Rinsho Byori. The Japanese Journal Of Clinical Pathology[JOURNAL]
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200 papers
[Efforts and the Future Agenda for Introducing the Quality Management System ISO 15189 in Akita University Hospital].
Mariko O, Yumiko K, Yuko K … +7 more , Rie Y, Yoko T, Noriko K, Ayumi O, Shigeharu U, Tomoo S, Hirokawa M
Rinsho Byori · 2017 Feb · PMID 30762992
Quality management systems are the tools that document the processes and responsibilities to achieve quality policies and objectives. Recently, increasing numbers of clinical laboratories have been certified for ISO 1518...
Quality management systems are the tools that document the processes and responsibilities to achieve quality policies and objectives. Recently, increasing numbers of clinical laboratories have been certified for ISO 15189, an international certification for hospital laboratories. However, our laboratory remains in the preparation process. Major obstacles in our hospital are the tight budget and the timing of introducing the ISO 15189 system because of the old equipment in our laboratory. To overcome these problems, we have made efforts including study workshops with invited lecturers with expertise, joining the prefectural work- shop for clinical technicians. We have also started to prepare standard operational procedures for each la- boratory test. As the preparation advances, it has become clear that gaining the understanding of the signifi- cance of ISO 15189 of hospital executives is indispensable, especially in respect to funding. It is our respon- sibility to achieve standardized and improved laboratory examinations, in order to contribute to high-quality medical care, research, and education. Achieving the certification for ISO 15189 offers a great opportunity to improve our skills in laboratory medicine.
[Achieving ISO 15189 Certification -Iwate Medical University Hospital's Approaches -].
Gotoh K, Suwabe A
Rinsho Byori · 2017 Feb · PMID 30762991
International clinical trials need to achieve ISO 15189 Certification. However, there are a large number of challenges to be addressed before the achievement. While the retirement of experienced staff may result in insuf...
International clinical trials need to achieve ISO 15189 Certification. However, there are a large number of challenges to be addressed before the achievement. While the retirement of experienced staff may result in insufficient knowledge, technology, quality assurance, or reliability, approaches to achieve ISO 15189 Certifi- cation are useful for human resource development and quality assurance. Furthermore, work efficiency improvement and standardization as part of such approaches can be incorporatea into programs for continuous education.
[Challenges for Certification of ISO 15189: Remarks of the Chairperson].
Shimura H
Rinsho Byori · 2017 Feb · PMID 30762990
In the Tohoku region, the evacuation of residents due to the Great East Japan Earthquake and subsequent accident at the Fukushima Dai-ichi Nuclear Power Plant has been prolonged due to radioactive contamination and delay...
In the Tohoku region, the evacuation of residents due to the Great East Japan Earthquake and subsequent accident at the Fukushima Dai-ichi Nuclear Power Plant has been prolonged due to radioactive contamination and delays in the construction of coastal areas. The destruction of local communities by the extended evacu- ation resulted in an increase of residents' health risks. Under such circumstances, the responsibilities of medical services are increasing more than before the earthquake, and even in the clinical laboratory, an in- crease in workload and higher quality assurance of examinations are required. The acquisition of ISO 15189 certification has recently been advanced as a means of guaranteeing the quality of laboratories, but in the Tohoku district, only 4 facilities (1 university hospital) have acquired it. Recent changes whereby ISO 15189 must be acquired by clinical research core hospitals and the "additional payment for the international standard management of samples" being newly established from April 2016 have promoted the acquisition of ISO 15189 certification. Therefore, at the 48th Tohoku Regional Congress of the Japanese Society of Labor- atory Medicine, we organized a symposium, entitled: "Challenges for Certification of ISO 15189".
[Development and Clinical Application of Glycan-Targeted Biomarkers for Prostate Cancer].
Ohyama C, Yoneyama T, Tobisawa Y … +4 more , Ishikawa T, Hatakeyama S, Koie T, Mori K
Rinsho Byori · 2017 Feb · PMID 30762989
Prostate cancer (PCa) is now the most common male malignant tumor in both Japan and Western countries. Prostate-specific antigen (PSA) has been widely used for the early detection of PCa; however, it is not an ideal biom...
Prostate cancer (PCa) is now the most common male malignant tumor in both Japan and Western countries. Prostate-specific antigen (PSA) has been widely used for the early detection of PCa; however, it is not an ideal biomarker due to its low specificity. Aberrant glycosylation is closely associated with malignant transformation and cancer progression. Recent advances in glycobiology techniques can be applied to the development of novel biomarkers for PCa. We previously identified PCa-associated aberrant glycosylation on PSA, that is, α2,3-linked sialylation as an additional terminal N-glycan on free PSA(S2,3PSA). We then developed a new assay system for the measurement of S2,3PSA utilizing the μTAS method. The area under the curve (AUC) for the detection of PCa with the %S2,3PSA ratio was significantly better than that with total PSA. Another urgent issue in clinical practice for PCa is the over-treatment of patients with a low malignant potential, as aggressive treatment is not necessary. To overcome this problem, it is essential to develop a useful tool for the measurement of the malignant potential. Core2 ,β-1,6-N-acetylglucosaminyltransferase-1 (GCNT1, C2GnT) is a key enzyme that forms core 2-branched 0-glycans. Its expression is associated with the progression of several cancers. We established a mouse IgG monoclonal antibody (mAb) against GCNT1 and examined the relationship of GCNT1 expression with the clinicopathological status of PCa. GCNT1- negative patients were associated with significantly better PSA-free survival compared with GCNT1-positive patients. Furthermore, we established new methods for GCNT1 detection using urine samples of PCa patients. Immunoblotting was used to examine post-digital rectal examination (DRE) urine from PCa patients. Over 90% of GCNT1-positive PCa patients with high concentrations of serum PSA showed extracapsular extension in prostatectomy specimens. In conclusion, the clinical application of glycobiology techniques is a promising approach to develop novel biomarkers for PCa.
[Workshop -A New Era of Specialists in Clinical Laboratory Medicine].
Tabe Y, Kotani K
Rinsho Byori · 2017 Feb · PMID 30762988
Here, we briefly report on the workshop entitled "A new era of specialists in clinical laboratory medicine." The following items were presented in the poster session on "work-life balance among specialists in clinical la...
Here, we briefly report on the workshop entitled "A new era of specialists in clinical laboratory medicine." The following items were presented in the poster session on "work-life balance among specialists in clinical laboratory medicine": routine work, troublesom issues at work, networking, and career development. Re- garding the topic of "lifelong education," participants in groups discussed the joy they derive from working in the field of clinical laboratory medicine. Many participants mentioned that they had been attracted to this field because of the wide range of academic disciplines available and the relative freedom in choosing special- ties. We believe that this workshop facilitates the sharing of information about routine work and viewpoints regarding the specialty of clinical laboratory medicine, as well as personnel networking on a nationwide level.
[How to Interpret Routine Laboratory Data? Challenge Faced by Inexperienced Certified Clinical Laboratory Physicians -Practical Advice from Experienced Certified Clinical Laboratory Physicians -].
Yonekawa O, Honda T
Rinsho Byori · 2017 Feb · PMID 30762987
At the annual meeting of the Japanese Society of Laboratory Medicine in Kobe in 2016, a joint symposium was held in cooperation between the Japanese Society of Laboratory Medicine and Japanese Association of Clinical Lab...
At the annual meeting of the Japanese Society of Laboratory Medicine in Kobe in 2016, a joint symposium was held in cooperation between the Japanese Society of Laboratory Medicine and Japanese Association of Clinical Laboratory Physicians. We presented and discussed 5 cases at the Reversed Clinico-pathological Conference. Each case was analyzed by 5 new members of the Japanese Association of Clinical Laboratory Physicians, who had passed the examination for Certified Clinical Laboratory Physicians in 2015. After the presentation of their interpretation for basic laboratory tests, the correct diagnosis and useful practical advice were given by experienced Certified Clinical Laboratory Physicians. The first case involved hemolytic anemia due to valve replacement and multiple myeloma with the BJP type. The second case involved primary aldos- teronism with hypokalemia. The third case involved cold agglutination with a high value of MCHC. The fourth case involved pneumonia due to influenza virus. The last case involved diabetic ketoacidosis. All 5 cases were common rather than rare, and any members of the clinical laboratories may encounter them in routine work. A systemic analysis of routine laboratory data can sometimes directly lead to the correct diag- nosis using laboratory data alone and give doctors valuable clinical information on patients. Continuous daily efforts in systemic analysis will ensure that the evaluation skills of inexperienced Certified Clinical Laboratory Physicians in their hospitals will increase. Certified Clinical Laboratory Physicians in clinical laboratories are gatekeepers in every hospital from the viewpoints of both "medical audit" and "risk management".
[Japanese Biobanks: Current Status, Problems, and Future Challenges].
Sueoka E
Rinsho Byori · 2017 Feb · PMID 30762986
A biobank is a facility that collects and manages biological specimens such as tissues, cells, and blood de- rived from living organisms. In addition to these materials, the biobank can also be used for storing urine, bo...
A biobank is a facility that collects and manages biological specimens such as tissues, cells, and blood de- rived from living organisms. In addition to these materials, the biobank can also be used for storing urine, body fluid, DNA, and intracellular structures like exosomes. The initial objective of stocking these materials was mainly for research purposes, such as searching for biomarkers and genes responsible for diseases, but due to the rapid clinical application of molecular-targeted therapy and personalized medicine based on genetic information, biobanking is now becoming one of the fundamental efforts indispensable for clinical practice. In Japan, the importance of stocks of biological samples has been recognized for a long time, and biobanking was implemented in various medical institutions alone or in several medical departments, but recently the organization of biobanks has been developed and they are carrying out activities according to each purpose. 1. Biobank as a national project Biobank, Japan 2. National Center Biobank Network NCBN 3. Biobanks operated by each institution other than those mentioned above As a part of Japan's research strategy, the Japan Agency for Medical Research and Development (AMED) has promoted the "Genomic medicine realization project", and the construction of medical biobanks is one of the major projects in the strategy. In this special issue, the current status of biobanks is introduced and problems and future challenges as a national project are discussed.
[Current Condition and Issues of Clinical Biobanks in Japan -From the Point of View of Laboratory Medicine-].
Matsushita K
Rinsho Byori · 2017 Feb · PMID 30762985
The final goal or aim of clinical biobanks is to share sample data and feed back their results to the public. For this purpose, it is essential to establish sustainable systems to share clinical samples among researchers...
The final goal or aim of clinical biobanks is to share sample data and feed back their results to the public. For this purpose, it is essential to establish sustainable systems to share clinical samples among researchers of academic institutes as well as commercial companies. So far, clinical biobanks have been considered an infrastructure that is advantageous or valuable for checking developing reagents, searching for companion biomarkers for diseases, cohort research, and constructing medical big data. However, easy-to-approach systems to access clinical samples between academia and commercial companies have yet to be established in Japan. The major reasons are ethical, legal, and social issues (ELSI), the lack of simple procedures to evaluate stored samples, and the financial burden among participants. Additionally, the cultivation/training of human resources in related fields is also required. Needless to say, laboratory medicine is expected to play responsible roles in this field. Recently, next-generation DNA sequencers (NGS) have begun to be used in clinics, called clinical sequences, based on the samples of clinical biobanks. Clinical biobanks that preserve standardized and/or high-quality clinical samples are required. Further, to accomplish "precision medicine" or "individualized medicine", NGS/clinical sequence/genetic testing by high-quality DNA samples is required. The authors discussed the problem lists and ELSI to overcome these situations in order to establish commercially available clinical biobank networks in Japan. Since so-called "medical big-data" based on personal data will lead to the development of future medicine, the rules or consensus in clinical biobanks for treating and/or sharing personal clinical data is also discussed. Furthermore, the concepts of clinical biobanks and clinical sequencing are considered regarding their ability to accelerate clinical biomarker research in this manuscript.
[Standardization of Biobank and Potential of IVD Industries to Utilize Biospecimens].
Okano K, Uchiyama H
Rinsho Byori · 2017 Feb · PMID 30762984
Many biobanks that have stored human clinical biospecimens have been established in Japan since 2005. Those biospecimens were mainly used in academia to perform basic research. The use of those biospeci- mens by industri...
Many biobanks that have stored human clinical biospecimens have been established in Japan since 2005. Those biospecimens were mainly used in academia to perform basic research. The use of those biospeci- mens by industries, especially pharmaceutical or in vitro diagnostic companies, was restricted for ethical rea- sons. In this review, we discuss the importance of the standardization of the quality of biospecimens and workflow at biobanks for the utilization of specimens, and the possibility and issues regarding specimen use by industries.
[Clinical Biobank: A Novel System to Support Cancer Clinical Sequencing in Japan].
Nishihara H
Rinsho Byori · 2017 Feb · PMID 30762983
The development of genomic medicine has enabled us to perform contemporary clinical sequencing, while the acquisition of high-quality biospecimens and the appropriate handling of these materials are indispensable. We sta...
The development of genomic medicine has enabled us to perform contemporary clinical sequencing, while the acquisition of high-quality biospecimens and the appropriate handling of these materials are indispensable. We started Clinical Biobank, a novel system for on-demand-type banking, in 2014. During the 22 months from August 2014, we stored around 6,000 biospecimens from 1,700 patients, and most of them were obtained for diverse clinical research. The quality and amount of extracted DNA and RNA from PFPE samples were markedly high; thus, these samples are adequate for targeted amplicon sequencing using MiSeq (Illumina). In addition, we recently established the Division of Clinical Cancer Genetics for personalized cancer medicine. We obtain biospecimens including blood and tissue fixed using the PAXgene Tissue system, and the samples are immediately analyzed for targeted amplicon sequencing using MiSeq. The rest of the samples are stored after adequate procedures in a -80 degree freezer. We obtain DNA and RNA from PAX-fixed paraffin- embedded samples with a high quality and sufficient amounts for clinical sequencing after pathological evalua- tion. For three months, we examined 40 cancer patients and performed targeted exome sequencing. As a result, detection rates of actionable and druggable gene mutations were around 85 and 50%, respectively. We have also established the Clinical Biobank Study Group in Japan, collaborating with several universities and cancer centers. We believe that this novel biospecimen repository system will help to effectively estab- lish cancer clinical sequencing throughout Japan.
[Present and Future of an iPS Cell Stock for Regenerative Medicine].
Hanatani T, Takasu N
Rinsho Byori · 2017 Feb · PMID 30762982
A haplobank of induced pluripotent stem cell (iPSC) lines derived from healthy donors with homozygous human leukocyte antigen(HLA), which is called "an iPSC stock", has been under construction in Japan. The iPSC stock is...
A haplobank of induced pluripotent stem cell (iPSC) lines derived from healthy donors with homozygous human leukocyte antigen(HLA), which is called "an iPSC stock", has been under construction in Japan. The iPSC stock is expected to enable HLA matching of a majority of recipients and reduce the risk of trans- plant rejection. Full-scale operations began in FY2013, with the aim of covering 30-50% of the Japanese population by FY2017 and most of the population by FY2022 with the iPSC stock. A novel feeder-free and xeno-free culture system for iPSCs was developed to comply with regulatory safety standards. In 2015, a clinical-grade iPSC line with homozygous HLA of the highest-frequency haplotype was released as a first in the world. Other clinical-grade lines are being generated successively. If all goes to plan, the first clinical research using the iPSC stock will start in 2017. However, many challenges remain to ensuring the future of iPSC stock. In accordance with the progress of the latest research, safety issues regarding iPSC-based cell therapy are being monitored with much interest, and one of the major concerns is tumorigenicity. We have to continue to discuss the extent of genomic abnormalities that would or would not be acceptable in not only iPSC-derived products but also iPSC stock, taking into account the risks and benefits of cell therapy. It is also necessary to demonstrate the clinical efficacy of HLA matching, which is indicated to promote graft survival and reduce immunosuppressive drug use.
[Development of Comprehensive Coagulation Assays Reflecting the Clinical Phenotype].
Matsumoto T, Nogami K
Rinsho Byori · 2017 Feb · PMID 30762981
PT, APTT, and coagulation factor activity are measured with clotting time-based methods. When coagula- tion and fibrinolysis are enhanced, TAT and PIC are detected, but evaluations of their hypofunctional state are diffi...
PT, APTT, and coagulation factor activity are measured with clotting time-based methods. When coagula- tion and fibrinolysis are enhanced, TAT and PIC are detected, but evaluations of their hypofunctional state are difficult. We devised a new method that can be used to comprehensively and continuously evaluate coagula- tion and fibrinolysis in real time. We elucidated the clinical phenotype of congenital and acquired coagulation disorders using the following methods; (1) Clot waveform analysis (CWA) to evaluate fibrin formation; (2) Thrombin generation test (TGT) to monitor one-step before fibrin formation. (3) Thrombin/Plasmin generation assay (T/P-G) to evaluate fibrinolysis simultaneously with TGT. The results revealed that (1) CWA enabled the measurement of a very low FVIII activity level (FVIII:C 0.2-1.0 IU/dL) and detected a markedly severe type with FVIII:C <0.2 IU/dL. (2) For TGT, acquired hemophilia A showed a much lower value than that of congenital severe hemophilia A, being consistent with its severe bleeding. (3) CWA parameters for acquired factor V inhibitors in patients with bleeding symptoms were more impaired than with non-bleeding. Taken together these comprehensive assays can reflect the clinical phenotype and make it possible to analyze unidentified coagulation/fibrinolysis abnormality.
[The Technical Evaluation of HCV Screening Assay].
Kobayashi Y, Tomoda M, Miura H … +1 more , Satho A
Rinsho Byori · 2017 Feb · PMID 30762980
Advances in treatment have resulted in a high rate of sustained virological response in patients with hepati- tis C, whereas many asymptomatic carriers of hepatitis C virus (HCV) remain untreated. Therefore, HCV antibody...
Advances in treatment have resulted in a high rate of sustained virological response in patients with hepati- tis C, whereas many asymptomatic carriers of hepatitis C virus (HCV) remain untreated. Therefore, HCV antibody screening holds great significance. However, the measurement principles or types of antigen used in screening vary according to the manufacturer, leading to discrepancies in the results obtained using differ- ent screening reagents. In this study, the performances of five HCV antibody screening assays - ARCHITECT HCV, ECLusys Anti-HCV II assay, HISCL HCV Ab assay, LUMIPULSE II Ortho HCV, and LUMIPULSE Presto Ortho HCV- were compared using 2,042 serum samples. The positive rates for the various assays ranged from 3.6% to 4.5%, and 1,937 and 70 samples were determined as negative and positive, respectively. Discordant results were obtained for 35 samples (1.7%). Additional confirmatory testing was performed on 105 samples that tested positive with at least one reagent. Thus, of the 35 samples with discordant results, 24 single-positive samples were highly likely to be false-positive and 5 single-negative sam- ples were likely to be truly positive. Considering that HCV antibody would not be missed by any assay, those showing no or minimal non-specific or crossover reactions would be ideal for HCV antibody screening. Indeed, further improvement of screening reagents is also needed.
[Left Atrial Strain Independently and Incrementally Predicts High Risk Thromboembolic Findings Over CHA2DS2-VASc Score and BNP].
Kurosawa K, Negishi K, Obokata M … +5 more , Sorimachi H, Masuda K, Machida T, Kurabayashi M, Murakami M
Rinsho Byori · 2017 Feb · PMID 30762979
BACKGROUND: Left atrial longitudinal strain(LAs) is a novel and useful parameter of LA function and reflecting thromboembolic risk. CHA₂DS₂-VASc score and brain natriuretic protein (BNP) are also used for risk stratifica...
BACKGROUND: Left atrial longitudinal strain(LAs) is a novel and useful parameter of LA function and reflecting thromboembolic risk. CHA₂DS₂-VASc score and brain natriuretic protein (BNP) are also used for risk stratifica- tion. However, little is known about the impact of LAs on stroke risk stratification over these parameters. In this study, we aimed to examine whether LAs has independent and incremental risk stratification over them. METHODS: We studied 97 consecutive patients (age: 66 ± 12, 70 males) who underwent transesophageal echocardi- ography for evaluation of left atrial appendage (LAA) thrombus with persistent or paroxysmal atrial fibrillation. We assessed whether patients had spontaneous echo contrast (SEC) or not. Patients with LAA thrombus or sponta- neous echo contrast (SEC) were defined as high risk. LAs was assessed by averaging the segments measured in the 4- and 2-chamber views by transthoracic echocardiography. RESULTS: Among the 97 patients, 51(53%) patients had sinus rhythm and 36 were with SEC. Although LAs (21.0 ?9.0%), CHA₂DS₂-VASc score (2.7± 1.7) and BNP were mutually associated, only LAs and CHA₂DS₂-VASc score were independent predictors of high thromboembolic risk but BNP not. In nested logistic regression model anal- yses, predictive ability of a model with CHA₂DS₂-VASc score was improved by the addition of BNP (p =0.004) and further by adding LAs (p =0.027). CONCLUSION: LAs predicts independently and incrementally LAA thrombus or SEC over CHA₂DS₂-VASc score and BNP, suggesting that LAs serves as a functional predictor for future thromboembolism. [Original].
[Evaluation of a Fully Automated Analyzer for Antinuclear Antibody Test Using Indirect Immunofluorescence Assay].
Uto K, Hayashi N, Oyabu C … +2 more , Sato I, Saegusa J
Rinsho Byori · 2017 Feb · PMID 30762978
The fully automated HELIOS® system for antinuclear antibody (ANA) test is capable of automatically per- forming all IFA procedures. We evaluated the analytical performance, characteristics and utility of HELIOS system as...
The fully automated HELIOS® system for antinuclear antibody (ANA) test is capable of automatically per- forming all IFA procedures. We evaluated the analytical performance, characteristics and utility of HELIOS system as ANA screening test. We compared HELIOS system and the conventional methods in sera from 161 connective tissue disease (CTD) patients and 250 healthy individuals. The presence and titer of ANA were automatically determined by performing HELIOS system at 1:80 dilution and the ANA titers were com- pensated by several dilution and visual determination in sera with a high ANA titer and ANA-positive sera combined with anti-cytoplasmic antibody. The ANA staining patterns were assessed by visual determination of the digital image on HELIOS system. The total concordance rate between the conventional method and HELIOS system was 94.4%. The concordance of ANA titer (within ± 1 tube difference) between the con- ventional method and automated or compensated evaluation of HELIOS system was 85.7% or 98.8%, respec- tively. The concordance rate of six nuclear staining patterns was from 81.4% to 100% and the discrepancies of granular staining pattern might be caused by the fixation of HEp-2 cells. The positive rates of ANA in CTD patients and healthy individuals were comparable with the conventional methods. Taken together, HELIOS system can appropriately perform the automated determination of ANA except in some cases and is useful as ANA screening test. Furthermore, this system can contribute not only an efficient IFA procedure but also the ANA standardization by IFA. [Original].
[A Novel Inhibitory Factor of Erythropoietin: Anti-Erythropoietin Receptor Antibody and Its Characteristics].
Hara A, Wada T
Rinsho Byori · 2017 Jan · PMID 30695518
During the exploration of factors that interfere with the erythropoietin (EPO) -EPO receptor (EPOR) interaction in anemia, a novel inhibitory factor of EPO, anti-EPOR antibody, has been detected in anemic pa- tients with...
During the exploration of factors that interfere with the erythropoietin (EPO) -EPO receptor (EPOR) interaction in anemia, a novel inhibitory factor of EPO, anti-EPOR antibody, has been detected in anemic pa- tients with immune-mediated diseases. The study also demonstrated that the antibodies were observed in some patients with chronic kidney disease (CKD). EPOR is known to be expressed not only in bone mar- row erythroblasts, but also in other organs including the kidneys. In addition, previous studies showed that EPO may contribute to protecting the kidneys from injury by binding EPOR on renal resident cells as well as through the correction of anemia. Based on this background, we recently examined the clinical significance of anti-EPOR antibodies in patients with CKD. With regard to patients with lupus nephritis, who showed the highest antibody levels among the patients examined, the antibodies were associated with overall disease activity and cell infiltration in the injured kidney, and they were inversely related to the preserved renal function. Here, we discuss the discovery of anti-EPOR antibodies in patients with anemia and CKD, and the possibil- ity of their use as an additional biomarker for the deterioration of the renal function. [Review].
[[Biomarkers of Leukemia ~Description of the Practical Use and Operation in the Clinical Laboratory~]-].
Kajiura Y, Yamamoto Y, Okada K … +4 more , Hattori H, Matsumoto H, Kishimoto M, Matsushita T
Rinsho Byori · 2017 Jan · PMID 30695517
Genetic testing of hematological malignancy is-.indispensable to categorize and diagnose leukemia. The quantitation of fusion gene mRNA built up by chromosomal translocation including BCR-ABL1 (major, minor), RUNX1-RUNX1...
Genetic testing of hematological malignancy is-.indispensable to categorize and diagnose leukemia. The quantitation of fusion gene mRNA built up by chromosomal translocation including BCR-ABL1 (major, minor), RUNX1-RUNX1T1, and PML-RARA and detection of the JAK2 (V617F) mutant gene are performed by our- selves in our hospital. Efficient, practical use is necessary because the number of medical technologists is limited and numbers of tests are increasing annually. The detection of leukemic cells is important in hematological tests. In addition, experienced medical technologists can predict the existence of fusion mutant genes. In this report, we introduce our experience regarding the practical use and operation of biomarkers for leukemia. Medical technologists take advantage of peripheral blood tests for screening, such as the complete blood count (CBC), hemogram, fibrin and fibrinogen degradation products (FDP), and the quantitation of fusion gene mRNA, which offers a definitive diagnosis including BCR-ABL1, RUNX1-RUNX1T1, and PML-RARA, and genetic tests are performed efficiently. [Review].
[Clinical Significance of Novel Serum Biomarkers in the Management of Liver Diseases].
Inoue T, Tanaka Y
Rinsho Byori · 2017 Jan · PMID 30695516
Serum biomarkers are playing an increasingly important role in the management of liver diseases. In this article, we provide an overview of the biomarkers that are currently used for the primary diagnosis of liver fibros...
Serum biomarkers are playing an increasingly important role in the management of liver diseases. In this article, we provide an overview of the biomarkers that are currently used for the primary diagnosis of liver fibrosis, hepatocellular carcinoma (HCC), and occult hepatitis B virus (HBV) infection. Because liver fibrosis is a significant risk factor for hepatocarcinogenesis, monitoring its progression is important for predicting and preventing HCC. In 2015, the novel liver fibrosis glycobiomarker Wisteriaflori- bunda agglutinin-positive Mac-2 binding protein (WFA'-M2BP, M2BP glycan isomer [M2BPGiI) became available in Japan. The HISCL M2BPGi assay is fully automated, rapid (17 minutes), and requires only a small sample volume (10 μL). Serum tumor markers are noninvasive and valuable for the management of patients with a high risk of de- veloping HCC. Although a-fetoprotein (AFP) has been commonly used, its insufficient sensitivity and specificity for early-stage HCC make it unsuitable for managing patients at high risk of developing HCC. However, a combination of AFP and protein induced by vitamin K absence factor II (PIVKA-II), or Lens culinaris agglutinin-reactive fraction of AFP (AFP-L3) and PIVKA-II are currently being evaluated for HCC pre- diction. Recently, a highly sensitive chemiluminescent enzyme immunoassay (CLEIA) for HBsAg detection by Lumipulse HBsAg-HQ has been reported as the latest clinical application. Although the sensitivity of this assay ( ≥5 mIU/mL) is 10-fold higher than that of the conventional assay, it is still lower than that of the HBV-DNA assay. HBsAg-HQ will be applied for detecting occult HBV infection and HBV reactivation. [Review].
[Chairmen's Introductory Remarks].
Sakai Y, Morimoto M
Rinsho Byori · 2017 Jan · PMID 30695515
The topic of this symposium "advancement of biomarkers" focused on biomarkers and laboratory medicine. The following 4 papers were presented: 1. Liver disease diagnoses and new biomarkers, 2. Atherosclerosis and new biom...
The topic of this symposium "advancement of biomarkers" focused on biomarkers and laboratory medicine. The following 4 papers were presented: 1. Liver disease diagnoses and new biomarkers, 2. Atherosclerosis and new biomarkers, 3. Leukemia biomarkers, and 4. A new inhibitory factor against erythropoietin for diagnosis and assessment of anemia. As these titles suggest, this symposium covered broad fields of medical practice. All presentations demonstrated the marked development of new biomarkers in association with advanced technology along with improved understanding of disease pathologies. These frontier research areas related to biomarkers lead to the expectation of further novel practical biomarkers in the future. Further explora- tion in all fields for biomarker development will be performed, leading to new clinically practical diagnostic tools. Laboratory medicine will further contribute through the development of novel diagnostic technologies. [Review].
[The Free Form of D-Amino Acids As a Novel Bioactive Substance: Physiological Functions and Involvement in Human Pathophysiology].
Katane M, Homma H
Rinsho Byori · 2017 Jan · PMID 30695514
It was long considered that.D-amino acids were either unnatural isomers or laboratorial artifacts, and that the important functions of amino acids were exerted only by L-amino acids. However, recent investigations have s...
It was long considered that.D-amino acids were either unnatural isomers or laboratorial artifacts, and that the important functions of amino acids were exerted only by L-amino acids. However, recent investigations have shown that a variety of D-amino acids are present in various organisms, including mammals, and that they play important roles in physiological functions in the body. Here, we present an overview of recent studies of free D-amino acids, focusing on the expression and localization in tissues and cells, biological and physiological activities, biosynthesis, cellular transport, and degradation. From the point of view of human pathophysiology, the possible relevance of free D-amino acids to disease is also described. [Review].
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