Elecsys Calcitonin

Electro-chemiluminescence immunoassay (ECLIA)

for the in vitro quantitative determination
of human calcitonin (hCT) in serum and plasma
Indication
Calcitonin determination is used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid
glands, including carcinoma and hyperparathyroidism in conjunction with other clinical and laboratory findings. The most
prominent clinical syndrome associated with a disordered hypersection of hCT is the medullary thyroid carcinoma (MTC),
which comprises 510% of all thyroid cancers. It may occur sporadically or in a familial form that is inherited as an auto
somal dominant trait. Furthermore, calcitonin m easurements can also be used to monitor the efficacy of therapy in patients
with calcitonin producing tumors.

Test principle: one-step sandwich assay

Streptavidin microparticle

Calcitonin in the sample

Ru 9 min Ru 9 min Ru Measurement

Biotinylated Ruthenylated
monoclonal antibody monoclonal antibodies
against calcitonin against calcitonin

1st incubation (9 minutes)

50 L of sample, a biotinylated monoclonal hCTspecific antibody and a monoclonal hCTspecific antibody labeled with
a ruthenium complex are incubated. A sandwich complex is formed with hCT carrying a biotinylated and a ruthenylated
antibody.

2nd incubation (9 minutes)

After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin
and streptavidin.

Measurement
The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the
surface of the electrode. Unbound substances are then removed. Application of a voltage to the electrode then induces
chemiluminescent emission which is measured by a photomultiplier.
Elecsys technology
ECL (ElectroChemiLuminescence) is Roches technology for immunoassay detection. Based on this technology and combined
with well-designed, specific and sensitive immunoassays, Elecsys delivers reliable results. The development of ECL immunoas
says is based on the use of a ruthenium-complex and tripropylamine (TPA). The chemiluminescence reaction for the detection
of the reaction complex is initiated by applying a voltage to the sample solution resulting in a precisely controlled reaction.
ECL technology can accommodate many immunoassay principles while providing superior performance.

Elecsys Calcitonin test characteristics

Testing time 18 min
Test principle One-step sandwich assay
Calibration 2 point
Sample material Serum
Li-heparin plasma
K2-EDTA plasma, K3-EDTA plasma
Sample volume 50 L
Limit of Blank 0.3 pg/mL
Limit of Determination 0.5 pg/mL
Limit of Quantitation 1 pg/mL with a total allowable error of 30%
Measuring range 0.52,000 pg/mL
Traceability IRP WHO 89/620
Total imprecision (NCCLS) cobas e 411 analyzer, E2010: 2.65.2%
cobas e 601 / e 602 modules, E170: 1.62.3%
Expected values* Apparently healthy females 6.39 pg/mL (97.5th percentile)
Apparently healthy males 10.2 pg/mL (97.5th percentile)
* Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine
its own reference ranges.

Typical calcitonin findings

Serum calcitonin levels are relatively high in infants, decline rapidly and are relatively stable from childhood through
adult life. In general calcitonin levels are higher in men than in women whereas smoking may lead to an additional increase
in calcitonin levels
Elevated calcitonin levels can be found in various pathological conditions e.g. medullary thyroid carcinoma, leukemic
and myeloproliferative disorders or may be produced ectopically in small cell lung cancer or breast cancer. Furthermore
elevated levels can also be found in conjunction with hyperparathyroidism, hypergastrinemia, renal failure and chronic
inflammatory disease
After total thyroidectomy detectable levels of serum calcitonin may be indicative of persistent or recurrent MTC

Order information
Elecsys Calcitonin 100 tests 06445853190
Calcitonin CalSet 4x1 mL 06445861190
PreciControl Varia 2x3 mL each 05618860190
Diluent MultiAssay 2x16 mL 03609987190

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