Calcitonin (CT), IRMA

The DiaSource CT-U.S.-IRMA kit is a non-automated immunoradiometric assay (IRMA) intended to be used for the quantitative measurement of calcitonin (CT) in human serum by trained professionals in medical laboratories.

The in vitro diagnostic medical device is intended to be used for aiding to diagnosis, for monitoring and for post-operative follow-up of Medullary Thyroid Carcinoma (MTC).

The measurement of CT is useful in patients at risk of MTC due to hereditary traits or with thyroid nodular disease found by palpation or ultrasound, as well as in patients after thyroidectomy.

The operation principle of immunoradiometric assays (IRMAs) is based on interactions of radio-labelled antibodies with epitopes on a target analyte. Such assays are used to detect very low concentrations of a target analyte.

The CT-U.S. IRAM kit, now IVDR format.

Hey, it seems that you’re connected from United States.

For registration requirements in countries outside of European market, please contact regulatory.affairs@diasource.be.

Technical Specifications

Ref.: KIP0429
Regulatory Status: CE-IVDR
Format: IRMA
Label: I125
Size: 96 tests
Sample Type: Serum
Sample Volume: 200 µL
Controls: 2 levels
Range: 8-700 pg/mL
Sensitivity: 3,7 pg/mL
Incubation: 18h ± 1h at 2-8°C
Shelf Life (weeks): 7
Calibration: WHO International Standard NIBSC 89/620

For registration requirements in countries outside of European market, please contact regulatory.affairs@diasource.be.