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Cortisol on Architect i1000 I. PRINCIPLE The ARCHITECT Cortisol assay is a delayed one-step immunoassay for the quantitative determination of cortisol in human serum, plasma, or urine using Chemiluminescent
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Cortisol on Architect i1000 I. PRINCIPLE The ARCHITECT Cortisol assay is a delayed one-step immunoassay for the quantitative determination of cortisol in human serum, plasma, or urine using Chemiluminescent Microparticle Immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex. Sample and anti-cortisol coated paramagnetic microparticles are combined to create a reaction mixture. Cortisol present in the sample binds to the anti-cortisol coated microparticles. After incubation, cortisol acridium-labeled conjugate is added to the reaction mixture. The cortisol acridium-labeled conjugate competes for the available binding sites on the anti-cortisol coated microparticles. Following a second incubation, the microparticles are washed, and pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured in relative light units (RLUs). An inverse relationship exists between the amount of cortisol in the sample and the RLUs detected by the ARCHITECT i System optics. II. POLICY/SCOPE This is intended for the China Basin Chemistry section of the Clinical Laboratories and intended for testing by licensed Clinical Laboratory Scientists and Clinical Laboratory staff. III. SPECIMEN REQUIRMENTS a. Serum or plasma from SST, red, or green top tubes (sodium/lithium heparin). Any other tube type is NOT acceptable. b. Allow complete clot formation to take place in serum samples prior to centrifugation. c. Samples should be free of fibrin, red blood cells, or other particulate matter. Centrifuge samples containing fibrin, red blood cells, or particulate matter. d. Samples should be free of bubbles. e. Specimen storage and stability: i. If testing will be delayed more than 8 hours, remove serum or plasma from the clot, serum separator or red blood cells. ii. Serum or plasma may be stored for up to 14 days at 2-8 C. iii. Serum or plasma stored at -10 C or colder is stable for 30 days. iv. Multiple freeze-thaw cycles of samples should be avoided. Samples must be mixed thoroughly after thawing by low speed vortexing or by gentle inversion and centrifuged prior to use to remove red blood cells or particulate matter to ensure consistency in the results. IV. EQUIPMENT, REAGENTS, AND SUPPLIES a. ARCHITECT Cortisol Reagent Kit (100 tests), Catalog # 8D15-25 i. Storage and Stability: 1. Store reagents at 2-8 C. 2. Unopened: Stable until the expiration date on the carton. 3. On-board: Stable for a maximum of 30 days. ii. Preparation: 1. Before loading the reagent kit on the system for the first time, gently invert the microparticle bottle 30 times or until all microparticles have been resuspended. NOTE: If the microparticles do not resuspend, DO NOT USE. 2. Once the microparticles are resuspended, remove caps from all reagent bottles and discard. Wearing clean gloves remove septums from the bag, squeeze to check the each opening, and then carefully snap the septum onto the top of the each reagent bottle. V. WARNINGS AND PRECAUTIONS Caution: This product requires the handling of human specimens. It is recommended that all human sourced materials are considered potentially infectious and be handled in accordance with the OSHA Standard on Bloodborne Pathogens. Appropriate biosafety practices should be used for materials that contain or are suspected of containing infectious agents. VI. CALIBRATION a. ARCHITECT Cortisol Calibrators, Catalog # 08D15-02 i. To obtain the recommended volume requirements for the ARCHITECT Cortisol Calibrators, hold the bottles vertically and dispense 6 drops of each calibrator into each respective sample cup. b. Six-point calibration is performed: i. Every 60 days ii. When changing lot numbers of primary reagent packs. iii. When quality control results are repeatedly out of range. c. Preparation and Storage i. Unopened: Store at -20 C and stable until expiration date on package. ii. Thawed/Opened: Store 2-8 C and stable for 90 days after thaw. iii. Preparation: Thaw completely at room temperature for minutes. Prior to use, mix thoroughly by inversion 5-10 times. After each use, immediately return thawed calibrators to 2-8 C. d. Refer to Architect i2000 Operating Procedure for instructions on checking calibration status, performing calibration, and reviewing calibration data. VII. QUALITY CONTROL a. BioRad Immunoassay Plus Controls Level 1 and Level 3. i. Preparation: Reconstitute with 5.0 ml of Type 1 deionized water. ii. Stability: 7 days when stored at 2-8 C. b. See posted QC chart for acceptability limits. c. Frequency: i. Analyze all levels of QC on each day that samples are analyzed. ii. Analyze all levels of QC every time a two-point calibration is performed. iii. Analyze all levels of QC on every primary reagent pack used for sample analysis. d. Refer to Architect i1000 Operating Procedure for instructions on programming QC on the instrument. VIII. PROCEDURE Refer to Architect i1000 Operating Procedure for instructions on scheduling and loading patient samples. IX. RESULTING/REPORTABLE RANGE a. Analytical Measuring Range (AMR) i. The AMR for Abbott Architect Cortisol assay is 1 to 60 ug/dl. b. Reportable Range i. The reportable range for Abbott Architect Cortisol assay is 1 ug/dl to dilute until a result is acheived. ii. Values below 1 ng/ml are reported as 1 ug/dl. iii. Results are reported as whole numbers. c. Dilutions i. Samples with cortisol levels greater than 60 ug/dl should be programmed to run an onboard 1:2 dilution that will automatically calculate the concentrations of the diluted sample. ii. A manual dilution may be performed for samples with cortisol levels 120 ug/dl. Suggested manual dilution is 1:4. To perform a 1:4 dilution, add 50 µl of the patient sample to 150 µl of ARCHITECT Cortisol Calibrator A. iii. Ensure that results are mathematically corrected for dilution. iv. Refer to Architect i1000 Operating Procedure for instructions on ordering dilutions. X. EXPECTED VALUES Adult Reference Range AM (before 10am) 4 19 ug/dl PM (after 5pm) 3 17 ug/dl Reference range adopted from vendor performed studies and verified by running lab personnel. Pediatric Reference Range Age Range 2-14 days days 1 year year - 9 years 14 years 17 years years 19 years 4 18 Pediatric reference ranges adopted from CALIPER Pediatric Reference Interval study performed on random samples using the Abbott Architect i2000 assay. Morning samples gave results approximately 10% higher than afternoon samples. Bailey et al. Clinical Chemistry 59: (2013) XI. LIMITATIONS OF PROCEDURE a. Due to the diurnal variation of cortisol levels in normal subjects, all serum/plasma cortisol measurements should be referenced to the time of day of sample collection. b. Patients receiving fludrocortisone, prednisolone or prednisone (which is converted to prednisolone in vivo) may show artificially elevated cortisol values due to cross-reactivity. c. If the cortisol results are inconsistent with clinical evidence, additional testing is suggested to confirm the result. d. For diagnostic purposes, results should be used in conjunction with other data; e.g., symptoms, results of other thyroid tests, clinical impressions, etc. e. Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (HAMA). Such specimens may show either falsely elevated or depressed values when tested with assay kits which employ mouse monoclonal antibodies. Additional information may be required for diagnosis. f. Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or animal serum products can be prone to this interference and anomalous values may be observed. Additional information may be required for diagnosis. g. The concentration of cortisol in a given specimen, determined with assays from different manufacturers, can vary due to differences in assay methods, calibration, and reagent specificity. XII. PERFORMANCE CHARACTERISTICS a. SPECIFICITY/INTERFERENCES i. The specificity of the ARCHITECT Cortisol assay was determined by studying the crossreactivity of compounds whose chemical structure or concurrent usage may potentially interfere with the ARCHITECT Cortisol assay. Specificity of the assay was determined by spiking each compound into human serum specimens with cortisol levels spiked between 11.4 and 12.0 µg/dl. ii. Potential interference in the ARCHITECT Cortisol assay from the following compounds is designed to be 15% at the levels indicated. A study based on guidance from the CLSI Protocol EP7-A223 was performed for the ARCHITECT Cortisol assay. Serum specimens with cortisol levels between 5.1 and 34.2 µg/dl and urine specimens with cortisol levels between 4.6 and 37.9 µg/dl were supplemented with the following potentially interfering compounds. The average amount of interference observed during the study ranged from -7.8% to 13.2%. b. SENSITIVITY i. The ARCHITECT Cortisol assay has an analytical sensitivity of 1 ug/dl. Analytical sensitivity is defined as the concentration at two standard deviations from the mean RLU value of the ARCHITECT Cortisol Calibrator Level A (0.0 ug/dl), and represents the lowest measureable concentration of cortisol that can be distinguished from zero. c. PRECISION i. Intra-Precision study performed with BioRad Immunoassay Plus Controls Lot 40311, Control CL1 CL3 Criteria 10% 10% Results 2.2% 0.9% ii. Inter-Precision study performed with BioRad Immunoassay Plus Controls Lot 40311, Control CL1 CL3 Criteria 10% 10% Results 3.1% 2.5% d. METHOD COMPARISON i. Laboratory performed study using 62 patient samples comparing Siemens Centaur XP results to the Architect i1000 results. Slope R value Mean Bias Criteria % Results % XIII. TECHNICAL NOTES (N/A) XIV. ALTERNATE METHODS Architect i2000 (S/N isr 06421) can be used if Architect i1000 is not operational. XV. REFERENCES a. Abbott ARCHITECT System Cortisol Package Insert, JL840819/R07
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