Rinsho byori. The Japanese journal of clinical pathology最新文献

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.

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.

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".

Our facilities acquired ISO 15189 accreditation in April 2011. The lead time was a little less than 2 years. I reported on the lead time and activity after ISO 15189 acquisition. I reported how creating a quality manual and SOP was advanced as preparation work. I showed the examination method in detail and the process after examination. I think an increase in per- sonnel as internal auditors is important for quality management system maintenance.

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].

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.

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.

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.

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 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].