Description

INTENDED USE

This in vitro diagnostic reagent is intended for the quantitative determination of total calcium in human serum, plasma and urine samples.

CLINICAL SIGNIFICANCE

In blood, approximately 45% of the plasma calcium is free, 45% is protein bound, mainly associated with albumin, and 10% is complexed to anions.

Calcemia measures total calcium but only free calcium is biologically active. Calcium plays an active physiological role in bone mineralization, neuromuscular excitability, muscle contraction, and blood coagulation.

Hypocalcemia can result from chronic renal failure with hyperphosphatemia, from hypoparathyroidism, or vitamin D deficiency (osteomalacia, rickets). The most com- mon cases of hypercalcemia are associated with hyperparathyroidism, tumors, or vitamin D overdose.

Calcemia measurement is mostly indicated to help diagnose bone pathologies, neurological disorders, pathologies associated with symptoms of hypercalcemia or hypocalcemia as well as for monitoring renal pathologies (including kidney transplant follow-up), certain types of cancers, or for monitoring treatments involving calcium or vitamin D supplements. It is also recommended for general routine assessments. Calciuria testing is indicated to help diagnose kidney stones or as a complementary information to a blood calcium test.

LIMITATION OF USE

Because hypoalbuminemia triggers pseudo-hypocalcemia, serum total protein and/ or albumin levels must be considered for the proper interpretation of total calcemia results.

The quantitative assay of calcium alone can not be used to diagnose a disease or a specific pathology.

The results must be interpreted in conjunction with other diagnostic test results, clinical findings and the patient’s medical history.

METHOD & PRINCIPLE

Arsenazo III – End point.

At slightly acidic pH, Ca2+ forms with Arsenazo III [2,7-(bis(2-arsonophenylazo))-1,8-di- hydroxynaphtalene-3,6-disulphonic acid], a blue complex the absorbance of which is directly proportional to total calcium concentration.

COMPOSITION

Reagent: R

Good’s Buffer, pH 6.5 (20-25°C) Arsenazo III                200 μmol/L

MATERIALS REQUIRED BUT NOT PROVIDED

• CALI-0550 ELICAL 2
• CONT-0060 ELITROL I
• CONT-0160 ELITROL II
• Normal saline solution (NaCl 9 g/L).
• General Laboratory equipment (e.g. pipette).
• Selectra Mach analyzer and
• Do not use materials that are not required as indicated