Pediatric reference intervals for 29 Ortho VITROS 5600 immunoassays using the CALIPER cohort of healthy children and adolescents.

Abstract:

BACKGROUND:Accurate reference intervals (RIs) based on a healthy pediatric population are essential for pediatric test result interpretation. The CALIPER project has recruited a large healthy cohort and completed a series of a priori studies to address gaps in pediatric RIs. As immunoassays from different manufacturers for endocrine and special chemistry markers are not standardized and show marked intermethod differences, direct RI studies are needed for each major analytical platform. Here, we report age- and sex-specific pediatric RIs for 29 immunoassays on the Ortho Clinical Diagnostics (Ortho) VITROS® 5600 analyzer. METHODS:Health information and blood samples were collected from healthy pediatric subjects. Using the Ortho VITROS 5600 Integrated System MicroWell Technology, 29 biomarkers were measured. Analyte concentrations were partitioned by age and sex according to the Harris and Boyd method. After removing outliers, age- and sex-specific RIs and corresponding 90% confidence intervals were calculated according to CLSI guidelines. RESULTS:All analytes required age partitioning except β-human chorionic gonadotropin (β-hCG), cancer antigen 15-3 (CA15-3), rubella immunoglobulin G (rubella IgG), and vitamin D. Several analytes including estradiol, progesterone, testosterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), free triiodothyronine (FT3), total triiodothyronine (TT3), total thyroxine (TT4), thyroid uptake, ferritin, intact parathyroid hormone (iPTH), total prostate-specific antigen (tPSA), free prostate-specific antigen (fPSA), cancer antigen 125 (CA125), creatine kinase MB (CK-MB), and myoglobin showed sex differences, observed mostly with the onset of puberty. CONCLUSIONS:Complex reference value trends were observed across the pediatric age range for several biomarkers examined on Ortho VITROS immunoassays. The availability of VITROS immunoassay RIs will enable accurate laboratory test interpretation and diagnosis for the pediatric population. As recommended by the CLSI EP28-A3c guidelines, implementation of these RIs should be validated for each laboratory's local pediatric population.

journal_name

Clin Chem Lab Med

authors

Higgins V,Fung AWS,Chan MK,Macri J,Adeli K

doi

10.1515/cclm-2017-0349

subject

Has Abstract

pub_date

2018-01-26 00:00:00

pages

327-340

issue

2

eissn

1434-6621

issn

1437-4331

pii

/j/cclm.ahead-of-print/cclm-2017-0349/cclm-2017-03

journal_volume

56

pub_type

杂志文章
  • Cardiovascular risk-associated allele frequencies for 15 genes in healthy elderly French and Chinese.

    abstract::In order to investigate possible ethnic differences in genetic and environmental determinants, we investigated several cardiovascular disease-associated genetic variations in successful ageing populations of France (Nancy) and China (Hong Kong). Allelic frequencies of these genetic variations were compared between hea...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2005.137

    authors: Xia Y,Baum L,Pang CP,Siest G,Visvikis S

    更新日期:2005-01-01 00:00:00

  • Long-term prognostic value of mid-regional pro-adrenomedullin and C-terminal pro-endothelin-1 in patients with acute myocardial infarction.

    abstract:BACKGROUND:Mid-regional pro-adrenomedullin (MR-proADM) and endothelin-1 have been shown to predict mortality of patients with acute myocardial infarction. However, the prognostic value of both biomarkers in predicting long-term clinical events after acute myocardial infarction remains unclear. METHODS:In a prospective...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2008.040

    authors: Behnes M,Papassotiriou J,Walter T,Fiedler E,Sauer T,Lang S,Elmas E,Hoffmann U,Borggrefe M,Brueckmann M

    更新日期:2008-01-01 00:00:00

  • Prevention of biochemical changes in gamma-irradiated rats by some metal complexes.

    abstract::The formation of superoxide partially accounts for the well-known oxygen enhancement of radiation-induced biochemical changes and cell damage. Radioprotective effects of copper (II), manganese (IV) or vanadium (IV) complexes, of superoxide dismutase-mimetic activity, on body weight, survival rate and some biochemical ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2003.141

    authors: Abou-Seif MA,El-Naggar MM,El-Far M,Ramadan M,Salah N

    更新日期:2003-07-01 00:00:00

  • Paraoxonase 1 gene polymorphisms in angiographically assessed coronary artery disease: evidence for gender interaction among Brazilians.

    abstract:BACKGROUND:Paraoxonases (PON) are members of an enzyme family involved in preventing low-density lipoprotein oxidation and therefore protecting against atherosclerotic plaque formation. METHODS:We studied the Met55Leu and Gln192Arg PON1 polymorphisms in 712 patients (437 Caucasian- and 275 African-Brazilians) who unde...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2007.136

    authors: Rios DL,D'Onofrio LO,Cerqueira CC,Bonfim-Silva R,Carvalho HG,Santos-Filho A,Galvão-Castro B

    更新日期:2007-01-01 00:00:00

  • Is capillary electrophoresis a method of choice for systematic toxicological analysis?

    abstract::This review presents an overview of current research on the use of capillary electrophoretic techniques for the analysis of drugs in biological matrices. The discussion focuses on the applicability of the methods for the identification of unknown toxic compounds, which is defined as systematic toxicological analysis (...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2003.117

    authors: Boone CM,Ensing K

    更新日期:2003-06-01 00:00:00

  • Combining antibody tests and taking into account antibody levels improves serologic diagnosis of celiac disease.

    abstract:BACKGROUND:The European Society for Pediatric Gastroenterology and Nutrition states that if IgA anti-tissue transglutaminase (tTG) exceeds 10 times the upper limit of normal (ULN), there is the possibility to diagnose celiac disease (CD) without duodenal biopsy, if supported by anti-endomysium testing and human leukocy...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2013-1099

    authors: Oyaert M,Vermeersch P,De Hertogh G,Hiele M,Vandeputte N,Hoffman I,Bossuyt X

    更新日期:2015-09-01 00:00:00

  • Research translation: a new frontier for clinical laboratories.

    abstract::Translational research and translational medicine (referred to hereafter as translational research) are interchangeable terms that underline the pressing need to translate into practical benefits for those affected by disease the extensive investments divested by the private and public sectors in biomedical research. ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2006.238

    authors: Plebani M,Marincola FM

    更新日期:2006-01-01 00:00:00

  • Experimental validation of specificity of the squamous cell carcinoma antigen-immunoglobulin M (SCCA-IgM) assay in patients with cirrhosis.

    abstract:BACKGROUND:Squamous cell carcinoma antigen-immunoglobulin M (SCCA-IgM) is a useful biomarker for the risk of development of hepatocellular carcinoma (HCC) in patients with cirrhosis due to its progressive increase associated to HCC evolution. In patients with cirrhosis, other assays have been affected by interfering re...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2010.044

    authors: Zuin J,Veggiani G,Pengo P,Gallotta A,Biasiolo A,Tono N,Gatta A,Pontisso P,Toth R,Cerin D,Frecer V,Meo S,Gion M,Fassina G,Beneduce L

    更新日期:2010-02-01 00:00:00

  • Urinary stone composition in pediatric patients: a retrospective study of 205 cases.

    abstract:BACKGROUND:Stone composition has changed substantially over the past decades in developed countries. We studied urinary stone composition in Tunisian children. METHODS:We studied 205 children ranging from 3 months to 16 years old age and who were diagnosed as having urinary stones (122 boys and 83 girls). Stone analys...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2011.046

    authors: Alaya A,Nouri A,Najjar MF

    更新日期:2011-02-01 00:00:00

  • Statistical methods for assessment of added usefulness of new biomarkers.

    abstract::The discovery and development of new biomarkers continues to be an exciting and promising field. Improvement in prediction of risk of developing disease is one of the key motivations in these pursuits. Appropriate statistical measures are necessary for drawing meaningful conclusions about the clinical usefulness of th...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2010.340

    authors: Pencina MJ,D'Agostino RB,Vasan RS

    更新日期:2010-12-01 00:00:00

  • Diagnosis biomarkers in acute intestinal ischemic injury: so close, yet so far.

    abstract::Acute intestinal ischemic injury (i3) is a life-threatening condition with disastrous prognosis, which is currently difficult to diagnose at the early stages of the disease; a rapid diagnosis is mandatory to avoid irreversible ischemia, extensive bowel resection, sepsis and death. The overlapping protein expression of...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/cclm-2017-0291

    authors: Peoc'h K,Nuzzo A,Guedj K,Paugam C,Corcos O

    更新日期:2018-02-23 00:00:00

  • Impact of calibration fitting models on the clinical value of chromogranin A.

    abstract:BACKGROUND:The clinical relevance of chromogranin A (CgA) concentrations depends on the analytical performance of the assay. The goal of the present study was to define the clinical involvements in CgA calibration models by evaluating the confidence intervals (CIs) for values from patients who were undergoing monitorin...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2009.278

    authors: Ferraro S,Marano G,Ciardi L,Vendramin C,Bongo AS,Bellomo G,Boracchi P,Biganzoli EM

    更新日期:2009-01-01 00:00:00

  • Lipid peroxidation and antioxidant defenses in cystic fibrosis patients.

    abstract::Lipid peroxidation biomarkers and antioxidant status were measured in 76 cystic fibrosis (CF) patients and compared to 40 control subjects. Univariate and multivariate statistics were performed in this study. Results showed that indicators of lipid peroxidation were higher in CF patients than in controls; thiobarbitur...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.1999.082

    authors: Benabdeslam H,Abidi H,Garcia I,Bellon G,Gilly R,Revol A

    更新日期:1999-05-01 00:00:00

  • European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay.

    abstract:BACKGROUND:International recommendations highlight the superior value of cardiac troponins (cTns) for early diagnosis of myocardial infarction along with analytical requirements of improved precision and detectability. In this multicenter study, we investigated the analytical performance of a new high sensitive cardiac...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,多中心研究

    doi:10.1515/cclm-2014-0107

    authors: Krintus M,Kozinski M,Boudry P,Capell NE,Köller U,Lackner K,Lefèvre G,Lennartz L,Lotz J,Herranz AM,Nybo M,Plebani M,Sandberg MB,Schratzberger W,Shih J,Skadberg Ø,Chargui AT,Zaninotto M,Sypniewska G

    更新日期:2014-11-01 00:00:00

  • From therapeutic drug monitoring to total drug monitoring and drug-omics.

    abstract::In view of the role of pharmacotherapy in medicine, on the one hand, and the powerful technical possibilities that are now available on the other hand, therapeutic drug monitoring is a surprisingly neglected area of laboratory medicine. In this viewpoint article, an "omics approach" to pharmacovigilance and drug monit...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2020-0339

    authors: Vogeser M

    更新日期:2020-05-05 00:00:00

  • Urinary cystatin C as a specific marker of tubular dysfunction.

    abstract:BACKGROUND:Cystatin C (CST3), a strong inhibitor of cysteine proteinases, is freely filtered by the kidney glomerulus and is reabsorbed by the tubules, where it is almost totally catabolized, with the remainder then eliminated in urine. In tubular diseases, it seems sensible to postulate that CST3 degradation would be ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2006.050

    authors: Conti M,Moutereau S,Zater M,Lallali K,Durrbach A,Manivet P,Eschwège P,Loric S

    更新日期:2006-01-01 00:00:00

  • Supportive therapy of the sepsis syndrome.

    abstract::Adequate volume loading may be the most important step in the treatment of patients with septic shock. Techniques allowing us to achieve and tightly control volume loading and regional perfusion are considered to be helpful. An elevated oxygen delivery may be beneficial in some patients but the increase of oxygen deli...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.1999.056

    authors: Meier-Hellmann A,Sakka S,Reinhart K

    更新日期:1999-03-01 00:00:00

  • Difficulties in establishing reference intervals for special fluids: the example of 5-hydroxyindoleacetic acid and homovanillic acid in cerebrospinal fluid.

    abstract::Biochemical measurements in "special fluids" are complicated with the problem of reference intervals. Reference intervals are difficult to establish for these types of samples since they are usually only collected in patients with clinical suspicion of disease. Determination of neurotransmitter metabolites in cerebros...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2004.137

    authors: Dhondt JL

    更新日期:2004-01-01 00:00:00

  • Investigation of the relationship between apolipoprotein E gene polymorphisms and hepatitis B virus infection in northern China.

    abstract:BACKGROUND:Certain genetic polymorphisms can lead to differences in immunity function, resulting in different clinical outcomes for hepatitis B virus (HBV) patients. The aim of this study was to investigate the association between apolipoprotein E (ApoE) gene polymorphisms and HBV infection status in northern Chinese i...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2010.354

    authors: Yin Z,Xiong C,Wang Y,Zhou X,Yan SK

    更新日期:2010-12-01 00:00:00

  • Accurate microsatellite typing and inter-study comparison: pitfalls and solutions using interferon-gamma (IFNG) and natural resistance-associated macrophage protein 2 (NRAMP2) genes as examples.

    abstract::Microsatellite typing is frequently used in disease diagnosis and in genetic association studies. Inter-study consistency and comparability is essential in both applications. In this study, we show that the interlaboratory comparison of microsatellite sizes is often discrepant and misleading. This is a matter of great...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2002.162

    authors: Rossouw M,Warren R,Hoal EG

    更新日期:2002-09-01 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

  • Time to reconsider the clinical value of immunoglobulin G4 to foods?

    abstract:BACKGROUND:The usefulness of serum antibodies to common food antigens (immunoglobulin G4; IgG4) assay in management of patients suffering from food intolerance was assessed. METHODS:A total of 22 asymptomatic healthy subjects and 68 patients with symptoms referred for suspected food intolerance were studied. Serum IgG...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm.2008.131

    authors: Bernardi D,Borghesan F,Faggian D,Bianchi FC,Favero E,Billeri L,Plebani M

    更新日期:2008-01-01 00:00:00

  • Elevated levels of plasma homocysteine in postmenopausal women in Burkina Faso.

    abstract:BACKGROUND:Low levels of plasma homocysteine have been found in children and adult populations living in Burkina Faso in association with a low prevalence of coronary heart disease. METHODS:Based on this finding, the levels of plasma homocysteine and other thiols (cysteine, cysteinylglycine, glutathione) in postmenopa...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2005.131

    authors: Chillemi R,Simpore J,Persichilli S,Minucci A,D'Agata A,Musumeci S

    更新日期:2005-01-01 00:00:00

  • Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO).

    abstract::The recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and their customers it is important that the scope of such accreditation is clear. Therefore the European co-operation for accreditation (EA) demands that the national...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,实务指引

    doi:10.1515/cclm-2015-0257

    authors: Thelen MH,Vanstapel FJ,Kroupis C,Vukasovic I,Boursier G,Barrett E,Bernabeu Andreu F,Brguljan PM,Brugnoni D,Lohmander M,Sprongl L,Vodnik T,Ghita I,Vaubourdolle M,Huisman W,Working Group Accreditation ISO\/CEN standards (WG-A

    更新日期:2015-07-01 00:00:00

  • Autoantibody profiling of patients with autoimmune thyroid disease using a new multiplexed immunoassay method.

    abstract:BACKGROUND:It has been proposed that only anti-thyroid-peroxidase (TPOAb) and not anti-thyroglobulin (TgAb) antibodies should be assayed in the diagnosis of autoimmune thyroid disease (AITD). METHODS:We analyzed the thyroid autoantibody profile with a multiplex bead array system, which allows simultaneous measurement ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2006.137

    authors: Tozzoli R,Villalta D,Kodermaz G,Bagnasco M,Tonutti E,Bizzaro N

    更新日期:2006-01-01 00:00:00

  • Brazilian laboratory indicators program.

    abstract:BACKGROUND:This paper describes the evolution, structure, operation and some outcomes of the Brazilian Laboratory Indicators Program created by the Brazilian Society of Clinical Pathology/Laboratory Medicine (Sociedade Brasileira de Patologia Clínica/Medicina Laboratorial, or SBPC/ML), in partnership with ControlLab, a...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2012-0357

    authors: Shcolnik W,de Oliveira CA,de São José AS,de Oliveira Galoro CA,Plebani M,Burnett D

    更新日期:2012-11-01 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

  • Elecsys® and Kryptor immunoassays for the measurement of sFlt-1 and PlGF to aid preeclampsia diagnosis: are they comparable?

    abstract::Background For pregnant women with suspected preeclampsia, the soluble fms-like tyrosine-kinase 1 (sFlt-1)/placental growth factor (PlGF) ratio is a biomarker to aid diagnosis. We performed method comparisons between Elecsys® and Kryptor sFlt-1 and PlGF immunoassays and assessed the diagnostic performance for preeclam...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2018-1228

    authors: Stepan H,Hund M,Dilba P,Sillman J,Schlembach D

    更新日期:2019-08-27 00:00:00

  • The evolution of transthyretin synthesis in the choroid plexus.

    abstract::Choroid plexus has the highest concentration of transthyretin (TTR) mRNA in the body, 4.4 microg TTR mRNA/g wet weight tissue, compared with 0.39 microg in the liver. The proportion of TTR to total protein synthesis in choroid plexus is 12%. All newly synthesized TTR is secreted towards the ventricles. Net transfer of...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2002.210

    authors: Schreiber G

    更新日期:2002-12-01 00:00:00

  • Highly accurate and explainable detection of specimen mix-up using a machine learning model.

    abstract::Background Delta check is widely used for detecting specimen mix-ups. Owing to the inadequate specificity and sparseness of the absolute incidence of mix-ups, the positive predictive value (PPV) of delta check is considerably low as it is labor consuming to identify true mix-up errors among a large number of false ale...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2019-0534

    authors: Mitani T,Doi S,Yokota S,Imai T,Ohe K

    更新日期:2020-02-25 00:00:00