Diagnostic reagent for quantitative in vitro determination of calcium in serum or plasma on DiaSys ® respons 920
Order Information Cat. No. Kit size
TruCal U 5 9100 99 10 063 20 x 3 mL Cat. No. 1 1181 99 10 920 5 9100 99 10 064 6 x 3 mL 4 twin containers for 200 determinations each TruLab N 5 9000 99 10 062 20 x 5 mL 5 9000 99 10 061 6 x 5 mL Method TruLab P 5 9050 99 10 062 20 x 5 mL Photometric endpoint determination with Phosphonazo III 5 9050 99 10 061 6 x 5 mL
Principle Performance Characteristics
At acidic pH calcium forms a purple-blue colored complex with phosphonazo Measuring range up to 25 mg/dL calcium (in case of higher III. In a second step calcium is bound to a chelating agent whereby the concentrations re-measure samples after manual dilution with NaCl specific signal is eliminated. The resulting difference in absorbance is solution (9 g/L) or use the rerun function). directly proportional to the calcium concentration in the sample. This Limit of detection** 0.2 mg/dL calcium guarantees a specific measurement of calcium. On-board stability 8 weeks Calibration stability 8 weeks Reagents Interferences < 10% by Components and Concentrations Ascorbate up to 30 mg/dL R1: Malonic acid buffer pH 5.0 150 mmol/L Hemoglobin up to 1000 mg/dL Phosphonazo III 150 µmol/L Conjugated Bilirubin up to 60 mg/dL R2: Malonic acid 150 mmol/L Unconjugated Bilirubin up to 60 mg/dL Chelating agent < 150 mmol/L Lipemia (triglycerides) up to 2000 mg/dL Storage Instructions and Reagent Stability Magnesium up to 20 mg/dL Reagents are stable up to the end of the indicated month of expiry, if stored Strontium salts in medicine may lead to strongly increased calcium at 2 – 8 °C and contamination is avoided. Do not freeze the reagents! values. For further information on interfering substances refer to Young DS [2]. Warnings and Precautions 1. Reagent 1: Warning. H319 Causes serious eye irritation. H412 Precision Harmful to aquatic life with long lasting effects. P273 Avoid release to Within run (n=20) Sample 1 Sample 2 Sample 3 the environment. P280 Wear protective gloves/protective clothing/eye Mean [mg/dL] 10.0 10.0 12.2 protection/face protection. P305+P351+P338 If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if Coefficient of variation [%] 1.00 0.68 0.80 present and easy to do. Continue rinsing. P337+P313 If eye irritation Between run (n=20) Sample 1 Sample 2 Sample 3 persists: Get medical advice/attention. P501 Dispose of Mean [mg/dL] 9.41 10.0 12.3 contents/container to hazardous or special waste collection point. Coefficient of variation [%] 2.08 1.28 2.05 2. As calcium is a ubiquitous ion, special precaution must be taken against accidental contamination. Only use disposable materials. Method comparison (n=152) 3. Traces of chelating agent, such as EDTA can prevent the formation of Test x DiaSys Calcium P FS (Hitachi 917) the colored complex. Test y ® DiaSys Calcium P FS (respons 920) 4. To avoid carryover interference, please take care of efficient washing Slope 0.987 especially after use of interfering reagents. Please refer to the DiaSys Intercept 0.322 mg/dL ® respons 920 Carryover Pair Table. Carryover pairs and automated Coefficient of correlation 0.996 washing steps with the recommended cleaning solution can be ** lowest measurable concentration which can be distinguished from zero specified in the system software. Please refer to the user manual. mean + 3 SD (n=20) of an analyte free specimen 5. In very rare cases, samples of patients with gammopathy might give falsified results [5]. Conversion factor 6. Please refer to the safety data sheets and take the necessary precautions for the use of laboratory reagents. For diagnostic Calcium [mg/dL] x 0.2495 = Calcium [mmol/L] purposes, the results should always be assessed with the patient’s medical history, clinical examinations and other findings. Reference Range [3] 7. For professional use only! 8.6 – 10.3 mg/dL (2.15 – 2.57 mmol/L) Waste Management Each laboratory should check if the reference ranges are transferable to its Please refer to local legal requirements. own patient population and determine own reference ranges if necessary.
Reagent Preparation Literature
The reagents are ready to use. The bottles are placed directly into the st 1. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1 ed. reagent rotor. Darmstadt: GIT Verlag; 2001. p. 20-1. 2. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th. ed. Specimen Volume 1 and 2. Washington, DC: The American Association for Serum or heparin plasma Clinical Chemistry Press, 2000. Do not use EDTA plasma. 3. Endres DB, Rude RK. Mineral and bone metabolism. In: Burtis CA, rd Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3 ed. Stability [1]: Philadelphia: W.B Saunders Company; 1999. p. 1395–1406. 7 days at 20 – 25°C 4. st Thomas L. Clinical Laboratory Diagnostics. 1 ed. Frankfurt: TH-Books 3 weeks at 4 – 8°C Verlagsgesellschaft; 1998. p. 231–241. 8 months at –20°C 5. Bakker AJ, Mücke M. Gammopathy interference in clinical chemistry Discard contaminated specimens. Freeze only once. assays: mechanisms, detection and prevention. ClinChemLabMed 2007;45(9):1240–1243. Calibrators and Controls For calibration, DiaSys TruCal U calibrator is recommended. This method Manufacturer has been standardized against the reference method Atomic Absorption DiaSys Diagnostic Systems GmbH Spectrometry (AAS). For internal quality control DiaSys TruLab N and P IVD Alte Strasse 9 65558 Holzheim Germany controls should be assayed. Each laboratory should establish corrective actions in case of deviations in control recovery.
Page 1 - Reagent Information * fluid stable
Calcium P FS Application for serum and plasma Test Details Test Volumes Reference Ranges Test : CA Auto Rerun
Report Name : Calcium Phosphonazo Online Calibration
Unit : mg/dL Decimal Places : 2 Cuvette Wash
Wavelength-Primary : 660 Secondary : 700 Total Reagents : 2
Assay Type : 2-Point Curve Type : Linear Reagent R1 : CA R1
M1 Start : 15 M1 End : 15 Reagent R2 : CA R2
M2 Start : 20 M2 End : 20
Sample Replicates : 1 Standard Replicates : 3 Consumables/Calibrators:
Serum Normal : 2.00 µl Dilution Ratio : 1 X Urine CSF Increase : 4.00 µl Dilution Ratio : 1 X Plasma Decrease : 2.00 µl Dilution Ratio : 2 X Whole Blood Other Standard Volume : 2.00 µl
