Calcitonin CANTIBODIES Laboratory, Inc. Scantibodies Immunoradiometric (IRMA) Assay for the Quantitative Determination of Calcitonin in Human Serum 1 9 7 6 S C A N T I B O D I E S 30 th Anniversary 2 0 0 6 SCANTIBODIES Laboratory, Inc. 9336 Abraham Way Santee, CA 92071 To Order Kits Please Call: Phone: (619) 258-9300 Fax: (619) 258-9366 or email: [email protected] www.scantibodies.com REF 3KG556 Calcitonin IRMA Assay Contents: - Calcitonin Standards - 6 vials - Calcitonin Control Serum - 2 vials - Anti-Calcitonin Coated Tubes - 100 - l Anti-Calcitonin - 2 vials - Wash Concentrate - Directional Insert For in vitro diagnostic use only. Scantibodies kits comply with IVDD 98/79/ ISO 9001 and ISO 13485 certified Representative Standard Curve Calcitonin (pg/mL) 100 1000 10 1 100 1000 10000 10000 100000 Corrected CPM Calculation of Results: A standard curve is generated using prepared Calcitonin standards. The following calculations are used: Average CPM of Zero Standard Average CPM of 10 pg/mL Standard CPM (10 pg/mL) - CPM (0 pg/mL) generates the Corrected CPM. SCANTIBODIES Laboratory recommends that each laboratory establish its own range of expected values. For the purpose of the directional insert, the Calcitonin level normal ranges were determined following the NCCLS guidelines (C28-A) in serum from 125 apparently healthy adults using the SCANTIBODIES Calcitonin Immunoassay. The normal range for 53 males as 3-21 pg/mL; whereas the normal value for 72 females was 1-8 pg/mL (slightly higher than in normal males, consistent with the literature). Expected Values: Description: The Scantibodies Calcitonin Immunoassay is a two-site Immunoradiometric Assay (IRMA) using coated-tube technology for the measurement of Calcitonin in human serum. Two different goat polyclonal antibodies to human Calcitonin have been purified by affinity chromatography to be specific for well-defined regions on the Calcitonin molecule. 125