A new simple and rapid dual assay for AFP and free beta hCG in screening for Down syndrome.

We have evaluated a simple and rapid 2-step dual-label assay (DELFIA) for alphafetoprotein (AFP) and free beta subunit of human gonadotropin (hCG beta) in second-trimester screening for Down syndrome. Based on stored serum samples from 1059 normal control pregnancies and 72 cases of Down syndrome, we have found the mean Multiple of Median (MoM) for AFP and free hCG beta to be 0.70 and 2.31, respectively. This is slightly but not significantly better than the values for the separate assay for AFP (0.76 MoM) and for intact hCG (2.11 MoM). However, the dual assay is much simpler than the separate assays and therefore prospective comparison trials should be carried out.