Iiquicolor Performance Characteristics

Linearity
Photometric Test for Calcium
The test is linear up to a calcium concentration of 15 mg/dI or
CPC Method 3.75 mmoI/l. Samples with a higher concentration have to be diluted
Package Size 1 + 1 with distilled water.
[REF] 10011 200 ml Complete test kit Repeat the assay and multiply the results by 2.
[IVD] Typical performance date can be found in the Verification Report,
accessible via
Method1,2 www.human.de/data/gb/vr/ey-ca.pdf or
Calcium ions react with o-cresoIphthalein-compIexone in an alkaline
medium to form a purple coloured complex. The absorbance of this www.human-de.com/data/gb/vr/ey-ca.pdf
complex is proportional to the calcium concentration in the sample.
Normal values
Contents Serum/plasma: 8.1 - 10.4 mg/dl or 2.02 - 2.60 mmol/l
[BUF] 100 ml Buffer Solution
Quality Control
Lysine buffer (pH 11.1) 0.2 moI/l
All control sera with calcium values determined by this method can be
Sodium azide 0.095 %
employed.
[RGT] 100 ml Colour Reagent
We recommend to use our quality control sera HumaTrol based on
8-Hydroxyquinoline 14 mmol/l
animal serum or our SERODOS based on human serum.
o-Cresolphthalein-complexone 0.1 mmol/l
Hydrochloric acid 40 mmol/l Automation
[STD] 3 ml Standard Proposals to apply the reagents on analysers are available on request.
Calcium (II) 8 mg/dl or 2 mmol/l Each laboratory has to validate the application in its own responsibility.
Sodium azide 0.095 %
Notes
Reagent Preparation 1. Contaminated glassware is the greatest source of error. Disposable
Add [RGT] to [BUF] in equal volumes as required, mix and allow to stand plastic ware is recommended for the test.
for 30 minutes at room temperature before use.
2. The test is not influenced by hemoglobin up to 200 mg/dI and bilirubin
Reagent Stability up to 20 mg/dl.
The reagents and the standard are stable even after opening up to the 3. Lipemic and haemolytic samples require a sample blank. By using the
stated expiry date when stored at 2...25°C. Contamination must be same pipetting scheme mix 20 µl of sample with 1000 µl of distilled
avoided. water and measure the absorbance (Asample blank) against distilled wa-
ter. Asample blank has to be subtracted from Asample.
The working reagent is stable for 7 days at 2...8°C and for 3 days at
15...25°C. 4. [BUF] and [STD] contain sodium azide (0.095%) as preservative. Do not
swallow. Avoid contact with skin and mucous membranes!
Specimen 5. Measurement at 546 nm results in OD values around 40% lower than
Serum, heparinised plasma at 570/578 nm. Make sure that the instrument used has a sufficient
Stability in serum: 10 days at 2...25°C. optical quality.
6. When measuring at 546 nm, the interference by haemoglobin is much
Assay
more prominent than at 578 nm. In this case, haemoglobin content of
Wavelength: 570 nm, Hg 578 nm; 546 nm the sample should be assessed separately.
Optical path: 1 cm 7. The chemicals sodium or magnesium perchlorate or drugs that contain
Temperature: 20...25°C perchlorate (such as Irenat®) may cause interference leading to falsely
Measurement: Against reagent blank. Only one reagent blank per series low values for ionised CA++. This interference has only been observed
is required. with other methods and has not so far been reported for [REF] 10011.
8. A slight brownish sediment may develop as [BUF] ages that does not
Pipetting Scheme influence the functionality of [BUF]. Do not swirl up this sediment
Pipette into cuvettes Reagent blank Sample or [STD] during pipetting.
Sample or [STD] --- 20 µl
References
Working reagent 1000 µl 1000 µl 1. PolIard F. H., Marun, J. V., AnaIyst 81, 348 (1956)
Mix and measure the absorbance of sample (Asample) and standard 2. Gitelman H., Anal. Biochem. 20, 521 (1967)
(A[STD]) against the reagent blank within 5 to 30 minutes.
3. Barnett R.N. et al., Amer. J. Clin. Path. 59, 836 (1973)

EY-CA INF 101101 GB 09-2012-21

Calculation of the Calcium Concentration

 Asample
c = 8 x (mg/dl)
A[STD]
or
Asample
c = 2 x  (mmol/l)
A[STD]

Human Gesellschaft für Biochemica und Diagnostica mbH

Max-Planck-Ring 21 · 65205 Wiesbaden · Germany
Telefon +49 6122-9988-0 · Telefax +49 6122-9988-100 · e-Mail human@human.de