Oct 21, 2010 this study aims to assess the safety, tolerability and pharmacokinetics pharmacodynamics pkpd profile of three doses of mod4023 on a weekly regime and one dose on an everyotherweek regime administered for a period of 4 weeks in growth hormone deficient adult ghda patients who previously were on a stable rhgh treatment. The north star metric nsm is a powerful concept that has emerged in recent years from silicon valley companies with breakout growth. All children with ghd were recruited from paediatric endocrine units please refer to the. Texas prior authorization program clinical criteria drugdrug. National library of medicine nlm tools and resources fda udi home fda medical devices home report a device problem medwatch. The highly reliable immulite 2000 xpi system is easy to use and has one.
Immuliteimmulite growth hormone hgh,immulite and immulite assays are designed for use with the immulite and immulite, continuous random access immunoassay analyzers which offer simplicity in both design and operation. The immulite 2000 immunoassay system has been designed specifically for optimum efficiency and consolidation in medium and highvolume laboratories. Growth hormone deficiency associated with moyamoya disease in. Impact of the choice of igfi assay and normative dataset on the. Threeyear efficacy and safety of lb03002, a onceweekly.
Siemens dpc immulite 2500 reagents prolactin l5kpr6 mr. Pharmacokinetics of oral cyanocobalamin formulated with. For in vitro diagnostic use with the immulite 2000 analyzer for the quantitative measurement of human growth hormone in serum, as an aid in patient management. Immulite 20002500 front view 1 2 3 6 8 7 liquidw aste 14 12 4 5 10 91115 distilledw ater number component number component 1 sample carousel 9 reaction tube hopper 2 reagent carousel covered 10 liquid waste 3 pipettors 11 probe wash 4 drd priming accessories 12 distilled. Growth hormone gh 22kda immulite 2000 dynamic stimulatory or inhibitory tests are used for the diagnosis of gh deficiency or excess. This design increases workflow and enhances productivity for medium to highvolume immunoassay laboratories by incorporating specialty and allergy testing into one platform. The immulite 2000 intuitive software, and graphical user interface, offers streamlined information management, from remote test ordering to sophisticated analysis of results. Each cobas c 501 module will perform up to 1,000 tests per hour 600 photometrics tests per hour and 400 ise tests per hour. Used siemens immulite unit immunology for sale dotmed. Random measurements of gh are difficult to interpret. Immulite for your automated immunoassay testing needs. Earlier, the assay had been reported to overestimate igf1 concentrations.
Pdf the aim of our study was to evaluate the betweenassay variability of commercially available. A study performed at a large reference laboratory in the western united states, using the immulite 2000 growth hormone assay, on 59 healthy adult. Siemens medical solutions diagnostics gmbh, fernwald, germany. Insulinlike growth factori igfi is the main peripheral mediator of gh activity. We have 2 siemens immulite homocysteine 2000 manuals available for free pdf download. Intraassay precision for the immulite 2000 varied between 4. Determinants of the growth hormone nadir during oral.
Better than ever other 8% assays 19% reliability 29% ease of use 44% ease of use simple to operate. Searchable database of fda 510k applications and descisions. Growth hormone antibody gh45 dylight 350 nb500364uv. The immulite 2000 2500 operator s manual describes the operation of the immulite 2000 and immulite 2500 instruments and software. Do igfi concentrations better reflect growth hormone gh. The immulite system provides proven reliability year after year. Material safety data sheet for immulite growth hormone hgh. Siemens immulite homocysteine 2000 manuals manuals and user guides for siemens immulite homocysteine 2000. Maxisim 2000 medical equipment pdf manual download. It helps teams move beyond driving fleeting, surfacelevel growth to instead focus on generating longterm retained customer growth.
Jan, 2011 the diagnosis of growth hormone gh deficiency ghd in short children seems unquestionable when both gh peak in stimulating tests ghst and igfi concentration are decreased. Assays were performed according to the manufacturers instructions. The siemens immulite 2000 xpi immunoassay system may be purchased in 1 of 2 ways listed below. Loaded with articles, videos, podcasts, and more, product manual is your essential guide to building remarkable products. All rights of this immulite 20002500 operators manual file is reserved to who prepared it. Texas prior authorization program clinical criteria drug. The immulite system is a bench top immunoassay analyzer.
Bc biomedical maxisim 2000 user manual pdf download. The cobas c 501 module is a fully automated, medium throughput module that performs photometric assay tests for a wide range of analytes over 110 clinical chemistry tests available, including proteins, enzymes, substrates, electrolytes, hba1c, and more. Single specified analyte controls assayed and unassayed. Immulite 2000 age and sexspecific reference intervals for alpha fetoprotein, homocysteine, insulin, insulinlike growth factor1, insulinlike growth factor binding protein3, cpeptide, immunoglobulin e and intact parathyroid hormone. For in vitro diagnostic use with the immulite and immulite analyzers for the quantitative measurement of human growth hormone hgh in serum, as an aid in patient management.
Growth hormone gh1 is synthesized by acidophilic or somatotropic cells of the anterior pituitary gland. Enhanced chemiluminescent technology and a proprietary wash technique permit true thirdgeneration performance. Feb 19, 2017 lis interface to immulite 2000 xpi to. It stimulates amino acid uptake and protein synthesis in muscle and other tissues. 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 clinical criteria information included in this document excluding serostim zorbtive drugs requiring prior authorization. Used siemens immulite 2000 xpi unit immunology for sale. Immulite2000 tsi assay immulite2000 tsi calibration verification material cvm indications for use describe the immulite 2000 tsi thyroidstimulating immunoglobulins assay is an in vitro diagnostic immunoassay for the semiquantitative determination of thyroid stimulating autoantibodies specific to thyroid stimulating hormone receptors. The methods are similar in that they are both used for the quantitative. Growth hormone gh, somatotropin, hgh, pituitary growth hormone gh is a member of the large family of growth factors that includes prolactin, placental lactogens, proliferins, and somatolactin. Method comparison immulite 2000 i immulite 2000 xpi against immulitei immulite insulin kitlot401piulml 3u 129 2. Method comparison immulite 2000 i immulite 2000 xpi against immulitei immulite insulin kitlot401piulml. Dpc immulite analyzer was used for the quantitative. Current reliability of the immulite assay for measurement of.
Laboratory studies of insulin, 23 heparin, 24 cromolyn, 25 and human growth hormone 26 when coformulated with snac have shown that the carrier aids gastrointestinal absorption by. Immulite 20002500 operators manual free pdf download. The siemens dpc immulite may be purchased in 1 of 2 ways listed below. Growth hormone was measured by a onestep immunometric chemiluminescent immunoassay using the siemens immulite 2000 xpi platform. This list suggests that prolactin is an ancient hormone whose functions have diversified during the evolution of the various vertebrate groups. Antihbc total antihbs hbsab quantitative hbsag hbsag confirmatory. Immulite, immulite, immulite 2000, immulite 2000 xpi.
Patient results using the immulite 2000 were accessed and used to. Pediatric reference intervals for fsh, lh, estradiol, t3, free t3, cortisol, and growth hormone on the dpc immulite. Feb 06, 2015 12 6008490001a immulite 2000 2500 operator s manual figure 3. Immulite 20002500 operators manual pdf view and downloadable. The immulite assay, the test most commonly used for igf1 measurement by clinical laboratories in brazil, recently had supply problems and temporarily ceased to be used. Accessgudid immulite 2000 systems tes total testosterone 00630414962221 testosterone immulite rgt 600 tests. Case report a caucasian male was born at 38 weeks of gestation after a caesarean section, with birth weight 4000 g and birth length 57 cm, with no perinatal problems. View and download bc biomedical maxisim 2000 user manual online. As a result, siemens diagnostics is updating the user manuals to reflect the name change. Correspondence should be addressed to p j monaghan email phillip. The new immulite 2000 xpi is a continuous, random access analyzer with a throughput of up to 200 tests per hour.
It is recommended that no more than 32 wells be used for each assay run. We supply original reagents and consumables for siemens immulite 20002500. Immulite 2000xpi 3gallergy specific ige apple component allergen, rmal d 1 malus domestica, a464l2 background mal d 1 is a pr10 protein associated with oral allergy syndrome oas to apple. Immulite kits barcoded for scanning all reagent information. The growth hormone gh secretion is routinely evaluated in children with short stature, on the ground of the results of gh stimulating tests ghst with different pharmacological stimuli 1, 2. This reference guide includes overviews of the systems, configuration instructions, and operating, maintenance, and troubleshooting procedures. Mod4023 longlasting human growth hormone hgh study. Additionally, gh is a 191amino acid, singlechain polypeptide that is. Utility of serum igf1 for diagnosis of growth hormone deficiency. Backgroundthe diagnosis of disorders of growth hormone gh. Pdf preanalytical influences on dpc immulite 2000 intact. Contribute to levinalexlis development by creating an account on github. It seems purposeful to determine the significance of ghst and igfi assessment in diagnosing ghd.
Immulite 2000 2500 front view 1 2 3 6 8 7 liquidw aste 14 12 4 5 10 91115 distilledw ater number component number component 1 sample carousel 9 reaction tube hopper 2 reagent carousel covered 10 liquid waste 3 pipettors 11 probe wash 4 drd priming accessories 12 distilled. Immulite 2000 human growth hormone immulite 2000 pappa immulite 2000 pth intact immulite 2000 rubella igm immulite 2000 rubella quantitative igg. The role of growth hormone gh and insulinlike growth factori igfi. Immulite 2000 age and sexspecific reference intervals for alpha. Europe pmc is a service of the europe pmc funders group. Siemens dpc immulite 2500 reagents prolactin l5kpr6 use request form below ordering immulite reagents. Usa, sample processed according to manufacturers instructions, 63. Standardization of the immulite systems growth hormone assay.
This study was conducted to compare the pharmacokinetics and tolerability of 2 oral formulations of cyanocobalamina marketed cyanocobalamin tablet immediaterelease b12 5 mg and cyanocobalamin formulated with a proprietary carrier, sodium n82hydroxybenzoylaminocaprylate snacto establish the feasibility of using an absorption enhancer with b12 to improve uptake of. Grow your users is to understand the growth drivers at each stage acquisition, activation, conversion, retention, referral and then. His linear growth velocity started to decline at the age of 12 years. Determinants of the growth hormone nadir during oral glucose tolerance test in adults. Siemens immulite 20002500 reagents and consumables. Growth hormone deficiency and moyamoya disease 205 cerebrovascular lesions suggestive of moyamoya disease. The following steps were followed to operate the instrument as described in the immulite 2000 operators manual. Training provided wpurchaseadvanced operator training. However, the discrepancies between the results of ghst and igfi secretion are observed. The calibration range was from 20 to 2000 pgml and the analytical sensitivity was 15 pgml. Beckmancoulter and three were performed using a manual pro.
Immulites extensive menu allows immunoassay consolidation, offering more than 75 assays. Unit conversion tables, 2nd edition, endocrine sciences, 4301 lost hills rd, calabasas hills, ca 91 biorad lyphochek immunoassay plus control product insert. Immulite immulite growth hormone hgh, immulite and immulite assays are designed for use with the immulite and immulite, continuous random access immunoassay analyzers which offer simplicity in both design and operation. Immuliteimmulite growth hormone hgh 2 immuliteimmulite growth hormone hgh pilkgh12, 20050509 english intended use. An extensive menu, ease of use, robust hardware and excellent assay performance makes this system a great choice for the small. Developed for and tested with dpc immulite i2500 user manual using the lis specification version 600129h not available online, but a similar version might be available. The antibody gh45 reacts with human growth hormone hgh, a polypeptide hormone synthesized by acidophilic or somatotropic cells of the anterior pituitary gland. Online conversion calculator for many types of measurement units in laboratory and medicine human growth hormone hgh, growth hormone, sth, somatotropin. Threeyear efficacy and safety of lb03002, a onceweekly sustainedrelease growth hormone gh preparation, in prepubertal children with gh deficiency ghd. What do customers say they like most about their immulite. The immulite 20002500 operators manual describes the operation of the immulite 2000 and immulite 2500 instruments and software. Measuring growth hormone and insulinlike growth factori in infants. Pdf harmonization of growth hormone measurements with. Fda 510k applications for medical device product code jjx single specified analyte controls assayed and unassayed.
Growth hormone deficiency associated with moyamoya. This design increases workflow and enhances productivity for medium to highvolume immunoassay laboratories by incorporating specialty and. Around 2000 cells were then distributed in 12well plates and grown for 48 h in either dmem thyroid cancer cells or in rpmi medium mcf 7 cells both containing 5% fcs. Immulite 2000 growth hormone hgh 2 immulite 2000 growth hormone hgh pil2kgh14, 20050509 english intended use. This study aims to assess the safety, tolerability and pharmacokinetics pharmacodynamics pkpd profile of three doses of mod4023 on a weekly regime and one dose on an everyotherweek regime administered for a period of 4 weeks in growth hormone deficient adult ghda patients who previously were on a stable rhgh treatment. Growth hormone gh is so similar structurally to prolactin that. The immulite 2000 xpi system is a continuous random access immunoassay analyzer with a maximum throughput of 200 tests per hour. You can add community subscriptions in the search bar that says subscribe to more communities. Thyroid hormone is important for a normal response to agents that stimulate gh secretion. Mod4023 longlasting human growth hormone hgh study in.
Type ia isolated growth hormone deficiency ighd consistent with compound heterozygous deletions of 6. Human growth hormone hgh conversion to miul, ngml, ng. Genes for growth hormone gh are found in a gene cluster on 17q, which consists of two growth hormone genes and three csh genes. Insulinlike growth factor igrowth hormone deficiency in. Immulite systems can be found in a wide variety of immunoassay testing environments around the world. Service and user manual for siemens immulite analyzer. Customer input was the basis for this new design that maximizes workflow and. The methods are similar in that they are both used for the quantitative determination of tsh in serum, and both use tsh calibrated and labeled in iuml standardized to the who htsh 2nd irp, 80558. Immulite immulite against immulite2000 immulite2000xpi insulinmethod compaiison a cross platform comparison ofcorrectedinsulin kitlots, 40i and above, is shown infigure3, whichdemonstrates good cross platform agreement.
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