AimsCarefully designed and established biobanks are considered one of the most essential resources to foster biomedical research as they provide cost-effective and rapid access to a vast variety of biological materials and related anthropometrics allowing for testing of various biomarkers as well as numerous original and pertinent bioclinical hypotheses related to human disease etiology and prognosis. The objective of the present study was to present the baseline data, design, and methods used for the establishment of the Vejle Diabetes Biobank. Further aims included assessment of the prevalence of diabetes and quality of diabetes treatment in a specified Danish region.MethodsThe Vejle Diabetes Biobank was established from 2007 to 2010 as a regional Biobank containing blood, DNA, and urine samples from patients with diabetes and a gender- and age-matched control population aged 25–75 years. Anthropometrics were obtained by physical examination, questionnaires, and interviews at the time of inclusion into the Biobank. The cohort was linked to the Danish Civil Registration System, the Danish National Patient Registry, and the Danish National Prescription Registry.ResultsIn total, 4,255 nondiabetic individuals and 3,320 patients with diabetes were included. Type 2 diabetes (T2D) patients had a higher body mass index (30 kg/m2) than type 1 diabetes (T1D) patients (25 and 26 kg/m2 in women and men, respectively) and control subjects (25 and 27 kg/m2 in women and men, respectively). Fasting levels of plasma triglycerides and blood pressure were higher in T2D patients (1.5 mmol/L and 148/85 mmHg, respectively) compared with T1D patients (0.9 mmol/L and 139/81 mmHg, respectively), whereas glycated hemoglobin (HbA1c), plasma high density lipoprotein, low density lipoprotein, and total cholesterol were lower in T2D patients (51 mmol/mol, 1.2 mmol/L, 2.2 mmol/L, and 4.2 mmol/L, respectively) compared with findings in T1D patients (61 mmol/mol, 1.6 mmol/L, 2.3 mmol/L, and 4.4 mmol/L, respectively). At the time of inclusion into the Biobank, 56% of the T2D patients and 25% of T1D patients had an HbA1c <7% (53 mmol/mol). Only 28% and 34% of the T2D patients, respectively, reached treatment target for blood pressure and lipids.ConclusionThe Vejle Diabetes Biobank represents one of the largest open diabetes case-control cohorts in Denmark. The Biobank invites collaborative investigations of diabetes and diabetes complication etiologies as well as studies of prognostic or predictive biomarkers.
Introduction: Analytical problems should be considered in case of a discrepancy between the results of biochemical tests and the clinical findings. Macro-hormones often artefactually elevate biochemical tests. Case Presentation: A young male was referred with persistently elevated TSH (148 mIU/L) measured by a sandwich electrochemiluminescence immunoassay, ECLIA (Cobas; Roche, Basel, Switzerland). The patient’s complaints were unspecific, and he appeared clinically euthyroid. The plasma levels of free T4 and free T3 were within the normal range, thyroid autoantibodies were negative, and thyroid ultrasonography was normal. During a short trial of thyroid hormone substitution, the level of TSH decreased to near-normal levels, but hyperthyroid symptoms emerged. TSH analysed by a different immunoassay (Architect; Abbott, Chicago, IL, USA) yielded similar results. In addition, serial dilutions were performed showing linearity, without detection of heterophilic antibody interference. Gel filtration chromatography confirmed the presence of macro-TSH. Conclusion: The patient harboured macro-TSH, which is a rare condition. The complex binding of TSH to other plasma proteins, most often immunoglobulins, results in elevated plasma TSH. However, the biologically active fraction of TSH is normal, reflected by clinical and biochemical euthyroidism.
BackgroundThe major obstacle in prescribing an appropriate and targeted antibiotic treatment is insufficient knowledge concerning whether the patient has a bacterial infection, where the focus of infection is and which bacteria are the agents of the infection. A prerequisite for the appropriate use of antibiotics is timely access to accurate diagnostics such as point-of-care (POC) testing.The study aims to evaluate diagnostic tools and working methods that support a prompt and accurate diagnosis of hospitalised patients suspected of an acute infection. We will focus on the most common acute infections: community-acquired pneumonia (CAP) and acute pyelonephritis (APN). The objectives are to investigate (1) patient characteristics and treatment trajectory of the different acute infections, (2) diagnostic and prognostic accuracy of infection markers, (3) diagnostic accuracy of POC urine flow cytometry on diagnosing and excluding bacteriuria, (4) how effective the addition of POC analysis of sputum to the diagnostic set-up for CAP is on antibiotic prescriptions, (5) diagnostic accuracy of POC ultrasound and ultralow dose (ULD) computerized tomography (CT) on diagnosing CAP, (6) diagnostic accuracy of specialist ultrasound on diagnosing APN, (7) diagnostic accuracy of POC ultrasound in diagnosing hydronephrosis in patients suspected of APN.Methods and analysisIt is a multifaceted multicentre diagnostic study, including 1000 adults admitted with suspicion of an acute infection. Participants will, within the first 24 hours of admission, undergo additional diagnostic tests including infection markers, POC urine flow cytometry, POC analysis of sputum, POC and specialist ultrasound, and ULDCT. The primary reference standard is an assigned diagnosis determined by a panel of experts.Ethics, dissemination and registrationApproved by Regional Committees on Health Research Ethics for Southern Denmark, Danish Data Protection Agency and clinicaltrials.gov. Results will be presented in peer-reviewed journals, and positive, negative and inconclusive results will be published.Trial registration numbersNCT04661085, NCT04681963, NCT04667195, NCT04652167, NCT04686318, NCT04686292, NCT04651712, NCT04645030, NCT04651244.
Decreasing values of S-HER2 predicts response to treatment whereas increasing levels predict resistance. S-HER2 above 1000 μg/L warns that standard doses of trastuzumab may be insufficient as reflected by low concentrations of S-trastuzumab.
S-HER2Ab can be measured accurately with the ImmunoCAP 100. There is an increased prevalence and concentration of S-HER2Ab in breast cancer patients but no correlation with HER2 gene amplification. We conclude that autoantibodies against HER2 do not seem to be the cause of HER2 gene amplification.
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