In all growth hormone gh related disorders gh deficiency ghd, gh. It stimulates the growth of essentially all tissues of the body, including bone, and is vital for normal physical growth in children. Immulite 2000 growth hormone calibration verification. The levels of gh and igf1 were measured by qualified staff using a chemiluminescent immunoassay method immulite 2000. Currently, all of the automated igfi assays and many of the manual. Fss siemens healthcare v797p7019 52008 gsa advantage. Based on its relationship to immulite 2000 growth hormone see method comparison 1 the assay can be expected to have esentially the same reference ranges. Growth hormone human immulite 2000 110 ul 145 ul 0.
Immulite r 2000 age and sexspecific reference intervals for alpha fetoprotein, homocysteine, insulin, insulinlike growth factor1, insulinlike growth factor binding protein3, cpeptide. Sensitive immunometric gh assays using monoclonal antibodies have been used to establish consensus guidelines for diagnosis of acromegaly. The immulite 2000 xpi system is a continuous random access immunoassay analyzer with a maximum throughput of 200 tests per hour. The extensive menu, high level reliability, and ease of use makes this system the right choice for laboratories with lowvolume immunoassay tests.
The immulite system is a bench top immunoassay analyzer. Immulite 2500 igfi 2 immulite 2500 igfi pil5kgf5, 20051012 english intended use. The fourth edition of the immunoassay handbook provides an excellent, thoroughly updated guide to the science, technology and applications of elisa and other immunoassays, including a wealth of practical advice. Immulite immunoassay system reliability that keeps your lab running download assay menu 259kb home healthcare laboratory diagnostics immunoassay immunoassay systems immulite immunoassay system assays 1. Standardization of the immulite systems growth hormone assay. Growth growth hormone hgh igfi igfbp3 hepatitis antihbc lgm antihbc total antihbs hbsab quantitative hbs ag hbs ag confirmatory infectious disease. Ross ha, endocrinology section and project group calibration 2000 of the skml dutch foundation for quality assessment in clinical laboratories reporting growth hormone assay results in terms of one consensus recombinant standard preparation offers less than optimal reduction of betweenmethod variation. Pdf the shortness of pygmies is associated with severe. Introduction of the idsisys total igf1 assay may have far. Growth hormone is synthesized and secreted by anterior pituitary cells called somatotrophs.
Protein synthesis in ls myoblasts was measured by incorporation of 3 hleucine and the potency expressed as ed 50. Package insert instructions must be carefully followed. Research article open access longterm auxological and. Growth hormone method growth hormone was measured by a onestep immunometric chemiluminescent immunoassay using the siemens immulite 2000 xpi platform siemens healthcare diagnostics, tarrytown, ny, usa. Pdf growth hormone, cortisol and prolactin responses to. Gh and igf1 have been demonstrated to promote hematopoiesis, particularly the megakaryocyte and erythroid lineages, both. Medium to highvolume laboratories can incorporate specialty and allergy testing into routine workloads to improve productivity and efficiency. Quantification of the endogenous growth hormone and prolactin. Immulite 2000 igfi 2 immulite 2000 igfi pil2kgf11, 20051012 english intended use. No rating or validation information has been found for immulite 2000 growth hormone hgh recombinant 98574 antibody. Performance characteristics of the immulite 2000 insulin. Growth hormone exerts its effects on target tissues either directly or via the production of insulinlike growth factor 1 igfi. Monitoring igfbp3 can be useful in the evaluation of short stature in children, acromegaly, nutritional status, and estimation of spontaneous growth hormone secretion. Performance characteristics of the immulite 2000 insulinlike.
Growth growth hormone hgh igfi igfbp3 hepatitis antihbs antihbc igm antihbc total hbsag hbsag confirmatory special id h. Mar 01, 2005 the dpc immulite 2000 igfbp3 immunoassay shows acceptable analytic performance for all criteria studied and is suitable for routine clinical quantification of igfbp3 levels. Siemens immulite 2500, 2000 and manual, ids elisa, biocode hycel irma and elisa, diasorin liason, mediagnost r20 and r22 ria, mediagnost e20 elisa, dsl elisa. Pediatric reference intervals for fsh, lh, estradiol, t3. Oct 01, 2009 immunossays used were inhouse assays and the following commercial kits.
The role of growth hormone, igf1, and somatostatin on immune development. The gh is considered to be the most important postnatal growth regulator, the ghbp reflects the number of cellular receptors for gh, and the igfi is the major ghdependent peripheral. The highly reliable immulite 2000 xpi system is easy to use and has one of the largest automated immunoassay menus available. Samples are incubated with ligandlabeled antigastrin monoclonal antibodies, alkalinephosphatase alpconjugated rabbit polyclonal antigastrin antibodies, and alpconjugated monoclonal antigastrin antibodies. Growth hormone distributions from a cohort of track and field. E411, roche integra, biomerieux vidas, siemens immulite, siemens immulite 1st generation, siemens immulite 2000 2500, siemens advia centaur, beckman access, beckman dxl800, beckman access, vitros eci and vitros, tosoh model a1a360, diasorin liaison. Intraassay precision for the immulite 2000 varied between 4. Igf1 and igfbp3 were analysed from individual serum samples using the siemens immulite 2000 sn 1832 igf1 assay and the dpc immulite 2000 igfbp3 assay, respectively quest diag. Beckmancoulter and three were performed using a manual pro. Growth hormone gh and insulinlike growth factor i igfi measurements are widely used in the diagnosis of disorders of gh secretion, evaluation of children with short stature from multiple. If you have access to journal via a society or associations, read the instructions below. Growth hormone response during oral glucose tolerance test.
From 2011 to 20, serum igfi and igfbp3 levels were assessed using the immulite 2000 siemens healthcare diagnostics, deerfield, il, with interassay cvs of 6. Immulite 2000 2000 xpi immunoassay systems the highly reliable immulite 2000 xpi system is easy to use and has one. It encompasses a wide range of methods and gives an insight into the latest developments and applications in clinical and veterinary practice and in pharmaceutical and life science. Frohman, in encyclopedia of neuroscience, 2009 introduction. The principal regulator of growth in the body is the ghigf system 2. Allergy ige, total anemia ferritin vitamin b12 bone metabolism pyrilinksd cardiac highsensitivity crp myoglobin troponin i diabetes cpeptide insulin microalbumin growth growth hormone hgh igfi metabolic acth cortisol homocysteine oncology afp ca 153 brma ca 125 omma calcitonin cea pap. Immulite 2000 cpeptide cvm immulite 2000 growth hormone scvm analyte cpeptide growth hormone matrix human albumin with preservatives equine serum with preservatives this material was tested negative for hivi, hiv2 and hepatitis by fda approved methods. Effect of sex and assay method on serum concentrations of. Siemens immulite 2000 xpi units mw 40251 mw 40252 mw 40253 units mw 40251 mw 40252 mw 40253 alpha fetoprotein afp ngml 20. The immulite 2000 intuitive software, and graphical user interface, offers streamlined information management, from remote test ordering to sophisticated analysis of results. Laboratory assessment of the growth hormone igf axis. Serum gh values were measured with immulite 2000, using 2 diff erent calibrators, is 98574, a recombinant 22 kda molecule of more than 95 % purity, and is 80505, of pituitary origin and resembling a variety of gh isoforms. The immulite system is a small bench top immunoassay analyzer.
Efficacy and safety of replacement treatment in isolated growth. Effect of pasireotide on glucose and growth hormonerelated. Not available for sale on the advia chemistry xpt system. The roche gh method is standardized against the second world health organization who internal standard is 98574. The sources of this heterogeneity reside at the level of the genome, mrna splicing, posttranslational. Results were partitioned by sex and by age or developmental status tanner stage prior to statistical analysis. Growth hormone is captured by a murine monoclonal antibody. Growth hormone hgh igf1 igfbp3 hepatitis antihbs antihbc igm antihbc total hbsag hbsag confirmatory inflamatorias il1b 1. The immulite 2000 hcg calibration verification materials are stable up to 2.
Growth hormone distributions from a cohort of track and. Pdf the aim of our study was to evaluate the betweenassay variability of commercially. Pdf diagnosis of growth hormone deficiency is affected. Harmonization of growth hormone measurements with different. Immulite 2000 new mul immulite 2000 old mul 0 20406080 14 12 10 8 6 4 2 0 2 0 20406080 mean immulite 2000 new mul immulite 2000 old mul figure 1 altmanbland plots comparing the two growth hormone gh assays on the immulite 2000. Immulite and immulite 2000 reference range compendium. Effect of pasireotide on glucose and growth hormone. Serum gh was analysed by immulite 2000 growth hormone, an automated chemiluminescence enzyme immunoassay analyser. May 01, 2005 a calibrated dpc immulite analyzer was used for the quantitative measurement of fsh, lh, estradiol, t3, free t3, cortisol, and growth hormone. Backgroundthe diagnosis of disorders of growth hormone gh secretion is. Immulite 2000, siemens, yes, alkaline phosphatase, whonibsc, 3. Three years of growth hormone treatment in young adults with.
The immulite 2000 immunoassay system has been designed specifically for optimum efficiency and consolidation in medium and highvolume laboratories. The intraassay and interassay variability coefficients for this kit at the decision limits were 2. Immulite 1st generation, siemens immulite 2000 2500, siemens advia centaur, beckman access, beckman dxl800, beckman access, vitros eci and vitros, tosoh model a1a360, diasorin liaison. For in vitro diagnostic use with the immulite 2000 analyzer for the quantitative measurement of insulinlike growth factor binding protein 3 igfbp3 in serum or heparinized plasma, as an aid in the evaluation of growth disorders. Apr 01, 2006 the immulite 2000 gastrin assay is a random access, automated twosite nonsequential chemiluminometric assay. Expected values the reference range values were generated on the immulite 2000 analyzer. The extensive menu, low cost of operation, reliability, and ease of use makes this system a great choice for laboratories with lowvolume immunoassay tests. Pdf harmonization of growth hormone measurements with. Label specimens appropriately with the corresponding collection times.
Jan 01, 2015 for this purpose, we compared absolute igf1 values measured by the oldgeneration igf1 assay immulite 2000 calibrated against the old standard who irr 87518 with the idsisys igf1 assay calibrated against the new standard who international standard 02254 in serum samples from adults with ghd and acromegaly. Results for both assays are expressed in milliunits per litre. The immulite system utilizes assayspecific, antibody or antigencoated plastic beads as the solid phase, alkaline phosphatelabeled reagent, and a chemiluminescent enzyme substrate. On july 26 2016, analysis of growth hormone gh at the providence health care laboratories will transition from the siemens immulite 2000 platform to the roche cobas e601 instrument. Preexercise growth hormone, cortisol and prolactin levels the mean fs. The immulite system is a benchtop immunoassay analyzer. This design increases workflow and enhances productivity for medium to highvolume immunoassay laboratories by incorporating specialty and. Utility of serum igf1 for diagnosis of growth hormone. It is an essential reference manual for staff using immunoassays and to students.
Harmonisation of growth hormone assays in australasia. Table 1 technical information for the 8 assays used for the measurement of hgh. Immulite 2000 igfbp3 2 immulite 2000 igfbp3 pil2kgb9, 20051230 english intended use. The cvm study protocols are run as part of the calibrator stability testing. Method analytical precision specificity reference conversion. Yet, adjustment of this data by linear regression or a conversion factor reduced the cv below 14%, and the ratio of assaydependent diagnoses below 8%. Mar 01, 2006 hypersecretion of growth hormone gh 1 as the cause of acromegaly is confirmed by measuring serum gh during an oral glucose tolerance test ogtt. The roche gh method is standardized against the second world. Immulite 2000 growth hormone hgh pil2kgrh10, 20150617. Gentamicin, growth hormone gh, immunoglobulin e, insulin, luteinizing hormone. This design increases workflow and enhances productivity for medium to highvolume immunoassay laboratories by incorporating specialty and allergy testing into one platform.
Laboratory measurements of hormones and related biomarkers. Human growth hormone gh is a heterogeneous protein hormone consisting of several isoforms. Gh exerts a broad spectrum of effects, leading to the promotion of growth and the regulation of carbohydrate, lipid, protein. Insulinlike growth factor i igf1 was measured on immulite 2000 siemens healthcare diagnostics sa, switzerland, piiinp was measured on radioactive manual test cisbio bioassays, codolet, france and gh isoforms were tested first on 49. A twocenter international evaluation of the immulite 2000. Introductionthe growth hormone gh, ghbinding protein ghbp and insulin growth factori igfi are among the key molecules involved in human growth 1. Test selection and interpretation the quest diagnostics manual.
Immulite 2000 igfbp3, immulite 2000 assays are designed for use with the immulite 2000, a highthroughput, continuous random access immunoassay analyzer. Immulite cpeptide assay on the immulite growth hormone assay s immulite 2000 systems. It is not known what mechanism is responsible for growth retardation in zn deficiency and how zn therapy stimulates growth in children 1. In the latter setting, the use of inaccurate criteria to guide clinical. If multiple specimens are drawn, submit each vial under a separate order. Gh exerts a broad spectrum of effects, leading to the promotion of growth and the regulation of carbohydrate, lipid, protein, and mineral. Immulite 2000 offers testing efficiency through centralization, and a rapidly expanding menu for effective patient management. Use controls or serum pools with at least two levels low and high of human growth hormone. Research open access effect of zinc supplementation on growth.
Pdf evaluation of variables influencing the measurement. Rns endocrinology insulin tolerance test protocol the electronic version of this document appears in quasar page 5 of 7 this document is uncontrolled in printed form document code. The recommended upper limit of intake is 2,000 iud. Lh, fsh, cortisol, estradiol and total testosterone. For in vitro diagnostic use with the immulite 2500 analyzer for the quantitative measurement of insulinlike growth factor i igfi in serum or heparinized plasma, as an aid in the evaluation of growth disorders. No alerts have been found for immulite 2000 growth hormone hgh recombinant 98574 antibody.
Within 60 days aro for a new immulite, immulite 2000, and. The betweenassay cv mean sd of values within the cutoff range was 24. Growth hormone gh is a singlechain protein of 191 amino acids with a molecular size of approximately 22 kda that is synthesized by and secreted from the somatotroph cells of the anterior pituitary gland. Introduction of the idsisys total igf1 assay may have. Measurement of human growth hormone by immunoassays. Growth hormone, peptide hormone secreted by the anterior lobe of the pituitary gland.
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