Calcium AS FS*

Diagnostic reagent for quantitative in vitro determination of calcium in serum, plasma or urine on
photometric systems

Order Information 4. In very rare cases, samples of patients with gammopathy

might give falsified results [7].
Cat. No. Kit size
5. Please refer to the safety data sheets and take the necessary
1 1130 99 10 021 R 6x 25 mL
precautions for the use of laboratory reagents. For diagnostic
1 1130 99 10 026 R 6x 100 mL
purposes, the results should always be assessed with the
1 1130 99 10 023 R 1x 1000 mL
patient’s medical history, clinical examinations and other
1 1130 99 10 704 R 8x 50 mL
findings.
Summary [1,2] 6. For professional use only!
Calcium plays an essential role in many cell functions: intracellularly Waste Management
in muscle contraction and glycogen metabolism, extracellularly, in Please refer to local legal requirements.
bone mineralization, in blood coagulation and in transmission of Reagent Preparation
nerve impulses. Calcium is present in plasma in three forms: free,
bound to proteins or complexed with anions as phosphate, citrate The reagent is ready-to-use.
and bicarbonate. Decreased total calcium levels can be associated Materials required but not provided
with diseases of the bone apparatus (especially osteoporosis), NaCl solution 9 g/L.
kidney diseases (especially under dialysis), defective intestinal General laboratory equipment
absorption and hypoparathyroidism. Increased total calcium can be
measured in hyperparathyroidism, malignant diseases with Specimen
metastases and sarcoidosis. Calcium measurements also help in Serum, heparin plasma or urine
monitoring of calcium supplementation mainly in the prevention of Do not use EDTA plasma.
osteoporosis.
Stability [5]
Method in Serum/Plasma: 7 days at 20 – 25°C
Photometric test using arsenazo III 3 weeks at 4 – 8°C
8 months at –20°C
Principle in Urine: 2 days at 20 – 25°C
Calcium with arsenazo III at neutral pH yields a blue colored 4 days at 4 – 8°C
complex, whose intensity is proportional to the calcium 3 weeks at –20°C
concentration. Interference by magnesium is eliminated by addition Add 10 mL of concentrated HCl to 24 h urine and heat the
of 8-hydroxyquinoline-5-sulfonic acid. specimen to dissolve calcium oxalate.
Discard contaminated specimens. Freeze only once!
Reagents
Assay Procedure
Components and Concentrations
Reagent: Application sheets for automated systems are available on
Phosphate buffer pH 7.5 50 mmol/L request.
8-Hydroxyquinoline-5-sulfonic acid 5 mmol/L Wavelength 650 nm, Hg 623 nm (630 – 670 nm)
Arsenazo III 120 µmol/L Optical path 1 cm
Temperature 20 – 25°C/37°C
Storage Instructions and Reagent Stability Measurement against reagent blank
Reagent is stable up to the end of the indicated month of expiry, if
stored at 2 – 8°C and contamination is avoided. Do not freeze the Blank Sample/Calibrator
reagent! Sample/Calibrator - 10 µL
Warnings and Precautions Dist. water 10 µL -
1. As calcium is an ubiquitous ion, essential precaution must be Reagent 1000 µL 1000 µL
taken against accidental contamination. Only use disposable Mix, incubate for 5 min. and read absorbance against reagent
materials. blank.
2. Traces of chelating agent, such as EDTA can prevent the
formation of the colored complex. Calculation
3. The reagent contains sodium azide (0.95 g/L) as preservative. With calibrator
Do not swallow! Avoid contact with skin and mucous
membranes. A Sample
Calcium [mg/dL] = x Conc. Cal. [mg/dL]
A Cal.

Conversion factor
Calcium [mg/dL] x 0.2495 = Calcium [mmol/L]
Calcium/U [mg/24 h] x 0.025 = Calcium/U [mmol/24 h]

Calcium AS FS – Page 1 * fluid stable

Calibrators and Controls Reference Range
For calibration of automated photometric systems, the DiaSys Serum/Plasma [2]:
TruCal U calibrator is recommended. This method has been 8.6 – 10.3 mg/dL (2.15 – 2.57 mmol/L)
standardized against the reference method Atomic Absorption
Urine [1]: Women < 250 mg/24 h (6.24 mmol/24 h)
Spectrometry (AAS). Calcium Standard FS may be used Men < 300 mg/24 h (7.49 mmol/24 h)
alternatively for calibration. For internal quality control, DiaSys
TruLab N and P or TruLab Urine controls should be assayed. Each Each laboratory should check if the reference ranges are
laboratory should establish corrective actions in case of deviations transferable to its own patient population and determine own
in control recovery. reference ranges if necessary.

Cat. No. Kit size Literature

TruCal U 5 9100 99 10 063 20 x 3 mL 1. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt:
5 9100 99 10 064 6 x 3 mL TH-Books Verlagsgesellschaft; 1998. p. 231–241.
TruLab N 5 9000 99 10 062 20 x 5 mL 2. Endres DB, Rude RK. Mineral and bone metabolism. In: Burtis
5 9000 99 10 061 6 x 5 mL CA, Ashwood ER, editors. Tietz Textbook of Clinical
TruLab P 5 9050 99 10 062 20 x 5 mL Chemistry. 3rd ed. Philadelphia: W.B Saunders Company;
5 9050 99 10 061 6 x 5 mL 1999. p. 1395–1406.
TruLab Urine Level 1 5 9170 99 10 062 20 x 5 mL 3. Michaylova V, Ilkova P. Photometric determination of micro
5 9170 99 10 061 6 x 5 mL amounts of calcium with arsenazo III. Anal Chim Acta
TruLab Urine Level 2 5 9180 99 10 062 20 x 5 mL 1971;53:194-8.
5 9180 99 10 061 6 x 5 mL 4. Bauer PJ. Affinity and stoichiometry of calcium binding by
Calcium Standard FS 1 1100 99 10 030 6 x 3 mL arsenazo III. Anal Biochem 1981;110:61-72.
5. Guder WG, Zawta B et al. The Quality of Diagnostic Samples.
Performance Characteristics 1st ed. Darmstadt: GIT Verlag; 2001. p. 20-1 and p. 50-1.
Measuring range 6. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th
ed. Volume 1 and 2. Washington, DC: The American
The test has been developed to determine calcium concentrations
Association for Clinical Chemistry Press 2000.
within a measuring range from 0.04 – 20 mg/dL (0.01 – 5 mmol/L).
7. Bakker AJ, Mücke M. Gammopathy interference in clinical
When values exceed this range, samples should be diluted 1 + 1
chemistry assays: mechanisms, detection and prevention.
with NaCl solution (9 g/L) and the result multiplied by 2.
ClinChemLabMed 2007;45(9):1240–1243.
Specificity/Interferences
No interference was observed by ascorbic acid up to 30 mg/dL, Manufacturer
bilirubin up to 40 mg/dL, hemoglobin up to 500 mg/dL, lipemia up to DiaSys Diagnostic Systems GmbH
2000 mg/dL triglycerides and magnesium up to 15 mg/dL. Strontium IVD Alte Strasse 9 65558 Holzheim Germany
salts in medicine may lead to strongly increased calcium values.
For further information on interfering substances, refer to Young DS
[6].
Sensitivity/Limit of Detection
The lower limit of detection is 0.04 mg/dL (0.01 mmol/L).
Precision (at 20 – 25°C)
Intra-assay precision Mean SD CV
n = 20 [mg/dL] [mg/dL] [%]
Sample 1 8.79 0.09 1.04
Sample 2 12.5 0.15 1.20
Sample 3 14.0 0.24 1.73

Inter-assay precision Mean SD CV

n = 20 [mg/dL] [mg/dL] [%]
Sample 1 8.82 0.18 2.01
Sample 2 12.3 0.11 0.90
Sample 3 13.7 0.26 1.92
Method Comparison
A comparison of DiaSys Calcium FS (y) with a commercially
available test (x) using 70 samples gave following results:
y = 1.02 x - 0.20; r = 0.999

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