1630 – SELco® Calcitonin

Intended Purpose
The SELco® Calcitonin is a quantitative immunoassay for the determination of human calcitonin (hCT) concentrations in serum samples. It is intended to be used in vitro by qualified laboratory professionals as an aid in the diagnosis of thyroid dysfunctions, particularly those associated with abnormal calcitonin secretion, when used in conjunction with other clinical and laboratory findings. The assay provides clinicians with valuable information in the assessment of C-cell activity and in the diagnosis, prognosis, and monitoring of disorders such as C-cell hyperplasia and medullary thyroid carcinoma (MTC). The SELco® Calcitonin immunoassay is designed for manual professional use and complies with the requirements of in vitro diagnostic use.
Diagnostic Relevance
Calcitonin (hCT) is a 32-amino-acid peptide hormone primarily secreted by the parafollicular C-cells of the thyroid gland. It is released in response to rising calcium levels and acts to lower blood calcium and phosphate concentrations. Consequently, calcitonin functions antagonistically to parathyroid hormone (PTH) in maintaining calcium homeostasis. Although its precise biological role in bone metabolism remains under investigation, calcitonin has proven to be an important biochemical marker in the evaluation of thyroid disorders.
Moreover, abnormally elevated calcitonin levels are characteristic of C-cell hyperplasia and medullary thyroid carcinoma (MTC). Therefore, quantifying serum calcitonin provides a sensitive and specific tool for diagnosis and disease monitoring. Additionally, the test can support screening programs for patients with a familial predisposition to MTC or multiple endocrine neoplasia type 2 (MEN 2). When interpreted together with clinical symptoms and complementary laboratory parameters, calcitonin measurement offers comprehensive diagnostic insight and enhances the accuracy of medical assessment.
Product Specifications
| Title | SELco® Calcitonin |
| Product code | 1630 |
| Indication | Thyroid diseases |
| Description | Radioimmunoassay for the quantitative determination of Calcitonin (hCT) in human serum |
| Format | Coated tube technology |
| Total incubation time | Overnight |
| Sample volume | 100 µL |
| No. of determinations | 100 (92 x 1) + 6 x Calibrators and 2 x Controls |
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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.