Newborn screening for cystic fibrosis using an enzyme linked immunoabsorbent assay (ELISA) technique.

Neonatal screening for cystic fibrosis (CF) has been conducted using conventional radioimmunoassay. An alternative immunoassay approach has been developed and applied to screening 35,550 newborns. Seventeen confirmed CF infants were detected by both assays. This monoclonal antibody-based enzyme immunoassay using microtitre plate ELISA technology has proved effective in case finding and offers a number of advantages. A reduced labour component, ease of handling, use of nonradioactive reagents, long reagent shelf-life, greater specificity and a reduction in potential sample handling and transposition errors combine to make this technology appropriate for a large volume neonatal screening laboratory.