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1. REF IS 3400 5 iSYS IDS iSYS Direct Renin immunodiagnosticsystems Instructions for Use IN VITRO DIAGNOSTIC CE Intended Use For In Vitro Diagnostic Use The IDS iSYS Direct Renin assay is intended for the quantitative determination of Direct Renin in human EDTA plasma on the IDS iSYS Multi Discipline Automated System Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of Hypertension related syndromes Summary and Explanation Renin is a proteolytic enzyme synthesised by the juxtaglomerular cells of the kidney Renin plays an integral role in the Renin Angiotensin Aldosterone System RAAS The RAAS regulates blood pressure through blood volume sodium and water homeostasis control and vasoconstriction The biochemical action of renin is to cleave Angiotensinogen to Angiotensin Angiotensin is immediately transformed to Angiotensin Il by Angiotensin Converting Enzyme ACE Angiotensin II is a small potent molecule able to regulate blood pressure through vasoconstriction Angiotensin II is the active hormone and is regulated by aldosterone level An over active RAAS leads to vasoconstriction and retention of sodium and water which can lead to hypertension Consequently assessment of the RAAS is essential for diagnostic and therapeutic purposes 1 in 3 people worldwide will develop hypertension regardless of age and2. be idsplc com www idsplc com Page 4 4 Device code IS 3400
3. calibrators are lyophilised Reconstitute immediately before use Add 1 0 mL of distilled or deionised water to each bottle Replace the stopper Leave for 10 minutes to reconstitute Invert calibrators gently before use Pipette the entire contents of the calibrator bottle into disposable 2mL polypropylene conical skirted base screw cap micro tubes and place on the system Proceed according to the instructions of the IDS iSYS User Manual DO NOT return material to the calibrator vial System Calibration The two Direct Renin 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 The reconstituted extracts kit controls MUST be run at the same time as the calibrators to perform a master curve adjustment 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 System Check for the presence of a Direct Renin 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 system load the data using the mini CD provided with the calibrator Start the immunoassay calibration on the IDS iSYS System according to the IDS iSYS User Manual The calibration is carried out in triplicate RLU CVs of gt 7 will result in a fai
4. levels 1mL Mini CD Contains IFU for IDS iSYS reagents and CRY files Materials Required But Not Provided IDS iSYS Multi Discipline Automated System IS 310400 IDS iSYS Direct Renin Control Kit IS 3430 IDS iSYS Cuvettes Cube IS CC100 IDS iSYS System Liquid IS CS100 IDS iSYS Wash Solution IS CW100 IDS iSYS Triggers Set A and B IS CT100 IDS iSYS Cartridge Check System IS 6010 Disposable polypropylene 2 mL 10 8 mm diameter conical skirted base screw cap micro tubes and screw cap with O ring Sarstedt 72 609 and 65 716 or equivalent Precision Pipetting Devices Distilled or Deionised water IS 3400PLv01 2012 06 08 English Page 2 4 Assay Procedure Reagent Cartridge The reagents provided in the cartridge are ready to use The system automatically performs the mixing of magnetic particles to maintain homogeneity Before a new cartridge is loaded on board the system 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 system 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 IDS iSYS Direct Renin
5. controls at least once per shift Refer to the IDS iSYS Direct Renin Control Set IFU for preparation and handling instructions Determination of Sample Renin levels Process samples according to the IDS iSYS User Manual Measurement Range Reportable Range The reportable range of the assay is 1 8 550 IU mL Any value that reads below 1 8 IU mL should be reported as lt 1 8 IU 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 Direct Renin Assay when the concentrations presented in the following table are below the stated threshold Expected Values Each laboratory should determine ranges for their local population The following ranges were determined using the IDS iSYS Direct Renin Assay and is provided for information only In order to determine the normal ranges for the IDS iSYS Direct Renin assay 244 Caucasian adult subjects collected in the US 18 65 years of age with normal blood pressure systolic diastolic lt 120 80 and normal BMI 18 24 9 were analysed using the IDS iSYS Direct Renin assay Samples were taken between 7 10am after overnight fasting upright 30 minutes standing or walking and s
6. d against a commercially available immunoassay for the quantitative determination of Renin following CLSI EP 9A2 Method Comparison and Bias Estimation Using Patient Samples A total of 164 samples selected to represent a wide range of Renin concentrations 2 0 385 IU mL were assayed by each method Linear regression analysis was performed on the comparative data IDS iSYS 1 06 x 0 22 95 CI of the slope and intercept were 1 04 to 1 09 and 1 00 to 0 67 respectively correlation coefficient r squared 0 98 Specificity Analyte Cross Reactivity Renin 100 Pro Renin lt 2 8 Bibliography 1 John W Funder et al Case Detection Diagnosis and Treatment of Patients with Primary Aldosteronism An Endocrine Society Clinical Practice Guideline JCEM September 2008 93 9 2266 3281 2 Wiliams Textbook of Endocrinology 10th Edition Editors Larsen Kronenberg Melmed Polonski Willson 3 Duncan J Campbell Juerg Nussberger Michael Stowasser A H Jan Danser Alberto Morganti Erik Frandsen and Joe Me nard Activity Assays and Immunoassays for Plasma Renin and Prorenin Information Provided and Precautions Necessary for Accurate Measurement Cl Chem 55 5 867 877 2009 4 Caroline Schirpenbach 1 Lysann Seiler Christiane Maser Gluth Felix Beuschlein Martin Reincke and Martin Bidlingmaier Automated Chemiluminescence Immunoassay for Aldosterone during Dynamic Testing Com
7. gender Hypertension can be classified as Primary essential in around 80 of hypertensive patients and Secondary in around the remaining 20 of hypertensive patients Plasma renin measurement is important in stratifying the diagnosis of the two most common forms of secondary hypertension which are Primary Aldosteronism and Renovascular Hypertension Plasma renin evaluation can also help in selecting the most appropriate antihypertensive treatment Method Description The IDS iSYS Direct Renin kit is based on chemiluminescence technology Two monoclonal antibodies against renin are utilised One is labelled with acridinium and the other with biotin Samples are incubated with both labelled antibodies along with buffer A and buffer B Streptavidin coated magnetic particles are 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 renin in the original sample Warnings and Precautions The IDS iSYS Direct Renin kit 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 Limited will not be held responsible for any loss or damage except as required by statute arising out of non compliance with the inst
8. led 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 Direct Renin assay has been standardised against the WHO IS 68 356 To obtain values expressed in pg mL it is necessary to divide the results with the IDS iSYS kit by a factor of 1 67 Calibration Frequency A new calibration is required Each time a new lot of cartridge is loaded onto the system Each time a new lot of trigger or cuvettes is used Device code IS 3400 REF IS 3400 als IDS iSYS Direct Renin immunodiagnosticsyster Instructions for Use IN VITRO DIAGNOSTIC CE When the control values do not fall within the defined ranges When the calibration interval of 14 days has expired After System service Verification of the calibration is automatic and managed by the system Quality Control To ensure validity of results at least three controls with varying levels of Renin should be measured Controls should be tested at or near the beginning of every run containing patient samples and also during calibrations and according to local regulations It is recommended that the controls be routinely run in duplicate Laboratories should test
9. on effects samples calibrators and controls should be measured within 8 hours of being placed on the system Before assay make sure that samples calibrators and controls are at room temperature 20 25 C It is recommended to follow the instructions of the tube manufacturer especially when processing samples in primary tubes The assay sample volume is 190 uL The total sample volume required for a single determination is dependent on the dead volume of the sample tube is use 190 uL dead volume of sample tube Procedure Materials Provided Reagent Cartridge MPT2 Magnetic particles coated with streptavidin in a phosphate buffer with sodium azide as a preservative lt 0 1 1 bottle 2 7mL CONJ Anti renin labelled with an acridinium ester derivative in a phosphate buffer contain bovine protein with sodium azide as a preservative lt 0 1 1 bottle 4 4mL Ab Biot Anti renin labelled with biotin in a phosphate buffer containing bovine protein with sodium azide as a preservative lt 0 1 1 bottle 7 25mL BUF A Equine serum with sodium azide as a preservative lt 0 1 1 bottle 7 25mL BUF B A phosphate buffer containing bovine and mouse proteins with sodium azide as a preservative lt 0 1 1 bottle 7 25mL Calibrators CALA CAL B An equine serum matrix containing renin with sodium azide as a preservative lt 0 1 3 each of 2 concentration
10. parison to Radioimmunoassays with and without Extraction Steps Cl Chem 52 9 1749 1755 2006 IS 3400PLv01 2012 06 08 English mal 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 idsplc 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 idsplc com USA Immunodiagnostic Systems Inc 8425 N 90th Street Suite 8 Scottsdale AZ 85258 Tel 1 480 278 8333 Fax 1 480 836 7437 e mail info us idsplc com www idsplc com Germany Immunodiagnostic Systems GmbH IDS GmbH Mainzer Landstrasse 49 60329 Frankfurt am Main Tel 49 69 3085 5025 Fax 49 69 3085 5125 e mail info de idsplc com www idsplc com France Immunodiagnostic Systems IDS 153 Avenue D Italie 75013 Paris France Tel 0 1 40 77 04 50 Fax 0 1 40 77 04 55 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 Danmark Tel 45 44 84 0091 e mail info nordic idsplc com www idsplc 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
11. r 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 NA 2 87 On board the System 28 days 8 hours Continuous on board stability Sample Collection and Storage The assay should be performed using EDTA plasma samples To avoid cryo activation samples must be collected centrifuged and stored at room temperature Do NOT store plasma at 2 8 C as cryo activation may occur Plasma samples must be stored deep frozen at 20 C If samples are turbid and or contain visible clots they should be centrifuged before testing Samples stored deep frozen at 20 C must be thawed quickly before testing After thawing if samples are turbid and or contain visible clots they should be centrifuged before testing Avoid repeated freeze thaw of samples Do not use severely lipaemic samples Device code IS 3400 IS 3400 IDS iSYS Direct Renin immunodiagnostics Instructions for Use IN VITRO DIAGNOSTIC CE To minimise possible evaporati
12. rdipine HCI 50pg mL 1305 80 78 60 102 78 Lasilix Furosemide BOug mL 1840 80 42 77 158 86 Trypsin 1 5ugm 198 60 61 31 140 7o asmin 100pg mL Human anti Mouse Antibody 30ng mL 3026 so so 26 200 66 HAMA mez o 134 32 309 74 Rheumatoid Factor Rf 1000IU mL 444 5 80 27 6 6 2 37 7 8 5 4 In patients receiving therapy with high biotin dose Recovery i e gt 5 mg day no sample should be taken until at Average recovery in EDTA plasma was 103 9 least 8 hours after the last biotin administration Linearity IS 3400PLv01 2012 06 08 English Page 3 4 Device code IS 3400 REF IS 3400 IDS iSYS Direct Renin immunodiagnosticsystems Instructions for Use IN VITRO DIAGNOSTIC CE Linearity was evaluated based on CLSI EP 6A Evaluation of the Linearity of Quantitative Measurement Procedures A Statistical Approach Samples containing varying concentrations of Renin 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 14 sets of samples covering the range of the assay were measured giving a total of 126 measured dilutions Average Observed Expected Direct Renin values were 94 9 with an r squared of 1 00 defined by linear regression analysis Method Comparison The IDS iSYS Direct Renin Assay was compare
13. ructions provided IS 3400PLv01 2012 06 08 English Page 1 4 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 Calibrators CAL A ICAL B contain sodium azide as preservative gt 0 1 lt 1 w w Xn Harmful Calibrators contain sodium azide gt 0 1 lt 1 w w 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 Various components of this kit contain sodium azide 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 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 for reconstitution methodology Before a new cartridge is loaded onto the system the magnetic particle containe
14. upine lying down for at least 30 minutes n Mean SD Range Upright 123 36 8 uIU mL 22 2 5 3 99 1 Supine 121 24 0 ulU mL 13 5 4 2 59 7 Performance Data Representative performance data are shown obtained at individual laboratories may vary Results Sensitivity The 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 78 blanks and 118 low level samples Analytical Sensitivity 0 6 IU mL LoD 1 8 uIlU mL LoQ 5 0 IU mL Precision Precision was evaluated in accordance with a modified Potentially Interfering Agent Threshold protocol based on CLSI EP 5A2 Evaluation of Precision Concentration Performance of Quantitative Measurement Methods Ten Triglycerides 30mg mL plasma controls were assayed using three lots of reagents in Haemoglobin 250mg dL duplicate twice per day for 20 days on 3 instruments Bilirubin 0 2mg mL Red Blood Cells 0 4 Conceniration n Within run Total Biotin 25nM IU mL CV CV Ae AT sp cv sp cv Beta 2 Microglobulin 50pg mL 163 80 11 70 16 96 Cathepsin B 0 1U mL 173 80 11 66 19 112 Cathepsin a wo ao or ai 16 68 aptopri 50ug mL Renitec Enalapril maleate 50ug mL 239 so 17 31 50 93 Loxen Nica
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