Evaluation of an enhanced luminescence assay for alpha-fetoprotein.

We evaluated a two-site enhanced luminescence immunoenzymometric assay (Amerlite; Amersham International) for alpha-fetoprotein (AFP) in maternal serum and amniotic fluid. The assay is rapid, involving two incubations totalling 4 h. The working range of the assay for serum AFP is 5.5 to 750 kilo-int. units/L (CV less than 10%), with a sensitivity of detection of 0.2 kilo-int. unit/L. The regression equation for the Amerlite assay (y) and our in-house RIA procedure (x) was y = 0.816x + 2.9 (n = 142, r = 0.96). Analytical recovery of added AFP (code 72/227) at three concentrations was 86.7%. Serum AFP concentrations were measured at 15 to 18 weeks of gestation in subjects with normal pregnancies and in subjects whose pregnancies resulted in open neural tube defects; all of the latter had serum AFP concentrations greater than 2.5 multiples of the median. We find the Amerlite system to be an efficient, reliable system for screening for open neural tube defects without use of hazardous radioactive labels.