Clinical Chemistry and Laboratory Medicine (CLIN CHEM LAB MED)

Publisher: De Gruyter

Journal description

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.

Current impact factor: 2.71

Impact Factor Rankings

2015 Impact Factor Available summer 2016
2014 Impact Factor 2.707
2013 Impact Factor 2.955
2012 Impact Factor 3.009
2011 Impact Factor 2.15
2010 Impact Factor 2.069
2009 Impact Factor 1.886
2008 Impact Factor 1.888
2007 Impact Factor 1.741
2006 Impact Factor 1.725
2005 Impact Factor 1.918
2004 Impact Factor 1.685
2003 Impact Factor 1.523
2002 Impact Factor 1.407
2001 Impact Factor 1.595
2000 Impact Factor 1.744
1999 Impact Factor 1.084
1998 Impact Factor

Impact factor over time

Impact factor

Additional details

5-year impact 2.47
Cited half-life 5.30
Immediacy index 0.89
Eigenfactor 0.01
Article influence 0.62
Website Clinical Chemistry and Laboratory Medicine website
Other titles Clinical chemistry and laboratory medicine (Online)
ISSN 1434-6621
OCLC 41941237
Material type Document, Periodical, Internet resource
Document type Internet Resource, Computer File, Journal / Magazine / Newspaper

Publisher details

De Gruyter

  • Pre-print
    • Author can archive a pre-print version
  • Post-print
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  • Restrictions
    • 12 months embargo
  • Conditions
    • Pre-print and abstract on author's personal website only
    • Author's post-print on funder's repository or funder's designated repository at the funding agency's request or as a result of legal obligation.
    • Publisher's version/PDF may be used, on author's personal website, editor's personal website or institutional repository
    • Authors cannot deposit in subject repositories
    • Published source must be acknowledged
    • Must link to publisher version and article's DOI must be given
    • Set statement to accompany deposit (see policy)
  • Classification

Publications in this journal

  • Clinical Chemistry and Laboratory Medicine 11/2015;
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    ABSTRACT: Background: Structural hemoglobinopathies do not usually have a clinical impact, but they can interfere with the analytical determination of some parameters, such as the glycated hemoglobin in diabetic patients. Thalassemias represent a serious health problem in areas where their incidence is high. The defects in the post-translational modifications produce hyper-unstable hemoglobin that is not detected by most of electrophoretic or chromatographic methods that are available so far. Methods: We studied seven patients who belong to six unrelated families. The first two families were studied because they had peak abnormal hemoglobin (Hb) during routine analytical assays. The other four families were studied because they had microcytosis and hypochromia with normal HbA2 and HbF without iron deficiency. HbA2 and F quantification and abnormal Hb separation were performed by chromatographic and electrophoretic methods. The molecular characterization was performed using specific sequencing. Results: The Hb Puerta del Sol presents electrophoretic mobility and elution in HPLC that is different from HbA and similar to HbS. The electrophoretic and chromatographic profiles of the four other variants are normal and do not show any anomalies, and their identification was only possible with sequencing. Conlcusions: Some variants, such as Hb Valdecilla, Hb Gran Vía, Hb Macarena and Hb El Retiro, have significant clinical impact when they are associated with other forms of α-thalassemia, which could lead to more serious forms of this group of pathologies as for HbH disease. Therefore, it is important to maintain an adequate program for screening these diseases in countries where the prevalence is high to prevent the occurrence of severe forms.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0649

  • Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0759
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    ABSTRACT: Background: The chronic stage of human immunodeficiency virus (HIV) infection, although clinically asymptomatic, is characterized by activation of the immune system and persistent inflammation. Procalcitonin (PCT) has been studied in HIV infection as a marker of bacterial infection. Our aim was to assess the effect of persistent immune activation on PCT levels in asymptomatic treatment naïve HIV infected subjects. Methods: This was a cross-sectional study of 68 asymptomatic antiretroviral therapy-naive HIV infected participants and 42 uninfected controls. Stored serum samples were used to measure: PCT, interleukin-6 (IL-6), lipopolysaccharide binding protein (LBP), high sensitivity C-reactive protein (hsCRP), immunoglobulin G (IgG) and albumin. PCT was correlated with markers of: disease progression (CD4 count and viral load), immune activation (CD 38 on CD8+ T cells, IgG and LBP), inflammation (IL-6, hsCRP and albumin). Results: IL-6, IgG and CD8/38 were all significantly increased while albumin and CD4 counts were significantly lower in the HIV infected group. PCT levels were not significantly different between the two groups. There was no significant difference in LBP and hsCRP; however, their levels were increased in both groups. PCT correlated only with LBP (p=0.0001). IL-6 and LBP correlated positively with hsCRP and IgG. Albumin correlated inversely with IL-6 and viral load. Only IgG and CD8/38 correlated inversely with CD4 counts. Conclusions: We demonstrated the activation of the innate (raised LBP), humoral (raised IgG) and cellular immune systems (increased CD8/38 T cells). Despite a state of persistent inflammation, PCT levels are not elevated in asymptomatic untreated HIV infection.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0549
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    ABSTRACT: Background: Hypermethylation of DLX4 (distal-less homeobox 4) has been disclosed in a variety of cancers. Our work was aimed to examine the pattern of DLX4 methylation and further investigate its clinical relevance in patients with myelodysplastic syndrome (MDS). Methods: Real-time quantitative methylation-specific PCR and bisulfite sequencing PCR were carried out to detect the level of DLX4 methylation. Clinical significance of DLX4 methylation was analyzed between the DLX4 hypermethylated and non-hypermethylated patients. Results: DLX4 was significantly hypermethylated in MDS patients than controls (p<0.001). No significant differences were observed between the hypermethylated and non-hypermethylated MDS patients in white blood cells, platelets, age, WHO classifications, FAB classifications, IPSS risks, and common gene mutations (p>0.05). However, DLX4 hypermethylated patients tended to have higher hemoglobin (HB) than DLX4 non-hypermethylated patients (p=0.079). Moreover, there was a trend that male patients, poor karyotype patients, and IPSS Int-2/High patients had a higher frequency of DLX4 hypermethylation (p=0.067, 0.065, and 0.068). DLX4 hypermethylated patients had significantly shorter overall survival than DLX4 non-hypermethylated patients (p=0.004). Multivariate analysis confirmed the prognostic value of DLX4 methylation in MDS patients (p<0.001). Conclusions: Our study indicated that DLX4 hypermethylation was a frequent event and acted as an independent prognostic biomarker in de novo MDS patients.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0536
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    ABSTRACT: Accurate measurement of IgA monoclonal proteins presents a significant challenge to laboratory staff. IgA heavy/light chain (Hevylite, HLC) analysis is an alternative methodology for monoclonal protein assessment, giving an independent measure of IgAκ and IgAλ concentrations. Clonality is assessed by calculating the ratio of involved immunoglobulin to background uninvolved immunoglobulin concentrations (e.g. IgAκ/IgAλ in an IgAκ patient). Here we discuss the challenges faced by the laboratory in IgA monoclonal protein assessment, and compare the performance of Hevylite assays with electrophoresis and total IgA results. We present data which validates the use of Hevylite for response assessment: in most cases, Hevylite provides comparable response assignment to that provided by serum protein electrophoresis (SPE) and total IgA; in other cases Hevylite provides additional information, such as detection of residual disease or relapse.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0696
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    ABSTRACT: Background: Haptoglobin is an acute-phase binding protein that scavenges free hemoglobin. The human haptoglobin gene (HP) is polymorphic with two main alleles, haptoglobin allele 1 (Hp1) and haptoglobin allele 2 (Hp2). The smaller Hp1 allele features no duplication and consists of four exons, whereas the larger Hp2 allele, containing a 1.7 kb duplication, consists of six exons, with the fifth and sixth being highly homologous to exons 3 and 4 of Hp1. Methods: We designed an exonuclease (TaqMan) assay targeting single nucleotide differences between the homologous regions of Hp1 and Hp2. The assay contained one probe specifically binding to a site in intron 4 of Hp2, and another probe binding equally to intron 4 of Hp1 and intron 6 of Hp2. Results: Measurement of post-PCR fluorescence allowed unambiguous discrimination of HP genotypes. Comparison with genotypes obtained by a method based upon allele-specific primers yielded fully corresponding results. Conclusions: The new HP genotyping method is fast, reliable, does not require real-time instruments and may be especially useful for high-throughput genotyping.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0586
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    ABSTRACT: Background: Charcot-Marie-Tooth type 1A (CMT1A) is the most common type of hereditary motor and sensory neuropathies (HMSN), caused by the duplication of the 17p11.2 region that includes the PMP22 gene. Reciprocal deletion of the same region is the main cause of hereditary neuropathy with liability to pressure palsies (HNPP). CMT1A accounts for approximately 50% of HMSN patients. Diagnostics of CMT1A and HNPP are based on quantitative analysis of the affected region or RFLP detection of breakage points. The aim of this study was to improve the sensitivity and efficiency of CMT1A and HNPP genetic diagnostics by introducing analysis of six STR markers (D17S261-D17S122-D17S839-D17S1358-D17S955-D17S921) spanning the duplicated region. Methods: Forty-six CMT1A and seven HNPP patients, all genetically diagnosed by RFLP analysis, were tested for duplication or deletion using six STR markers. Results: In all CMT1A and HNPP patients, microsatellite analysis comprising six STR markers confirmed the existence of a duplication or deletion. In 89% (41/46) CMT1A patients the confirmation was based on detecting three alleles on at least one locus. In the remaining 11% (5) CMT1A patients, duplication was also confirmed based on two peaks with clear dosage difference for at least two different markers. All HNPP patients (7/7) displayed only one allele for each analyzed locus. Conclusions: Microsatellite analysis using six selected STR loci showed a high level of sensitivity and specificity for genetic diagnostics of CMT1A and HNPP. The results here strongly suggest STR marker analysis as a method of choice in PMP22 duplication/deletion testing.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0602
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    ABSTRACT: Background: Manual microscopy still represents the gold standard for urinary sediment (US) examination. We report the results obtained in the period 2012-2015 by the EQA Italian program on US, which today involves about 260 laboratories. Methods: The program includes four surveys per year. In two surveys, participants are asked to supply identification and clinical association of US particles. In two other surveys, they are asked to supply the diagnosis of clinical cases, presented with images, some key laboratory findings and a short clinical history. Sixty-six images of US particles (21 cells, 2 lipids, 21 casts, 10 crystals, 3 microorganisms, 15 contaminants) and seven clinical cases were presented. Results: The correct identification rate for each category of particles, in decreasing order, was: micro-organisms (mean±SD: 92.4%±4.5%), lipids (92.0%±1.8%), casts (82.8%±8.8%), crystals (79.4%±29.8%), cells (77.3%±13.5%), and contaminants (70.9%±22.2%). For 13 particles, a correct clinical association was indicated by 91.5%±11.7% of participants, while it was 52.7% for particles associated with urinary tract infection. For clinical cases, due to a high rate of particles misidentification, only 44.3%±10.1% of participants achieved access to clinical diagnosis, which was then correctly indicated by 92.5%±5.3% of them. Conclusions: The results of the EQA program confirm that, while some US particles are well known in terms of identification, clinical association and clinical meaning, others particles still are not, and this represents an important reason to encourage EQA programs on US.
    Clinical Chemistry and Laboratory Medicine 10/2015; 53. DOI:10.1515/cclm-2015-0794

  • Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0664
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    ABSTRACT: Background: Traumatic brain injury management is a tricky issue in children and pregnant women (due to adverse effects of computer tomography). To facilitate management, we report the main analytical performances and reference ranges for blood tests for the well-established S100B biomarker in under-16 children on a DiaSorin® Liaison XL analyzer and in pregnant women on DiaSorin® Liaison XL and Roche Diagnostics® Cobas e411 analyzers. Methods: Serum S100B concentrations were determined by chemiluminescent immunoassay on a DiaSorin® analyzer in a population of 409 healthy children aged 0-16 years and on DiaSorin®/Roche Diagnostics® instruments in a population of 50 pregnant women (one blood sample for each trimester). The analytical performances of both instruments and the influence of blood cells and skin pigmentation on the assay were also studied. Results: For children, four age-groups emerged, i.e. 0-3 months (mean: 0.97 μg/L; standard deviation (SD): 0.36; 95th percentile: 1.55), 4-9 months (mean: 0.58 μg/L; SD: 0.30; 95th: 1.18), 10-24 months (mean: 0.31 μg/L; SD: 0.12; 95th: 0.54) and 2-16 years (mean: 0.20 μg/L; SD: 0.07; 95th: 0.32). For pregnant women, serum S100B concentrations were similar to defined ranges for adults and not significantly different between trimesters on DiaSorin® (p=0.652)/Roche Diagnostics® (p=0.877) analyzers. We also found S100B expression (protein, total mRNA) in lymphocytes, an influence of skin pigmentation, and good analytical performances for both instruments. Conclusions: Data provided here is useful for interpreting serum S100B test results, in terms of preanalytical conditions, analytical performances, pediatric and pregnancy' environment.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0771

  • Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0641
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    ABSTRACT: The 21st century challenge is to redesign healthcare systems to be safe, efficient, effective, timely, equitable and patient-centred. Although laboratory medicine is integral to many of these objectives involving prevention, diagnosis, treatment, and managing disease of patients, it suffers from poor visibility as a medical discipline and as a profession and fewer rewards for educational efforts when compared to other medical disciplines. Laboratory scientists are often perceived as managing machinery and equipment, but conversely they need to take a position of shared clinical leadership, showing the role of laboratory tests to guarantee optimal care for patients. This is however challenging because of some reluctance by laboratory professionals to involve themselves in test structuring and requesting and in the inspection of work as it arrives because it is assumed that all requests are clinically necessary; there is a poor communication and integration between clinical wards and laboratory; and, importantly, there is the need for an excellent cultural and scientific background of laboratory professionals for implementing outcome research and to act as knowledge managers and skilled clinical consultants. By combining the unique talent of performing quality laboratory assays with knowledge of the pathophysiologic rationale behind the tests, laboratory professionals have the expertise to advise their clinical colleagues in regard to the appropriate test selection and interpretation of laboratory results, thereby creating opportunities to define the added value and the pivotal role of laboratory medicine on healthcare delivery.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0803
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    ABSTRACT: Background: Purine nucleoside phosphorylase (PNP) deficiency has been recently introduced in the newborn screening program in Tuscany. In order to improve the PNP screening efficiency, we developed a 2nd tier test to quantify PNP primary markers deoxyguanosine (dGuo) and deoxyinosine (dIno). Methods: Dried blood spots (DBS) samples were extracted with 200 μL of methanol and 100 μL of water (by two steps). Internal standards were added at a final concentration of 10 μmol/L. After extraction, samples were analysed by LC-MS/MS. The chromatographic run was performed in gradient mode by using a Synergi Fusion column. Results: The assay was linear over a concentration range of 0.05-50 μmol/L (R2>0.999) for dGuo and 0.5-50 μmol/L (R2>0.998) for dIno. Intra- and interassay imprecision (mean CVs) for dIno and dGuo ranged from 2.9% to 12%. Limit of quantitaion (LOQ) were found to be 0.05 μmol/L and 0.5 μmol/L for dGuo and dIno, respectively. The reference ranges, obtained by measuring dGuo and dIno concentrations on DBS, were close to zero for both biomarkers. Moreover, DBS samples from seven patients with confirmed PNP were retrospectively evaluated and correctly identified. Conclusions: The LC-MS/MS method can reliably measure dIno and dGuo in DBS for the diagnosis of PNP. Validation data confirm the present method is characterised by good reproducibility, accuracy and imprecision for the quantitation of dIno and dGuo. The assay also appears suitable for use in monitoring treatment of PNP patients.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0436
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    ABSTRACT: Background: Vitamin D deficiency is an important concern in clinical settings although there is no consensus on who should undergo 25-OH-vitamin D testing. We studied the prevalence of vitamin D deficiency before and after introducing adequacy (clinical and biochemical) criteria for testing. Methods: A total of 32,363 tests for 25-OH-vitamin D were retrospectively evaluated. Requests were unrestricted until December 2010 and justification criteria were applied from January 2011. During 6 years, 25,656 samples were analyzed (UHPLC) of which 12,315 were considered the first visit. The prevalence of deficiency was assessed for all the samples and according to the year, sex, season, age, origin of the requests, inclusion of adequacy criteria and consecutive visits. Results: A significant proportion of the requests (25%) were unjustified and less than half of the clinically or biochemically-justified tests displayed serum concentrations indicative of deficiency. Application of adequacy criteria resulted in a non-significant increase in the prevalence of deficiency, both at the first visit (36.5 vs. 41.7, p=0.17) and for all the samples analyzed (32.0 vs. 35.5, p=0.14). The percentage of deficiency decreased in consecutive visits although 2/3 and 41% of the patients remained deficient on the second and third visit, respectively. Moreover, at least 1/5 of sufficient patients at the first test became deficient in subsequent evaluations. Conclusions: A significant proportion of the requests was unjustified by clinical or biochemical criteria. Our data also indicate that clinical and biochemical criteria may be necessary (to be present) to justify vitamin D testing but not sufficient (predictive) to indicate the presence of vitamin D deficiency.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0781
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    ABSTRACT: Background: Most of the factors causing preanalytical and analytical variation in ammonia measurement have been identified. Biological variation data for ammonia is still lacking. We therefore estimated the components of biological variation (within-subject=CVI and between-subject=CVG), reference change value (RCV) and quality specifications for ammonia in a group of healthy individuals using fresh and frozen plasma samples. Methods: Blood samples from 20 healthy subjects were collected in K2EDTA tubes daily over a period of 4 consecutive days from each subject. Each plasma sample was split into two aliquots; one was immediately analyzed as the samples were collected and the other was stored -80 °C until testing at the end of the collection period and analyzed at once in one analytical run. All samples were analyzed in duplicate. Estimations were calculated according to Fraser and Harris methods. Results: CVI value for fresh samples (13.78%) was significantly lower than that in frozen samples (18.91%) (p<0.001). However, there was no statistically significant difference in CVG values between fresh (16.91%) and frozen (18.43%) samples (p=0.570). The index of individuality did not exceed 1.4 for fresh and frozen samples. The estimated RCVs were high for both fresh and frozen samples (43.37% and 56.85%, respectively). Quality specifications were established. Conclusions: The present study for the first time described the components of biological variation for ammonia in healthy individuals. These data regarding biological variation of ammonia could be useful for a better evaluation of ammonia test results in clinical interpretation and for determining quality specifications based on biological variation.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0591
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    ABSTRACT: Background: This study aimed to determine whether patients with lower abdominal symptoms can be investigated quickly using results of faecal haemoglobin concentration (f-Hb) measurements, and whether this test could form part of a diagnostic pathway for significant colorectal disease. Methods: Nine hundred and nine consecutive patients referred from primary care for colonoscopy were invited: 507 submitted samples for f-Hb measurement with a quantitative faecal immunochemical test for haemoglobin (FIT) (HM-JACKarc, Kyowa-Medex, Japan) and a diagnostic colonoscopy was completed in 484 patients. Results: Colorectal cancer (CRC), higher risk adenoma (HRA), inflammatory bowel disease (IBD) and/or colitis was found in 45 patients (9.3%); these had significantly higher (p<0.0001) f-Hb than the group of 243 with normal colonoscopy plus the 196 patients with less significant clinical findings. The 11 (2.2%) patients with CRC all had f-Hb >190 μg Hb/g faeces. Using a f-Hb cut-off of 10 μg Hb/g faeces, for the group with CRC or HRA or IBD or colitis, sensitivity was 68.9%, specificity 80.2%, positive predictive value (PPV) 26.3% and negative predictive value (NPV) 96.2%. Sensitivity and NPV were 100% for CRC suggesting f-Hb is a good rule-in test for CRC. Of the 243 patients with normal colonoscopy, 81.2% had f-Hb<10 μg Hb/g faeces. Conclusions: The high NPV for significant colorectal diseases suggests that f-Hb could be used as a rule-out test in this context. Potential exists for using f-Hb measurements to investigate symptomatic patients and guide the use of colonoscopy resources: detailed algorithms for the introduction of f-Hb measurements requires further exploration.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0617
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    ABSTRACT: Background: Laboratory investigation with specific factor XIII (FXIII) assays plays a crucial role in diagnosis of FXIII deficiency. According to the International Society on Thrombosis and Hemostasis (ISTH), it is necessary a blank sample with iodoacetamide, provided by the kit or locally prepared, when the ammonia release assays are used, to avoid FXIII activity overestimation. Methods: In this study we set up a modification of the Berichrom FXIII chromogenic assay, in which iodoacetamide was added by the BCS analyzer in the reaction mixture of the blank sample, without modifications of the original reagents. We analyzed 100 plasma samples of outpatients with clinical symptoms suggestive of a bleeding diathesis (20 samples had FXIII activity <20%). Results: In all samples blank subtraction significantly reduced FXIII activity, mostly in the low activity range group (from 10.1% to 2.4%, p<0.0001). In this group correction with iodoacetamide also increased the agreement with the immunoassay and allowed FXIII activity measure up to 0%. Conclusions: Despite the low number of samples included in the study, the described automatic procedure seemed to decrease FXIII activity overestimation and, especially for low activity range samples (<20%), to improve the agreement between FXIII activity and concentration. Our data suggested that iodoacetamide correction could allow the detection of severe FXIII deficiencies (activity <5%) otherwise undiagnosed using the original method.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0547
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    ABSTRACT: Background: Macroprolactinaemia is a major cause of hyperprolactinaemia. The detectability of macroprolactin varies widely among different immunoassay systems, but the causes are not fully known. This study aimed to identify the factors influencing the detectability of macroprolactin by immunoassay systems. Methods: The study included 1544 patients who visited an obstetric and gynaecological hospital. Macroprolactinaemia was screened using the polyethylene glycol (PEG) method and confirmed using gel filtration chromatography and the protein G method. The prolactin (PRL) values determined by enzyme immunoassay (EIA) were compared with those of a chemiluminescence immunoassay system (Centaur) that is known to cross-react the least with macroprolactin. Results: Macroprolactinaemia was found in 62 of 1544 patients (4.02%) who visited an obstetric and gynaecological hospital. The ratio of EIA-determined total PRL to free PRL in the supernatant after PEG precipitation was significantly elevated in all 62 serum samples with macroprolactin compared to those in 1482 serum samples without macroprolactin. In contrast, the ratio of Centaur-determined total PRL to free PRL was significantly elevated in 32 serum samples (group 1) and was within the normal range in 30 (group 2) of 62 serum samples with macroprolactin. The prevalence of non-IgG-type macroprolactin was significantly higher in group 1 than in group 2. Centaur diagnosed hyperprolactinaemia less frequently than EIA (n=2 vs. 16) in 62 patients with macroprolactinaemia. Those two hyperprolactinaemic patients diagnosed by Centaur had non-IgG-type macroprolactin. Conclusions: Macroprolactinaemia was present in 4% of patients visiting an obstetric and gynaecological hospital. The nature of macroprolactin (IgG-type or non-IgG-type) may partly explain why macroprolactin detectability varies among different immunoassay systems.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0484
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    ABSTRACT: Harmonisation and risk management policies represent key-issues in modern laboratory medicine as they focus on a more patient-centred delivery of laboratory information based on the recognition of the importance of all steps of the total testing process (TTP) for assuring quality and patient safety. However, a further essential step in project aiming to improve the value of laboratory medicine becomes the assessment of the impact of testing on patient-important outcomes. The grading of recommendations assessment, development and evaluation (GRADE) evidence to decision (EtD) frameworks may provide a systematic and transparent approach for translating the best clinical evidence available into healthcare decisions and recommendations. GRADE is a tool appropriate not only for evaluating test accuracy but also for clinical impact, such as mortality, morbidity, symptoms, and quality of life and therefore it should be applied to the outcome research in laboratory medicine. The application of GRADE requires the recognition that a recommendation about the use of test results should result from a balance between the desirable and the undesirable consequences, including non-health related consequences such as resource utilisation, feasibility, acceptability, equity and other factors. GRADE EtDs, represents a fundamental step in projects designed to improve care quality. Patient-physician-laboratory feedback can be assured through the GRADE process, where the team developing the recommendations should include the "three-parties" representatives; clinicians, laboratorians and patient/consumers. This ensures that the laboratory-patient interaction should not be a one-way process only (information from laboratory to patient) but a two-way process, incorporating patient expectations and feedback.
    Clinical Chemistry and Laboratory Medicine 10/2015; DOI:10.1515/cclm-2015-0867