Publications by authors named "Cindy S Knudsen"

Background: Idiopathic intracranial hypertension is a secondary headache disorder potentially causing visual loss. Neurofilament light chain is a candidate, prognostic biomarker, but further studies of neuronal biomarkers are needed. Our objective was to investigate neurofilament light chain in cerebrospinal fluid (cNfL) and plasma (pNfL), amyloid-beta 42 (Aβ-42), total-tau and phosphorylated-tau in cerebrospinal fluid in new-onset idiopathic intracranial hypertension.

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Plasma calprotectin is a promising new biomarker of inflammatory activity and has been found to correlate well with clinical and endoscopic activity in children and adolescents with inflammatory bowel disease. A pediatric reference interval for plasma calprotectin has not been established for the Phadia 250 EliA™ Calprotectin fluoroenzyme immunoassay. In studies regarding pre-analytical properties, excellent precision and stability was found.

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Elevated levels of neurofilament light chain (NfL) in the blood is an unspecific biomarker for damage to neuronal axons. The measurement of NfL levels in the blood can provide useful information for monitoring and prognostication of various neurological disorders in children, but a reference interval (RI) is needed before the clinical implementation of the biomarker. We aimed to establish a RI for children aged 0-17 years.

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Background: Haptocorrin (HC) and holotranscobalamin (holoTC) carry vitamin B12 (B12) in the circulation and can be useful biomarkers for evaluating B12 status. The concentration of both proteins depends on age, but data on reference intervals for children and the elderly are sparse. Similarly, not much is known about the effect of preanalytical factors.

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Objectives: Glial fibrillary acidic protein (GFAP) in blood is an emerging biomarker of brain injury and neurological disease. Its clinical use in children is limited by the lack of a reference interval (RI). Thus, the aim of the present study was to establish an age-dependent continuous RI for serum GFAP in children.

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Background: Analysis of beta-amyloid 1-42 (Aβ42), total tau (t-tau) and phosphorylated-tau 181 (p-tau) in the cerebrospinal fluid (CSF) is often performed as a part of the diagnostic work-up in case of suspected Alzheimer's dementia (AD). Unfortunately, studies on optimal CSF biomarker cut-offs in a real-world clinical setting are scarce.

Methods: We retrospectively evaluated the biomarker levels of 264 consecutive patients referred to our dementia clinic.

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Objectives: Glial fibrillary acidic protein (GFAP) is a promising biomarker that could potentially contribute to diagnosis and prognosis in neurological diseases. The biomarker is approaching clinical use but the reference interval for serum GFAP remains to be established, and knowledge about the effect of preanalytical factors is also limited.

Methods: Serum samples from 371 apparently healthy reference subjects, 21-90 years of age, were measured by a single-molecule array (Simoa) assay.

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As an activation product of neutrophil granulocytes, calprotectin has been widely used in fecal samples for diagnosis and monitoring of patients with inflammatory bowel disease. However, fecal sample collection is cumbersome, and pre-analytical sources of error are plentiful. Therefore, plasma calprotectin is being investigated as a promising new biomarker.

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Background: Plasma/serum vitamin B12 (B12) is often used to screen for B12 deficiency complemented with analysis of methylmalonic acid (MMA) in case of low B12. The concentration of both analytes likely depends on age, and we, therefore, aimed at establishing 95% age-adjusted reference intervals (RIs) for plasma B12 and serum/plasma MMA in the Danish population.

Methods: We collected and analysed blood samples from healthy children, adults, and elderly individuals and extracted routine clinical B12 and MMA results to establish RIs.

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Biotin is increasingly used as dietary supplement. As many immunoassays rely on a binding between biotin and streptavidin, intake of biotin may interfere with laboratory tests, leading to spurious test results. We examined the extent to which levels of aldosterone, renin, insulin-like growth factor 1 (IGF-1), growth hormone (GH) and bone alkaline phosphatase (BAP) were affected by biotin.

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Objectives: The glycated haemoglobin fraction A (HbA) is widely used in the management of diabetes mellitus, and the Siemens DCA Vantage™ point-of-care testing (POCT) instrument offers rapid HbA results even far from a clinical laboratory. However, the analytical performance has been questioned, and not much is known about effects of changing reagent lot, instrument and operator. We therefore compared the analytical performance of the DCA Vantage™ with established routine methods (Tosoh G8/G11 ion exchange HPLC) in a true clinical setting at two Danish hospitals.

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Hypersensitivity pneumonitis (HP) is an interstitial lung disease (ILD) caused by the inhalation of antigens. Antigen-specific IgG antibodies (sIgG) are used as biomarkers of exposure when diagnosing HP, but little is known about the longitudinal relation between antibody levels and risk of HP or other ILD. In a follow-up design, we explored the relationship between sIgG antibodies against and the diagnosis of HP in 647 subjects suspected of HP.

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Procollagen III, N-terminal propeptide (PIIINP) is used as a biomarker for increased collagen III-synthesis. Reference intervals have not been established for the MAGLUMI 800 chemiluminescence immunoassay (CLIA) in Northern European adults or in children. The present study aimed to establish age-specific reference intervals in a Northern European population.

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In coeliac disease, the diagnostic work-up is based on a combination of clinical, histopathological and serological evaluation. Among the serological tests, the presence of tissue transglutaminase (tTG) IgA antibodies is the cornerstone owed to a high sensitivity and specificity. Recently, Immunodiagnostic Systems Ltd (IDS) introduced the fully automated chemiluminescent autoimmune assays for use on the IDS-iSYS Multi-Discipline Automated System.

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The neurofilament light chain (NfL) is a promising biomarker of neuronal injury which is approaching routine clinical use. With the development of ultra-sensitive technologies, NfL has become measurable in the peripheral blood but the reference interval for serum NfL remains to be established. NfL was measured by a single-molecule array (Simoa™) analysis under internal and external quality control which is established for routine clinical use.

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Thyrotropin (TSH) receptor antibodies (TRAb) mediate the hyperthyroidism of Graves' disease (GD). The aim of the study was to compare the diagnostic performance and assay agreement between three immunoassays for the measurement of TRAb in patients with newly diagnosed GD. TRAb was measured with three different assays [H-TRAb (BRAHMS Diagnostica), M22-Man (RSR Limited) and M22-Aut (Roche Diagnostics)] in 387 participants who were recruited from two Danish population-based studies and diagnosed with GD (n = 101), multinodular toxic goitre (n = 88), primary autoimmune hypothyroidism (n = 100) or included as controls (n = 98).

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Background: Previous studies have reported problems measuring testosterone with immunological assays. Here we explore an automatic second generation immunoassay compared to a LC-MS/MS method.

Methods: We collected blood samples from 76 women and measured testosterone, progesterone, gender hormonebinding globulin (SHBG), and albumin employing Cobas e601/c501.

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Introduction: The aim of this study was to investigate and compare the stability of adrenocorticotrophic hormone (ACTH) in whole blood stored on ice and at room temperature for up to 48 hours. This study differs from previous studies by a larger data material.

Materials And Methods: EDTA-blood samples from 30 patients were collected, aliquoted and stored on ice or at room temperature for 0, 2, 4, 24, or 48 h before centrifugation, and the plasma was stored frozen until analysis.

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Introduction. Decreased salivary flow and xerostomia are frequent findings in Parkinson's disease (PD), possibly caused by alterations in the parasympathetic tonus. Here we explore salivary acetylcholinesterase (AChE) activity as a potential biomarker in PD.

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Background: Recently, measurement of amino terminal propeptide of type III procollagen (PIIINP) was introduced as a part of the hepatic cirrhotic marker enhanced liver fibrosis™ test on the automated ADVIA Centaur(®) immunoassay platform (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA). In this article, we show that the Centaur PIIINP may be used in place of the much more labor-intensive RIA method, and we present an age stratified reference interval.

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Background: Vitamin D deficiency is considered a major health issue and therefore there is a need for reliable routine tests for measurement of the vitamin in blood samples. Here we present a validation of the recently released Roche 25-OH Vitamin D Total assay (Vitamin D Total).

Methods: We analyzed control materials (2 levels) and patient serum pools (3 levels) ranging from 34 to 123 nmol/L 84 times over a period of 21 days, and we analyzed five serum pools in 10 separate runs to verify the limit of quantification.

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Background: The cerebrospinal fluid (CSF) biomarkers amyloid β (Aβ)-42, total-tau (T-tau), and phosphorylated-tau (P-tau) demonstrate good diagnostic accuracy for Alzheimer's disease (AD). However, there are large variations in biomarker measurements between studies, and between and within laboratories. The Alzheimer's Association has initiated a global quality control program to estimate and monitor variability of measurements, quantify batch-to-batch assay variations, and identify sources of variability.

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Immobilization of submonolayers to 4-5 multilayers of organic molecules on carbon surfaces can be performed by in situ generation of aryl radicals from aryltriazenes. The central idea consists of oxidatively forming an electrogenerated acid of N,N'-diphenylhydrazine to convert the aryltriazene to the corresponding diazonium salt in the diffusion layer of the electrode. In a second step, the diazonium salt is reduced at the same electrode to give a surface of covalently attached aryl groups.

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