No abstract available.
Stroke ; Subclavian Artery

BACKGROUND: Neutrophil gelatinase-associated lipocalin (NGAL) has recently been introduced as a renal biomarker and an increase in its level suggests tubular injury. Diabetic nephropathy, a leading cause of end-stage renal disease, causes typical changes characterized by glomerulosclerosis and eventual tubular damage in the kidney. In the present study, we attempted to validate the usefulness of plasma NGAL (pNGAL) as a biomarker for tubular damage in diabetic nephropathy. METHODS: The plasma NGAL levels of 260 diabetes mellitus patients and 50 healthy individuals werewas measured by means of fluorescent immunoassay using with the Triage NGAL test (Biosite, USA). The patients were divided into 3 groups on the basis of their urinary albumin excretion (UAE) levels, and the pNGAL differences among each group were analyzed. The degree of albuminuria and cystatin C-based glomerular filtration rate (GFR) were also compared with the pNGAL levels. RESULTS: The mean pNGAL levels of the normal subjects and diabetic patients were 61.9 +/- 4.81 ng/mL and 93.4 +/- 71.78 ng/mL, respectively. pNGAL level was significantly increased in patients with severe albuminuria (P < 0.001). The pNGAL level was found to be positively correlated with the degree of albuminuria (R2 = 0.218, P < 0.001) and inversely correlated with GFR (R2 = 0.269, P < 0.001). Particularly, the pNGAL level of patients with diabetic nephropathy was found to be associated with the renal damage and independent of other factors influencing the renal damage (R2 = 0.218). CONCLUSIONS: pNGAL level independently reflects renal damage in patients with diabetic nephropathy. Measurement of pNGAL level combined with UAE would help enable to detect both glomerular and tubular damage in diabetic nephropathy patients.
Albuminuria ; Diabetes Mellitus ; Diabetic Nephropathies ; Glomerular Filtration Rate ; Humans ; Immunoassay ; Kidney ; Kidney Failure, Chronic ; Lipocalins ; Neutrophils ; Plasma ; Triage

BACKGROUND: We have evaluated the analytical performance of SureStep Flexx (Johnson and Johnson, USA) which can report the plasma equivalent glucose test results and be connected to the hospital information networks, following ISO15197 analytic procedure for glucometer for the first time. METHODS: Adopting the guidelines of ISO15197, we measured the precision of ten glucometers from their repeatability and intermediate precision, and determined the accuracies of the glucometer, comparing to those of GEM Premier 4000 (Instrumentation Laboratory, USA). In addition, the guidelines of CLSI EP9-A2 and EP6-A were applied to correlate between data of glucometer and those of laboratory reference method by TBA-200FR (Toshiba Medical Systems, Japan) and to examine its linearity of glucose concentrations measured by SureStep Flexx. We used the clinical specimens and commercial control materials. RESULTS: Repeatabilities and intermediate precisions of those glucometers were 4.0-7.3%, and 4.3-6.2%, respectively. When glucose levels are under 75 mg/dL, the difference between results of those meters and the reference values were within +/-6 mg/dL. However when glucose levels are over 75 mg/dL, those differences were within +/-12.7%. These results were acceptable for the ISO15197 criteria in all glucose concentrations. The glucose concentrations showed the clinically relevant linearity in the range from 36 mg/dL to 491 mg/dL. Moreover, Error Grid Analysis showed that all glucose results were in "zone A", which means that these values were clinically accurate. CONCLUSIONS: This study showed that SureStep Flexx can provide reliable results for patients and clinicians to manage the diabetes mellitus, satisfying the ISO15197 criteria.
Blood Glucose/*analysis ; Blood Glucose Self-Monitoring/*instrumentation/methods/*standards ; Diabetes Mellitus/blood/diagnosis ; Humans ; Quality Control ; Reference Values ; Reproducibility of Results

Invasive aspergillosis is one of rare causes of mortality for the immune-compromised patients. We present a case of invasive aspergillosis complicated by the occlusion of the internal carotid artery and cerebral infarction in a patient with diabetes mellitus. Although initial biopsy did not find the pathogen, the repeated attempts of sampling showed aspergillosis. Combination of surgical removal of necrotic tissue and voriconazole medication improved symptoms and reduced the burden of infection.
Aspergillosis* ; Biopsy ; Carotid Arteries ; Carotid Artery, Internal* ; Cerebral Infarction* ; Diabetes Mellitus ; Humans ; Mortality ; Voriconazole

Background: Liquid biopsy is a useful assay for the diagnosis, treatment, and prognosis prediction of solid tumors and its clinical application is expanding. Therefore, the need for developing an External Quality Assessment (EQA) protocol for liquid biopsy is increasing. In this study, we developed and implemented the liquid biopsy EQA program for the epidermal growth factor receptor mutation. Methods: We validated the feasibility of the protocol using citrate instead of ethylenediaminetetraacetic acid (EDTA). Additionally, we analyzed the homogeneity and stability of the aliquoted quality control (QC) materials. Mutation-positive QC material with four mutations (exon 19 deletion, L858R, T790M, and exon 20 insertion) was used to make two types of QC materials (low and high) and the wild type material was used for the negative controls. If the EQA results showed consensus in more than 80% of the participating laboratories, the results were reported as acceptable or unacceptable. If not, we reported the results as not graded. Results: Citrate showed equivalent performance to EDTA. Highly mutated QC material and mutation-negative QC material passed the homogeneity and stability test, but low-level mutant specimens showed inconsistent results. In total, 11 laboratories participated, and all of them reported consistent results except for low-grade mutant samples. Thus, the evaluation results were acceptable except for low mutation QC material. Conclusions The applicability of liquid biopsy is expanding. To obtain accurate test results, EQA is indispensable. Here, QC materials for liquid biopsy EQA were produced, distributed, and had its results analyzed. This study could be the foundation for further development of liquid biopsy EQA.

Background: High LDL-cholesterol (LDL-C) is an established risk factor for cardiovascular disease and is considered an important therapeutic target. It can be measured directly or calculated from the results of other lipid tests. The Friedewald formula is the most widely used formula for calculating LDL-C. We modified the Friedewald formula for a more accurate and practical estimation of LDL-C. Methods: Datasets, including measured triglyceride, total cholesterol, HDL-cholesterol, and LDL-C concentrations were collected and assigned to derivation and validation sets. The datasets were further divided into five groups based on triglyceride concentrations. In the modified formula, LDL-C was defined as total cholesterol − HDL-cholesterol − (triglyceride/adjustment factor). For each group, the adjustment factor that minimized the difference between measured LDL-C and calculated LDL-C using modified formula was obtained. For validation, measured LDL-C and LDL-C calculated using the modified formula (LDL-CM), Friedewald formula (LDL-CF), Martin-Hopkins formula (LDL-CMa), and Sampson formula (LDL-CS) were compared. Results: In the derivation set, the adjustment factors were 4.7, 5.9, 6.3, and 6.4 for the groups with triglyceride concentrations <100, 101–200, 201–300, and >300 mg/dL, respectively. In the validation set, the coefficient of determination (R2) between measured and calculated LDL-C was higher for LDL-CM than for LDL-CF (R2=0.9330 vs. 0.9206). The agreement according to the National Cholesterol Education Program Adult Treatment Panel III classification of LDL-C was 86.36%, 86.08%, 86.82%, and 86.15% for LDL-CM, LDL-CF, LDL-CMa, and LDL-CS, respectively. Conclusions We proposed a practical, improved LDL-C calculation formula by applying different factors depending on the triglyceride concentration.

No abstract available.
*Algorithms ; Automation ; Clinical Laboratory Information Systems/*standards ; Humans ; Immunoassay/*methods ; Indicator Dilution Techniques ; alpha-Fetoproteins/*analysis