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    5705 results match your criteria Clinical Chemistry and Laboratory Medicine CCLM [Journal]

    1 OF 115

    The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability.
    Clin Chem Lab Med 2018 Jan 17. Epub 2018 Jan 17.
    Amphia Hospital, Clinical Chemistry and Haematology, Breda, The Netherlands.
    Calibration 2.000 was initiated 20 years ago for standardization and harmonization of medical tests. The program also intended to evaluate adequate implementation of the In Vitro Diagnostics (IVD) 98/79/EC directive, in order to ensure that medical tests are fit-for-clinical purpose. Read More

    Increased serum concentrations of soluble ST2 are associated with pulmonary complications and mortality in polytraumatized patients.
    Clin Chem Lab Med 2018 Jan 17. Epub 2018 Jan 17.
    Department of Trauma Surgery, Medical University of Vienna, Vienna, Austria.
    Background: We sought to evaluate the role of soluble ST2 (suppression of tumorigenicity) serum concentrations in polytraumatized patients and its potential role as biomarker for pulmonary complications.

    Methods: We included severely injured patients (injury severity score≥16) admitted to our level I trauma center and analyzed serum samples obtained on the day of admission and on day 2. Furthermore, patients with isolated thoracic injury and healthy probands were included and served as control groups. Read More

    Analysis of anti-ganglioside antibodies by a line immunoassay in patients with chronic-inflammatory demyelinating polyneuropathies (CIDP).
    Clin Chem Lab Med 2018 Jan 12. Epub 2018 Jan 12.
    Charité - Universitätsmedizin Berlin, Department of Neurology, Berlin, Germany.
    Background: Unlike for acute immune-mediated neuropathies (IN), anti-ganglioside autoantibody (aGAAb) testing has been recommended for only a minority of chronic IN yet. Thus, we used a multiplex semi-quantitative line immunoassay (LIA) to search for aGAAb in chronic-inflammatory demyelinating polyneuropathy (CIDP) and its clinical variants.

    Methods: Anti-GAAb to 11 gangliosides and sulfatide (SF) were investigated by LIA in 61 patients with IN (27 typical CIDP, 12 distal-acquired demyelinating polyneuropathy, 6 multifocal-acquired demyelinating sensory/motor polyneuropathy, 10 sensory CIDP, 1 focal CIDP and 5 multifocal-motoric neuropathy), 40 with other neuromuscular disorders (OND) (15 non-immune polyneuropathies, 25 myasthenia gravis), 29 with multiple sclerosis (MS) and 54 healthy controls (HC). Read More

    Performance evaluation of a new automated fourth-generation HIV Ag/Ab combination chemiluminescence immunoassay.
    Clin Chem Lab Med 2018 Jan 10. Epub 2018 Jan 10.
    Department of Laboratory Medicine/Clinical Research Center of Laboratory Medicine, West China Hospital of Sichuan University, No.37 GuoXue Alley, Chengdu, Sichuan 610041, P.R. China, Phone: +86-28-85422612, Fax: +86-28-85582944.

    Predictive value of serum gelsolin and Gc globulin in sepsis - a pilot study.
    Clin Chem Lab Med 2018 Jan 10. Epub 2018 Jan 10.
    Department of Laboratory Medicine, University of Pécs, Medical School, Pécs, Hungary.
    Background: Simultaneous determination of the two main actin scavenger proteins in sepsis has not been investigated until now. In our pilot study, we elucidated the predictive values of Gc globulin and gelsolin (GSN) in sepsis by comparing them to classic laboratory and clinical parameters.

    Methods: A 5-day follow-up was performed, including 46 septic patients, 28 non-septic patients and 35 outpatients as controls. Read More

    Precision, accuracy, cross reactivity and comparability of serum indices measurement on Abbott Architect c8000, Beckman Coulter AU5800 and Roche Cobas 6000 c501 clinical chemistry analyzers.
    Clin Chem Lab Med 2018 Jan 9. Epub 2018 Jan 9.
    Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia.
    Background: The aim of our study was to perform verification of serum indices on three clinical chemistry platforms.

    Methods: This study was done on three analyzers: Abbott Architect c8000, Beckman Coulter AU5800 (BC) and Roche Cobas 6000 c501. The following analytical specifications were verified: precision (two patient samples), accuracy (sample with the highest concentration of interferent was serially diluted and measured values compared to theoretical values), comparability (120 patients samples) and cross reactivity (samples with increasing concentrations of interferent were divided in two aliquots and remaining interferents were added in each aliquot. Read More

    Site-specific DNA methylation detection based on enzyme-linked immunosorbent assay using recombinant methyl-CpG binding protein.
    Clin Chem Lab Med 2018 Jan 8. Epub 2018 Jan 8.
    The Fifth Affiliated Hospital, Guangzhou Medical University, No. 78, Hengzhigang Road, Guangzhou 510095, Guangdong Province, P.R. China, Phone: +86-20-32015316, Fax: +86-20-32015314.

    Screening for connective tissue disease-associated antibodies by automated immunoassay.
    Clin Chem Lab Med 2018 Jan 8. Epub 2018 Jan 8.
    Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.
    Background: Antinuclear antibodies (ANAs) are useful for the diagnosis of ANA-associated systemic rheumatic disease (AASRD). The objective of this study was the evaluation of an immunoassay that detects antibodies to a mixture of 17 antigens as an alternative to indirect immunofluorescence (IIF).

    Methods: Nine thousand eight hundred and fifty-six consecutive patients tested for ANAs were tested by IIF and EliA connective tissue disease screen (Thermo-Fisher). Read More


    Diagnosis of acute pediatric appendicitis from children with inflammatory diseases by combination of metabolic markers and inflammatory response variables.
    Clin Chem Lab Med 2018 Jan 8. Epub 2018 Jan 8.
    Department of Infectious Diseases, The Second Affiliated Hospital of Nanchang University, School of Pharmaceutical Science, Nanchang University, Nanchang 330006, P.R. China, Phone: +86 791 86361839, Fax: +86 791 86361839.
    Background: The discovery of new metabolic markers may be helpful for early diagnosis of acute pediatric appendicitis (APA). However, no studies have been reported regarding identification of potential metabolic markers for the APA diagnosis by metabonomics.

    Methods: Serum samples of APA (n=32), non-appendicitis inflammation (NAI, n=32) and healthy children (HS, n=65) were analyzed by the 1H NMR-based metabonomics. Read More

    LC-MSMS assays of urinary cortisol, a comparison between four in-house assays.
    Clin Chem Lab Med 2018 Jan 8. Epub 2018 Jan 8.
    Department of Biochemistry, INSERM U1235 University Hospital of Nantes, Nantes, France.
    Background: Twenty-four hour urinary free cortisol (UFC) determination can be used for screening and follow-up of Cushing syndrome (CS). As immunoassay methods lack specificity for UFC measurement, the use of high-performance liquid chromatography coupled to mass spectrometer (LC-MSMS) is recommended. The aim of our study was to compare UFC results using four LC-MSMS methods performed in four independent laboratories in order to evaluate interlaboratory agreement. Read More

    Detection of EGFR, KRAS and BRAF mutations in metastatic cells from cerebrospinal fluid.
    Clin Chem Lab Med 2018 Jan 8. Epub 2018 Jan 8.
    APHM, Hôpital la Timone, Service de Biologie Cellulaire, Marseille, France.
    Background: In lung adenocarcinoma, molecular profiling of actionable genes has become essential to set up targeted therapies. However, the feasibility and the relevance of molecular profiling from the cerebrospinal fluid (CSF) in the context of meningeal metastasis have been poorly assessed.

    Methods: We selected patients with stage IV lung adenocarcinoma harbouring metastatic cells in the CSF after cytological analysis. Read More

    Systematic comparison of routine laboratory measurements with in-hospital mortality: ICU-Labome, a large cohort study of critically ill patients.
    Clin Chem Lab Med 2018 Jan 8. Epub 2018 Jan 8.
    Department of Critical Care, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB Groningen, The Netherlands, Phone: 00-31-50-3616161, Fax: 0031-50-3615644.
    Background: In intensive care unit (ICU) patients, many laboratory measurements can be deranged when compared with the standard reference interval (RI). The assumption that larger derangements are associated with worse outcome may not always be correct. The ICU-Labome study systematically evaluated the univariate association of routine laboratory measurements with outcome. Read More

    An update report on the harmonization of adult reference intervals in Australasia.
    Clin Chem Lab Med 2018 Jan 6. Epub 2018 Jan 6.
    Pathology Queensland, Chemical Pathology Department, Royal Brisbane and Woman's Hospital, Herston, Queensland, Australia.
    The Australasian Association of Clinical Biochemists (AACB) has over the past 5 years been actively working to achieve harmonized reference intervals (RIs) for common clinical chemistry analytes using an evidence-based checklist approach where there is sound calibration and metrological traceability. It has now recommended harmonized RIs for 18 common clinical chemistry analytes which are performed in most routine laboratories and these have been endorsed by the Royal College of Pathologists of Australasia (RCPA). In 2017 another group of analytes including urea, albumin and arterial blood gas parameters were considered and suggested harmonized RIs proposed. Read More

    GSTP1 methylation in cancer: a liquid biopsy biomarker?
    Clin Chem Lab Med 2018 Jan 6. Epub 2018 Jan 6.
    Biosciences Laboratory, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
    The coding region of GSTP1 gene is preceded by a large CpG-rich region that is frequently affected by methylation. In many cancer types, GSTP1 is affected by hypermethylation and, as a consequence, it has a low expression. The aim of this review is to give an overview on GSTP1 methylation studies with a special focus on liquid biopsy, thus to summarize methods, results, sample types, different diseases, to have a complete information regarding this promising epigenetic biomarker. Read More


    Short- and medium-term biological variation estimates of red blood cell and reticulocyte parameters in healthy subjects.
    Clin Chem Lab Med 2018 Jan 5. Epub 2018 Jan 5.
    Section of Clinical Biochemistry, University of Verona, Verona, Italy.
    Background: The integrated evaluation of traditional and innovative red blood cell (RBC) and reticulocyte parameters is a rapid, inexpensive and non-invasive diagnostic tools for differential diagnosis and follow-up of anemia and other pathological conditions needing bone marrow erythropoiesis assessment. Therefore, estimating the biological variation (BV) of these parameters is essential for evaluating the analytical performance of hematological analyzers, and for enabling accurate data interpretation and appropriate clinical management. This study aims to define short- and medium-term BV estimates and reference change value (RCV) of RBC and reticulocyte parameters. Read More

    Harmonization of accreditation to ISO15189.
    Clin Chem Lab Med 2018 Jan 5. Epub 2018 Jan 5.
    European Federation of Clinical Chemistry and Laboratory medicine (EFLM) Committee for Quality and Regulations (C-QR) of the EFLM, The Hague, The Netherlands.
    Over the years, ISO15189 has established itself as the international standard for quality management systems for all fields in laboratory medicine. As a result, also accreditation to this standard has increased in international adaptation. As a consequence, its impact grows as governments make the standard obligatory and/or national funding systems require ISO15189 accreditation for reimbursement. Read More

    Reference intervals for biochemical, haemostatic and haematological parameters in healthy Chinese women during early and late pregnancy.
    Clin Chem Lab Med 2018 Jan 5. Epub 2018 Jan 5.
    Clinical Laboratory, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, P.R. China.
    Background: Variations in maternal blood parameters, which are mostly induced by the physiological changes that occur during pregnancy, have been reported in different gestational periods. The use of the established reference intervals for healthy adult females leads to the misclassification of healthy pregnant women as abnormal. Our aim was to establish appropriate reference intervals for biochemical, haematological and haemostatic parameters in the first and third trimesters of pregnancy. Read More

    Detection of autoantibodies to the p200-epitope of SSA/Ro52 antigen. A comparison of two laboratory assays.
    Clin Chem Lab Med 2018 Jan 5. Epub 2018 Jan 5.
    Rheumatology Unit, Department of Medicine-DIMED, University of Padua, Padua, Italy.
    Background: Anti-p200 antibodies have been receiving growing interest in view of findings associating their presence to risk of fetal autoimmune congenital heart block (CHB). The study compares and evaluates the performance of two assays currently being used for their detection.

    Methods: One hundred and sixteen pregnant women positive for anti-SSA/Ro52 antibodies were considered as the study population. Read More

    No additional value of conventional and high-sensitivity cardiac troponin over clinical scoring systems in the differential diagnosis of type 1 versus type 2 myocardial infarction.
    Clin Chem Lab Med 2018 Jan 5. Epub 2018 Jan 5.
    Molecular and Clinical Sciences Research Centre, St George's Hospital, University of London, Cranmer Terrace, London, UK.
    Background: The distinction of type 1 and type 2 myocardial infarction (MI) is of major clinical importance. Our aim was to evaluate the diagnostic ability of absolute and relative conventional cardiac troponin I (cTnI) and high-sensitivity cardiac troponin T (hs-cTnT) in the distinction between type 1 and type 2 MI in patients presenting at the emergency department with non-ST-segment elevation acute chest pain within the first 12 h.

    Methods: We measured cTnI (Dimension Vista) and hs-cTnT (Cobas e601) concentrations at presentation and after 4 h in 200 patients presenting with suspected acute MI. Read More

    Circulating miR-21, miR-210 and miR-146a as potential biomarkers to differentiate acute tubular necrosis from hepatorenal syndrome in patients with liver cirrhosis: a pilot study.
    Clin Chem Lab Med 2018 Jan 5. Epub 2018 Jan 5.
    Internal Medicine, Tanta University, Faculty of Medicine, Tanta, Egypt.
    Background: Acute kidney injury (AKI) in cirrhotic patients may be functional (hepatorenal syndrome [HRS]) or structural (acute tubular necrosis [ATN]). The differentiation between these two conditions remains challenging; no definite biomarker with a clear cutoff value had been declared. miRNAs seem to be attractive innovative biomarkers to identify the nature of kidney injury in cirrhotic patients. Read More


    A new ELISA for autoantibodies to steroid 21-hydroxylase.
    Clin Chem Lab Med 2017 Dec 21. Epub 2017 Dec 21.
    FIRS Laboratories, RSR Ltd., Parc Ty Glas, Llanishen, Cardiff, UK.
    Background: A new ELISA for autoantibodies to steroid 21-hydroxylase (21-OH Ab) is described.

    Methods: In the assay test sample autoantibodies form a bridge between 21-OH coated onto the plate well and liquid phase 21-OH-biotin. Bound 21-OH-biotin is detected by the addition of streptavidin peroxidase and colorogenic peroxidase substrate. Read More

    Rule-out of non-ST elevation myocardial infarction by five point of care cardiac troponin assays according to the 0 h/3 h algorithm of the European Society of Cardiology.
    Clin Chem Lab Med 2017 Dec 19. Epub 2017 Dec 19.
    Institute for Clinical Chemistry, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
    Background: Point of care (POC) assays for cardiac troponins I or T (cTnI or cTnT) may accelerate the diagnosis of patients with suspected acute coronary syndrome (ACS). However, their clinical utility according to the 0 h/3 h algorithm recommended by the European Society of Cardiology (ESC) for non-ST elevation myocardial infarction (NSTEMI) is unknown.

    Methods: Blood samples from 90 patients with suspected ACS were obtained at hospital admission and 3 h later. Read More

    Extra-analytical quality indicators - where to now?
    Clin Chem Lab Med 2017 Dec 18. Epub 2017 Dec 18.
    Department of Laboratory Medicine, University Hospital of Padova, Padova, Italy.
    A large body of evidence collected in recent years demonstrates the vulnerability of the extra-analytical phases of the total testing process (TTP) and the need to promote quality and harmonization in each and every step of the testing cycle. Quality indicators (QIs), which play a key role in documenting and improving quality in TTP, are essential requirements for clinical laboratory accreditation. In the last few years, wide consensus has been achieved on the need to adopt universal QIs and common terminology and to harmonize the management procedure concerning their use by adopting a common metric and reporting system. Read More

    Gender-partitioned patient medians of serum albumin requested by general practitioners for the assessment of analytical stability.
    Clin Chem Lab Med 2017 Dec 18. Epub 2017 Dec 18.
    Department of Research, Nordsjællands Hospital University of Copenhagen, Hillerød, Denmark.
    Background: Recently, the use of separate gender-partitioned patient medians of serum sodium has revealed potential for monitoring analytical stability within the optimum analytical performance specifications for laboratory medicine. The serum albumin concentration depends on whether a patient is sitting or recumbent during phlebotomy. We therefore investigated only examinations requested by general practitioners (GPs) to provide data from sitting patients. Read More

    Serum exosomal hnRNPH1 mRNA as a novel marker for hepatocellular carcinoma.
    Clin Chem Lab Med 2017 Dec 18. Epub 2017 Dec 18.
    Department of Laboratory Medicine, Hangzhou First People's Hospital, Hangzhou, P.R. China.
    Background: Distinctive exosomal contents could be useful for cancer diagnosis and prognosis. However, little is known about whether serum exosomal heterogeneous nuclear ribonucleoprotein H1 (hnRNPH1) mRNA is a satisfactory biomarker for hepatocellular carcinoma (HCC).

    Methods: Two hundred and ninety-one participants divided into four age- and gender-matched groups, including a HCC group (n=88), a liver cirrhosis (LC) group (n=67), a chronic hepatitis B (CHB) group (n=68) and a healthy control group (n=68), were enrolled. Read More

    A Black Swan in clinical laboratory practice: the analytical error due to interferences in immunoassay methods.
    Clin Chem Lab Med 2017 Dec 7. Epub 2017 Dec 7.
    .
    It is well known that the results of immunoassay methods can be affected by specific or non-specific interferences, ranging from 0.4% to 4.0%. Read More

    Association of adrenal hormone metabolites and mortality over a 6-year follow-up in COPD patients with acute exacerbation.
    Clin Chem Lab Med 2017 Dec 7. Epub 2017 Dec 7.
    .
    Background: The release of hormones from the adrenal gland is vital in acute and chronic illnesses such as chronic obstructive pulmonary disease (COPD) involving recurrent exacerbations. Using a metabolomic approach, we aim to investigate associations of different adrenal hormone metabolites with short- and long-term mortality in COPD patients.

    Methods: We prospectively followed 172 COPD patients (median age 75 years, 62% male) from a previous Swiss multicenter trial. Read More

    The UGT1A1*28 gene variant predicts long-term mortality in patients undergoing coronary angiography.
    Clin Chem Lab Med 2017 Dec 7. Epub 2017 Dec 7.
    .
    Background: Uridine diphosphate glycosyltransferases 1A1 (UGT1A1) plays an essential role in detoxification and excretion of several endogenous and exogenous compounds. A functional polymorphism in the promoter of the UGT1A1 gene (TA repeat insertion, UGT1A1*28, rs3064744) has been associated with reduced UGT1A1 enzyme activity. The purpose of the present study was to investigate the role of UGT1A1 genotypes in mortality. Read More

    Development of a new biochip array for APOE4 classification from plasma samples using immunoassay-based methods.
    Clin Chem Lab Med 2017 Dec 7. Epub 2017 Dec 7.
    .
    Background: Apolipoprotein E (APOE) is a key player in lipid transport and metabolism and exists in three common isoforms: APOE2, APOE3 and APOE4. The presence of the E4 allelic variant is recognized as a major genetic risk factor for dementia and other chronic (neuro)degenerative diseases. The availability of a validated assay for rapid and reliable APOE4 classification is therefore advantageous. Read More

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