Clinical Chemistry and Laboratory Medicine (CLIN CHEM LAB MED )

Publisher: Walter de Gruyter


CCLM is an official journal of the Belgian Society of Clinical Chemistry (BVKC/SBCC), the German United Society of Clinical Chemistry and Laboratory Medicine (DGKL), Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC), and the Slovenian Association for Clinical Chemistry. CCLM keeps you up-to-date with the latest developments in the clinical laboratory sciences. It reports on progress in fundamental and applied research. Areas covered include: clinical biochemistry, molecular medicine, hematology, immunology, microbiology, virology, drug measurement, genetic epidemiology, evaluation of diagnostic markers, new reagents and systems, reference materials, and reference values. CCLM further promotes communication concerning these topics by the publication of news, letters and meeting reports. New teaching and training methods applicable to laboratory medicine are also covered.

  • Impact factor
    Show impact factor history
    Impact factor
  • 5-year impact
  • Cited half-life
  • Immediacy index
  • Eigenfactor
  • Article influence
  • Website
    Clinical Chemistry and Laboratory Medicine website
  • Other titles
    Clinical chemistry and laboratory medicine (Online)
  • ISSN
  • OCLC
  • Material type
    Document, Periodical, Internet resource
  • Document type
    Internet Resource, Computer File, Journal / Magazine / Newspaper

Publisher details

Walter de Gruyter

  • Pre-print
    • Author can archive a pre-print version
  • Post-print
    • Author cannot archive a post-print version
  • Restrictions
    • 12 months embargo
  • Conditions
    • Pre-print and abstract on author’s personal website only
    • Publisher's version/PDF must be used
    • Publisher’s version on author’s personal website or open repository
    • Published source must be acknowledged
    • Institutional repositories may be allowed to include scanned version of articles not available in electronic format
    • Must link to publisher version or article’s DOI must be given
    • Some journals may have alternative policies
    • NIH funded authors may submit their authors final version to PubMed Central for release 12 months after publication
  • Classification
    ​ yellow

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: Abstract The cancer biomarker field appears to be stagnant. Very few, if any, new cancer biomarkers have been introduced into clinical practice the last 20 years. The reason is that most of the newly discovered cancer biomarkers are inferior in terms of sensitivity and specificity to the classical cancer biomarkers that we currently use. The revolutionary technologies of proteomics, genomics, and other omics did not deliver on the promise to discover new and improved cancer biomarkers. However, more recently, the explosive growth of whole genome and exome sequencing has provided for the first time nearly complete mutational landscapes of many cancer types, in thousands of samples. We now know that many of these mutations are only found in cancer. It is thus possible that the mutant proteins encoded by these genes may represent the long-sought, highly specific cancer molecules that we may envision to use as cancer biomarkers. I here speculate that modern mass spectrometry may have the necessary sensitivity and specificity to detect mutant proteins in various biological fluids for the purpose of diagnosis, prognosis, and disease monitoring.
    Clinical Chemistry and Laboratory Medicine 06/2014; 52(6):791-4.
  • Clinical Chemistry and Laboratory Medicine 05/2014;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Abstract Background: An increased focus on the biological behaviour of serum biomarkers for ovarian cancer, i.e., carbohydrate antigen 125 (CA-125) and human epididymis protein 4 (HE4), has been advocated to improve their clinical use. Due to the paucity and poor design of available studies evaluating biological variation (BV) of CA-125 and the lack of BV data for HE4, in this study we evaluated BV of both biomarkers. Methods: Monthly we obtained serum samples from 14 pre- (PreM) and 14 post-menopausal (PostM) healthy women for 4 consecutive months. Once all samples were available, they were analysed in a single run in duplicate for CA-125 and HE4 on Roche Modular system. Data were analysed by ANOVA. Results: For both biomarkers no difference in median concentrations was found between PreM and PostM. For CA-125 the intra-individual CV (CVI) was not different between groups (9.1% in both). For HE4 CVI was higher in PreM (12.1%) than in PostM (6.5%) (p<0.001). Between-subject CVs were 10.6% for CA-125 and 16.4% for HE4, with no influence by the fertility status. Both biomarkers showed high individuality meaning that the use of population-based reference limits may have limited value for their interpretation. Reference change values were 26% for CA-125 (all), 34% for HE4 PreM and 18% for HE4 PostM. Conclusions: Monitoring longitudinal changes in serum concentrations of ovarian cancer biomarkers over time is probably better than using single threshold rules. According to differences in BV due to the hormonal status, one should differently interpret HE4 changes in PreM and PostM.
    Clinical Chemistry and Laboratory Medicine 05/2014;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Abstract Background: Human epididymis protein 4 (HE4) is a reliable tumor marker for ovarian cancer, but only limited data are available on HE4 levels in lung malignancies. Methods: HE4 levels were measured at diagnosis in 98 men with lung cancer at different stages of the disease, and these results were compared to an age-matched healthy male cohort (n=98). The concentrations of classical tumor markers were also determined, and their efficacy was compared to that of HE4. Results: Compared to healthy controls, patients with lung neoplasm showed significantly higher HE4 levels [118.2 (80.6-150.1) pmol/L vs. 62.2 (47.2-76.1) pmol/L; p<0.001]. Although age and smoking modulated HE4 levels in the healthy cohort, no such effect was observed in the patient population. The area under the receiver operating characteristic curve (ROC-AUC) for HE4 was 0.848 (95% CI 0.792-0.904) for differentiating lung cancer patients from healthy controls, with a cut-off value of 97.6 pmol/L (sensitivity: 64.3%, specificity: 95.9%). HE4 levels were significantly elevated in all stages of lung cancer, and even in patients without clinical symptoms (p<0.05), but no difference was found between the different histological subgroups. A significant correlation was found between HE4 values and the tumor size determined by CT/MRI (Spearman's ρ=0.227, p=0.030). The combination of HE4 with CEA and CA 125 considerably enhanced the diagnostic efficacy [ROC-AUC: 0.963 (95% CI 0.937-0.990), sensitivity: 91.8%, specificity: 92.8%]. Conclusions: Our data suggest that serum HE4, especially in combination with CEA and CA 125, qualifies as a surrogate diagnostic marker in men with lung cancer.
    Clinical Chemistry and Laboratory Medicine 05/2014;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Abstract Background: Macro-hormones are circulating conjugates of hormones with immunoglobulins, which often artefactually elevate biochemical test results. Particularly when causing only moderate elevation no suspicion will be raised. By far the most frequently encountered macro-hormone is macro-prolactin. Here we report a female patient with rheumatoid arthritis who had persistently and grossly elevated thyroid stimulating hormone (TSH) but normal free thyroxine in electrochemiluminescent assays. Although clinically euthyroid, she was put on thyroxine therapy which caused hyperthyroid symptoms. Methods: An analytic interference by macro-TSH was assumed by dilution experiments, polyethylene-glycol-precipitation, the addition of a heterophilic antibody blocking reagent and size exclusion chromatography. Results: Further workup, however, revealed the presence of anti-ruthenium antibodies. Conclusions: To our knowledge this is the first report of anti-ruthenium antibodies selectively interfering with a TSH assay and causing erratic gross elevation of TSH mimicking macro-TSH.
    Clinical Chemistry and Laboratory Medicine 05/2014;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Abstract Background: Circulating nucleic acids acquired non-invasively have been confirmed as useful biomarkers in cancer and prenatal medicine. The most important molecules in the field of circulating nucleic acids research are circulating DNA and miRNA. In this study, the possibility of co-isolation of total circulating DNA, cell-free fetal DNA and miRNA from the plasma of pregnant women was tested, and the yields of co-isolated circulating nucleic acids using two commercial kits and three protocols were compared. Methods: Cell-free fetal DNA and miRNA from the plasma of pregnant women carrying male fetuses were co-isolated with the miRCURY™ RNA Isolation Kit according to the original protocol and the QIAamp Circulating Nucleic Acid Kit (CNA kit) according to the manufacturer's protocol for DNA isolation and miRNA isolation. For comparison of DNA isolation, the AR and DYS14 gene-based assays were used for the detection and quantification of total circulating and cell-free fetal DNA. For miRNA detection and quantification, the miR-16 and miR-451 assays were used. Results: Two different protocols for isolation using the CNA kit did not significantly differ in the yields of isolated tcDNA and cffDNA; however, the amount of isolated cffDNA using the miRCURY™ RNA Isolation Kit was significantly less (p<0.05, F=4.776). There was a statistically significant difference for miRNA isolation (p<0.0001, F=859 for miR-16 and p<0.0001, F=854.4 for miR-451), with the highest amount of isolated miRNA obtained using the miRCURY™ RNA Isolation Kit. Conclusions: All three methods used in our study were successful in the co-isolation of tcDNA, cffDNA and miRNA from the same sample. The best combined results were obtained with the miRCURY™ RNA Isolation Kit.
    Clinical Chemistry and Laboratory Medicine 05/2014;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Abstract Background: Thrombocytopenia is the most common coagulation disorder in critically ill patients. No studies have investigated the epidemiology and clinical impact of this condition in emergency department (ED) patients. We aimed to investigate epidemiological features, incidence of bleeding, and diagnostic and therapeutic requirements of patients with thrombocytopenia admitted to the ED. Methods: We performed a retrospective observational study enrolling all patients admitted to the medical-surgical ED of the "Città della Salute e della Scienza di Torino" Hospital with a platelet count <150×109 PLTs/L, during four non-consecutive months. There were no exclusion criteria. Results: The study included 1218 patients. The percentage of patients with severe (<50×109 PLTs/L) or very severe (<20×109 PLTs/L) thrombocytopenia was about 12%. Thrombocytopenia associated with liver cirrhosis was the most represented etiology. On the contrary, the most frequent cause in patients with newly recognized low platelet count was disseminated intravascular coagulation/sepsis. The incidence of bleeding and hypovolemia, as well as the need of transfusional support and mechanical, surgical or endoscopic hemostasis progressively increased with the severity of thrombocytopenia. Conclusions: Our results suggest that the detection of a platelet count lower than 50×109 PLTs/L may help to identify patients with higher bleeding risk in the ED setting. Additional studies are required to evaluate whether, in this setting, thrombocytopenia may represent an independent risk factor for bleeding episodes and increased mortality.
    Clinical Chemistry and Laboratory Medicine 05/2014;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Abstract Heart failure is a complex mechanical and neurohormonal syndrome where the left ventricle fails as a pump, resulting in stasis of blood in the lungs and the periphery resulting in the cardial features of effort intolerance, fatigue, and peripheral edema. As part of the neurohormonal and local mechanical strain, tissue macrophages resident in the myocardium secrete galectin-3 which is a paracrine and endocrine factor which stimulates additional macrophages, pericytes, myofibroblasts, and fibroblasts to proliferate and secrete procollagen I which is irreversibly crosslinked resulting in myocardial fibrosis. In the general population, normal plasma concentrations of galectin-3 are <11.0 ng/mL. Galectin-3 measured in blood has been shown to: 1) identify increased risk for new onset heart failure in healthy middle-aged adults; 2) predict cardiac failure in patients after acute coronary syndromes; 3) help establish the diagnosis of heart failure with preserved ejection fraction in patients presenting with exercise intolerance; and 4) aid in the prognosis of heart failure with preserved and reduced left ventricular ejection fraction. This manuscript will present practical real case management in these applications to highlight the importance of this new in vitro diagnostic test.
    Clinical Chemistry and Laboratory Medicine 05/2014;
  • Clinical Chemistry and Laboratory Medicine 05/2014;
  • Clinical Chemistry and Laboratory Medicine 05/2014;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Abstract Background: The measurement of serum IgE aids in the diagnosis and management of atopic allergic disease and hyper-IgE immunodeficiency syndromes. The 2nd World Health Organization (WHO) International Reference Reagent (IRR) for serum IgE (75/502; 5000 IU/ampoule), is widely used to calibrate assays for serum IgE. Exhaustion of stocks of the 2nd IRR necessitated the production of a replacement preparation and its evaluation in an international collaborative study to determine its suitability to serve as the 3rd International Standard (IS) for serum IgE. Methods: Sera and defibrinated plasma with elevated IgE levels were pooled and lyophilised in ampoules. This preparation, coded 11/234, was assayed by 18 laboratories in 11 countries using commercial assay methodology for IgE, along with the 2nd IRR, 75/502, and two lyophilised serum samples. Results: Overall, there were no consistent differences in the way that the candidate IS (11/234), the IRR (75/502), and the two serum samples behaved in the assays with respect to linearity and parallelism. The mean IgE value of the candidate IS, 11/234, relative to the IRR, 75/502, was 13,411 IU/mL based on parallel line analysis of raw assay data at NIBSC, and 13,551 IU/mL based on the laboratories' own estimates after correcting for the values obtained for 75/502. Conclusions: The use of 11/234 will ensure that assays for serum IgE continue to be well standardised. The preparation was established by the WHO Expert Committee on Biological Standardization as the 3rd IS for serum IgE with an assigned value of 13,500 IU/mL, corresponding to 6750 IU/ampoule.
    Clinical Chemistry and Laboratory Medicine 05/2014;
  • Clinical Chemistry and Laboratory Medicine 05/2014;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Abstract Reticulated platelets are immature platelets circulating in blood; they reflect the activity of megakaryopoiesis in the bone marrow. Therefore, they can be used as a non-invasive test in patients with thrombocytopenia in various clinical conditions. The preferred method of analysis is by flow cytometry. However, there is an evident lack of analytical standardization, making it difficult to compare results obtained in different laboratories. Currently, two types of hematology analyzers are on the market offering fully automated measurement of reticulated or immature platelets: the high end analyzers manufactured by Sysmex (XE- and XN-series) and Abbott (CELL-DYN Sapphire). Although the methods are essentially different and cannot be used interchangeably, both have been proven to have clinical utility. Reticulated or immature platelet assays are useful for the differential diagnosis of thrombocytopenia and for monitoring bone marrow recovery after chemotherapy or stem cell transplantation. These assays may aid clinicians in platelet transfusion decisions when recovery from thrombocytopenia is imminent. In addition, preliminary findings indicate that there is a rationale for reticulated or immature platelets for risk stratification in acute coronary syndromes and for monitoring the effect of treatment with antiplatelet drugs in patients with coronary artery diseases. The aim of this paper is to present the present technology available for measuring reticulated platelets as well as an overview of the current status of clinical application. This overview also indicates that more research is needed before reticulated or immature platelet assays can be applied in other clinical conditions than thrombocytopenia and after transplantation.
    Clinical Chemistry and Laboratory Medicine 05/2014;