about 95% and intrahepatic cholangiocarcinoma for about 4% of primary liver cancer. Recently, the prevalence of and mortality due to liver cancer have been rapidly decreasing in Japan. The main etiology of HCC is chronic infection of hepatitis B virus (HBV) and hepatitis C virus (HCV). However, the rate of these viral infections is decreasing, but the rate of HCC caused by non-alcoholic steato- hepatitis (NASH) is gradually increasing. The characteristic pathogeneses are multi-centric carcinogenesis, intrahepatic metastasis, and multi-step carcinogenesis. These pathogeneses are related to high rates of recurrence of HCC even after curative treatment. Clinical symptoms of HCC are rare in Japan because most patients with HCC are diagnosed by surveillance or incidental imaging analysis. HCC is diagnosed by not pathology but also classical images defined as showing early staining during the arterial phase and hypoattenuation compared with the surrounding non-tumorous liver during the portal or equilibrium phase (washout) on dynamic CT or MR. Three tumor markers: a-fetoprotein (AFP), protein induced by vitamin K absence or antagonist-II (PIVKA-II), and LCA-reactive a-fetoprotein isoform (AFP-L3), support the diagnosis. The surveillance of high-risk groups is recommended in Japanese Clinical Practice Guidelines for Hepatocellular Carcinoma 2013. Treatments for HCC are selected by considering the tumor progression and hepatic reserve and consist of surgery(hepatic resection, liver transplantation), local ablation therapy, transarterial chemoembolization (TACE), chemotherapy (sorafenib, hepatic arterial infusion chemotherapy), and radiation therapy. The algorithm for treatment selection is presented in the Japanese Clinical Practice Guidelines for Hepatocellular Carcinoma 2013. [Review].
[Recent Advances in Anti-Hepatitis C Viral Treatment and Future Perspective].
Asahina Y
Rinsho Byori · 2016 Jul · PMID 30695466
Hepatitis C virus (HCV) infection is a common cause of hepatocellular carcinoma (HCC), which is the third most common cause of cancer mortality worldwide. Previous anti-HCV therapies using interferon-based regimens lead...
Hepatitis C virus (HCV) infection is a common cause of hepatocellular carcinoma (HCC), which is the third most common cause of cancer mortality worldwide. Previous anti-HCV therapies using interferon-based regimens lead to sustained virologic response (SVR) rates in only approximately 50% of patients infected with HCV genotype 1. Along with recent advances in treatment for HCV infection by direct-acting antiviral agents (DAAs), the efficacy of anti-viral therapy has markedly improved, and almost 100% of sustained HCV eradication has been achieved by interferon-free regimens. Although combination therapy with DAAs with- out interferon offers fewer side effects and higher SVR rates, this may introduce issues regarding affordability and accessibility, including the emergence of drug-resistant HCV mutants and hepatocarcinogenesis. Espe- cially, HCC continues to develop in patients, even in those who have achieved an SVR, particularly in those showing signs of advanced liver fibrosis or severe steatosis, or those from an older age group. Therefore, the assessment of liver fibrosis and/or the risk of HCC development is essential for the management of pa- tients with chronic hepatitis C, not only before treatment but also after achieving an SVR. In this article, recent advances in anti-HCV treatment are reviewed and the future perspective is discussed. [Review].
[Hepatitis B Virus Infection: Current Management and Prevention].
Inoue T, Tanaka Y
Rinsho Byori · 2016 Jul · PMID 30695465
Hepatitis B virus (HBV) is transmitted mainly via percutaneous or permucosal exposure to HBV- containing body fluids. Because HB vaccination is effective and safe, it is recommended for all children, ado- lescents, and a...
Hepatitis B virus (HBV) is transmitted mainly via percutaneous or permucosal exposure to HBV- containing body fluids. Because HB vaccination is effective and safe, it is recommended for all children, ado- lescents, and all unvaccinated adults at risk of HBV infection (individuals with occupational risk, immunosup- pressed individuals, and sexually active individuals). In Japan, universal HB vaccination will be introduced for all infants in October 2016. In Japan, the prevalence of HBV genotype A, which is frequently found in North America, northwestern Europe, India, and Africa, has been increasing as a sexually transmitted infection. HBV reactivation under anticancer chemotherapy and immunosuppressive therapy is well-known as a seri- ous complication in HBV-resolved patients. Monthly monitoring of HBV-DNA is recommended for prevent- ing HBV reactivation-related hepatitis among HBV-resolved patients with non-Hodgkin B-cell lymphoma under steroid plus rituximab chemotherapy. Recently, a highly sensitive chemiluminescent enzyme immunoassay (CLEIA) for HBsAg detection by Lumipulse HBsAg-HQ was reported as the latest clinical application. Although the sensitivity of this assay (≥5 mIU/mL) is 10-fold higher than the conventional assay, it is still lower than that of the HBV-DNA assay. The useful HBsAg-HQ will be applied for detecting occult HBV infection and HBV reactivation. The aim of treatment for chronic HBV infection is to reduce the risk of complications, including cirrhosis and hepatocellular carcinoma (HCC). Pegylated interferon alfa and nucleoside/nucleotide analogues (NAs) are the current treatments for chronic HBV infection. NAs have improved the outcomes of patients with cirrhosis and HCC, and decreased the incidence of acute liver failure. [Review].
[Potential Application of Fibrinogen Measurement Based on the Clauss Assay to Monitoring of Dabigatran].
Fujimorl Y, Wakui M, Katagiri H … +4 more , Ohir A K, Shimizur N, Mitsuhashi T, Murata M
Rinsho Byori · 2016 Jul · PMID 30695464
A direct thrombin inhibitor (DTI), dabigatran was expected to be available for therapeutic use without mon- itoring. However, a number of severe bleedings occurring in patients on medication with dabigatran have been rep...
A direct thrombin inhibitor (DTI), dabigatran was expected to be available for therapeutic use without mon- itoring. However, a number of severe bleedings occurring in patients on medication with dabigatran have been reported. The impact of dabigatran concentrations on major bleeding risk has also been revealed. Therefore, the significance of monitoring of dabigatran is of considerable interest. Hemoclot thrombin inhib- itor assay enables quantification of dabigatran concentrations but is not yet routinely available for clinical la- boratories in Japan. Based on spiking experiments with another DTI, argatroban, we previously demon- strated that the discrepancy in resulting quantification of fibrinogen concentrations between two different thrombin concentrations used in the Clauss assay may enable monitoring of DTIs. In the present study, analogous experiments using dabigatran were carried out, providing similar findings. The measured values of fibrinogen in the presence of dabigatran were similar to those in the absence of dabigatran when assayed using the high thrombin concentration (high-thrombin). The measured values of fibrinogen decreased in parallel with the increase in dabigatran concentrations when assayed using the low thrombin concentration (low-thrombin). Fibrinogen ratio, which is calculated by dividing the fibrinogen value measured with high- thrombin by that measured with low-thrombin, increased more sensitively at the high range of dabigatran concentrations than at the low range. Our observations suggest that the fibrinogen measurement based on the Clauss assay is practically applicable to monitoring of dabigatran especially for prediction of the bleeding risk. [Original].
[Clinical Application of Methods for the Qualitative Evaluation of Lipid Abnormalities].
Hirayama S
Rinsho Byori · 2016 Feb · PMID 27311287
Recent lifestyle and social environment changes in Japan have been accompanied by increasing incidencerates of metabolic disorders, such as dyslipidemia and diabetes. Therefore, the rates of cardiovascular disease due to...
Recent lifestyle and social environment changes in Japan have been accompanied by increasing incidencerates of metabolic disorders, such as dyslipidemia and diabetes. Therefore, the rates of cardiovascular disease due to the progression of atherosclerosis are also increasing, and cardiovascular disease remains the leading cause of death in Japan. In particular, dyslipidemia, represented by hypercholesterolemia, hypertriglyceridemia, and hypoalphalipoproteinemia, is closely related to the onset and progression of atherosclerosis. Total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol have been used as quantitative markers of lipids to evaluate cardiovascular risks. However, these markers are not sufficient to fully assess the risks. Therefore, we focused on qualitative markers that represent lipid abnormalities, and examined the utility of qualitative lipids evaluation as clinical markers of atherosclerotic disorders. Previously, we reported that HDL and LDL subclasses and sterol markers are clinically important for evaluating the pathogenesis and risks of cardiovascular disorders. Moreover, lipoprotein subclasses may be useful as therapeutic markers for cardiovascular disorders, and oxysterols may also be useful as diagnostic markers for dementing disorders and diseases of the central nervous system. These issues remain to befully elucidated in the future.
[Latest Treatment of Viral Hepatitis--Overcoming Hepatitis C and Reactivation of Hepatitis B].
Tanaka Y
Rinsho Byori · 2016 Feb · PMID 27311286
Hepatitis B virus (HBV) and hepatitis C virus (HCV), discovered as causative viruses of post-transfusion hepatitis, become persistent infections, leading to chronic hepatitis, cirrhosis, and hepatocellular carcinoma (HCC...
Hepatitis B virus (HBV) and hepatitis C virus (HCV), discovered as causative viruses of post-transfusion hepatitis, become persistent infections, leading to chronic hepatitis, cirrhosis, and hepatocellular carcinoma (HCC). For HCV, recent IFN-free direct-acting antiviral (DAA) therapies have increased sustained virological response (SVR) rates and reduced adverse events. IFN-based therapies, still the standard of care in Asian countries, are influenced by IL28B genetic variants and the liver fibrosis stage, but the DAA combinations obscure the influence of these factors. These new therapies can eradicate HCV and prevent HCC development. On the other hand, it is difficult to eradicate HBV completely. Although HBV infection can be prevented by vaccination, reactivation of HBV following anti-cancer chemotherapy and immunosuppressive therapy is a well-known complication. HBV reactivation has been reported to be associated with anti-CD20 monoclonal antibody rituximab-containing chemotherapy and TNF-α inhibitor-containing immunosuppressive therapy in HBV-resolved patients. Our prospective observational study revealed that monthly monitoring of HBV DNA was useful for preventing HBV reactivation-related hepatitis among B-cell non-Hodgkin lymphoma patients with resolved HBV infection following rituximab-steroid-chemo, suggesting that preemptive therapy guided by serial HBV DNA monitoring should be recommended. Recently, highly sensitive HBsAg detection by Lumipulse HBsAg-HQ may be useful for several clinical applications. The sensitivity of this assay (5 mIU/mL) was approximately 10-fold higher than Abbott ARCHITECT, but still lower than HBV-DNA assays. The convenient HBsAg-HQ may be useful for detecting occult HBV infection and HBV reactivation in relatively low-risk groups except for those receiving rituximab-steroid-chemo. [
[How to Understand "Clinical Ethics" and "Research Ethics" in Clinical Settings--Incorporation of IRB, REC, and CEC in Hospital Organizations].
Ita K
Rinsho Byori · 2016 Feb · PMID 27311285
As the traditional definition of "medical ethics" has recently changed markedly with advances in medical knowledge and technology, medical doctors and researchers in Japan are required to understand and apply both resear...
As the traditional definition of "medical ethics" has recently changed markedly with advances in medical knowledge and technology, medical doctors and researchers in Japan are required to understand and apply both research and clinical ethics. Quite frequently, ethical problems in clinical settings cannot be addressed by the simple application of good will, hard work, and perseverance by medical personnel. The Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Education, Culture, Sports, Science and Technology (MEXT) have jointly published "Ethical Guidelines for Clinical Studies;" however, clear guidelines (legal, ministerial, or governmental) outlining the expectations regarding clinical ethics do not exist. All medical personnel face deep ethical dilemmas. In these instances, if the fulfillment of 'ethics' relies solely on the capacity of personnel to apply their own individual moral efforts, the result will be burn-out among these workers who have a strong sense of responsibility. In order to avoid this, a system which comprises multiple physicians, nurses, and other personnel must be established, allowing collaboration when an appropriate response is required. A major factor supporting this approach is the offering of Clinical Ethics Consultations.
[Clinical Application of Analytical and Medical Instruments Mainly Using MS Techniques].
Tanaka K
Rinsho Byori · 2016 Feb · PMID 27311284
Analytical instruments for clinical use are commonly required to confirm the compounds and forms related to diseases with the highest possible sensitivity, quantitative performance, and specificity and minimal invasivene...
Analytical instruments for clinical use are commonly required to confirm the compounds and forms related to diseases with the highest possible sensitivity, quantitative performance, and specificity and minimal invasiveness within a short time, easily, and at a low cost. Advancements of technical innovation for Mass Spectrometer (MS) have led to techniques that meet such requirements. Besides confirming known substances, other purposes and advantages of MS that are not fully known to the public are using MS as a tool to discover unknown phenomena and compounds. An example is clarifying the mechanisms of human diseases. The human body has approximately 100 thousand types of protein, and there may be more than several million types of protein and their metabolites. Most of them have yet to be discovered, and their discovery may give birth to new academic fields and lead to the clarification of diseases, development of new medicines, etc. For example, using the MS system developed under "Contribution to drug discovery and diagnosis by next generation of advanced mass spectrometry system," one of the 30 projects of the "Funding Program for World-Leading Innovative R&D on Science and Technology" (FIRST program), and other individual basic technologies, we succeeded in discovering new disease biomarker candidates for Alzheimer's disease, cancer, etc. Further contribution of MS to clinical medicine can be expected through the development and improvement of new techniques, efforts to verify discoveries, and communications with the medical front.
[Physiological Function of Apolipoproteins and Atherosclerosis].
Seishima M
Rinsho Byori · 2016 Feb · PMID 27311283
We have studied the physiological function of four apolipoproteins. First, apo A-I is a major component of HDL and plays a crucial role in reverse cholesterol transport. The lipid-poor apo A-I concentration in plasma was...
We have studied the physiological function of four apolipoproteins. First, apo A-I is a major component of HDL and plays a crucial role in reverse cholesterol transport. The lipid-poor apo A-I concentration in plasma was significantly increased in patients with coronary artery disease compared with healthy controls, which may be caused by the impairment of the reverse cholesterol transport pathway. Second, the plasma A-IV concentration was significantly elevated in uremic patients, and we revealed the mechanism of apo A-IV accumulation in plasma using a rat model. Third, apo B48 is associated with lipid absorption in the intestinal epithelium, but the lymph apo B48 output was not changed during the absorption of mid-chain triglycerides, unlike apo A-IV. Fourth, we showed for the first time that the cerebrospinal apo E level was reduced in early-onset Alzheimer's disease and increased in a late-onset group. Taken together, apolipoproteins show various functions via the regulation of lipid metabolism. We have also studied the effect of cytokines on atherosclerosis using cytokine knockout mice. TNF-α and IL-1β increased the number and size of atherosclerotic lesions, but IFN-γ attenuated the lesions. Plaque formation is influenced by not only the cholesterol level in plasma but also cytokine levels and other unknown factors. It may be of no merit to give cholesterol-lowering drugs to hypercholesterolemic patients without plaque. It is, thus, strongly expected that a biomarker which can predict the presence of plaque will be developed in the future.
[Osaka Medical Laboratory ISO15189 Study Group: History and Future Prospects of the Group].
Iguchi K
Rinsho Byori · 2016 Feb · PMID 27311282
The IS015189 "Medical laboratories: Specific requirements regarding quality and competence" is an international standard issued by the International Organization for Standardization (ISO) in February 2003. In October 200...
The IS015189 "Medical laboratories: Specific requirements regarding quality and competence" is an international standard issued by the International Organization for Standardization (ISO) in February 2003. In October 2004, pilot surveys were initiated in Japan prior to accreditation surveys scheduled to be started in 2005. In September 2005, the first ever ISO15189-accredited facility was established in Japan. With the background of limited information about and few opportunities to study ISO15189 in 2004, we established the Osaka Medical Laboratory ISO15189 Study Group as a unique association that anyone interested in the ISO is able to join. Approximately 900 people have participated in group meetings, which have been held a total of 11 times. Thus, our group has played a major role in ISO development in Japan. To date, approximately 100 facilities have been ISO15189-accredited in Japan, suggesting the need to take new steps regarding its accreditation. As our group has achieved our initial objective, we are planning to work towards taking new steps, such as interaction with accredited facilities.
[Challenges and Outcomes of the Process for Achieving Certification].
Kadosaka Y, Suzuki R, Yoshika M … +1 more , Tsuta K
Rinsho Byori · 2016 Feb · PMID 27311281
Clinical laboratory tests have been indispensable for medical services in recent years, and such a situation is associated with the offering of accurate test results by clinical laboratory units. A large number of facili...
Clinical laboratory tests have been indispensable for medical services in recent years, and such a situation is associated with the offering of accurate test results by clinical laboratory units. A large number of facilities wishing to achieve ISO 15189 Certification follow preparatory procedures with support from consulting companies. However, in our facility, a limited budget did not allow us to use such services. As a solution, we participated in the Future Lab Session in OSAKA (FLS), a support group for the achievement of ISO 15189 Certification, when it was organized. Aiming to extensively cover and fulfill its responsibility for all processes, including clinical interpretations of the results obtained through patient preparation, in order to continuously offer high-quality test results to clinicians, our clinical laboratory unit underwent examination for certification, and consequently realized the necessity of third-party evaluation. The provision of laboratory services, fully complying with these standards, contributes to medical safety, in addition to accuracy improvement. Although the certification and its maintenance are costly, it is sufficiently cost-effective to achieve it, when focusing on improved efficiency and the enhanced quality and safety of medical services after work standardization.
[Education and Training of Personnel in Morphology].
Katagiri H, Yamagata J
Rinsho Byori · 2016 Feb · PMID 27311280
We introduce our efforts to utilize education, training, competence assessment, and quality control of personnel engaged in urinary sediment and blood cell morphology examinations in our laboratory. There are no standard...
We introduce our efforts to utilize education, training, competence assessment, and quality control of personnel engaged in urinary sediment and blood cell morphology examinations in our laboratory. There are no standard samples for these morphological examinations, and standardization has not been completed for all types of blood cells or urinary sediment components. We had been carrying out simultaneous microscopic examination involving trainee staff and senior laboratory technologists as a means of education and evaluation, but acceptance criteria were unclear. Moreover, we had continued our operation without assessment of the level of achievement of routine works or the competence of individual staff members. Taking the opportunity of receiving ISO 15189 certification, we have been able to establish clear standards for evaluating personnel education and training in morphological examinations. We will continuously make efforts to maintain and manage this system.
[ISO 15189, Up-To-Date Information and Prospective View].
Shimoda K
Rinsho Byori · 2016 Feb · PMID 27311279
"Accreditation Activities for Medical Laboratories in Japan" Audits for transition to ISO 15189:2012 continue to progress. Besides the continual increase of accreditations for medical laboratory testing and pathological...
"Accreditation Activities for Medical Laboratories in Japan" Audits for transition to ISO 15189:2012 continue to progress. Besides the continual increase of accreditations for medical laboratory testing and pathological examinations, preparations for the addition of physiological testing to the scope of accreditation have finally been completed. As a part of the revision to Japan's Medical Service Act, the external evaluation of medical laboratories is now a requirement to approve clinical trial core hospitals. Accordingly, the importance of third-party accreditation in medical laboratory testing is attracting a growing level of attention. World Accreditation Day 2015 "Accreditation: Supporting the Delivery of Health and Social Care" JAB is being used to make every effort to contribute to this system in order to improve the quality of healthcare in Japan and the health of its citizens.
[Basic Evaluation of Microsemi LC-767CRP as POCT Model for Simultaneous Measurement of CBC and CRP].
Inaba T, Ikeda M, Saitoh K … +8 more , Yuasa S, Mishima N, Ogura K, Oku N, Kodama M, Fujitomo Y, Nakanishi M, Fujita N
Rinsho Byori · 2016 Feb · PMID 27311278
Microsemi LC-767CRP (LC-767, Horiba, Ltd.) is capable of simultaneous measuring of complete blood count (CBC) including 3-part differentials (3-part Diff.) of white blood cells (WBC) and C-reactive protein (CRP) in 4 min...
Microsemi LC-767CRP (LC-767, Horiba, Ltd.) is capable of simultaneous measuring of complete blood count (CBC) including 3-part differentials (3-part Diff.) of white blood cells (WBC) and C-reactive protein (CRP) in 4 minutes. Data obtained using LC-767 were intra-assay-reproducible (n = 10, CV = 0.6-4.0% for CBC, 0.6-2.5% for 3-part Diff. and 2.8-7.7% for CRP). They also showed the good linearity, no definite carry-over and the excellent correlations with routine instruments in our institution. Concerning CRP, the minimal detectable concentration revealed < 0.1 mg/dL, and prozone was observed in the sample containing > 30 mg/dL of CRP. LC-767 showed better correlation with a routine instrument in monocyte percentage than LC-667, probably due to modification of the hemolysis solution ratio and diluent temperature. In conclusion, LC-767 provided accurate CBC and CRP results, and showed improvement in CRP linearity and monocyte percentage compared with LC-667. LC-767, which is equipped with a bar-code reader with easy accessibility to electronic medical record, is suitable as the next-generation point of care testing model in the era of information and network-oriented medicine.
[Evaluation of a Computer-Aided Microscope System and Its Anti-Nuclear Antibody Test Kit for Indirect Immunofluorescence Assay].
Hayashi N, Saegusa J, Uto K … +5 more , Oyabu C, Saito T, Sato I, Kawano S, Kumagai S
Rinsho Byori · 2016 Feb · PMID 27311277
Antinuclear antibody (ANA) testing is indispensable for diagnosing and understanding clinical conditions of autoimmune diseases. The indirect immunofluorescence assay (IFA) is the gold standard for ANA screening, and it...
Antinuclear antibody (ANA) testing is indispensable for diagnosing and understanding clinical conditions of autoimmune diseases. The indirect immunofluorescence assay (IFA) is the gold standard for ANA screening, and it can detect more than 100 different antibodies, such as anti-PCNA as well as anti-cytoplasmic antibodies. However, complicated procedures of conventional IFA and visual interpretation require highly skilled laboratory staff. This study evaluates the capability, characteristics, and applicability of the recently developed ANA detection system (EUROPattern Cosmic IFA System, EPA) using HEp20-10 cells and the automated pattern recognition microscope. Findings using EPA and conventional methods were compared in 282 sera obtained from connective tissue disease patients and 250 sera from healthy individuals. The concordance of the positivity rate, antibody titer (within +/- 1 tube difference), and the accurate recognition rate of ANA patterns between the automated EPA method and the microscopic judgement of the EPA image by eye was 98.9, 97.4, and 55.3%, respectively. The EPA method showed concordance of the positivity rate as high as 93.3% and concordance of the antibody titer as high as 94.0% (within +/- 1 titer) compared with the conventional method. Regarding the four typical patterns of ANA (homogeneous, speckled, nucleolar, and centromere), large differences between the EPA and conventional methods were not observed, and the rate of concordance between the final EPA result and the conventional method was from 94.1 to 100%. The positivity rate of ANA using the EPA and conventional methods showed marked agreement among the six connective tissue diseases (SLE, MCTD, SSc, PM/DM, and SS) and healthy individuals. Although the EPA system is not considered a complete system and laboratory staff should verify the results, it is a useful system for routine ANA analysis because it contributes to ANA standardization and an efficient workflow.
[How to Apply Bayesian Theorem to the Evaluation of Myocardial Injury by Measuring High Sensitive Cardiac Troponins in the Patients with Suspected Acute Myocardial Infarction].
Shimada T, Yokochi T, Ikoma Y … +5 more , Sonoda A, Amemiya N, Murakoshi D, Kuzumi H, Kosugiyama H
Rinsho Byori · 2016 Feb · PMID 27311276
118 consecutive patients of suspected acute myocardial infarction with acute chest pain and shortness of breath visiting our emergency room were subjected for this clinical study. Based on final diagnosis of acute myocar...
118 consecutive patients of suspected acute myocardial infarction with acute chest pain and shortness of breath visiting our emergency room were subjected for this clinical study. Based on final diagnosis of acute myocardial infarction (AMI) comprehensively determined by medical record, physical examination, ECG, echocardiography, cardiac catheterization, etc., except for cardiac biomarkers, the patients were classified into two groups, with AMI group (1) and without AMI group (0) and then ROC curve analysis was performed between without AMI group (1) and with AMI group (0). As a result of ROC curve analysis, AUC, cutoff value, sensitivity, specificity and likelihood ratio (LR) were calculated as shown in Fig. 4 (1-7) and Table 2 (1-7). Based on calculating equation led from Bayesian rules, post-test odds were calculated as product of pre-test odds and LR at the cutoff value in each biomarker such as hsCTnT, hsCTnI, h-FABP CK, CKMB activity and CKMB mass. As a result, post-test probability was improved from predictive pre-test probability 30% to post-test probability 89% and 86% in hsCTnT and hsTnI, respectively but less improved from 30% to 68% in h-FABP and unexpectedly improved from 30% to 82% in CKMB mass compared with hsCTnT and hsTnI. Based on Bayesian rule, it is very valuable to predict post-test probability from predictive pre-test probability 30% by calculation in particular, when post-test probability is over 85-90%. In conclusion, we believe that prediction of post-test probability by Bayesian rule can be surely used to evaluate clinical quality of biomarkers which are not depend on at least, specialty and experience of physicians.
[Value of Fractional Exhaled Nitric Oxide after Using a Beta-2 Bronchodilator in the Differential Diagnosis of Bronchial Asthma and Chronic Obstructive Pulmonary Disease].
Ura M, Tanaka H, Takahashi K … +2 more , Yamazaki H, Fujimoto K
Rinsho Byori · 2016 Feb · PMID 27311275
It has been established that an increase in fractional exhaled nitric oxide (FeNO) is one of the indicators of bronchial asthma (BA) in clinical settings. However, the differential diagnosis of BA and chronic obstructive...
It has been established that an increase in fractional exhaled nitric oxide (FeNO) is one of the indicators of bronchial asthma (BA) in clinical settings. However, the differential diagnosis of BA and chronic obstructive pulmonary disease (COPD) is difficult due to pathological similarities. Therefore, to determine if FeNO may be utilized in the differential diagnosis of BA and COPD, we compared FeNO values before and after inhalation of a short-acting beta-2 agonist (SABA). There were 3 groups of subjects recruited to this study: (1) 23 normal healthy controls, (2) 36 patients with BA, and (3) 13 patients with COPD. We measured FeNO, forced vital capacity, forced expiratory volume in 1 second (FEV1), and FEV1%, calculated using spirometry. Then, after the subjects inhaled the SABA, we measured these data after 10 and 30 minutes. Here we found that after inhalation of a SABA, 8 cases in the BA group who showed reversibility of airway obstruction demonstrated significantly increased FeNO values compared to the BA patients with non-reversible airway obstruction, those with COPD, and healthy subjects. This finding may be because the obstructed pulmonary peripheral airway was expanded by inhaling a SABA, and nitric oxide, which had been produced in the peripheral airway, was then exhaled. These results suggest the possibility that FeNO may be utilized in the differential diagnosis of BA and COPD.
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