Performance characteristics of the IMMUNLITE 2000 erythropoietin assay.
BACKGROUND
Erythropoietin (EPO) is a glycoprotein hormone produced by specialized cells in the kidney that acts as the primary regulator of erythropoiesis. Serum EPO measurements are useful for diagnostic evaluations of anemia and polycythemia.


METHODS
The IMMULITE 2000 is an automated random access immunoassay analyzer for the central laboratory. The limit of detection (LOD), linearity, imprecision, comparison to another commercially available assay, and reference interval of a new EPO assay for this analyzer were assessed.


RESULTS
The LOD was 0.2 U/l. The assay was linear within an allowable systematic error of 10% over the range tested (2-178 U/l). The total imprecision of the new assay was <7% for concentrations from 15.8 to 68.4 U/l. Comparison with the Advantage EPO assay method showed comparable results. Deming regression analysis gave a slope of 1.13+/-0.02, an intercept of -1.09+/-0.97, and a S(y/x) of 7.1 (r=0.99) over the range tested (2-200 U/l).


CONCLUSIONS
The IMMULITE 2000 EPO assay shows acceptable performance and is suitable for routine clinical use.
Owen
William E
WE
ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT 84108, USA.
Roberts
William L
WL
D001322:Autoanalysis / Q000379:methods; D004921:Erythropoietin / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008163:Luminescent Measurements
D004921:Erythropoietin