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Establishment of reference intervals for soluble ST2 from a United States population
Jun Lu1, James V Snider, David G Grenache
1ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT 84108, USA.
Background:
Soluble ST2 (sST2) is a protein in the interleukin-1 receptor family secreted by myocytes in response to mechanical strain. Elevated sST2 is strongly prognostic in patients with heart failure.
Methods:
sST2 was measured using the Presage ST2 ELISA. Evaluation included imprecision, linearity, recovery, analytical sensitivity, limit of quantification, stability, and sample type comparisons. Gender-specific reference intervals were established from 245 male and 245 female serum specimens.
Results:
At sST2 concentrations of 11.6, 26.9, and 88.0 ng/mL, the within-day CV was 7.6, 2.4, and 3.8%, respectively and the total CV was 11.5, 14.0, and 6.3%, respectively. The assay was linear over a concentration range of 2.8-161.1 ng/mL (y=0.95x+2.25; R(2)=0.997; Sy.x=3.03). The limit of quantification was 3.3 ng/mL. sST2 was stable for 2 days at room temperature, 10days at 4 °C, and 30 days at -20 °C. Concentrations of sST2 were significantly higher in males compared to females (24.9 vs. 16.9 ng/mL; p<0.0001) but were not correlated by age in either gender (r=-0.07; p=0.14). Reference intervals for sST2 were determined to be 8.6-49.3 and 7.2-33.5 ng/mL for males and females, respectively.
Conclusion:
The Presage ST2 ELISA had acceptable performance characteristics for quantifying sST2 in serum or plasma. The assay is precise and linear over a wide sST2 concentration range and can measure low sST2 concentrations. Concentrations of sST2 are unaffected by age but are higher in males compared to females.
