[Harmonization of TSH Measurements.]

The measured concentration of thyroid stimulating hormone (TSH) differs depending on the reagents used. Harmonization of TSH is crucial because the decision limits are described in current clinical practice guide- lines as absolute values, e.g. 2.5 mIU/L in early pregnancy. In this study, we tried to harmonize the report- ed concentrations of TSH using the all-procedure trimmed mean. TSH was measured in 146 serum samples, with values ranging from 0.01 to 18.8 mIU/L, using 4 immunoassays. The concentration of TSH was highest with E test TOSOH and lowest with LUMIPULSE. The concentrations with each reagent were recalculated with the following formulas: E test TOSOH 0.855x-0.014; ECLusys 0.993x+0.079; ARCHITECT 1.041x- 0.010; and LUMIPULSE 1.096x-0.015. Recalculation eliminated the between-assay discrepancy. These formulas may be used until harmonization of TSH is achieved by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

[What Has Been Done in Surugadai Nihon University Hospital as a Laboratory Physician--Encounter with FAB Classification and Establishing the Additional Laboratory Management Fee].

I was requested by Nihon University to contribute to the official journal of the Japanese Society of Laboratory Medicine (Rinsho Byori). A special review of the final lecture at Surugadai Nihon University Hospital was requested by the editorial board of the Japanese Society of Laboratory Medicine. I submitted a review under the heading of "I have carried out upon retirement, ..." based on the final lecture at Surugadai Nihon University Hospital. The contents of the lecture were how to widely disseminate the FAB classification of acute leukemia and how to establish an additional laboratory management fee. Finally, I showed how to charge an additional management fee correctly based on a laboratory physician's activities in Surugadai Nihon University Hospital. I summarize the lecture in this article.

[Laboratory management fee; laboratory physician's work at university hospital].

The laboratory additional management fee is subdivided into I to IV. Each additional management fee is a large source of income for hospitals. This is important in order to show the value to hospitals of laboratory physicians and clinical laboratory technologists. At this symposium, in order to charge an additional management fee correctly according to a laboratory physician's work at Surugadai Nihon University Hospital, an outline of a laboratory physician's duties is described.

Nutrient agar with sodium chloride supplementation for presumptive detection of Moraxella catarrhalis in clinical specimens.

We previously reported that Nissui nutrient agar (N medium) promoted the growth of Moraxella catarrhalis but not commensal Neisseria spp. In the present study, we examined which constituent of N medium was responsible for the selective growth of M. catarrhalis using 209 M. catarrhalis and 100 commensal Neisseria spp. clinical strains. We found that peptone, but not meat extract or agar of N medium, had growth-promoting or growth-inhibiting ability with respect to M. catarrhalis and commensal Neisseria spp. Thus, we investigated the amino acid content of N peptone and found it had higher concentrations of amino acids than other commercial peptone products. On varying the sodium chloride concentration of reconstituted N medium, we noted that the concentration was an important factor in bacterial growth differences. Varying the sodium chloride concentration of other commercial nutrient agars achieved similar results to those for N medium. This is, to our knowledge, the first study observing that sodium chloride concentration is responsible for difference in growth between the two organisms. We also successfully isolated colonies of M. catarrhalis from respiratory specimens on N medium, whereas the growth of commensal Neisseria spp. was inhibited, and by adding bovine hematin and ß-NAD we were able to isolate Haemophilus influenzae colonies as efficiently as with a chocolate agar. In conclusion, nutrient agar can be used as a medium for the preferential isolation of M. catarrhalis from upper respiratory tract specimens.

[Education for medical students and post-graduates--Training of laboratory medicine at Nihon University Medical School and Surugadai Nihon University Hospital].

Laboratory medicine is defined as 'a field which analyzes the patients' clinical condition and contributes to the procedures such as diagnosis, treatment, follow-up, and prognostic determination'. In other words, it involves not only in every process of medical treatment for patients, but also in the field of preventive medicine and occupational health. Therefore, it is unavoidable for every department to interpret the laboratory data. This necessarily requires all medical students to master laboratory test procedures, comprehend various impediments to the accurate laboratory data, and acquire the basics of the interpretation of laboratory data. During postgraduate training period, they must acquire enough skill of test procedures and determination methods such as Gram stain, and their interpretation of the test results should also be wide and directly connected to the treatment. Physicians who are trained in each particular department and aim to become a laboratory physician are in need of enough understanding of the specialized tests relate to each specialized area. Based on the fact that laboratory physicians involve in all of these educations, this symposium addresses the early training during pre- and post-graduation in Nihon University.

[The effective and the promotion of proper use on laboratory at Surugadai Nihon University Hospital].

It is well known that laboratory data is essential to medical diagnosis and treatments. The use of laboratory tests is related to almost every process of medicine such as diagnosis, treatment, prognostic expectation, and health checkup. Since diagnoses are based on evidence now, it is obvious that the laboratory data are extremely important as objective evidence. It is necessary to have a number of laboratory tests to be conducted in order to collect the information as much as possible. However, there is 'simplification of the tests' in health insurance, or that medical institutions introducing DPC have no alternative but to restrict the number of tests. This restriction by insurance occasionally leads to the atrophic condition of laboratory tests selection. However, in primary education, proper selection of tests for first year residents is important. Surugadai Nihon University Hospital conceives this contrariety as good occasion, and is working to disseminate efficiently in order to conduct the test properly and effectively. This paper presents some specific activities which Surugadai Nihon University Hospital undertakes.

Evaluation of the short-term stability of specimens for clinical laboratory testing.

BACKGROUND: A major concern in both the laboratory-medicine and research communities is the quality of human specimens for analysis. However, there is insufficient scientific evidence regarding optimal conditions for handling and storing routine specimens, especially those in liquid form. Thus, we investigated the stability of clinically relevant samples stored under various conditions. MATERIALS AND METHODS: Ten clinical laboratories in Japan conducted analyses of the stability of post-clinical (left over after analysis) test samples in relation to temperature and storage duration. We examined serum, whole blood, and urine samples submitted to each laboratory for routine testing. In this study, at least 5 samples for each of 35 tests were analyzed at each laboratory. After completion of routine testing, specimens with sufficient residual volume and values between LL-R/2 (lower limit of reference interval) and UL+R/2 (upper limit) were divided into 300 µL aliquots, where R=UL - LL. Aliquots of serum specimens were stored at either room temperature (23°C), 4°C, -20°C, or -80°C without light exposure. Aliquots of whole blood and urine specimens were stored at either 23°C or 4°C. The storage time was either 1, 3, or 7 days. Average differences between pre- and post-storage test results were evaluated for each laboratory test by two-way ANOVA. F-values for between-day variations were used for judging the statistical significance of storage-related changes in test values, whereas the ratio of between-day SD to between-individual SD (one-fourth of reference interval) was used to indicate the practical significance of the change. RESULTS AND CONCLUSION: Sample denaturation is clearly temperature- and storage-duration dependent for almost all analytes. In general, specimens were most susceptible to denaturation at 23°C, then 4°C, -20°C, and -80°C. This study confirmed the accumulated routine, practice-based, detailed knowledge regarding specimen stability and will help to ensure the reliability of laboratory test results.

[An attempt for standardization of serum CA19-9 levels, in order to dissolve the gap between three different methods].

It is well known that serious method-related differences exist in results of serum CA19-9, and the necessity of standardization has been pointed out. In this study, differences of serum tumor marker CA19-9 levels obtained by various immunoassay kits (CLEIA, FEIA, LPIA and RIA) were evaluated in sixty-seven clinical samples and five calibrators and the possibility to improve the inter-methodological differences were observed not only for clinical samples but also for calibrators. We supposed an assumed standard material using by a calibrator. We calculated the serum levels of CA19-9 when using the assumed standard material for three different measurement methods. We approximate the CA19-9 values using by this method. It is suggested that the obtained CA19-9 values could be approximated by recalculation with the assumed standard material would be able to correct between-method and between-laboratory discrepancies in particular systematic errors.

Reevaluation of glomerular charge selective protein-sieving function.

Recently, disorders of the slit diaphragm have been considered as major causes of proteinuria in renal disease and the charge barrier function of the glomerular capillary wall has been given less attention. We evaluated the charge selectivity index (CSI) in 40 patients with podocyte disease (PD), 75 with chronic glomerulonephritis (CGN), and 8 with Dent disease, to reexamine the charge barrier function. We evaluated CSI in Dent disease because the urinary protein profile in Dent disease was assumed to be a concentrate of a normal glomerular filtrate. CSI was defined as the renal clearance ratio between IgA and IgG. CSI values (mean +/- SD) in the CGN and PD groups and in Dent disease were 1.12 +/- 0.25, 0.42 +/- 0.31, and 0.16 +/- 0.06, respectively, suggesting that the charge barrier function was defective in the CGN group and of reduced capacity in the PD group. The results suggest that functional interactions between the slit diaphragm and the glomerular basement membrane exist, and that a slit diaphragm disorder is accompanied by a decrease in the charge barrier function in PD, as argued by the conventional hypothesis.