Objectives: To assess the performance of the Immulite 2000 serum gastrin assay.
Design and methods: Two-center validation and comparison with two manual gastrin assays.
Results: Serum, serum separator, EDTA and heparin tube results differed <20%. Samples showed <20% degradation for <6 h at room temperature, 3-day-refrigerated, and underwent 3 freeze-thaw cycles. Imprecision was <8% between 20 and 824 ng/L (10-393 pmol/L). Spike recovery was 88.5-106%, and recovery on dilution was 62-135%. There were no interferences from gastrin 1-14, pentagastrin, and cholecystokinin (CCK) 1-33 and CCK 26-33. The fasting reference range was <100 ng/L (<48 pmol/L). Regression slopes to the manual assays were 0.9 and 0.97, with comparable clinical performance.
Conclusions: The Immulite 2000 assay is precise, accurate, and fast and compares well with established gastrin assays.