Establishment of glycated albumin unit conversion equation from the standardized value (mmol/mol) to the routinely used value (%).

BACKGROUND: To promote glycated albumin standardization, the Committee on Diabetes Mellitus Indices, Japan Society of Clinical Chemistry published the recommended reference method and is supplying the reference standard material (JCCRM 611). In this study, we evaluated the basic performance of 'standardized enzymatic method' that is traceable to JCCRM 611 and established a unit conversion formula from standardized glycated albumin value (mmol/mol) to the routinely used glycated albumin value (%). METHODS: To evaluate the accuracy and within-run reproducibility of the 'standardized enzymatic method', JCCRM 611 was measured 20 times. To establish the unit conversion formula, serum specimens with known HbA1c concentrations were collected, and their glycated albumin (%) and glycated albumin (mmol/mol) were measured. RESULTS: The accuracy of glycated albumin value of the 'standardized enzymatic method' was 100.8-103.0%. The within-run reproducibility CV (coefficient of variation, %) of glycated albumin value was 0.6-0.9%. In total, 240 serum specimens were collected, and the distribution of their HbA1c values was HbA1c ≤ 4.9% ( n = 23), 5.0-5.9% ( n = 50), 6.0-6.9%, ( n = 44), 7.0-7.9% ( n = 40), 8.0-8.9% ( n = 37) and ≥9.0% ( n = 46). The unit conversion equation was defined as: GA (%) = 0.05652 × GA (mmol/mol)-0.4217 ( r = 0.999). Glycated albumin (%) calculated by the equation was in close agreement (96.6-104.2%) with the actual measured glycated albumin (%). CONCLUSIONS: The glycated albumin unit conversion formula was established from mmol/mol to %. This formula provides an easy method to convert the unit and is expected to be useful for the standardization of glycated albumin measurement.

[The Technical Evaluation of HCV Screening Assay].

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.

[Evaluation of a Newly Developed Reagent "Lias Auto P-FDP" on Coapresta 2000 and Clinico-Pathological Analysis of Discrepant Samples in FDP Value].

Patients with disseminated intravascular coagulation (DIC) exhibit increased levels of fibrin/fibrinogen degradation products (FDP), and FDP levels are carefully monitored as a marker of fibrinolysis during the diagnosis of DIC and other fibrinolysis-related conditions. Although FDP levels can be measured using automatic analyzers, it is reported that measured FDP values differ depending on the reagent used. Recently, a newly developed reagent for measuring FDP levels (Lias Auto P-FDP) was launched. In this study, we used Lias Auto P-FDP in combination with the Coapresta 2000 automatic analyzer and evaluated its reactivity. We confirmed the reproducibility of the measurements obtained with the Lias Auto P-FDP reagent when the manufacturer's instructions were followed and that the Lias Auto P-FDP reagent can be used with the Coapresta 2000. In the reactivity test, the Lias Auto P-FDP reagent exhibited stronger reactivity with low molecular weight FDP than the reagent we currently use (BL2 P-FDP). Moreover, the samples that exhibited non-specific reactions to the BL2 P-FDP reagent did not display similar reactions to the Lias auto P-FDP reagent. In the clinico-pathological analysis of divergent value between Lias Auto P-FDP and BL2 P-FDP, seven cases were highly discrepant value of FDP. Interestingly, we found the description of pleural fluid and/or ascites in 85.7% cases. In conclusion, we confirmed that the Lias Auto P-FDP reagent can be used in combination with the Coapresta 2000. In addition, the reactivity of FDP varied depending on the reagent used. It is important to understand the characteristics of each FDP reagent and which automatic analyzers they can be used with. [Original].

Inter-Method Variability of Ferritin and Transferrin Saturation Measurement Methods in Patients on Hemodialysis.

Serum ferritin level and transferrin saturation (TSAT) are widely used to evaluate iron status in patients with chronic kidney disease, and are also important variables for performing statistical analyses. Many guidelines have set control targets or upper limits for these markers. Inter-method variability is an important consideration in iron control and statistical analysis. We used 10 ferritin assay kits and five iron/unsaturated iron-binding capacity/total iron-binding capacity assay kits to determine ferritin levels and TSAT in 114 patients on maintenance dialysis, and evaluated measurement bias using Passing-Bablok regression analyses. The variance of distributions categorized by differences in assay kits was examined using Fisher's exact test. Slopes ranged from 1.00 to 1.63 (1.00 to 0.61) for ferritin and 1.00 to 1.10 (1.00 to 0.91) for TSAT. The distribution according to the 2015 JSDT Guideline for Renal Anemia in Chronic Kidney Disease significantly changed (P = 0.01). TSAT thus provides more precise control than ferritin in multi-center comparisons where no particular assay is specified. Developers must reduce variability in serum ferritin assay kits. Researchers must analyze measured values by taking into account the propagation of errors, and clinicians must evaluate laboratory data carefully.

[Roles of and Team Medical Care Involving Clinical Engineers in Blood Purification Therapy].

Progress in medical care strongly depends on the development of pharmaceutical and medical technologies. Multi-disciplinary care by a medical team is required for the diversity of medical care. "Clinical engineering technician (CET) " is one of the national medical licenses in Japan. Many CETs are engaged in blood purification therapies. Team medical care, involving medical doctors, nurses, CETs, etc., in the hemodialysis field is useful for the early detection of complications in dialysis patients and provision of appropriate treatments. In some medical facilities, for example, progressive approaches such as appropriate nutritional guidance by a dietitian or exercise therapy by a physical therapist are practiced in advance. Clinical laboratory technologists (CLTs), furthermore, play an important role in team medical care for dial- ysis therapy. They can use ultrasonic equipment for vascular access management. Based on the results of the ABI and SPP measurements by CLTs, medical doctors can diagnose PAD in dialysis patients. [Review].

Candidemia Diagnosed from Peripheral Blood Smear: Case Report and Review of Literature 1954-2013.

BACKGROUND: Yeast with pseudohyphae or those that have been phagocytized by white blood cells are coincidentally found in peripheral blood smears. The clinical diagnostic value and outcome of candidaemia diagnosed from peripheral blood smears (CPBSs) are unclear. CASE PRESENTATION: A 45-year-old man with diabetes and panhypopituitarism for 20 years received 10 mg of hydrocortisone and 100 µg of levothyroxine sodium hydrate daily. He has been admitted seven times because of adrenal failure triggered by infections and was admitted for pneumonia. On day 56, some budding yeast was found microscopically in a peripheral blood smear with May-Giemsa staining. Some of them were phagocytized by white blood cells. The two blood cultures yielded Candida parapsilosis. Despite antifungal treatment and removal of an intravenous catheter, on day 98 (42 days after the candidaemia diagnosis), the patient died. CONCLUSION: We analysed 36 cases including the present case. Almost all CPBS patients (96.5 %, n = 29) were using an intravenous catheter. The most frequently isolated species was C. parapsilosis (35.1 %), followed by C. albicans (29.7 %). The overall mortality rate was 53.6 % (n = 28). The time from the discovery of yeast-like pathogens using peripheral blood smears to death ranged from a few hours to 93 days (median 19 days). The present results suggest that intravenous catheter use and the underlying conditions of patients are responsible for CPBSs. The detection of yeast in peripheral blood smears suggests advanced infections with uncontrollable complications, which means a poor prognosis. Rapid detection methods besides blood culture are needed.

Intraocular pressure decreases after muscle union surgery for highly myopic strabismus.

PURPOSE: To analyze the relationship between changes in the intraocular pressure (IOP) and dislocation angle in highly myopic strabismus patients who had undergone muscle union surgery. METHODS: Medical data were examined of eight eyes of seven consecutive patients with highly myopic strabismus, who had some limitation in abduction, received muscle union surgery and undergone pre- and postoperative IOP evaluation with a noncontact tonometer, and were retrospectively reviewed. In addition, 15 eyes of 15 patients with comitant horizontal strabismus who underwent unilateral recess-resect procedure as well as pre- and postoperative IOP evaluation were also included. The correlation between IOP changes after strabismus surgery and the dislocation angle of the globe was analyzed. RESULTS: The IOP was significantly reduced in the highly myopic strabismus group (-5.6 mmHg) but not in the fellow eye or in comitant horizontal strabismus patients. The decrease in IOP after surgery was significantly correlated with the preoperative dislocation angle of the globe (r = -0.725, p = 0.042). CONCLUSIONS: IOP is often higher in highly myopic strabismus patients than perceived, and it may indicate abnormal anatomy of the orbit rather than glaucoma. In that case, muscle union surgery can improve eye position and normalizes the IOP.

Three-Dimensional Features of Polypoidal Choroidal Vasculopathy Observed by Spectral-Domain OCT.

Five eyes of five patients with polypoidal choroidal vasculopathy (PCV) without acute hemorrhagic changes or subretinal proliferative tissue to observe the three-dimensional structures and to demonstrate the nature of these images and their interpretation. The abnormal networks surrounding polypoidal lesions were considered to be abnormal pathological blood vessels. The segmentation analysis of spectral-domain optical coherence tomography (OCT) has revealed the three-dimensional features of polypoidal lesions and surrounding abnormal blood vessel networks beneath retinal pigment epithelium. The changes of pathological findings of PCV were also detected, including the enlargement of hemorrhagic pigment epithelium detachment (PED). The segmentation analysis is useful to observe PCV lesions from the bird's eye view.