Précautions d`utilisation du produit :
Contents
1. Triglycerides 500 mg dl Bilirubin 5 mg dl Haemoglobin 40 mg dl Biotin 300 nmol HAMA 500 ng ml Rheumatoid Factor 1500 IU ml Red Blood Cells 0 2 Vitamin DBP 2000 ng ml Expected Values There is no universal agreement on the optimal concentration of 250HD Ranges should be based on clinical decision values that apply to both sexes of all ages rather than population based reference ranges for 25OHD In the case of 25OHD there are also many other factors that may influence values diet time of day sun exposure season of year geographic location a age use of sunscreen and or protective clothing and skin pigmentation 11 24 From a review of the available literature the recommendations for 25OHD levels are shown below Vitamin D Status Range ng ml Range nmol l Deficient lt 20 lt 50 Insufficient 20 lt 30 50 lt 75 Sufficient 30 100 75 250 IS 2700SPL V01 2013 11 07 GB English Page 3 5 Performance Data Representative performance data are shown Results obtained at individual laboratories may vary Measurement Range Reportable Range The IDS iSYS 250HD Assay reportable range is 7 125 ng ml 18 313 nmol l Any value that reads below 7 ng ml 18 nmol l should be reported as lt 7 ng ml lt 18 nmol l Sensitivity The limit of blank LOB limit of detection LoD and limit of quantitiation LoQ were determined with guidance from CLSI EP17 A 0 6 ng ml 1 5 nmol l 2 42. each concentrations screen or printed is produced as per the user settings To convert results to SI units nmol l ng ml x 2 5 The IDS iSYS 250HD assay uses a 4 parameter logistic curve fit 4PL to calculate the 250OHD concentrations Dilution Samples with 25OHD 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 Heterophilic antibodies in human serum can react with reagent immunoglobulins interfering with in vitro immunoassays Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed 4 Donot use samples showing sign of haemolysis Haemoglobin at concentrations gt 40 mg dL might cause to falsely depressed values 5 The following substances do not interfere in the IDS iSYS 250HD assay when the concentrations presented in the following table are below the stated threshold Potentially Interfering Threshold Concentration
3. fr idsplc com www idsplc com Scandinavia Immunodiagnostic Systems Nordic a s IDS Nordic a s International House Center Boulevard 5 2300 K benhavn S Denmark 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 be idsplc com www idsplc com Device code IS 2700S
4. ng ml 6 0 nmol l 7 0 ng ml 17 5 nmol l Precision Precision was evaluated in accordance with a modified protocol based on CLSI EP 5A2 Evaluation of Precision Performance of Quantitative Measurement Methods 6 serum samples were assayed using 3 lots of reagents in duplicate twice per day for 20 days n 80 replicates per sample on 3 systems Mean Within run Total ng ml CV CV Mean bii run Ki nmol l CV CV 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 25 hydroxyvitamin D 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 The linear regression of the Observed concentrations versus the expected concentrations is Observed 1 03 x Expected 0 7 ng ml Observed 1 03 x Expected 1 8 nmol l Regression coefficient R 0 99 Device code IS 2700S IS 2700S o o IDS iSYS 25 Hydroxy Vitamin D gt ej IN VITRO DIAGNOSTIC CE Traceability The IDS iSYS 25OHDS assay is aligned to the isotope dilution liquid chromatography tandem mass spectrometry ID LC MS MS 25 OH D Reference Method Procedure RMP which was used in assigning the target value for the VDSP samples The ID LC MS MS RMP is traceable to the
5. 50HD and sodium azide as preservative lt 0 1 1 each of 2 concentration levels 2 5 mL Mini CD Contains the IFU for IDS iSYS 250HD reagents and CRY files Materials Required But Not Provided IDS iSYS Multi Discipline Automated System 1IS 310400 IDS iSYS 25OHD Control Set S 27308 IDS iSYS Cuvettes Cube IS CC100 IDS iSYS System Liquid IS CS100 IDS iSYS Wash Solution IS CW100 IDS iSYS Triggers Set IS CT100 IDS iSYS Cartridge Check System IS 6010 IDS iSYS Sample Cups 500 uL IS SC105 Materials Available on Request Certificate of Analysis Assay Procedure Reagent Cartridge The reagents provided in the kit are ready to use Before a new cartridge is loaded onto the System mix the magnetic particles container by a brisk rotation motion This will resuspend the magnetic particles that have settled during shipment and storage Ensure that there is no foam formation in the cartridge reagents IS 2700SPL V01 2013 11 07 GB English Page 2 5 The barcode is read when the cartridge is loaded on the reagent tray If the label cannot be read by the System s barcode reader a manual procedure exists to enter the barcode data see the IDS iSYS User Manual Once the cartridge is on the reagent tray the System automatically performs the mixing of magnetic particles to maintain homogeneity Load the cartridge on the reagent tray and wait for at least 40 minutes before starting the assay If the cartridge is removed
6. Hydroxide Solution Solution contains sodium hydroxide lt 0 5M 0 5 lt C lt 2 0 EYE Irrit 2 Skin Irrit 2 H315 Causes skin irritation H319 Causes serious eye irritation P280 Wear protective gloves protective clothing eye protection face protection Shelf Life and Storage of Reagents Store the cartridge and 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 E al To the expiry date To the expiry date Ae ue at 21 Days To the expiry date On board the 21 Daye Continuous on board stability Sample Collection and Storage The assay should be performed using serum standard sampling tubes or tubes containing serum separating gel Serum Samples Storage Stability Duration Room temperature 2 8 C Freeze thaw cycles For the IDS iSYS 250HD assay the following tube types gave the following correlations e Serum Separator Tubes Y 1 00 x serum 0 4 ng ml R 0 97 Y 1 00 x serum 1 0 nmol l R 0 97 e Lithium Heparin Plasma Tubes Y 0 84 x serum 2 7 ng ml R 0 99 Y 0 84 x serum 6 8 nmol l R 0 99 e Sodium Heparin Plasma Tubes Y 0 83 x serum 2 1 ng ml R 0 99 Y 0 83 x serum 5 3 nmol l R 0 99 Device code IS 2700S IS 2700S o o IDS iSYS 25 Hydroxy Vitamin D gt ej immuno IN VITRO DIAGNOSTIC cE NOTE i EDTA plasma cannot be use
7. IS 2700S o o IDS iSYS 25 Hydroxy Vitamin D gt ej immuno IN VITRO DIAGNOSTIC cE Intended Use For In Vitro Diagnostic Use The IDS iSYS 25 Hydroxy Vitamin pS Assay IDS iSYS 250HD is intended for the quantitative determination of 25 hydroxyvitamin D 25OHD and other hydroxylated metabolites in human serum on the IDS iSYS Multi Discipline Automated System System Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population Summary and Explanation Vitamin D is a commonly used collective term for a family of closely related seco steroids Upon exposure to sunlight 7 dehydrocholesterol located deep in the actively growing layers of the epidermis undergoes photolytic cleavage of the B ring to yield pre vitamin D3 which is isomerised to vitamin Ds cholecalciferol Vitamin Dg and vitamin D ergocalciferol may also be obtained by dietary supplementation or from a limited number of foods Vitamin D is metabolised in a similar way to vitamin D3 Vitamin D is stored in adipose tissue and enters the circulation bound to vitamin D binding protein VDBP and albumin In the liver vitamin D is hydroxylated to give 25OHD which also circulates as a complex with VDBP A small proportion of the 25OHD is further hydroxylated in the kidney under direct regulation by parathyroid hormone and ionised calcium levels to
8. National Institute of Standards and Technology Standard Reference Material SRM 2972 gt 89 samples in the range of 7 3 to 145 1 ng ml 18 3 to 362 8 nmol by LC MS MS were used to further assess the IDS iISYS 25OHD traceability against an LC MS MS assay which is in turn standardised against the NIST SRM 2972 and ID LC MS MS RMP through VDSP samples The relationship between the IDS iSYS y and the LC MS MS x is described using Passing Bablok regression IDS iSYS 0 98 x LC MS MS 1 4 ng ml IDS iSYS 0 98 x LC MS MS 3 5 nmol l 95 Cl of the slope 0 89 to 1 08 95 Cl of the intercept 1 1 to 4 4 ng ml 2 8 to 11 0 nmol l Pearson correlation coefficient r 0 93 Method Comparison The IDS iSYS 250HD assay was compared against a recognised automated chemiluminescent immunoassay CLIA for the quantitative determination of 25OHD following CLSI EP 9A2 Method Comparison and Bias Estimation Using Patient Samples A total of 333 samples selected to represent a wide range of 250HD concentrations 7 0 102 7 ng ml 17 5 256 8 nmol l by CLIA was assayed by each method Passing Bablok regression analysis was performed on the comparative data IDS iSYS 0 98 x CLIA 0 6 ng ml IDS iSYS 0 98 x CLIA 1 5 nmol l 95 Cl of the slope 0 94 to 1 03 95 Cl of the intercept 0 9 to 1 8 ng ml 2 3 to 4 5 nmol l Pearson correlation coefficient r 0 95 Specificity Cross Reactivity 25 hydr
9. d with the IDS iSYS 250HD assay Specimens should be separated as soon as possible after collection For long term storage store at 20 C or below Avoid repeated freeze thaw of samples Samples containing particulate matter must be centrifuged before performing the assay iv Do not use heat inactivated samples v To minimise possible evaporation effects samples calibrators and controls should be measured within 2 5 hours after being placed on the System vi Some sample collection tubes that are commercially available might affect the results of testing in particular cases vii It is recommended to follow the instructions of the tube manufacturer especially when processing samples in primary tubes Procedure Materials Provided Reagent Cartridge MPV1 Magnetic particles coated with 250HD in phosphate buffer containing methanol gt 3 but lt 10 with sodium azide as preservative lt 0 1 1 bottle 2 0 mL CONJ Anti 250HD sheep polyclonal antibody labelled with an acridinium ester derivative in buffer containing bovine sheep rabbit and mouse proteins with sodium azide as preservative lt 0 1 1 bottle 10 1 mL NaOH odium hydroxide solution lt 0 5 M 1 bottle 5 2 mL BUF Assay buffer containing proprietary displacing compounds methanol gt 10 but lt 20 and sodium azide as preservative lt 0 1 1 bottle 26 mL ee rke Calibrators Equine serum buffer matrix containing 2
10. form the biologically active calcitropic hormone 1 25 dihydroxyvitamin D Further hydroxylation and metabolism of vitamin D produces compounds that are water soluble and readily excreted Hepatic vitamin D 25 hydroxylase activity is not tightly regulated and changes in cutaneous production of vitamin D3 or ingestion of vitamin D D3 or Ds result in changes in circulating levels of 250HD Serum concentration of 25OHD is considered to be the most reliable measure of overall vitamin D status and thus can be used to determine whether a patient is vitamin D sufficient Method Description The assay is based on chemiluminescence technology 10uL of samples are subjected to a pre treatment step to denature the VDBP The treated samples are then neutralised in assay buffer and a specific anti 25OHD antibody labelled with acridinium is added Following an incubation step magnetic particles linked to 250HD are added Following a further incubation step the magnetic particles are captured using a magnet After a washing step and addition of trigger reagents the light emitted by the acridinium label is inversely proportional to the concentration of 25OHD in the original sample Warnings and Precautions The IDS iSYS 250HD 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 no
11. from the reagent tray store the cartridge vertically at 2 8 C in the dark Calibrators The IDS iSYS 25OHD calibrators are ready to use Leave the calibrators at room temperature for 10 minutes and gently mix the vials by hand Avoid the formation of foam Pipette approximately 200 uL of calibrators into sample cups and place onto the System NOTE i DISCARD the material in the sample cups after use li DO NOT return material to the calibrator vials System Calibration Two 25OHD calibrators are required to perform the adjustment of the master curve These calibrators are supplied with the kit and calibrators from another lot must not be used All levels of IDS iSYS 25OHD control MUST be measured in duplicate at the same time as the calibrators to perform a master curve adjustment Use calibrators A and B to adjust the master curve to the reagents on board the System Check for the presence of an IDS iSYS 25OHD cartridge on the reagent tray and the availability of the cartridge master curve in the database If the data for the lot of calibrators are not available on board the System load the data using the mini CD provided with the kit During calibration the calibrators are measured in triplicate RLU CVs of gt 7 will result in a failed calibration One replicate may be removed to meet the calibration requirements All levels of 25OHD control must be measured in duplicate to calibrate the System Verify and approve
12. l practice guideline J Clin Endocrinol Metab 2011 Jul 96 7 191 1 30 25 Sempos CT Vesper HW Phinney KW Thienpont LM Coates PM Vitamin D Standardization Program VDSP Vitamin D status as an international issue national surveys and the problem of standardization Scand J Clin Lab Invest Suppl 2012 Apr 243 32 40 26 Thienpont LM Stepman HC Vesper HW Standardization of measurements of 25 hydroxyvitamin D3 and D2 Scand J Clin Lab Invest Suppl 2012 Apr 243 41 9 seal 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 ukK 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
13. oassays Clin Chem 1988 34 27 33 Holick MF Sunlight and vitamin D for bone health and prevention of autoimmune diseases cancers and cardiovascular disease Am J Clin Nutr 2004 80 1678S 1688S Webb AR Kline L Holick MF Influence of season and latitude on the cutaneous synthesis of vitamin Ds exposure to winter sunlight in Boston and Edmonton will not promote vitamin D3 synthesis in human skin J Clin Endocrinol Metab 1988 67 373 378 Holick MF Matsuoka LY Wortsman J Age vitamin D and solar ultraviolet Lancet 1989 ii 1104 1105 Matsuoka LY Ide L Wortsman J et al Sunscreens suppress cutaneous vitamin D3 synthesis J Clin Endocrinol Metab 1987 64 1165 1168 Salih FM Effect of clothing varieties on solar photosynthesis of previtamin D3 an in vitro study Photodermatol Photoimmunol Photomed 2004 20 53 58 Clemens TL Henderson SL Adams JS Holick MF Increased skin pigment reduces the capacity of skin to synthesize vitamin D3 Lancet 1982 9 74 76 KDOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Children With Chronic Kidney Disease http www kidney org PROFESSIONALS kdogi guidelines _p edbone quides htm Freeman RG Vitamin D the sunshine hormone How and when to treat deficiencies Menopausal Medicine 2009 17 2 S8 S11 Bruce W Hollis and Carol L Wagner Assessment of dietary vitamin D requirements during pregnancy and lactation Am J Clin Nutr 2004 79 717 26 B Dawson Hughes Ser
14. oxyvitamin D3 Cholecalciferol Ds Ergocalciferol D2 3 epi 25 OH Ds Specificity for 25 hydroxyvitamin D2 was determined from analysis of samples from patients supplemented with ergocalciferol vitamin Dz A total of 25 samples containing a wide range of 250OHD gt 2 concentrations 2 0 120 4 ng ml 5 0 301 0 nmol l by LC MS MS was assayed by each method Passing Bablok regression analysis was performed on the comparative data IDS iSYS 0 95 x LC MS MS 0 1 ng ml IDS iSYS 0 95 x LC MS MS 0 3 nmol l Pearson correlation coefficient r 0 90 IS 2700SPL V01 2013 11 07 GB English Page 4 5 Device code IS 2700S IS 2700S o IDS iSYS 25 Hydroxy Vitamin D gt 20 IS 2700SPL V01 2013 11 07 GB English ej IN VITRO DIAGNOSTIC CE Bibli 1 ography Holick MF Vitamin D importance in the prevention of cancers type 1 diabetes heart disease and osteoporosis Am J Clin Nutr 2004 79 362 371 Dusso AS Vitamin D Am J Physiol Renal Physiol 2005 289 1 F8 28 Reichel H Koeffler HP Norman AW The role of the vitamin D endocrine system in health and disease N Engl J Med 1989 320 981 991 Holick MF Vitamin D Photobiology Metabolism etc In Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism American Society for Bone and Mineral Research 1996 3rd Ed Lippincott Raven Philadelphia 74 81 Boscato LM Stuart MC Heterophilic antibodies a problem for all immun
15. t 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 IS 2700SPL V01 2013 11 07 GB English Page 1 5 Magnetic Particles Magnetic Particles contain methanol at gt 3 but lt 10 Acute Tox 4 STOT SE 1 EYE Irrit 2 Skin Irrit 2 H302 Harmful if swallowed H315 Causes skin irritation H319 Causes serious eye irritation H370 Causes damage to organs P280 Wear protective gloves protective clothing eye protection face protection Assay Buffer Assay buffer contains methanol at gt 10 but lt 20 Acute Tox 4 STOT SE 1 EYE Irrit 2 Skin Irrit 2 H302 Harmful if swallowed H315 Causes skin irritation H319 Causes serious eye irritation H370 Causes damage to organs P280 Wear protective gloves protective clothing eye protection face protection Sodium
16. the calibration according to the calibration status displayed in the calibration windows Discard the calibrators and controls from the sample tray after use Calibration Frequency A new calibration is required e Each time a new lot of cartridges is loaded onto the System Each time a new lot of triggers or cuvettes are used e When the control values do not fall within the defined ranges e When the calibration interval of 14 days has expired e After System service Verification of the calibration is automatic and managed by the IDS iSYS System Quality Control The IDS iSYS 250HD Control Set IS 2730S is required for quality control Controls should be tested minimally at least once every 24 hours when the test is in use and during every calibration in conformance with local state and or federal regulations or accreditation requirements and your laboratory s quality procedure It is recommended that labs testing the specimens in multiple shifts in a day should measure the controls during each shift Refer to the IDS iSYS 250HD Control Set Instructions for Use for preparation and handling procedures Determination of Sample 25OHD levels Process samples according to the IDS iSYS User Manual Device code IS 2700S IS 2700S o o IDS iSYS 25 Hydroxy Vitamin D gt ej immuno IN VITRO DIAGNOSTIC cE Calculation of Results The 250OHD concentration of each sample is calculated automatically The display of
17. um 25 hydroxyvitamin D and functional outcomes in the elderly Am J Clin Nutr 2008 88 suppl 537S 40S WB Grant MF Holick Benefits and requirements of vitamin D for optimal health a review Altern Med Rev 2005 10 2 94 111 Heaney RP The vitamin D requirement in health and disease J Steroid Biochem Mol Biol 2005 97 13 9 S J Whiting M S Calvo Dietary recommendations for vitamin D critical need for functional endpoints to establish an estimated average requirement EAR J Nutr 135 2 2005 304 309 Hollis BW Circulating 25 hydroxyvitamin D levels indicative of vitamin D sufficiency implications for establishing a new effective dietary intake recommendation for vitamin D J Nutr 2005 135 31 7 322 Cannell J Hollis B Zasloff M Heaney R Diagnosis and treatment of vitamin D deficiency Expert Opin Pharmacother 2008 9 107 118 Page 5 5 immuno 21 Heaney RP Functional indices of vitamin D status and ramifications of vitamin D deficiency Am J Clin Nutr 2004 80 6 suppl 1706S 1709S 22 Holick MF The vitamin D epidemic and its health consequences J Nutr 2005 135 2739S 2748S 23 Holick MF High prevalence of vitamin D inadequacy and implications for health Mayo Clin Proc 2006 81 353 373 24 Holick MF Binkley NC Bischoff Ferrari HA Gordon CM Hanley DA Heaney RP Murad MH Weaver CM Endocrine Society Evaluation treatment and prevention of vitamin D deficiency an Endocrine Society clinica
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