Determination of quality control limits for serological infectious disease testing using historical data.

Abstract:

BACKGROUND:An effective quality control (QC) program requires the establishment of control limits within which the results of the QC sample is expected to fall. Traditionally, the mean plus/minus two standard deviations calculated for a set of QC sample results is used to establish control limits. Allowable total error (TEa) and Westgard rules aid in interpreting QC sample results. Westgard rules assume QC sample results are normally distributed and TEa assumes commutability between the QC sample and patient results. None of these paradigms apply to infectious disease testing. METHODS:RESULTS from the NRL's QC program were extracted and sorted into assay/QC lot number-specific data. Control limits for selected QC samples used to monitor 64 commonly used serological assays were calculated and validated using the within- and between-QC lot variance of data from each of the assay/QC combinations. RESULTS:No assay/QC combination had more than 10% of results less than the lower control limit or greater than the upper control limit. Of the 423 assay/QC lot combinations, 14 (3.3%) had more than 5% of results less than the lower limit and 48 (11.3%) had more than 5% of results greater than the upper limit calculated for that assay/QC combination. CONCLUSIONS:The control limits, established by this novel method, are based on more than a decade of QC test results from >300 laboratories from 30 countries and provides users of the NRL QC program evidence-based control limits that can be applied in isolation or in conjunction with more traditional methods for establishing control limits.

journal_name

Clin Chem Lab Med

authors

Dimech W,Vincini G,Karakaltsas M

doi

10.1515/cclm-2014-0546

subject

Has Abstract

pub_date

2015-02-01 00:00:00

pages

329-36

issue

2

eissn

1434-6621

issn

1437-4331

pii

/j/cclm.ahead-of-print/cclm-2014-0546/cclm-2014-05

journal_volume

53

pub_type

杂志文章
  • Diagnostic performance of cerebrospinal fluid free light chains in Lyme neuroborreliosis - a pilot study.

    abstract::Background The aim of this study was to evaluate the diagnostic performance of cerebrospinal fluid (CSF) free light chains (FLCs) in the diagnosis of Lyme neuroborreliosis (LNB). Methods Serum and CSF levels of κ- and λ-FLC, albumin and total concentration of immunoglobulin M (IgM) were determined together with CSF ch...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2019-0315

    authors: Tjernberg I,Johansson M,Henningsson AJ

    更新日期:2019-11-26 00:00:00

  • A systematic evaluation of stool DNA preparation protocols for colorectal cancer screening via analysis of DNA methylation biomarkers.

    abstract:Objectives:Colorectal cancer (CRC) screening using stool samples is now in routine use where tumor DNA methylation analysis for leading markers such as NDRG4 and SDC2 is an integral part of the test. However, processing stool samples for reproducible and efficient extraction of human genomic DNA remains a bottleneck fo...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2020-0300

    authors: Jin S,Ye Q,Hong Y,Dai W,Zhang C,Liu W,Guo Y,Zhu D,Zhang Z,Chen S,Wang Y,Li D,Ma W,Yang Z,Li J,Zheng Z,Luan J,Wu X,Jiang F,Xu C,Ding C

    更新日期:2020-07-16 00:00:00

  • Acid ribonuclease and alkaline ribonuclease isoenzymes in plasma of patients with decreased glomerular filtration rate.

    abstract::Removal of low molecular weight proteins from plasma by kidneys depends on glomerular filtration rate (GFR), protein-glomerular membrane electric charge, steric interactions and a number of functionally active nephrons present in the kidneys. There is a well documented relationship between the concentration of low mol...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2004.051

    authors: Naskalski J,Anyszek T,Surdacka E,Hoyer B,Sulowicz W

    更新日期:2004-03-01 00:00:00

  • Use of a fully automated immunoassay for celiac disease screening in a pediatric population.

    abstract:BACKGROUND:Celiac disease (CD) is an immune-mediated disorder of the small bowel in which gluten and related cereal ingestion leads to chronic inflammation and damage to the small bowel mucosa in genetically susceptible individuals. The presence of IgA type tissue-transglutaminase antibodies (IgA-anti-tTG) in individua...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2011.164

    authors: Ress K,Harro J,Uibo O,Uibo R

    更新日期:2011-06-01 00:00:00

  • Hyperhomocysteinemia and B-vitamin deficiencies in infants and children.

    abstract::Measurement of total homocysteine (tHcy) in healthy and diseased children has documented the utility of this marker in pediatric research and diagnostics. This article focuses on novel data obtained in infants, children and adolescents, with emphasis on cobalamin status in infants. In children, determinants of plasma ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2003.218

    authors: Ueland PM,Monsen AL

    更新日期:2003-11-01 00:00:00

  • Thrombophilia screening--at the right time, for the right patient, with a good reason.

    abstract::Thrombophilia can be identified in about half of all patients presenting with venous thromboembolism (VTE). Thrombophilia screening for various indications has increased tremendously, but whether the results of such tests help in the clinical management of patients is uncertain. Here, current recommendations for throm...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2010.367

    authors: Stegnar M

    更新日期:2010-12-01 00:00:00

  • Standards of practice and uniformity in references style.

    abstract::Authors are usually invited to follow the instructions to authors in scientific journals, because this section is likely to contain unique requirements, such as the references style requested. Authors not only must accurately check the instructions, but are also expected to verify references against the original docum...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2008.114

    authors: Salvagno GL,Lippi G,Montagnana M,Guidi GC

    更新日期:2008-01-01 00:00:00

  • Prostate-specific antigen and new related markers for prostate cancer.

    abstract::Although prostate-specific antigen (PSA), or human kallikrein 3, is the most valuable tool available for the diagnosis and management of prostate cancer, as currently used it is insufficiently sensitive and specific for early detection or staging of the malignancy. Many new concepts have been introduced in order to op...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.1998.120

    authors: Daher R,Beaini M

    更新日期:1998-09-01 00:00:00

  • Instability of cerebrospinal fluid after delayed storage and repeated freezing: a holistic study by drop coating deposition Raman spectroscopy.

    abstract:BACKGROUND:The handling of cerebrospinal fluid (CSF) affects the biomarker quantification used to diagnose Alzheimer's disease (AD). Only specialized centers can test for AD markers. The precise timing and freezing is required to correctly measure these biomarkers. Therefore, the effects of CSF storage temperature and ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2013-0800

    authors: Klener J,Hofbauerová K,Bartoš A,Ríčný J,Rípová D,Kopecký V

    更新日期:2014-05-01 00:00:00

  • HAND1 loss-of-function mutation associated with familial dilated cardiomyopathy.

    abstract:BACKGROUND:The basic helix-loop-helix transcription factor HAND1 is essential for cardiac development and structural remodeling, and mutations in HAND1 have been causally linked to various congenital heart diseases. However, whether genetically compromised HAND1 predisposes to dilated cardiomyopathy (DCM) in humans rem...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2015-0766

    authors: Zhou YM,Dai XY,Qiu XB,Yuan F,Li RG,Xu YJ,Qu XK,Huang RT,Xue S,Yang YQ

    更新日期:2016-07-01 00:00:00

  • Polymorphisms of coagulation factor genes--a review.

    abstract::Common genetic variants of coagulation factor genes associated with differences in concentration and/or function of coagulation factors have been studied in search of variability that could explain the individual susceptibility to thrombosis and atherothrombotic diseases. The more outstanding polymorphisms in genes of...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.1998.156

    authors: Ferrer-Antunes C

    更新日期:1998-12-01 00:00:00

  • Increased level of circulating U2 small nuclear RNA fragments indicates metastasis in melanoma patients.

    abstract:UNLABELLED:Background: Melanoma is the most aggressive skin cancer and, despite recent advances in therapy, about 20% of the patients die of their disease. Early relapse detection and monitoring of therapy response are crucial for efficient treatment of advanced melanoma. Thus, there is a need for blood-based biomarker...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2014-1064

    authors: Kuhlmann JD,Wimberger P,Wilsch K,Fluck M,Suter L,Brunner G

    更新日期:2015-03-01 00:00:00

  • Point-of-care testing, medical error, and patient safety: a 2007 assessment.

    abstract::Point-of-care testing (POCT) is the fastest growing segment of a US$30 billion worldwide market. "Errors" in the testing process, as well as medical data interpretation and treatment associated with POCT, are recognized as leading to major compromises of patient safety. In today's environment, most testing errors (pre...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2007.164

    authors: Ehrmeyer SS,Laessig RH

    更新日期:2007-01-01 00:00:00

  • Multidisciplinary training activities for decreasing preanalytical mistakes in samples from primary care.

    abstract:BACKGROUND:The presence of preanalytical mistakes (PM) in samples from primary care centres (PCC) is a widely studied topic. Different correcting strategies have been proposed, with variable success. We planned a series of multidisciplinary sessions for clinical update, with the aim to decrease PM rates in samples from...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2016-1002

    authors: Romero A,Gómez-Salgado J,Gómez-Fernández JA,Cobos A,Ruiz-Frutos C

    更新日期:2017-10-26 00:00:00

  • Speed of sample transportation by a pneumatic tube system can influence the degree of hemolysis.

    abstract:BACKGROUND:The objective of the study was to find the incidence of hemolysis in samples transported through a pneumatic tube system (PTS) at different speeds. METHODS:This prospective observational study was done in three phases: "short distance and high speed (115 m at 3 m/s)", "long distance and high speed (225 m at...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2011.779

    authors: Tiwari AK,Pandey P,Dixit S,Raina V

    更新日期:2011-11-10 00:00:00

  • Detection of CYP2D6*3 and 2D6*4 allelic variants by PCR-restriction fragment length polymorphism.

    abstract::The mutant of CYP2D6*3 allele with A2637 deletion in exon 5 and the mutant of CYP2D6*4 allele G1934-->A, splice site defect are among the most common polymorphic alleles of CYP2D6 gene, resulting in a decreased or no activity of CYP isoenzyme. In this study, a reliable polymerase chain reaction-restriction fragment le...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.1998.116

    authors: Topić E,Stefanović M,Nikolić V,Zoricić I,Ivanisević AM,Zuntar I

    更新日期:1998-08-01 00:00:00

  • May thrombopoietin be a useful marker of sepsis severity assessment in patients with SIRS entering the emergency department?

    abstract:BACKGROUND:Thrombopoietin (TPO), a growth factor primarily involved in regulating thrombopoiesis, has been recently implicated in the pathogenesis of sepsis. TPO levels are, indeed, greatly increased in patients with sepsis compared to control subjects, and correlate with sepsis severity. The aim of this study was to e...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,多中心研究

    doi:10.1515/cclm-2014-0219

    authors: Segre E,Pigozzi L,Lison D,Pivetta E,Bosco O,Vizio B,Suppo U,Turvani F,Morello F,Battista S,Moiraghi C,Montrucchio G,Lupia E

    更新日期:2014-10-01 00:00:00

  • Performance of free beta-human chorionic gonadotrophin (free beta-hCG) and pregnancy associated plasma protein-A (PAPP-A) analysis between Delfia Xpress and AutoDelfia systems in The Netherlands.

    abstract:BACKGROUND:The VU University Medical Center (VUmc) was the first hospital in the Netherlands to introduce the Delfia Xpress for the analysis of free beta-human chorionic gonadotrophin (beta-hCG) and pregnancy associated plasma protein-A (PAPP-A) in the first trimester screening program for Down syndrome. Since then, ot...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2009.042

    authors: Linskens IH,Levitus M,Frans A,Schielen PC,van Vugt JM,Blankenstein MA,Dijstelbloem HM

    更新日期:2009-01-01 00:00:00

  • High-dose biotin therapy leading to false biochemical endocrine profiles: validation of a simple method to overcome biotin interference.

    abstract:BACKGROUND:High-dose biotin therapy is beneficial in progressive multiple sclerosis (MS) and is expected to be adopted by a large number of patients. Biotin therapy leads to analytical interference in many immunoassays that utilize streptavidin-biotin capture techniques, yielding skewed results that can mimic various e...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2016-1183

    authors: Piketty ML,Prie D,Sedel F,Bernard D,Hercend C,Chanson P,Souberbielle JC

    更新日期:2017-05-01 00:00:00

  • Relationships between C-reactive protein concentration and genotype in healthy volunteers.

    abstract:BACKGROUND:Polymorphisms of the gene for C-reactive protein (CRP) alter baseline serum CRP concentrations. The impact of polymorphisms of the CRP gene (genotype) on the normal range for CRP concentrations (phenotype) has not been determined. This study evaluated the median serum CRP concentrations in normal subjects st...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2009.005

    authors: Jones J,Chen LS,Baudhuin L,Peterson S,Harmsen WS,Zinsmeister AR,McConnell J,Sandborn WJ

    更新日期:2009-01-01 00:00:00

  • Immunoglobulin G Fc(gamma) receptor expression on polymorphonuclear cells in bronchoalveolar lavage fluid of HIV-infected and HIV-seronegative patients with bacterial pneumonia.

    abstract::This study was designed to test the hypothesis that impaired neutrophil function might contribute to the development of bacterial pneumonia in patients with HIV-infection. Numbers of inflammatory cells and immunoglobulin G Fcgamma receptor (IgG FcgammaR) I, II, III levels were investigated in bronchoalveolar lavage (B...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2004.035

    authors: Armbruster C,Krugluger W,Huber M,Stephan K

    更新日期:2004-02-01 00:00:00

  • Free light chains and heavy/light chains in monitoring POEMS patients.

    abstract:BACKGROUND:POEMS syndrome is defined by Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin changes. The vascular endothelial growth factor (VEGF) appears to play a key role in the pathogenesis of the syndrome, and its concentrations are deemed to correlate to disease activity. The aim of the p...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2015-0910

    authors: Altinier S,Proko K,Zaninotto M,Ciubotaru D,Seguso M,Varagnolo M,Lessi F,Briani C,Adami F,Plebani M

    更新日期:2016-06-01 00:00:00

  • Comparative evaluation of capillary zone electrophoresis and HPLC in the determination of carbohydrate-deficient transferrin.

    abstract:BACKGROUND:Transferrin (Tf) glycoform lacking one or two complete or incomplete glycan chains (i.e., asialo-monosialo- and disialo-Tf) typically appear in blood after chronic alcohol consumption, though recently it was reported that monosialo-Tf is associated with trisialo-Tf but not with alcohol consumption. These gly...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2011.630

    authors: Daves M,Cemin R,Floreani M,Pusceddu I,Cosio G,Lippi G

    更新日期:2011-10-01 00:00:00

  • Study of apo(a) length polymorphism and lipoprotein(a) concentrations in subjects with single or double apo(a) isoforms.

    abstract::Cardiovascular risk is associated with high lipoprotein(a) (Lp(a)) concentrations and low molecular weight apolipoprotein(a) (apo(a)) isoforms. We studied the relationship between these two biological parameters, particularly in subjects expressing two apo(a) isoforms. Plasma Lp(a) was measured by immunonephelometry i...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2003.096

    authors: Alaoui M,Merle C,Garnotel R,Jolly D,Durlach V,Gillery P

    更新日期:2003-05-01 00:00:00

  • Normal prions as a new target of cobalamin (vitamin B12) in rat central nervous system.

    abstract::The pathogenesis of cobalamin (Cbl)-deficient (Cbl-D) neuropathy and the role of normal prions (PrPcs) in myelin maintenance are both subjects of debate. We have demonstrated that Cbl deficiency damages myelin by increasing tumor necrosis factor (TNF)-α, and decreasing epidermal growth factor (EGF) levels in the rat c...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/cclm-2012-0474

    authors: Scalabrino G,Veber D

    更新日期:2013-03-01 00:00:00

  • Associations of blood levels of insulin-like growth factor (IGF)-I, IGF-II and IGF binding protein (IGFBP)-3 in schizophrenic Arab subjects.

    abstract:BACKGROUND:Insulin-like growth factors (IGFs) are believed to be important in brain development and repair following neuronal damage. It is also speculated that IGFs are involved in the association of foetal and pre-adult growth with schizophrenia (SZ). METHODS:The aim of this study was to assess levels of IGF-I, IGF-...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2007.265

    authors: Akanji AO,Ohaeri JU,Al-Shammri SA,Fatania HR

    更新日期:2007-01-01 00:00:00

  • Immunoassays for the detection of IgA antibodies to tissue transglutaminase: significance of multiples of the upper limit of normal and inter-assay correlations.

    abstract:BACKGROUND:The presence of IgA antibodies to tissue transglutaminase (anti-tTg) is associated with variable risk for celiac disease. The use of common multiples of the upper limit of normal (ULN) has been suggested to optimize diagnostic pathways as well as improve harmonization between assays. METHODS:The characteris...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2015-0348

    authors: Suh-Lailam BB,Davis KW,Tebo AE

    更新日期:2016-02-01 00:00:00

  • Total iron binding capacity and transferrin concentration in the assessment of iron status.

    abstract::Transferrin concentration and total iron binding capacity (TIBC) are currently used to assess iron status. Although correlation between TIBC and transferrin is generally considered as good, conversion factors between the two analytes found in literature show large differences. Although the price per test is lower for ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2002.176

    authors: Kasvosve I,Delanghe J

    更新日期:2002-10-01 00:00:00

  • Bone mass density selectively correlates with serum markers of oxidative damage in post-menopausal women.

    abstract:BACKGROUND:Post-menopausal osteoporosis (PO) affecting a large fraction of elderly women, is triggered by the decline in 17β-estradiol (E2) level. Experimental studies in animal models and cell cultures have suggested that the fall in E2 might contribute to developing oxidative stress (OS) which in turn is believed to ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2012-0095

    authors: Cervellati C,Bonaccorsi G,Cremonini E,Bergamini CM,Patella A,Castaldini C,Ferrazzini S,Capatti A,Picarelli V,Pansini FS,Massari L

    更新日期:2013-02-01 00:00:00

  • Age-related macular degeneration: genetic and clinical findings.

    abstract::Age-related macular degeneration (AMD) is a sight threatening eye disease that affects millions of humans over the age of 65 years. It is considered to be the major cause of irreversible blindness in the elderly population in the developed world. The disease is prevalent in Europe and the United States, which has a la...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2011.091

    authors: Kokotas H,Grigoriadou M,Petersen MB

    更新日期:2011-04-01 00:00:00