ICT (Na +, K +, Cl ) Sample Diluent

Transcription

1 ICT (Na +, K +, Cl ) Sample Diluent 2P32-11 and 2P /R1 ICT (Na +, K +, Cl ) Sample Diluent This package insert contains information to run the ICT Sodium, Potassium, and assays on the c Systems. NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Customer Support United States: Canada: International: ABBOTT (English speaking customers) (French speaking customers) Call your local Abbott representative Symbols in Product Labeling Calibrator High Reagent 1 Calibrator Low Concentration Contents of kit Authorized Representative in the European Community ICT Cleaning Fluid ICT Lyophilized Cleaning Solution Ingredients In vitro diagnostic medical device Catalog number/list number Serial number Calibrator High Calibrator Low Manufacturer Consult instructions for use Temperature limitation Use by/expiration date Batch code/lot number October Abbott Laboratories 1

2 NAME ICT (Na +, K +, Cl ) Sample Diluent INTENDED USE The c Systems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine. SUMMARY AND EXPLANATION OF TEST Sodium is the major cation of extracellular fluid; it plays an essential role in the normal distribution of water and in the maintenance of osmotic pressure in extracellular fluid compartments. Decreased levels of sodium may be caused by an excessive use of diuretics, prolonged vomiting, a decrease in the intake of sodium in the diet, and metabolic acidosis. Increased levels of sodium may be found in Cushing s syndrome, severe dehydration, or in high levels of salt intake without an adequate supply of water. 1 Potassium is the major intracellular cation. The concentration of potassium in the erythrocytes is approximately 23 times the concentration in plasma. For this reason, only unhemolyzed samples must be used. Decreased levels of extracellular potassium are characterized by weakness in the muscles, irritability, paralysis, accelerated heartbeat, and eventually cardiac arrest, and may be caused by a poor intake of potassium in the diet, by a redistribution of extracellular potassium, and by an increased loss of body fluids rich in potassium. 1 Abnormally elevated levels of extracellular potassium produce mental confusion, general weakness, numbness, flaccid paralysis in the extremities, a slowed heart rate, and eventually collapse of the peripheral vascular system and cardiac arrest. Causes of increased potassium levels may be linked to inappropriate intravenous therapy, dehydration, shock, diabetic ketoacidosis, and severe burns. 1 is the major extracellular anion. The majority of ingested chloride is absorbed, and the excess is excreted along with other ions into the urine. Low levels of chloride are observed in the case of prolonged vomiting accompanied by the loss of hydrochloric acid (HCl), in some cases of metabolic acidosis in which there is an increased accumulation of organic anions, in critical cases of Addison s disease, and in kidney disease resulting in loss of salt. Elevated levels of chloride are observed in metabolic acidosis associated with prolonged diarrhea and with loss of sodium bicarbonate (NaHCO 3 ), and in the case of renal tubular diseases in which there is a decreased excretion of hydrogen ion (H + ), which causes in turn a decrease in the reabsorption of bicarbonate ion (HCO 3 ). Elevated levels of serum chloride are also implicated in certain cases of hyperparathyroidism. 1 PRINCIPLES OF PROCEDURE Ion-selective electrodes for sodium, potassium, and chloride utilize membranes selective to each of these ions. An electrical potential (voltage) is developed across the membranes between the reference and measuring electrodes in accordance with the Nernst equation. The voltage is compared to previously determined calibrator voltages and converted into ion concentration. Methodology: Ion-selective electrode diluted (Indirect) REAGENTS Reagent Kit 2P32 ICT Sample Diluent (ICTD5) is supplied as a liquid, ready-to-use single reagent kit which contains either: 2P x 93 ml Estimated samples per kit: 12,000* 2P x 54 ml Estimated samples per kit: 7,000* *Calculation is based on the minimum diluent fill volume per kit. One sample can generate one to three test results. Reactive Ingredients Buffer Concentration N/A REAGENT HANDLING AND STORAGE Reagent Handling Remove air bubbles, if present in the diluent cartridge, with a new applicator stick. Alternatively, allow the diluent to sit at the appropriate storage temperature to allow the bubbles to dissipate. To minimize volume depletion, do not use a transfer pipette to remove the bubbles. CAUTION: Bubbles may interfere with proper detection of diluent level in the cartridge, causing insufficient diluent aspiration which could impact results. Reagent Storage Unopened diluent is stable until the expiration date when stored at 15 to 30 C. Diluent stability is 30 days if it is uncapped and onboard. REAGENT HANDLING AND STORAGE (Continued) Indications of Deterioration Instability or deterioration should be suspected if there are visible signs of leakage, extreme turbidity, microbial growth, or if ICT Module calibration does not meet the appropriate package insert and/or System Operations Manual criteria. Acetic acid odor from the diluent is normal. WARNINGS AND PRECAUTIONS Precautions for Users 1. For in vitro diagnostic use. 2. Do not use components beyond the expiration date. 3. Do not mix materials from different kit lot numbers. 4. CAUTION: This product requires the handling of human specimens. It is recommended that all human sourced materials be considered potentially infectious and be handled in accordance with the OSHA Standard on Bloodborne Pathogens. 2 Biosafety Level 2 3 or other appropriate biosafety practices 4,5 should be used for materials that contain or are suspected of containing infectious agents. SPECIMEN COLLECTION AND HANDLING Suitable Specimens Serum, plasma, and urine are acceptable specimens. Serum: Use serum collected by standard venipuncture techniques into glass or plastic tubes with or without gel barriers. Ensure complete clot formation has taken place prior to centrifugation. When processing samples, separate serum from blood cells or gel according to the specimen collection tube manufacturer s instructions. Some specimens, especially those from patients receiving anticoagulant or thrombolytic therapy, may take longer to complete their clotting processes. Fibrin clots may subsequently form in these sera and the clots could cause erroneous test results. For Potassium, hemolyzed specimens must not be used. Plasma: Use plasma collected by standard venipuncture techniques into glass or plastic tubes. Acceptable anticoagulants are lithium heparin (with or without gel barrier) and sodium heparin (full draw). Ensure centrifugation is adequate to remove platelets. When processing samples, separate plasma from blood cells or gel according to the specimen collection tube manufacturer s instructions. NOTE: Multiple myeloma and lipid samples are known to give low results on diluted ISE systems due to the high level of proteins/lipids present in the sample. 6,7 : Collect random or 24 hour urine specimens without the addition of preservatives. 1 The sample volume for the ICT assays is 15 μl. This volume is mixed with 69 μl of ICT Sample Diluent and 276 μl of system water. For total sample volume requirements, refer to Section 5 of the System Operations Manual. Specimen Storage Serum and Plasma Temperature Maximum Storage Bibliographic Sodium Potassium Reference 20 to 25 C 2 weeks 1 week 7 days 8 2 to 8 C 2 weeks 1 week 7 days 8, 9-20 C 1 year 1 year > 1 year 8 Temperature Maximum Storage Bibliographic Sodium Potassium Reference 20 to 25 C 45 days 45 days 8 2 to 8 C 45 days 2 months 8, 9-20 C 1 year 1 year 8 Temperature Maximum Storage Bibliographic Reference 20 to 25 C 7 days 10 2 to 8 C 7 days 9, C 7 days 9 Guder et al. 8 suggest storage of frozen specimens at -20 C for no longer than the time intervals cited above. However, limitations of laboratory equipment make it necessary in practice for clinical laboratories to establish a range around -20 C for specimen storage. This temperature range may be established from either the freezer manufacturer s specifications or your laboratory standard operating procedure(s) for specimen storage. NOTE: Stored specimens must be inspected for particulates. If present, mix and centrifuge the specimen to remove particulates prior to testing. 2

3 PROCEDURE Materials Provided 2P32 ICT Sample Diluent (ICTD5) Kit Materials Required but not Provided 9D28 ICT Module 1E49 ICT Reference Solution 2 x 2 L 1E50 ICT Cleaning Fluid 1 x 150 ml 10 x 12 ml 1E46 ICT Serum Calibrator 5 x 10 ml 5 x 10 ml 1E47 ICT Calibrator 5 x 10 ml 5 x 10 ml Control Material Disposable Pipette Assay Procedure For a detailed description of how to run an assay, refer to Section 5 of the System Operations Manual. CALIBRATION Calibration is stable up to 24 hours and calibration is required with each change in diluent lot number. The laboratory may choose any calibration interval up to 24 hours. The use of a particular calibration time interval is dependent on individual laboratory policy or preference. Verify calibration curve with at least two levels of controls according to the established quality control requirements for your laboratory. If control results fall outside acceptable ranges, recalibration may be necessary. For a detailed description of how to calibrate an assay, refer to Section 6 of the System Operations Manual. For information on calibrator standardization, refer to 1E46 ICT Serum Calibrator and 1E47 ICT Calibrator package inserts. QUALITY CONTROL The following is the recommendation of Abbott Laboratories for quality control. As appropriate, refer to your laboratory standard operating procedure(s) and/or quality assurance plan for additional quality control requirements and potential corrective actions. Two levels of controls (normal and abnormal) are to be run every 8 hours and following calibration. If more frequent control monitoring is required, follow the established quality control procedures for your laboratory. If quality control results do not meet the acceptance criteria defined by your laboratory, patient values may be suspect. Follow the established quality control procedures for your laboratory. Recalibration may be necessary. Review control results and acceptance criteria following a change of ICT Sample Diluent, ICT Reference Solution, or calibrator lot. RESULTS Refer to Appendix C of the System Operations Manual for information on results calculations. Representative performance data are given in the EXPECTED VALUES and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this package insert. Results obtained in individual laboratories may vary. LIMITATIONS OF THE PROCEDURE Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this package insert. Cross contamination testing for the ICTD5 Sample Diluent 2P32 was performed on an c System. c Systems Assays affected by ICTD5 Sample Diluent Configure ICTD5 Sample Diluent SmartWash entries in the following assay files on the c System. Configure COMPONENT REAGENT / ASSAY WASH VOL REP Mg 7D70 R1 Only ICTD5 0.5% Acid Wash Mg-U 7D70 R1 Only ICTD5 0.5% Acid Wash EXPECTED VALUES Reference Range A study was conducted using 145 serum samples and 155 plasma samples from 84 female and 72 male volunteers. Data were analyzed as described by Clinical and Laboratory Standards Institute (CLSI) protocol NCCLS C28-A2. 11 A non-parametric method was used to calculate the 95% reference interval. From this study 95% of sodium results fell within 137 to 144 mmol/l with samples ranging from 133 to 145 mmol/l; 95% of potassium results fell within 3.5 to 5.0 mmol/l with samples ranging from 3.1 to 5.4 mmol/l; and 95% of chloride results fell within 101 to 110 mmol/l with samples ranging from 93 to 113 mmol/l. From this same study 95% of anion gap results fell within 5 to 13 meq/l with sample results ranging from 3 to 14 meq/l. Anion gap values were calculated as ([Na + ] - ([CO 2 ] + [Cl - ])). Serum/Plasma 12 Range (mmol/l) Sodium Premature, Cord 116 to 140 Premature, 48 hours 128 to 148 Newborn, Cord 126 to 166 Newborn 133 to 146 Infant 139 to 146 Child 138 to 145 Thereafter 136 to 145 Potassium Premature, Cord 5.0 to 10.2 Premature, 48 hours 3.0 to 6.0 Newborn, Cord 5.6 to 12.0 Newborn 3.7 to 5.9 Infant 4.1 to 5.3 Child 3.4 to 4.7 Thereafter 3.5 to 5.1 Plasma, Male 3.5 to 4.5 Plasma, Female 3.4 to 4.4 Cord 96 to 104 Newborn, 0 to 30 days 98 to 113 Thereafter 98 to Range mmol/day Sodium Male6 to 10 years 41 to to 14 years 63 to 177 Adult 40 to 220 Female 6 to 10 years 20 to to 14 years 48 to 168 Adult 40 to 220 Full-term, 7 to 14 day old neonates have sodium clearance of about 20% of adult values. Potassium General 25 to 125 Varies with diet. Infant 2 to 10 Child 15 to 40 Thereafter 110 to 250 Varies greatly with Cl intake. For Sodium, Potassium, and, results expressed in mmol/l are equivalent to meq/l; results expressed in mmol/day are equivalent to meq/day. It is recommended that each laboratory determine its own reference range based upon its particular locale and population characteristics. 24 Hour Urinary Excretion: Sodium, Postassium, and To convert results from mmol/l to mmol/day (24 hour urinary excretion) Where: V = 24 hour urine volume (ml) c = analyte concentration (mmol/l) 24 hour excretion = [(V c) 1000] mmol/day 3

4 SPECIFIC PERFORMANCE CHARACTERISTICS Linearity Sodium serum is linear up to 200 mmol/l. Sodium urine is linear up to 400 mmol/l. Potassium serum is linear up to 10 mmol/l. Potassium urine is linear up to 300 mmol/l. serum is linear up to 150 mmol/l. urine is linear up to 300 mmol/l. Linearity was verified using CLSI protocol NCCLS EP6-P. 13 Reportable Range Serum/Plasma (mmol/l) (mmol/l) Sodium 100 to to 400 Potassium 1.0 to to to to 300 Interfering Substances Interference studies were conducted using CLSI protocol NCCLS EP7-P. 14 Interference effects were assessed by Dose Response and Paired Difference methods, at the medical decision level of the analyte. Bilirubin solutions at the concentrations listed below were prepared by addition of a bilirubin stock to human serum pools. Hemoglobin solutions at the concentrations listed below were prepared by addition of hemolysate to human serum pools. Intralipid solutions at the concentrations listed below were prepared by addition of Intralipid to human serum pools. Interfering Substance Bilirubin Hemoglobin Intralipid Sodium Interferent Concentration N Target Observed (mmol/l) (% of Target) 30 mg/dl (513 μmol/l) mg/dl (1,026 μmol/l) ,000 mg/dl (10.0 g/l) ,000 mg/dl (20.0 g/l) ,000 mg/dl (10.0 g/l) ,000 mg/dl (20.0 g/l) For the Sodium urine application, protein up to 50 mg/dl, glucose up to 1,000 mg/dl, ascorbate up to 200 mg/dl, acetic acid up to 6.25 ml/dl, boric acid up to 250 mg/dl, hydrochloric acid up to 2.5 ml/dl, and nitric acid up to 5.0 ml/dl demonstrated less than 10% interference. Sodium carbonate at 1.25 g/dl and sodium fluoride at 400 mg/dl demonstrated greater than 10% interference. Sodium oxalate at 60 mg/dl demonstrated less than 10% interference at a sodium concentration of 162 mmol/l. At a sodium concentration of 74 mmol/l, sodium oxalate demonstrated greater than 10% interference. Interfering Substance Bilirubin Hemoglobin Intralipid Potassium Interferent Concentration N Target Observed (mmol/l) (% of Target) 30 mg/dl (513 μmol/l) mg/dl (1,026 μmol/l) mg/dl (1.25 g/l) mg/dl (2.50 g/l) ,000 mg/dl (10.0 g/l) ,000 mg/dl (20.0 g/l) For the Potassium urine application, protein up to 50 mg/dl, glucose up to 1,000 mg/dl, ascorbate up to 200 mg/dl, acetic acid up to 6.25 ml/dl, boric acid up to 250 mg/dl, hydrochloric acid up to 2.5 ml/dl, nitric acid up to 5.0 ml/dl, sodium carbonate up to 1.25 g/dl, sodium fluoride up to 400 mg/dl, and sodium oxalate up to 60 mg/dl demonstrated less than 10% interference. Interfering Target Observed Interferent Concentration N Substance (mmol/l) (% of Target) 30 mg/dl (513 μmol/l) Bilirubin 60 mg/dl (1,026 μmol/l) ,000 mg/dl (10.0 g/l) Hemoglobin 2,000 mg/dl (20.0 g/l) ,000 mg/dl (10.0 g/l) Intralipid 2,000 mg/dl (20.0 g/l) For the urine application, protein up to 50 mg/dl, glucose up to 1,000 mg/dl, ascorbate up to 200 mg/dl, acetic acid up to 6.25 ml/dl, boric acid up to 250 mg/dl, nitric acid up to 5.0 ml/dl, sodium carbonate up to 1.25 g/dl, sodium fluoride up to 400 mg/dl, and sodium oxalate up to 60 mg/dl demonstrated less than 10% interference. Hydrochloric acid at 2.5 ml/dl demonstrated greater than 10% interference. Interferences from medications or endogenous substances may affect results SPECIFIC PERFORMANCE CHARACTERISTICS (Continued) Precision Serum The imprecision of the ICT assays for serum samples are as follows: Sodium 1.5%, Potassium 2.7%, 2.0%. Representative data from studies using CLSI protocol NCCLS EP5-A 16 are summarized below. Sodium Potassium Control Level 1 Level 2 Level 1 Level 2 Level 1 Level 2 N Mean (mmol/l) Within Run SD %CV Between Run SD %CV Between Day SD %CV Total SD %CV The imprecision of the ICT assays for urine samples are as follows: Sodium 3.0%, Potassium 3%, 1.8%. Representative data from studies using CLSI protocol NCCLS EP10-A 17 are summarized below. Sodium Potassium Control Level 1 Level 2 Level 1 Level 2 Level 1 Level 2 N Mean (mmol/l) Within Run SD %CV Between Run SD %CV Between Day SD %CV Total SD %CV

5 SPECIFIC PERFORMANCE CHARACTERISTICS (Continued) Method Comparison Correlation studies were performed based on CLSI protocol NCCLS EP9-A. 18 Serum and urine results from the Sodium, Potassium, and assays on the AEROSET System were compared with those from a commercially available ion-selective electrode methodology. Serum and urine results from the Sodium, Potassium, and assays on an c System were compared with the results on the AEROSET System. Sodium Serum N Y - Intercept Correlation Coefficient Slope Range (mmol/l)* to to N Y - Intercept Correlation Coefficient Slope Range (mmol/l)* to to Potassium Serum N Y - Intercept Correlation Coefficient Slope Range (mmol/l)* 2.34 to to 9.89 N Y - Intercept Correlation Coefficient Slope Range (mmol/l)* 1.07 to to Serum N Y - Intercept Correlation Coefficient Slope Range (mmol/l)* to to N Y - Intercept Correlation Coefficient Slope Range (mmol/l)* to to BIBLIOGRAPHY 1. Tietz NW, Pruden EL, Siggaard-Anderson O. Electrolytes. In: Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994: US Department of Labor, Occupational Safety and Health Administration. 29 CFR Part Bloodborne Pathogens. 3. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories, 5th ed. Washington, DC: US Government Printing Office, January World Health Organization. Laboratory Biosafety Manual, 3rd ed. Geneva: World Health Organization, Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline Third Edition (M29-A3). Wayne, PA: Clinical and Laboratory Standards Institute, Kaplan LA, Pesce AJ, Kazmierczak SC. Clinical Chemistry Theory, Analysis, and Correlation, 3rd ed. St Louis, MO: Mosby, 1996: McPherson RA, Bidkorpeh EK, Castellani WJ, et al. Analysis of Body Fluids in Clinical Chemistry; Approved Guideline (C49-A). Wayne, PA: The National Committee for Clinical Laboratory Standards, Guder WG, Narayanan S, Wisser H, et al. List of analytes preanalytical variables. Annex In: Samples: From the Patient to the Laboratory. Darmstadt, Germany: GIT Verlag; 1996:Annex 10 1, 20 1, US Pharmacopeial Convention, Inc. General notices. In: US Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18). Rockville, MD: The US Pharmacopeial Convention, Inc; 1994: Pesce AJ, Kaplan LA, editors. Methods in Clinical Chemistry. St Louis, MO: CV Mosby, 1987: Sasse EA, Doumas BT, Miller WG, et al. How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline Second Edition (C28-A2). Wayne, PA: The National Committee for Clinical Laboratory Standards, Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994:2182, , Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity of Quantitative Analytical Methods; Proposed Guideline (EP6-P). Villanova, PA: The National Committee for Clinical Laboratory Standards, Powers DM, Boyd JC, Glick MR, et al. Interference Testing in Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The National Committee for Clinical Laboratory Standards, Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed. Washington, DC: AACC Press, 1995: , , Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline (EP5-A). Wayne, PA: The National Committee for Clinical Laboratory Standards, Krouwer JS, Castañeda-Méndez K, Dawson JM, et al. Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline (EP10-A). Wayne, PA: The National Committee for Clinical Laboratory Standards, Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP9-A). Wayne, PA: The National Committee for Clinical Laboratory Standards, TRADEMARKS The c System family of instruments consists of c 4000, c 8000, and c instruments. AEROSET,, c 4000, c 8000, c 16000, c System, and SmartWash are trademarks of Abbott Laboratories in various jurisdictions. All other trademarks are property of their respective owners /R1 Abbott Laboratories Abbott Park, IL USA ABBOTT Max-Planck-Ring Wiesbaden Germany

6 c SYSTEMS ASSAY PARAMETERS Sodium Serum/Plasma Conventional and SI Units Assay: Na-C Type: Potentiometric Number: 1101 Sodium Conventional and SI Units Assay: Na-CU Type: Potentiometric Number: 1133 Assay: Na-C Calibrator low: ICT-Low Low Concentration: Calibrator high: ICT-High High Concentration: Assay: Na-C Assay: Na-CU Calibrator low: ICTU-Low Low Concentration: Calibrator high: ICTU-High High Concentration: Assay: Na-CU Assay: Na-C Assay number: 1101 Low-Linearity: 100 High-Linearity: 200 Either (Y) Assay: Na-C Decimal places: 0 [Range 0 4] Assay: Na-CU Assay number: 1133 Low-Linearity: 20 High-Linearity: 400 Assay: Na-CU Decimal places: 0 [Range 0 4] Due to differences in instrument systems and unit configurations, version numbers may vary. * Calibration interval can be edited up to 24 hours. 6

7 c SYSTEMS ASSAY PARAMETERS Potassium Serum/Plasma Conventional and SI Units Assay: K-C Type: Potentiometric Number: 1102 Potassium Conventional and SI Units Assay: K-CU Type: Potentiometric Number: 1134 Assay: K-C Calibrator low: ICT-Low Low Concentration: Calibrator high: ICT-High High Concentration: Assay: K-C Assay: K-CU Calibrator low: ICTU-Low Low Concentration: Calibrator high: ICTU-High High Concentration: Assay: K-CU Assay: K-C Assay number: 1102 Low-Linearity: 1.0 High-Linearity: 10.0 Either (Y) Assay: K-CU Assay number: 1134 Low-Linearity: 1.0 High-Linearity: Assay: K-C Decimal places: 1 [Range 0 4] Assay: K-CU Decimal places: 1 [Range 0 4] Due to differences in instrument systems and unit configurations, version numbers may vary. * Calibration interval can be edited up to 24 hours. 7

8 c SYSTEMS ASSAY PARAMETERS Serum/Plasma Conventional and SI Units Assay: Cl-C Type: Potentiometric Number: 1103 Conventional and SI Units Assay: Cl-CU Type: Potentiometric Number: 1135 Assay: Cl-C Calibrator low: ICT-Low Low Concentration: Calibrator high: ICT-High High Concentration: Assay: Cl-C Assay: Cl-CU Calibrator low: ICTU-Low Low Concentration: Calibrator high: ICTU-High High Concentration: Assay: Cl-CU Assay: Cl-C Assay number: 1103 Low-Linearity: 50 High-Linearity: 150 Either (Y) Assay: Cl-CU Assay number: 1135 Low-Linearity: 20 High-Linearity: 300 Assay: Cl-C Decimal places: 0 [Range 0 4] Assay: Cl-CU Decimal places: 0 [Range 0 4] Due to differences in instrument systems and unit configurations, version numbers may vary. * Calibration interval can be edited up to 24 hours. 8