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  • Page 1 D01727_10_insert_Na_Micro_Volume(ISE)_MU

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    EN

    Sodium Micro Volume Electrode 981594 (Konelab™, Indiko™)

    THIS PACKAGE INSERT IS APPLICABLE FOR USE

    OUTSIDE THE US.

    INTENDED USE For the in vitro quantitative determination of the sodium concentration in human serum, plasma or urine on Konelab and in human serum and plasma on Indiko analyzers. All test results must be interpreted with regard to the clinical context. Any reference to the Konelab systems also refers to the T Series.

    SUMMARY (1) Sodium ions are the major cations of extracellular fluid. Na+ is responsible for almost half the osmolality of the plasma and has a central role in maintaining the normal distribution of water and the osmotic pressure in the extracellular fluid compartment. The average daily diet contains 130 - 260 mmol of sodium chloride, but the body requirement is only 1 to 2 mmol / day. The excess is excreted by the kidneys, which are regulators of the amount of Na+ in the body. Hyponatremia may be the result of excessive sweating, prolonged vomiting, persistent diarrhea or salt-losing renal diseases. Hypernatremia can arise from excessive water loss or failure to replace normal water losses as may occur in profuse sweating, diarrhea or polyuria. Other causes are decreased production of antidiuretic hormone (ADH) or decreased tubular sensitivity to ADH.

    PRINCIPLE OF THE PROCEDURE Electrolyte measurements in Konelab and Indiko analyzers are made with ion selective electrodes (ISE) directly without any dilution of the sample. The measurement cell consists of several ion selective electrodes and one reference electrode. The measured potential between each ISE and the common reference electrode is in the simplest case related to the natural logarithm of the ionic activity according to Nernst equation (6). The changes in potential are developed across the ISE membrane/ sample interface.

    PRODUCT INFORMATION The kit code 981594 contains a sodium micro volume (Na+) electrode which is packed in a foil bag. The electrode is coded with a yellow dot.

    Precautions For in vitro diagnostic use only. Exercise the normal precautions required for handling all laboratory reagents. Do not remove the electrode pin. The electrode is maintenance free and has been filled during the manufacturing process and there is no need for refilling the electrode. There must always be a small O-ring between two electrodes. When removing an electrode block from the instrument, detach it from the end slices and leave them intact. While using urine samples give occasional serum samples to ensure proper electrode performance.

    Preparation The electrode is ready for use and doesn’t require activation or filling. In order to install the electrode proceed as follows 1) Remove the foil bag from the electrode box and tear it at the cut to open. 2) Check that the inner filling solution is covering the membrane. 3) If there are air bubbles hold the electrode upright and gently force out any trapped air from

    the membrane surface with a flick of the wrist. (Don’t tap the electrode on a hard surface) 4) The electrode is now ready to be installed according to the electrode order described in the

    following documents: Konelab: Reference Manual or the instrument Indiko: Installation Manual or ISE Reference (981998) insert

    5) Fill in the installation sheet. 6) Run some serum based samples through the instrument in the normal fashion immediately

    after installation of the electrodes prior to calibration. 7) Perform the calibration.

    Storage and Stability Regular use of washing solution e.g. Washing solution 4.5%, code 984030, is essential for electrode performance. See the last possible installation date on the electrode package label (install before). The warranty is valid for 6 months from the installation date. Electrodes must be stored at 2…8°C before installation.

    SPECIMEN COLLECTION

    Sample Type Konelab: Serum or Li-heparin plasma or urine can be used. Do not use Na-heparin. Indiko: Serum or Li-heparin plasma can be used. Do not use Na-heparin. Note: When processing samples in sample collection tubes, follow the instructions of the tube manufacturer carefully to avoid erroneous results. Pay special attention to the preanalytical variables such as mixing, standing time before centrifugation and centrifuge settings

    Precautions Human samples should be handled and disposed of as if they were potentially infectious. Check that there are no bubbles in the sample cups or on the surface of samples when inserting cups into the analyzer.

    Storage (2) Serum and plasma 1 week at 20…25 °C, 1 week at 4…8 °C, or 1 year at -20 °C Urine 1 week at 20…25 °C, 1 week at 4…8 °C, or 1 year at -20 °C

    TEST PROCEDURE Refer to the Reference Manual and Application Notes for an automated procedure on your analyzer. Any application, which has not been validated by Thermo Fisher Scientific Oy, cannot be performance guaranteed and therefore must be evaluated by the user.

    Indiko instrument settings Enter the application parameters via barcode found in the Indiko application sheet or via electronical file as appropriate.

    Materials provided The sodium electrode as described above.

    Materials required but not provided ISE Reference, code 981998 (Indiko) ISE Prime serum, code 981990 (Konelab, Indiko) Reference Electrode Kit, code 980845 (Konelab) Tencell Cuvette, code 986000 (Indiko) Washing Solution 4.5%, code 984030 (Konelab, Indiko)

    Calibration Serum (Konelab, Indiko): ISE Calibrator 1, code 984031 and ISE Calibrator 2 & 3, code 984035. Urine (Konelab): ISE Calibrator 1, code 984031, ISE Calibrator 3, code 984035 and ISE Calibrator 4, code 984034. Use calibrators according to the instructions given to your analyzer. Calibrator may be in the analyzer for a maximum of one hour.

    Note: Check that there are no bubbles in the calibration cups or on the surface of calibrators when inserting cups into the analyzer. It is recommended to calibrate the instrument at least once a month and always when electrodes have been replaced or whenever control results require recalibration.

    Traceability: Refer to the package insert of ISE Calibrator 1, 2 & 3, 4.

    Quality Control Use quality control samples at least twice per day, after each calibration and every time a new bottle or bag of ISE Calibrator 1, 2, 3 or 4 is used. It is recommended to use at least two levels (low and high) of controls or sample pools. Always follow the local, state and federal regulations in performing QC. Available controls in serum measurements: Serum/Plasma: Konelab, Indiko: Nortrol, code: 981043 Abtrol, code: 981044 Konelab: Select Ion Low, code: 981059 Select Ion Normal, code: 981058 Select Ion High, code: 981094 Urine: Konelab: uTrol, code 981821 uTrol High, code 981822 The control intervals and limits must be adapted to the individual laboratory requirements. The results of the quality control sample(s) should fall within the limits pre-set by the laboratory.

    CALCULATION OF RESULTS The results are calculated automatically by the analyzer using a calibration curve.

    Calibration curve, serum (Konelab example)

    Calibration curve (Indiko example)

    -6.0 -5.0 -4.0 -3.0 -2.0 -1.0 0.0 1.0

    120.0 150.0

    m V

    mmol/l

    Calibration curve, urine (Konelab example)

    y-axis: response in millivolts x-axis: concentration in mmol/l

    LIMITATIONS OF THE PROCEDURE

    Interference Criterion: Recovery within ± 5% of initial values. Bilirubin (conjugated): No interference found up to 750 µmol/l (43 mg/dl) of conjugated bilirubin. Hemolysate: No interference found up to 10 g/l (1000 mg/dl) of hemoglobin. Lipemia: No interference found up to 10 g/l (1000 mg/dl) of Intralipid®.

    EXPECTED VALUES (1) Serum/plasma Adults: 136 - 145 mmol/l Urine 24 hours Adults: 40 - 220 mmol/day The quoted values should serve as a guide only. It is recommended that each laboratory verify this range or derive a reference interval for the population that it serves.

    Conversion factor Na+ mmol/l x 1  mEq/l

    MEASURING RANGE 100 - 200 mmol/l (serum) 20 - 200 mmol/l (urine)

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