Clinical Chemistry

2010/03/30 A93A01239BEN

A11A01646

ABX Pentra Magnesium RTU

Pentra C200

2 x 25 mL

Intended Use: Diagnostic reagent for quantitative in vitro determination of Magnesium in serum and plasma by colorimetry.

Clinical Interest (1, 2)

Deficiency of magnesium is a quite common disorder which can be caused by malnutrition, malabsorption, renal loss and endocrinological disturbances. Complications associated with decreased magnesium concentrations are neuromuscular irritability (e.g. tremor, seizures) and cardiac symptoms (e.g. tachycardia, arrhythmia). Decreased magnesium concentrations are often related to decreased calcium and potassium levels, taking into account that hypomagnesemia may be the primary cause of hypocalcemia. Elevated magnesium values can be observed in dehydration, renal disorders and after intake of excessive amounts of antacids and can be associated with weakness of reflexes and low blood pressure.

Handling
1. Identify the cassette by using dedicated reagent stickers with barcode (605). 2. Transfer the reagent into compartment 1 (30 ml capacity) of the cassette 30/10 provided (see diagram below). The compartment 2 of the cassette will be unused.

Method (3)
Photometric test using xylidyl blue. Magnesium ions form a purple colored complex with xylidyl blue in alkaline solution. In presence of GEDTA, which complexes calcium ions, the reaction is specific. The intensity of the purple color is proportional to the magnesium concentration.

3. If present, remove foam by using a plastic pipette. 4. Place the reagent cassette at an available position on the reagent tray in the refrigerated Pentra C200.

Calibrator
For calibration, use: ABX Pentra Multical, Ref. A11A01652 (not included) 10 x 3 mL (lyophilisate)

Reagents
ABX Pentra Magnesium RTU is ready-to-use.

Control
For internal quality control, use: ABX Pentra N Control, Ref. A11A01653 (not included) 10 x 5 mL (lyophilisate) ABX Pentra P Control, Ref. A11A01654 (not included) 10 x 5 mL (lyophilisate) Each control should be assayed daily and/or after a calibration.

Reagent:
Ethanolamine pH 11.0 GEDTA (Glycoletherdiamine acid) Xylidyl blue Detergents
Form-0846 Rev.4

750 mmol/L -tetraacetic 60 mol/L 110 mol/L

ABX Pentra Magnesium RTU should be used according to this reagent notice. The manufacturer cannot guarantee its performance if used otherwise.

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Clinical Chemistry

ABX Pentra Magnesium RTU

The frequency of controls and the confidence intervals should correspond to laboratory guidelines and countryspecific directives. The results must be within the range of the defined confidence limits. Each laboratory should establish a procedure to follow if the results exceed these confidence limits.

Packaging spoiling
In case of protective packaging spoiling, do not use the reagent if the damages might have an effect on the product performance.

Materials Required but not Provided

Automated clinical chemistry analyzer: Pentra C200 Calibrator: ABX Pentra Multical, Ref. A11A01652 Controls: ABX Pentra N Control, Ref. A11A01653, and ABX Pentra P Control, Ref. A11A01654 Standard laboratory equipment

Waste Management
Please refer to local legal requirements.

General Precautionsb
This reagent is for professional in vitro diagnostic use only. S25: avoid contact with eyes. Observe the standard laboratory precautions for use. The reagent vials should be discarded after use. Please refer to the MSDS associated with the reagent. Do not use the product if there is visible evidence of biological, chemical or physical deterioration.

Specimena
Serum. Plasma in lithium heparin. Do not use EDTA plasma. Stability (4): 7 days at 20-25C 7 days at 4-8C 1 year at -20C

Performance on Pentra C200

The performance data listed below have been obtained on the Pentra C200 analyzer. Number of Tests: approximately 2 x 88 tests On Board Reagent Stability: Once opened, the reagent cassette placed in the refrigerated Pentra C200 compartment is stable for 19 days. Sample Volume: 2.5 L/test Limit of Quantitation: The limit of quantitation is determined according to CLSI (NCCLS), EP17-A protocol (6) and equals 0.05 mmol/L (0.12 mg/dL). Accuracy and Precision: Repeatability (within-run precision) 3 specimens of low, medium and high concentration and 2 controls are tested 20 times according to the recommendations found in the Valtec protocol (7).

Reference Range (1, 5)

Each laboratory should establish its own reference ranges. The values given here are used as guidelines only. Neonates: Children: Women: Men: 1.2 - 2.6 mg/dL (0.48 - 1.05 mmol/L) 1.5 - 2.3 mg/dL (0.60 - 0.95 mmol/L) 1.9 - 2.5 mg/dL (0.77 - 1.03 mmol/L) 1.8 - 2.6 mg/dL (0.73 - 1.06 mmol/L)

Storage and Stability

Reagents, in unopened cassettes, are stable up to the expiry date on the label if stored tightly closed between 2-8C and contamination is avoided. Stability after opening: refer to the paragraph "Performance on Pentra C200".

Assay Procedure
Test instructions for other automated systems than Pentra C 200 are available on request (not available in the USA).
a Modification b Modification

from index A to B: modification of specimen stability. from index A to B: addition of safety phrases.

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Clinical Chemistry

ABX Pentra Magnesium RTU

Mean value mmol/L Control specimen 1 Control specimen 2 Specimen 1 Specimen 2 Specimen 3 0.88 1.54 0.66 1.00 1.59 mg/dL 2.13 3.75 1.61 2.42 3.86 CV % 0.69 0.77 0.62 0.61 0.69

Triglycerides:

No significant influence is observed up to 7 mmol/L (612.5 mg/dL) (as Intralipid, representative of lipemia). Total Bilirubin: No significant influence is observed up to 375 mol/L (21.9 mg/dL). Direct Bilirubin: No significant influence is observed up to 375 mol/L (21.9 mg/dL). Other limitations are given by Young as a list of drugs and preanalytical variables known to affect this methodology (12, 13). Calibration Stability: The reagent is calibrated on Day 0. The calibration stability is checked by testing 2 control specimens. The calibration stability is 19 days. Note: A recalibration is recommended when reagent lots change, and when quality control results fall outside the range established. Application releasec : 01.xx Conversion factor: mmol/L x 24.3 = mg/L mmol/L x 2.43 = mg/dL

Reproducibility (total precision) 3 specimens of low, medium and high levels and 2 controls are tested in duplicate for 20 days (2 series per day) according to the recommendations found in the CLSI (NCCLS), EP5-A2 protocol (8).
Mean value mmol/L Control specimen 1 Control specimen 2 Specimen 1 Specimen 2 Specimen 3 0.89 1.59 0.66 0.99 1.58 mg/dL 2.2 3.9 1.6 2.4 3.8 CV % 2.91 2.85 3.23 3.15 2.77

Warning
It is the user's responsibility to verify that this document is applicable to the reagent used.

Measuring Range: The assay confirmed a measuring range from 0.05 to 1.9 mmol/L (0.12 to 4.61 mg/dL), with an automatic postdilution up to 5.7 mmol/L (13.83 mg/dL). The reagent linearity has been assessed up to 1.9 mmol/L (4.61 mg/dL) according to the recommendations found in the CLSI (NCCLS), EP6-A protocol (9). Correlation: 93 patient samples (serum) are correlated with a commercial reagent taken as reference according to the recommendations found in the CLSI (NCCLS), EP9-A2 protocol (10). Values ranged from 0.09 to 1.80 mmol/L (0.22 to 4.37 mg/dL). The equation for the allometric line obtained using PassingBablock regression procedure (11) is: Y = 1.02 X - 0.01 (mmol/L) Y = 1.02 X - 0.04 (mg/dL) with a correlation coefficient r2 = 0.9683. Interferences: Haemoglobin: No significant influence is observed up to 100 mol/L (172 mg/dL).
c Modification

Reference
1. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: THBooks Verlagsgesellschaft (1998): 231-241. Endres DB, Rude RK. Mineral and bone metabolism. In: Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: WB Saunders Company (1999): 1395-1457. Burcar PJ, Boyle AJ. Spectrophotometric determination of magnesium in blood Serum Using Magon. Clin. Chem. (1964) 10: 1028-1038. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1st ed. Darmstadt: GIT Verlag (2001): 38-39, 50-51. Sitzmann FC. Normalwerte. Mnchen: Hans Marseille Verlag GmbH (1986): 166. Protocols for determination of limits of detection and limits of quantitation. Approved Guideline, CLSI (NCCLS) document EP17-A (2004) 24 (34) .

2.

3. 4.

5. 6.

from index A to B: Addition of minor index.

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Clinical Chemistry

ABX Pentra Magnesium RTU

7. 8. 9. 10. Vassault A, Grafmeyer D, Naudin C et al. Protocole de validation de techniques (document B). Ann. Biol. Clin. (1986) 44: 686-745. Evaluation of Precision Performance of Quantitative Measurement Method. Approved Guideline, CLSI (NCCLS) document EP5-A2 (2004) 24 (25). Evaluation of the Linearity of Quantitative Analytical Methods. Approved Guideline, CLSI (NCCLS) document EP6-A (2003) 23 (16). Method Comparison and Bias Estimation Using Patient Samples. Approved Guideline, 2nd ed., CLSI (NCCLS) document EP9-A2 (2002) 22 (19) . Passing H, Bablock W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J. Clin. Chem. Clin. Biochem. (1983) 21: 709-20. Young DS. Effects of Drugs on Clinical Laboratory Tests. 4th Edition, Washington, DC, AACC Press (1997) 3: 143-163. Young DS. Effects of Preanalytical Variables on Clinical Laboratory Tests. 2nd Edition, Washington, DC, AACC Press (1997) 3: 120-132.

11.

12.

13.

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