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1. REF IS 3700 IDS iSYS Human Growth Hormone e le i eve hGH 2 immunodiagnosticsystems Instructions for Use IN VITRO DIAGNOSTIC CE Intended Use For In Vitro Diagnostic Use The IDS iSYS Human Growth Hormone Assay IDS iSYS hGH is intended for the quantitative determination of Human Growth Hormone hGH in human serum or plasma on the IDS iSYS Multi Discipline Automated Analyser Analyser Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of growth disorders Summary and Explanation Growth hormone hGH is a polypeptide hormone secreted from the acidophil cells of the anterior pituitary gland Secretion is episodic and is associated with exercise the onset of deep sleep or post prandially in response to falling glucose levels Synthesis and release are under the control of hypothalamic releasing peptides and inhibitory peptides such as somatostatin More recently a gastric peptide Ghrelin has been shown to also stimulate hGH secretion In contrast the mediator of many hGH actions in the periphery insulin like growth factor IGF I exerts an inhibitory effect through negative feedback mechanisms hGH in circulation consists of several molecular isoforms with 22 000 Dalton hGH being the most abundant followed by a 20 000 Dalton hGH variant produced by alternative splicing Approximately 50 of circulating hGH is bound to a hi2. GH are generally low in subjects whose blood is drawn while they are awake For these reasons a single measurement of GH does not provide adequate information for evaluating GH adequacy Even among normal healthy individuals a single fasting sample is highly variable and is not considered a useful measure of GH Stimulation tests are commonly employed with baseline and post stimulation blood sampling and normal baseline levels are generally less than 10 ng mL Basal GH Normal Adults lt 10 ng mL n 150 Performance Data Representative performance data are shown Results obtained at individual laboratories may vary Sensitivity The limit of blank LoB limit of detection LoD and limit of quantitation LoQ were determined with guidance from CLSI EP17 A Protocols for Determination of Limits of Detection and Limits of Quantitation using 60 blanks and at least 120 low level samples Page 3 5 Device code IS 3700 REF IS 3700 IDS iSYS Human Growth Hormone hGH i miba immunodiagnostics Instructions for Use IN VITRO DIAGNOSTIC CE LoB 0 005 ng mL LoD 0 005 ng mL LoQ 0 049 ng mL Predicted Measured Variati Concentration Concentration ariation Precision ng mL ng mL ng mL Precision was evaluated in accordance with a protocol 0 43 0 39 0 04 9 based on CLSI EP 5A2 Evaluation of Precision 7 Performance of Quantitative Measurement Methods 259 263
3. the Bio Rad Lyphochek Immunoassay Plus Control Instructions For Use for preparation handling and storage instructions Stability of Controls Onboard Controls are stable on board the analyser for up to 3 hours continuous on board stability When using the Controls Pipette approximately 300 uL of each control into sample cups and place on the machine Discard the material in the sample cups after use DO NOT return material to the control bottles Controls should be run as duplicate determinations at least once every 24 hours when the test is in use and during every calibration The control values must be within the acceptable ranges specified If a control is out of its specified range the associated test results are invalid and samples must be retested Recalibration may be required Determination of Sample hGH levels Process samples according to the IDS iSYS User Manual Calculation of Results The hGH concentration of each sample is calculated automatically The display of the concentrations screen or printed is produced upon user request The IDS iSYS hGH Assay uses a 4 parameter logistic curve fit 4PL to calculate the hGH concentrations Conversion of Units x 3 00 gt X ng mL Y IU mL lt x 0 333 IS 3700PLV1 2009 09 08 English Measurement Range Reportable Range The reportable range of the assay is 0 050 100 ng mL Any value that reads below 0 050 ng mL should be reported as lt 0 050 ng mL Dilu
4. 004 2 Three serum controls were assayed using three lots of 4 75 4 83 0 08 2 reagents in duplicate twice per day for 20 days on two 6 90 6 79 0 11 2 Deeper 9 06 9 05 0 01 0 Control n mean Within run Total 11 21 11 28 0 07 1 13 37 13 34 0 03 0 40 1 49 0 03 1 8 0 16 10 4 2 40 9 87 0 35 3 5 0 88 8 9 ngimL sD cv SD cv 3 40 25 23 0 55 2 2 1 48 5 9 Recovery Recovery was assessed by adding intact hGH to samples prior to assay Sample hGH Conc added Measured Recovery Recovery ng mL ng mL ng mL ng mL 0 58 12 50 13 03 12 45 100 0 58 25 00 26 05 25 47 102 0 58 37 50 39 43 38 85 104 0 58 50 00 50 91 50 33 101 0 53 12 50 13 23 12 70 102 0 53 25 00 25 82 25 29 101 0 53 37 50 39 15 38 62 103 0 53 50 00 50 52 49 99 100 Mean 102 Linearity Linearity was evaluated based on CLSI EP 6A Evaluation of the Linearity of Quantitative Measurement Procedures A Statistical Approach Samples containing varying concentrations of hGH were assayed in duplicate The resulting mean concentrations were compared to predicted concentrations Samples were prepared by diluting a high patient sample with a low patient sample prior to assay Predicted Measured Ss Concentration Concentration Variation ng mL ng mL ng mL lt 0 05 0 24 15 68 14 77 0 91 6 31 44 30 80 0 64 2 47 19 47 5
5. 5 0 36 1 62 95 64 40 1 45 2 78 70 79 95 1 25 2 94 46 92 64 1 82 2 IS 3700PLV1 2009 09 08 English Method Comparison The IDS iSYS hGH Assay was compared against a recognised hGH assay X for the quantitative determination of hGH following CLSI EP 9A2 Method Comparison and Bias Estimation Using Patient Samples A total of 49 samples selected to represent a wide range of hGH concentrations 0 11 19 12 ng mL were assayed by each method Linear regression analysis was performed on the comparative data IDS iSYS 0 95 X 0 05 95 Cl of the slope and intercept were 0 90 to 1 01 and 0 22 to 0 32 respectively correlation coefficient r 0 98 Specificity The specificity was assessed with the following analytes Analyte Cross Reactivity hGH 22kDa 100 hGH 20kDa 10 ng mL ND Placental hGH 200 ng mL ND HPL 10 000 ng mL ND Prolactin 40 000 ng mL ND Pegvisomant 50 000 ng mL ND Not detectable Bibliography 1 Giustina A Veldhuis JD Pathophysiology of the neuroregulation of growth hormone secretion in experimental animals and the human Endocr Rev 1998 Dec 19 6 717 97 2 Baumann G Growth hormone heterogeneity genes isohormones variants and binding proteins Endocr Rev 1991 Nov 12 4 424 49 3 Moller N Jorgensen JO Effects of growth hormone on glucose lipid and protein metabolism in human subjects En
6. C To the expiry date After opening at 2 8 C 28 Days To the expiry date On board the Analyser 11 Days 3 hours Continuous on board stability Sample Collection and Storage The assay should be performed using serum standard sampling tubes or tubes containing serum separating gel or plasma sodium citrate lithium heparin sodium heparin or ammonium heparin samples Samples should be Page 1 5 Device code IS 3700 REF IS 3700 IDS iSYS Human Growth Hormone 2 immunodiagnosticsystems Instructions for Use IN VITRO DIAGNOSTIC CE separated as soon as possible after collection EDTA plasma cannot be used with the IDS iSYS hGH assay Store samples at 20 C Avoid repeated freeze thaw of samples Samples containing particulate matter must be centrifuged before performing the assay Do not use heat inactivated samples To minimise possible evaporation effects samples calibrators and controls should be measured within 3 hours after being placed on the analyser Before assaying make sure that samples calibrators and controls are at room temperature 20 25 C Note Some sample collection tubes that are commercially available might affect the results of testing in particular cases It is recommended to follow the instructions of the tube manufacturer especially when processing samples in primary tubes Procedure Materials Provided Reagent Cartrid
7. DS iSYS Sample Cups 500 pL IS SC105 IS 3700PLV1 2009 09 08 English Assay Procedure Reagent Cartridge The reagents provided in the cartridge are ready to use The analyser automatically performs the mixing of magnetic particles to maintain homogeneity Before a new cartridge is loaded on board the analyser mix the magnetic particles container by brisk rotation motion Avoid foam formation The barcode is read when the cartridge is loaded on the reagent tray If the label cannot be read by the analyser barcode reader a manual procedure exists to enter the barcode data see the IDS iSYS User Manual Load the cartridge on the reagent tray and wait for at least 40 minutes before starting the assay If the cartridge is removed from the reagent tray store the cartridge vertically at 2 8 C in the dark Calibrators The hGH calibrators are ready to use Leave the calibrators at room temperature for 10 minutes and gently mix the bottles by hand Avoid formation of foam Pipette approximately 300 uL of calibrators into sample cups and place on the machine Discard the material in the sample cups after use DO NOT return material to the calibrator bottle Analyser Calibration The two hGH calibrators are required to perform the adjustment of the master curve The calibrators are supplied with the kit and calibrators from another lot must not be used Note that to perform a master curve adjustment controls MUST be run at the sa
8. characterised by progressive thickening of bone and soft tissue Diagnosis is usually confirmed by dynamic function testing which demonstrates a raised serum hGH level which does not fall in response to an oral glucose load In conditions where there are nutritional disturbances such as anorexia starvation renal failure and hepatic cirrhosis increased basal hGH levels may be found Recombinant hGH is available for treatment of hGH deficiency in both children and adults hGH excess is IS 3700PLV1 2009 09 08 English treated by surgery irradiation therapy or somatostatin analogues More recently a hGH receptor antagonist has been developed which shares structural homology to hGH and competes with hGH for binding to the hGH receptor Method Description The assay is based on chemiluminescence technology Samples are incubated with a biotinylated anti hGH monoclonal antibody and streptavidin labelled magnetic particles The magnetic particles are captured using a magnet and a wash step performed An acridinium labelled anti hGH monoclonal is added and following a further incubation step a second wash step is performed Trigger reagents are added and the resulting light emitted by the acridinium label is directly proportional to the concentration of hGH in the original sample Warnings and Precautions The IDS iSYS hGH is for in vitro diagnostic use only and is not for internal use in humans or animals This product m
9. docr Rev 2009 Apr 30 2 152 77 4 Cohen P Rogol AD Deal CL Saenger P Reiter EO Ross JL Chernausek SD Savage MO Wit JM 2007 ISS Consensus Workshop participants Consensus statement on the diagnosis and treatment of children with idiopathic short stature a summary of the Growth Hormone Research Society the Lawson Wilkins Pediatric Endocrine Society and the European Society for Paediatric Endocrinology Workshop J Clin Endocrinol Metab 2008 Nov 93 11 4210 7 5 Ho KK 2007 GH Deficiency Consensus Workshop Participants Consensus guidelines for the diagnosis and treatment of adults with GH deficiency Il a statement of the GH Research Society in association with the European Society for Pediatric Page 4 5 Device code IS 3700 REF IS 3700 IDS iSYS Human Growth Hormone immunodiagnosticsystems Instructions for Use IN VITRO DIAGNOSTIC CE Endocrinology Lawson Wilkins Society European Society of Endocrinology Japan Endocrine Society and Endocrine Society of Australia Eur J Endocrinol 2007 Dec 157 6 695 700 6 Molitch ME Clemmons DR Malozowski S Merriam GR Shalet SM Vance ML Endocrine Society s Clinical Guidelines Subcommittee Stephens PA Evaluation and treatment of adult growth hormone deficiency an Endocrine Society Clinical Practice Guideline J Clin Endocrinol Metab 2006 May 91 5 1621 34 7 Growth Hormone Research Society Pituitary Society Biochemical assess
10. ge Note Bottle 4 is deliberately empty and is not used MPS3 Magnetic particles coated with streptavidin in phosphate BSA buffer with sodium azide as preservative lt 0 1 1 bottle 2 3 mL Anti hGH monoclonal antibody labelled with an acridinium ester derivative in buffer containing BSA mouse serum and horse serum with sodium azide as preservative lt 0 1 1 bottle 23 mL Ab BIOT Anti hGH monoclonal antibody labelled with biotin in buffer containing BSA and mouse proteins with sodium azide as preservative lt 0 1 1 bottle 11 5 mL Calibrators CALA CAL B Horse serum containing hGH and sodium azide as preservative lt 0 1 1 each of 2 concentration levels 2 mL Mini CD Contains IFU for IDS iSYS reagents and CRY files Materials Required But Not Provided IDS iSYS Multi Discipline Automated Analyser S 310400 Bio Rad Lyphochek Immunoassay Plus Control Cat No 370 Trilevel 12 x 5 mL or Cat No 371 for Level 1 12 x 5 mL and Cat No 372 for Level 2 12 x 5 mL and Cat No 373 for Level 3 12 x 5 mL or Cat No 370X Trilevel MiniPak 3 x 5 mL IDS iSYS Cuvettes Cube IS CC100 box of 960 cuvettes IDS iSYS System Liquid IS CS100 5 L container ready to use IDS iSYS Wash Solution IS CW100 10L container ready to use IDS iSYS Triggers Set A and B IS CT100 2 x 250 mL per bottle ready to use IDS iSYS Cartridge Check System IS 6010 ready to use I
11. gh affinity binding protein hGH is physiologically important in two main areas Firstly it has an integral role in skeletal growth which is well demonstrated in either excess or deficiency in childhood The action of hGH in part is mediated through IGF I as well as promoting protein synthesis and the uptake of amino acids into cells Secondly hGH influences intermediary metabolism by stimulating lipolysis and is antagonistic to the insulin mediated uptake of glucose hGH secretion is stimulated by hypoglycaemia and suppressed by hyperglycaemia In childhood symptoms of hGH deficiency are retarded growth and dwarfism Aetiology is often unknown and an absolute or relative deficiency usually becomes apparent at about 2 years of age Diagnosis can be confirmed by demonstrating low serum hGH which does not respond to stimulation tests hGH deficiency is a major cause of severe short stature and diagnosis at an early stage is essential for successful therapy Hyposecretion in adults usually becomes apparent during the laboratory investigation of hypopituitarism Hypersecretion commonly due to adenoma of the acidophil cells is characterised by two conditions depending on whether it becomes apparent before or after fusion of the bony epiphyses In childhood excess hGH is characterised by gigantism Heights of 8 feet 2 4 metres may be achieved and may also be associated with hypogonadism In adults acromegaly results a condition
12. many Tel 49 69 3085 5025 Fax 49 69 3085 5125 e mail info de idsplc com www idsplc com France Immunodiagnostic Systems EURL IDS EURL 55 rue Sainte Anne 75002 PARIS France Tel 33 1 42 44 12 63 Fax 33 1 42 44 40 76 e mail info fr idsplc com www idsplc com Scandinavia Immunodiagnostic Systems Nordic a s IDS Nordic a s Marielundvej 30 2 Sal 2730 Herlev Denmark Tel 45 44 84 0091 e mail info nordic idsplc com www idspic com Belgium Immunodiagnostic Systems S A Rue E Solvay 101 4000 Li ge Belgium Tel 32 4 252 26 36 Fax 32 4 252 51 96 e mail info be idsplc com www idsplc com IS 3700PLV1 2009 09 08 English Page 5 5 Device code IS 3700
13. me time as the calibrators All data required for the calibration of the cartridge batch can be found on the mini CD Use calibrator levels A and B to adjust the master curve to the reagents on board the Analyser Check for the presence of a hGH cartridge on the reagent tray and the availability of the cartridge master curve in the database If the data for the lot of calibrators is not available on board the analyser load the data using the mini CD provided with the calibrator Start the immunoassay calibration on the IDS iSYS Analyser according to the IDS iSYS User Manual The calibration is carried out in triplicate RLU CVs of gt 5 will result in a failed calibration One replicate may be removed to meet the calibration requirements As stated above please note that controls must also be run Verify and approve the calibration according to the calibration status displayed in the calibration windows and discard the calibrator from the sample tray after use Calibration The IDS iSYS hGH assay is calibrated to the WHO International Standard for Somatropin from NIBSC code 98 574 Calibration Frequency A new calibration is required e Each time a new lot of cartridges is loaded on board Each time a new lot of trigger or cuvettes is used When the control values do not fall within the defined ranges e When the calibration has expired Page 2 5 Device code IS 3700 REF IS 3700 IDS iSYS Human Gro
14. ment and long term monitoring in patients with acromegaly statement from a joint consensus conference of the Growth Hormone Research Society and the Pituitary Society J Clin Endocrinol Metab 2004 Jul 89 7 3099 102 8 Consensus statement medical management of acromegaly Melmed S Casanueva F Cavagnini F Chanson P Frohman LA Gaillard R Ghigo E Ho K Jaquet P Kleinberg D Lamberts S Laws E Lombardi G Sheppard MC Thorner M Vance ML Wass JA Giustina A Eur J Endocrinol 2005 Dec 153 6 737 40 9 Kopchick JJ Parkinson C Stevens EC Trainer Pu Growth hormone receptor antagonists discovery development and use in patients with acromegaly Endocr Rev 2002 Oct 23 5 623 46 sal Immunodiagnostic Systems Ltd IDS Ltd 10 Didcot Way Boldon Business Park Boldon Tyne amp Wear NE35 9PD England Tel 44 191 519 0660 Fax 44 191 519 0760 e mail info uk idsplc com www idsplic com Immunodiagnostic Systems UK Immunodiagnostic Systems Ltd IDS Ltd 10 Didcot Way Boldon Business Park Boldon Tyne amp Wear NE35 9PD England Tel 44 191 519 0660 Fax 44 191 519 0760 e mail info uk idsplc com www idsplic com USA Immunodiagnostic Systems Inc IDS Inc P O Box 17063 Fountain Hills AZ 85269 7063 USA Tel 1 480 836 7435 Fax 1 480 836 7437 e mail info us idsplc com www idsplic com Germany Immunodiagnostic Systems GmbH IDS GmbH Mainzer Landstrasse 49 60329 Frankfurt am Main Ger
15. tion Samples with hGH concentrations above the reportable range should be diluted manually with a low concentration human serum sample in a ratio of 1 in 2 The results for diluted samples must be multiplied by the dilution factor 2 and corrected for the concentration of the low sample Limitations of Use 1 As in the case of any diagnostic procedure results must be interpreted in conjunction with the patient s Clinical presentation and other information available to the physician 2 The performance characteristics of this assay have not been established in a paediatric population 3 The following substances do not interfere in the IDS iSYS hGH Assay when the concentrations presented in the following table are below the stated threshold Potentially Interfering Agent Threshold Concentration Lipid 3000 mg dL Bilirubin 200 mg L Haemoglobin 500 mg dL Biotin 300 nmol L Growth Hormone 140 ng mL Binding Protein GHBP 4 The hook effect was tested using concentrations of hGH up to 15 000 ng mL No hook effect was observed Expected Values Each laboratory should determine ranges for their local population Growth Hormone GH is secreted from the anterior pituitary gland in a pulsatile or episodic manner and has a short half life Regulation of GH level in blood is influenced by a number of hormonal and physiological factors Normal serum GH levels average less than 5 ng mL and single measurements of
16. ust be used strictly in accordance with the instructions set out in these Instructions for Use IFU IDS Limited will not be held responsible for any loss or damage except as required by statute howsoever caused arising out of non compliance with the instructions provided CAUTION This kit contains material of animal origin Handle kit reagents as if capable of transmitting an infectious agent Appropriate precautions and good laboratory practice must be used in the storage handling and disposal of the kit reagents Disposal of kit reagents should be in accordance with local regulations Sodium Azide Some reagents in this kit contain sodium azide lt 0 1 w w which may react with lead copper or brass plumbing to form highly explosive metal azides On disposal flush with large volumes of water to prevent azide build up Handling Precautions The reagents provided in the kit are ready to use Before a new cartridge is loaded onto the Analyser the magnetic particle container requires mixing by the operator with a brisk rotation motion This will resuspend the magnetic particles that have settled during shipment It is very important to avoid any foam formation Shelf Life and Storage of Reagents Prior to first use store the cartridge and the calibrators in an upright position in the dark at 2 to 8 C Do not freeze the cartridge or the calibrators Reagent shelf life Cartridge Calibrators Before opening at 2 8
17. wth Hormone e le i eve hGH 2 immunodiagnosticsystems Instructions for Use IN VITRO DIAGNOSTIC CE e After Analyser service Verification of the calibration is automatic and managed by the Analyser Quality Control The regular use of control samples at several analyte levels is advised to ensure day to day validity of results Use Bio Rad Lyphochek Immunoassay Plus Control for quality control To ensure validity of results at least three controls with varying levels of hGH should be measured Other suitable control material can be used in addition to the Bio Rad Lyphochek Immunoassay Plus Control Controls should be tested at or near the beginning of every run containing patient samples and also during calibrations or according to local regulations It is recommended that the controls be routinely run in duplicate Laboratories should test controls at least once per shift Entering Control Targets into the IDS iSYS Software Open the IDS iSYS software and in the Management Of Lots drop down menu select Control Select the control level that you wish to enter the value for and click the New Lot button In the Identification window enter the lot number and expiry of the control level in their respective fields In the Analytes window enter the supplied Target Value and Deviation Click Validate to confirm Repeat the process for the other control levels Preparation Handling and Storage of Controls Refer to
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