Estradiol III REF SYSTEM
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Estradiol III REF SYSTEM MODULAR ANALYTICS E170 06656021 119 100 cobas e 411 cobas e 601 cobas e 602 For USA: Elecsys Estradiol III Assay . Results are determined via a calibration curve which is instrument•specifically generated by 2-point calibration and a master English curve provided via the reagent barcode or e-barcode. System information Reagents – working solutions For cobas e 411 analyzer: test number 1370 The reagent rackpack is labeled as E2 III. For MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers: Application Code Number 223 M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Intended use Streptavidin-coated microparticles 0.72 mg/mL; preservative. Immunoassay for the in vitro quantitative determination of estradiol in human R1 Anti-estradiol-Ab~biotin (gray cap), 1 bottle, 9 mL: serum and plasma. Two biotinylated monoclonal anti-estradiol antibodies (rabbit) The electrochemiluminescence immunoassay “ECLIA” is intended for use on 2.5 ng/mL and 4.5 ng/mL; mesterolone 130 ng/mL; MESb) buffer Elecsys and cobas e immunoassay analyzers. 50 mmol/L, pH 6.0; preservative. Note : 2+ R2 Estradiol-peptide~Ru(bpy)3 (black cap), 1 bottle, 9 mL: Please note that the catalogue number appearing on the package insert Estradiol derivative, labeled with ruthenium complex 4.5 ng/mL; MES retains only the first 8 digits of the 11-digit Catalogue number: 06656021190 buffer 50 mmol/L, pH 6.0; preservative. for the Estradiol III. The last 3 digits -190 have been replaced by -119 for logistic purposes. b) MES = 2-morpholino-ethane sulfonic acid Precautions and warnings Summary For in vitro diagnostic use. Estrogens are responsible for the development of the secondary female sex characteristics. Together with gestagens they control all the important female Exercise the normal precautions required for handling all laboratory reagents. reproductive processes. Disposal of all waste material should be in accordance with local guidelines. The biologically most active estrogen is 17ß-estradiol. This is a steroid Safety data sheet available for professional user on request. hormone having a molecular weight of 272 daltons. For USA: For prescription use only. Estrogens are produced primarily in the ovary (follicle, corpus luteum), but Avoid foam formation in all reagents and sample types (specimens, small quantities are also formed in the testes and in the adrenal cortex. calibrators and controls). During pregnancy, estrogens are mainly formed in the placenta. About 98 % Reagent handling of estradiol is bound to transport proteins (SHBG = sex hormone binding The reagents in the kit have been assembled into a ready-for-use unit that globulin).1 cannot be separated. Estrogen secretion is biphasic during the menstrual cycle. The determination All information required for correct operation is read in from the respective of estradiol is utilized clinically in the elucidation of fertility disorders in the reagent barcodes. hypothalamus-pituitary-gonad axis, gynecomastia, estrogen-producing Storage and stability ovarian and testicular tumors and in hyperplasia of the adrenal cortex. Further clinical indications are the monitoring of fertility therapy and Store at 2- 8 °C. determining the time of ovulation within the framework of in vitro fertilization Do not freeze. (IVF).2,3,4 Store the Elecsys reagent kit upright in order to ensure complete availability The Elecsys Estradiol III assay employs a competitive test principle using two of the microparticles during automatic mixing prior to use. monoclonal antibodies specifically directed against 17ß-estradiol. Stability: Endogenous estradiol released from the sample by mesterolone competes unopened at 2-8 °C up to the stated expiration date with the added estradiol derivative labeled with a ruthenium complexa) for the binding sites on the biotinylated antibody. after opening at 2-8 °C 12 weeks 2+ on the analyzers 8 weeks a) Tris(2,2'-bipyridyl)ruthenium(II)-complex(Ru(bpy)3 ) Test principle Specimen collection and preparation Competition principle. Total duration of assay: 18 minutes. Only the specimens listed below were tested and found acceptable. 1st incubation: By incubating the sample (25 µL) with two estradiol- Serum collected using standard sampling tubes or tubes containing specific biotinylated antibodies, immunocomplexes are formed, the separating gel. amount of which is dependent upon the analyte concentration in the Li-heparin, K2-EDTA and K3-EDTA plasma as well as plasma separation sample. tubes. 2nd incubation: After addition of streptavidin-coated microparticles and Criterion: Slope 0.9-1.1 + intercept within < ± 10 pg/mL + coefficient of an estradiol derivative labeled with a ruthenium complex, the still-vacant correlation ≥ 0.95. sites of the biotinylated antibodies become occupied, with formation of an For individual samples recovery within 70-130 % of serum value antibody-hapten complex. The entire complex becomes bound to the > 100 pg/mL, recovery of ± 20 pg/mL of serum value ≤ 100 pg/mL. solid phase via interaction of biotin and streptavidin. Stable for 12 hours at 20-25 °C, 2 days at 2-8 °C, 6 months at -20 °C. The reaction mixture is aspirated into the measuring cell where the Freeze only once. microparticles are magnetically captured onto the surface of the The sample types listed were tested with a selection of sample collection electrode. Unbound substances are then removed with tubes that were commercially available at the time of testing, i.e. not all ProCell/ProCell M. Application of a voltage to the electrode then induces available tubes of all manufacturers were tested. Sample collection systems chemiluminescent emission which is measured by a photomultiplier. from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes 2016-11, V 4.0 Can English 1 / 5 Estradiol III (sample collection systems), follow the instructions of the tube manufacturer. GC/MS (isotope dilution-gas chromatography/mass spectrometry).5 Centrifuge samples containing precipitates and frozen samples before Every Elecsys reagent set has a barcoded label containing specific performing the assay. information for calibration of the particular reagent lot. The predefined master Do not use heat-inactivated samples. curve is adapted to the analyzer using the relevant CalSet. Do not use samples and controls stabilized with azide. Calibration frequency: Calibration must be performed once per reagent lot Ensure the samples, calibrators and controls are at 20-25 °C prior to using fresh reagent (i.e. not more than 24 hours since the reagent kit was measurement. registered on the analyzer). Renewed calibration is recommended as follows: Due to possible evaporation effects, samples, calibrators and controls on the . after 1 month (28 days) when using the same reagent lot analyzers should be analyzed/measured within 2 hours. after 7 days (when using the same reagent kit on the analyzer) Materials provided . as required: e.g. quality control findings outside the defined limits See “Reagents – working solutions” section for reagents. Quality Control Materials required (but not provided) For quality control, use PreciControl Universal. REF 06656048190, Estradiol III CalSet, for 4 x 1 mL In addition, other suitable control material can be used. REF 11731416190, PreciControl Universal, for 4 x 3 mL Controls for the various concentration ranges should be run individually at . REF 11731416160, PreciControl Universal, for 4 x 3 mL (for USA) least once every 24 hours when the test is in use, once per reagent kit, and . REF 03609987190, Diluent MultiAssay, 2 x 16 mL sample diluent following each calibration. General laboratory equipment The control intervals and limits should be adapted to each laboratory’s . MODULAR ANALYTICS E170 or cobas e analyzer individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values Accessories for cobas e 411 analyzer: fall outside the defined limits. REF 11662988122, ProCell, 6 x 380 mL system buffer Follow the applicable government regulations and local guidelines for quality . REF 11662970122, CleanCell, 6 x 380 mL measuring cell cleaning control. solution Calculation . REF 11930346122, Elecsys SysWash, 1 x 500 mL washwater additive The analyzer automatically calculates the analyte concentration of each . REF 11933159001, Adapter for SysClean sample (either in pmol/L, pg/mL, ng/L or additionally in nmol/L with . REF 11706802001, AssayCup, 60 x 60 reaction cups MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers). REF 11706799001, AssayTip, 30 x 120 pipette tips Conversion factors: pmol/L x 0.272 = pg/mL (ng/L) . REF 11800507001, Clean-Liner pg/mL x 3.67 = pmol/L Accessories for MODULAR ANALYTICS E170, cobas e 601 and pg/mL x 0.00367 = nmol/L cobas e 602 analyzers: Limitations – interference . REF 04880340190, ProCell M, 2 x 2 L system buffer The assay is unaffected by icterus (bilirubin ≤ 1129 µmol/L or ≤ 66 mg/dL), . REF 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning solution hemolysis (Hb ≤ 0.621 mmol/L or ≤ 1.0 g/dL), lipemia (Intralipid . REF 03023141001, PC/CC-Cups, 12 cups to prewarm ProCell M and ≤1000 mg/dL) and biotin (≤ 147 nmol/L or ≤ 36 ng/mL). CleanCell M before use Criterion: Recovery within ± 10 % of initial value. REF 03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run Samples should not be taken from patients receiving therapy with high biotin finalization and rinsing during reagent change doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin . REF 03004899190, PreClean M, 5 x 600 mL detection cleaning solution administration. No interference was observed from rheumatoid factors up to a concentration . REF 12102137001, AssayTip/AssayCup, 48 magazines x 84 reaction cups or pipette tips, waste bags of 1200 IU/mL. In vitro tests were performed on 17 commonly used pharmaceuticals. No . REF 03023150001, WasteLiner, waste bags interference with the assay was found.