Endocrine Abstracts

Introduction: Automated calcitonin assays are one-step sandwich chemiluminescence immunoassay, intended for the quantitative determination of calcitonin in human serum. Calcitonin is the most specific and sensitive marker of medullar thyroid carcinoma for both primary diagnosis and the post-surgical follow-up. Recently a new fast and high throughput Calcitonin II-Gen assay developed on the fully automated LIAISON instruments, which is suitable for high working capacity laboratories.

Design: Evaluation took place in Clalit HMO central lab, currently using the SIEMENS IMMULITE^® 2000 Calcitonin assay. Forty-one randomly outpatients’ serum samples collected from Clalit Central Laboratory, 42 from Clalit Haifa and Western Galilee Laboratory and nine from Clalit Jerusalem laboratory. The samples were tested on LIAISON XL and IMMULITE 2000 in parallel. Results were analysed according to patients’ gender and kit performance was tested.

Results: Correlation between LIAISON^® Calcitonin II-Gen and IMMULITE^® 2000 calcitonin was analysed for: i) samples from Clalit Atidim central laboratory. ii) Samples from Clalit Haifa and Western Galilee Laboratory. iii) Samples from Clalit Jerusalem laboratory. Calculated total clinical agreement was 100, 100 and 89% respectively. Correlation and total clinical agreement were calculated on all three labs’ samples showed r=0.995, and 99% respectively. Correlation between LIAISON and IMMULITE Calcitonin of NEQAS samples showed r=0.9995. Precision of LIAISON^® Calcitonin II-Gen was tested between and within runs and found to be 3.75–5.54% CV and 1.24–3.45% CV respectively. Functional sensitivity showed values of 1.136, 1.299 and 2.233 pg/ml. Dilution test showed linearity of r=0.9922.

Conclusions: High correlation observed between LIAISON and IMMULITE Calcitonin together with high clinical agreement. It is concluded that the LIAISON^® Calcitonin II-Gen can be used as reliable and accurate kit for high throughput laboratories