Calcium MonlabTest® Blank Calibrator Sample

R 1 (mL) 1,0 1,0 1,0

o-Cresolphtalein v/v. Colorimetric R 2 (mL) 1,0 1,0 1,0
Calibrator(Note 3, 4) (µL) -- 20 --
Quantitative determination of calcium Sample (µL) -- -- 20

Only for professional in vitro diagnostic use 4. Mix and incubate for 5 min. at 37ºC / 15-25ºC.
Store at 2-8°C 5. Read the absorbance (A) of the samples and calibrator, against the
PRINCIPLE OF THE METHOD Blank. The color is stable for at least 40 minutes.
The measurement of calcium in the sample is based on formation of CALCULATIONS
color complex between calcium and o-cresolphtalein in alkaline Serum and plasma
medium: ( A ) Sample x 10 (Calibrator conc.) = mg/dL calcium in the sample
OH+ ( A ) Calibrator
Ca + o-Cresolphtalein 
++
→ Colored complex
The intensity of the colour formed is proportional to the calcium Urine 24 h
concentration in the sample1,2,3. ( A ) Sample x 10 (Calibrator conc.)x vol. (dL) urine/24 h =mg/24 h
( A ) Calibrator
CLINICAL SIGNIFICANCE
calcium
Calcium is the most abundant and one of the most important minerals Conversion factor: mg/dL x 0,25= mmol/L.
in the human body. Approximately 99% of body calcium is found in
bones. A decrease in albumin level causes a decrease in serum QUALITY CONTROL
calcium. Control sera are recommended to monitor the performance of assay
Among causes of hypercalcemia are cancers, large intake of vitamin procedures: CONTROL Normal and Pathologic (Ref. MO-165107 and MO-
D, enhaced renal retention, osteoporosis, sarcosidosis, thyrotoxicosis, 165108).
hyperparathyroidism. If control values are found outside the defined range, check the instrument,
Low levels of calcium are found in hypoparathyroidism, reagents and calibrator for problems.
pseudohypoparathyroidism, vitamin D deficiency, malnutrition and Each laboratory should establish its own Quality Control scheme and
intestinal malabsortion1,6,7. corrective actions if controls do not meet the acceptable tolerances.
Clinical diagnosis should not be made on a single test result; it should REFERENCE VALUES1
integrate clinical and other laboratory data.
Serum or plasma:
Adults 8,5-10,5 mg /dL ≅ 2,1-2,6 mmol/L
REAGENTS Children 10 -12 mg/dL ≅ 2,5 - 3 mmol/L
Newborns 8 -13 mg/dL ≅ 2 - 3,25 mmol/L
R1
Ethanolamine 500 mmol/L Urine:
Buffer
Adults 50 - 300 mg/24h ≅ 1,25 – 7,5 mmol/24h
R2 o-Cresolphtalein 0,62 mmol/L
Children 80 -160 mg/24h ≅ 2 - 4 mmol/24h
Chromogen 8-Hidroxyquinolein 69 mmol/L
These values are for orientation purpose; each laboratory should establish
CALCIUM CAL Calcium aqueous primary standard 10 mg/dL
its own reference range.
PRECAUTIONS
PERFORMANCE CHARACTERISTICS
R1/R2: Corrosive (C):R35:Causes severe burns. Measuring range: From detection limit of 0,071 mg/dL to linearity limit of
PREPARATION 35 mg/dL.
All the reagents are ready to use. If the results obtained were greater than linearity limit, dilute the sample
1/2 with NaCl 9 g/L and multiply the result by 2.
STORAGE AND STABILITY Precision:
All the components of the kit are stable until the expiration date on
the label when stored tightly closed at 2-8ºC, protected from light and Intra-assay (n=20) Inter-assay (n=20)
contaminations prevented during their use. Mean (mg/dL) 9,14 16,02 9,34 16,27
Do not use reagents over the expiration date. SD 0,07 0,11 0,20 0,37
Signs of reagent deterioration: CV (%) 0,74 0,68 2,16 2,27
- Presence of particles and turbidity.
- Blank absorbance (A) at 570 nm ≥ 0,2.
Sensitivity: 1 mg/dL = 0,044 A.
ADDITIONAL EQUIPMENT Accuracy: Results obtained using MONLABTEST reagents (y) did not show
- Spectrophotometer or colorimeter measuring at 570 nm. systematic differences when compared with other commercial reagents (x).
- Matched cuvettes 1.0 cm light path. The results obtained using 50 samples were the following:
-
General laboratory equipment (Note 1, 2). Correlation coefficient (r): 0,981.
Regression equation: y=0,8234x + 1,5484.
SAMPLES The results of the performance characteristics depend on the analyzer used.
- Serum or plasma1: Separated from cells as rapidly as possible. Blood
anticoagulants with oxalate or EDTA are not acceptable since these INTERFERENCES
chemicals will strongly chelate calcium. No interferences were observed with triglycerides up to 1,25 g/L1,2,3.
- Urine1: Collect 24 hour urine specimen in calcium free containers. A list of drugs and other interfering substances with calcium determination
The collecting bottles should contain 10 ml of diluted Nitric acid has been reported4,5.
(50% v/v). Record the volume. NOTES
Dilute a sample 1/2 in distilled water. Mix. Multiply results by 2 1. CALCIUM CAL: Proceed carefully with this product because due its
(dilution factor). nature it can get contamined easily.
Stability of the samples: Calcium is stable 10 days at 2-8ºC. 2. It is recommended to use disposable material. If glassware is used the
PROCEDURE material should be scrupulously cleaned with diluted 1/1 HNO3 in water
1. Assay conditions: and then thoroughly rinsed it with distilled water.
Wavelength: . . . . . . . . . . . . . .. . . . . .570 nm (550-590) 3. Most of the detergents and water softening products used in the
Cuvette: . . . . . . . . . . . . . . . . . . . . .. . . . . 1 cm. light path laboratories contains chelating agents. A defective rinsing will
Temperature . . . . . . . . . . . . . . . . . . . . . . .37ºC / 15-25ºC invalidate the procedure.
2. Adjust the instrument to zero with distilled water.
3. Pipette into a cuvette:
Ref: MO-165076 Monlab SL Selva de Mar 48 08019 Barcelona Spain + 34 93 433 58 60 Fax +34 93 436 38 94 [email protected] www.monlab.com
Rev: JANUARY 2014
4. Calibration with the aqueous standard may cause a systematic
error in automatic procedures. In these cases, it is recommended
to use a serum Calibrator.
5. Use clean disposable pipette tips for its dispensation.
6. MONLAB has instruction sheets for several automatic
analyzers. Instructions for many of them are available on
request.
BIBLIOGRAPHY
1. Farell E C. Calcium. Kaplan A et al. Clin Chem The C.V. Mosby
Co. St Louis. Toronto. Princeton 1984; 1051-1255
1255 and 418.
2. Kessler G. et al. Clin Chem Vol 10, No 8 1964; 686-706.
686
3. Connerty H. V. et al. Am J Clin Path Vol 45, No 3 1996; 200-296.
200
4. Young DS. Effects of drugs on Clinical Lab. Tests, 4th ed AACC
Press, 1995.
5. Young DS. Effects of disease on Clinical Lab. Tests, 4th ed. AACC
2001.
6. Burtis A. et al. Tietz Textbook of Clinical Chemistry, 3rd ed. AACC
1999.
7. Tietz N W et al. Clinical Guide to Laboratory Tests, 3rd ed. AACC
1995.
PACKAGING

R1: 1 x 125 mL
MO-165076 R2: 1 x 125 mL
CAL Ca: 1 x 5mL

SYMBOLS FOR IVD COMPONENTS

ONENTS AND REAGENTS

For in vitro diagnostic

Manufacturer
use only
Consult instructions
Don’t re-use
for use
Contains sufficient
n Keep dry
for <n> tests
Catalogue Code Temperature limitation
Lot Number Use by

Ref: MO-165076 Monlab SL Selva de Mar 48 08019 Barcelona Spain + 34 93 433 58 60 Fax +34 93 436 38 94 [email protected] www.monlab.com
Rev: JANUARY 2014