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1. REF IS 3200 IDS iSYS Intact PTH immunodiagnosticsystems Instructions for Use IN VITRO DIAGNOSTIC CE Intended Use For In Vitro Diagnostic Use The IDS iSYS Intact PTH assay is intended for the quantitative determination of PTH 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 The main function of PTH is the regulation of serum ionized calcium levels Measurement of circulating PTH levels is important in the differential diagnosis of hypercalcaemia and hypocalcaemia Summary and Explanation Parathyroid hormone PTH is a polypeptide hormone of 84 amino acids secreted by the parathyroid glands Synthesis of PTH is governed by direct negative feedback of ionised calcium on the parathyroid tissues 1 A fall in serum calcium stimulates PTH release which acts on the kidneys to promote calcium reabsorption and 1 25 dihydroxyvitamin D production This stimulates bone resorption restoring serum calcium levels to physiologically acceptable levels 2 PTH is rapidly metabolised in the liver and kidney half life of full length 1 84 PTH is 2 4 minutes to N and C terminal fragments 3 In healthy individuals however PTH fragments are effectively cleared by the kidneys Impaired renal function results in the accumulation of PTH fragments to very high levels 42. 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 Refer to the IDS iSYS Intact PTH Control Set IFU for preparation and handling instructions Determination of Sample Intact PTH levels Process samples according to the IDS iSYS User Manual Calculation of Results The PTH concentration of each sample is calculated automatically The display of the concentrations screen or printed is produced upon user request The IDS iSYS PTH Assay uses a 4 parameter logistic curve fit 4PL to calculate the Intact PTH concentrations Measurement Range Reportable Range The reportable range of the assay is 5 5000 pg mL Any value that reads below 5 pg mL should be reported as lt 5 pg mL 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 Intact PTH Assay when the concentrations presented in the following table are below the stated threshold Potentially Interfering Threshold Agent Concentration
3. Lipid 3000 mg dL Bilirubin 20 mg dL Haemoglobin 250 mg dL Biotin 300 nmol L Red Blood Cells 0 4 Human Calcitonin 10 000 pg mL Cross laps CTX 1 12 ng mL Osteocalcin 400 ng mL HAMA 1000 ng mL Rheumatoid Factor 2530 IU mL PTH 53 84 100 000 pg mL PTH 39 68 100 000 pg mL PTH 44 68 100 000 pg mL IS 3200PLv02 2011 02 21 English 4 The hook effect was tested using concentrations of PTH up to 95 000 pg mL No hook effect was observed Expected Values Each laboratory should determine ranges for their local population The following range was determined using the IDS iSYS Intact PTH Assay and is provided for information only The 95 reference interval for the following group was calculated by a non parametric method following the NCCLS guideline C28 A2 How to Define and Determine Reference Intervals in the Clinical Laboratory All subjects had 25 OH Vitamin D levels of gt 10 ng mL Normal Adults 11 5 78 4 pg mL n 243 Performance Data Representative performance data are shown obtained at individual laboratories may vary Results 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 100 blanks and 50 low level samples LoB 1 2 pg mL LoD 2 5 pg mL LoQ lt 5 pg mL Precision Precision was evaluate
4. H in the original sample Warnings and Precautions The IDS iSYS Intact PTH Assay is for in vitro diagnostic use only and is not for internal use in humans or animals This product must be used strictly in accordance with the instructions set out in these Instructions for Use IFU IDS IS 3200PLv02 2011 02 21 English 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 Xn Harmful Calibrators contain sodium azide NaN3 gt 0 1 w w lt 1 R22 Wear suitable protective clothing and gloves R52 53 Harmful to aquatic organisms may cause long term adverse effects in the aquatic environment S46 If swallowed seek medical advice immediately and show this container or label 36 37 Wear suitable protective clothing and gloves S60 This material and or its container must be disposed of as hazardous waste Handling Precautions Apart from the calibrators which are lyophilised the reagents provided in the kit are ready to use Refer to the calibrator section of the procedure f
5. L container ready to use IDS iSYS Wash Solution IS CW100 10 L 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 IDS iSYS Sample Cups 500 pL IS SC105 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 IS 3200PLv02 2011 02 21 English If the cartridge is removed from the reagent tray store the cartridge vertically at 2 8 C in the dark Calibrators The PTH calibrators are lyophilised Reconstitute immediately before use Add 1 0mL of distilled or deionised water to each bottle Replace the stopper Leave for 20 minutes to reconstitute with occasional gentle vortexing Invert calibrators gently before use Pipette approximately 450 uL of calibrators into sample cups and place on the machine Proceed according to the instructions o
6. Measurement of circulating PTH is of particular value in the differential diagnosis of hypercalcaemia improving the clinical discrimination between patients with hyperparathyroidism and those with hypercalcaemia of malignancy HCM Hyperparathyroidism may be secondary to intestinal malabsorption of calcium or vitamin D deficiency and is a consistent feature of chronic kidney disease CKD 5 Elevated PTH levels are linked to adverse cardiovascular events in CKD 6 Grossly elevated levels of C terminal PTH fragments can lead to misdiagnosis due to interference in immunoassays not specifically formulated to avoid this 2 Method Description The Intact PTH assay is based on chemiluminescence technology Two polyclonal antibodies against human PTH are utilised An antibody recognising the C terminal region amino acids 39 84 is used as the capture antibody For detection an acridinium conjugated antibody recognising the N terminal region amino acids 13 34 is used In addition to full length PTH amino acids 1 84 the large PTH fragment amino acids 7 84 will also be detected Samples are incubated with both labelled antibodies for a period of time Streptavidin coated magnetic particles are then added and following a further incubation step the particles are captured using a magnet After a washing step and addition of trigger reagents the light emitted by the acridinium label is directly proportional to the concentration of PT
7. ation of Intact PTH following CLSI EP 9A2 Method Comparison and Bias Estimation Using Patient Samples A total of 158 samples selected to represent a wide range of PTH concentrations 5 7 4744 pg mL was assayed by each method Linear regression analysis was performed on the comparative data IDS iSYS 1 06 x 3 8 95 Cl of the slope and intercept were 1 06 to 1 07 and 8 9 to 1 3 respectively correlation coefficient r squared 1 00 Specificity Analyte Cross Reactivity PTH 1 84 100 PTH 7 84 60 PTH 1 34 0 5 PTH 39 84 Not detectable Bibliography 1 Potts JT Parathyroid Hormone Past and present J Enocrinology 2005 187 311 325 2 Bringhurst FR et al Circulating forms of parathyroid hormone Peeling back the onion Clin Chemistry 2003 49 1973 1975 3 Komaba H et al Critical issues of PTH assays in CKD Bone 2009 45 514 518 4 D Amour P et al Structure of non 1 84 PTH fragments secreted by parathyroid glands in primary and secondary hyperparathyroidism Kidney Int 2005 68 998 1007 5 Lamb EJ et al Parathyroid hormone kidney disease evidence and guidelines Ann Clin Biochem 2007 44 1 4 6 Meunier P et al Plasma PTH level and prevalent cardiovascular disease in CKD stages 3 and 4 An analysis from the kidney early evaluation program KEEP Am J Kid Dis 2009 53 supp 4 S3 S10 ual Immunodiagnostic Systems Ltd IDS Ltd 10 Didcot Way Boldon Bu
8. d in accordance with a modified protocol based on CLS EP 5A2 Evaluation of Precision Performance of Quantitative Measurement Methods Three serum controls were assayed using three lots of reagents in duplicate twice per day for 20 days on three instruments Page 3 4 Concentration Within run Total pomt 133 21 0 192 1956 2599 3807 Recovery Recovery was assessed by adding PTH 1 84 to samples prior to assay Average recovery in EDTA plasma was 104 average recovery in serum samples was 98 Linearity Linearity was evaluated based on CLSI EP 6A Evaluation of the Linearity of Quantitative Measurement Procedures A Statistical Approach Samples containing varying Device code IS 3200 REF IS 3200 IDS iSYS Intact PTH immunodiagnosticsystems Instructions for Use IN VITRO DIAGNOSTIC CE concentrations of PTH 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 Four sets of samples covering the range of the assay were measured giving a total of 76 measured dilutions Average Observed Expected Intact PTH values were 99 with an r squared of 1 00 defined by linear regression analysis Method Comparison The IDS iSYS Intact PTH Assay was compared against a recognized immunoassay for the quantitative determin
9. f the IDS iSYS User Manual DO NOT return material to the calibrator vial If calibrators are to be used more than once they should be aliquotted and stored at 20 C or lower within 15 minutes of reconstitution When re using frozen calibrators thaw at room temperature and mix well Ensure that calibrators are at room temperature before they are placed on the machine Calibrators should be placed on the machine within 30 minutes of thawing Aliquots should not be re frozen Analyser Calibration The two PTH 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 same 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 PTH 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
10. or reconstitution methodology 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 Reagent shelf life Cartridge Calibrators Before opening at 2 8 C To the expiry date Cartridge after opening at 28 days N A 2 8 C Calibrators after N A 14 days reconstitution at 20 C On board the Analyser 21 days 2 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 lithium heparin or potassium EDTA samples Samples should be separated as soon as possible after collection due to the labile nature of PTH Store samples at 20 C or below Avoid repeated freeze thaw of samples Note Improper handling and storage of samples may result on loss of assayable PTH To minimise possible evaporation effects samples calibrators and controls should be measured within 2 hours after being placed on the analyser Before assay make sure that samples calibrators and controls are at room tempera
11. 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 Intact PTH assay has been standardized against in house reference standards Conversion Factor to International PTH Standard A conversion factor to the WHO International Standard for Parathyroid Hormone NIBSC Reference 95 646 has been established IDS iSYS Intact PTH 1 46 x WHO PTH Standard Calibration Frequency A new calibration is required e Each time a new lot of cartridges is loaded on board e Each time a new lot of trigger or cuvettes is used e When the control values do not fall within the defined ranges Page 2 4 Device code IS 3200 REF IS 3200 fs IDS iSYS Intact PTH immunodiagnosticsystems Instructions for Use IN VITRO DIAGNOSTIC CE When the calibration has expired e After Analyser service Verification of the calibration is automatic and managed by the Analyser Quality Control Use the IDS iSYS Intact PTH Control Set for quality control To ensure validity of results at least three controls with varying levels of PTH should be measured Other suitable control material can be used in addition to the IDS iSYS Intact PTH Control Set Controls should be tested at or near
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13. ture 20 25 C Page 1 4 Device code IS 3200 REF IS 3200 IDS iSYS Intact PTH immunodiagnosticsystems Instructions for Use IN VITRO DIAGNOSTIC CE 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 Cartridge Magnetic particles coated with streptavidin in a phosphate buffer containing sodium azide as preservative lt 0 1 1 bottle 2 7 mL Anti PTH labelled with an acridinium ester derivative in buffer containing goat serum with sodium azide as preservative lt 0 1 1 bottle 7 25 mL Ab BIOT Anti PTH labelled with biotin in buffer containing bovine and goat proteins with sodium azide as preservative lt 0 1 1 bottle 13 mL Calibrators CALA CAL B A buffered porcine serum matrix containing PTH and sodium azide as preservative lt 0 2 2 each of 2 concentration levels 1 mL Mini CD Contains IFU for IDS iSYS reagents control ranges and CRY files Materials Required But Not Provided IDS iSYS Multi Discipline Automated Analyser IS 310400 IDS iSYS PTH Control Set S 3230 6 x 1 mL each of level 1 2 and 3 IDS iSYS Cuvettes Cube IS CC100 box of 960 cuvettes IDS iSYS System Liquid IS CS100 5
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