SUMMARY. A microtiter plate based Dual Analyte enzymeimmunoassay method for the simultaneous measurement of o-fetoprotein (AFP) and Free-d human chorionic gonadotrophin (hCG) was evaluated. This rapid assay, which has application in both Neural Tube Defect screening and Down's screening, shows good precision with between assay coefficients of variation between 5 and 7· 5OJo for AFP and 3' 7 to 5·8% for Free-{3(hCG). Correlation with single analyte procedures is good, with correlation coefficients being greater than O'91 in both cases. Clinical discrimination in detecting both types of abnormalities is not compromised by this new simultaneous Dual Analyte assay. We conclude that the Dual Analyte approach, which combines analytes achieving the highest known detection efficiency, will bring about improvements in the efficiency of screening, reduce costs and improve report turnaround, all leading to better quality of patient care.
Additional key phrases: alphafetoprotein; Free beta human chorionic gonadotrophin; simultaneous enzymeimmunoassay; clinical evaluationThe use of maternal serum o-fetoprotein (AFP) quantitation in prenatal screening of unselected pregnant populations for structural malformations (anencephaly and spina bifida) was introduced in the mid 1970s and is now a routine part of obstetric care in many parts of the world. The subsequent observation that lowered AFP levels during the second trimester of pregnancy could be associated with fetal chromosomal trisomies added a new dimension (albeit a mediocre 20% detection rate) to an evolving screening protocol. I The search for additional markers to improve Down's syndrome detection efficiency ensued.Currently a variety of protocols including combinations of two or more analytes have been proposed.v" Recent evidence documents little or no utility for maternal serum unconjugated oestriol. 5-9 Maternal serum quantitation of intact human chorionic gonadotrophin (hCG), however, can independently identify approximately 40% of cases of Down's syndrome and, in combination with maternal age and the biochemical marker AFP, approximately 50-60% of cases of Down's Correspondence: Mr K Spencer. 390 syndrome. However, in a recent side by side comparison study," the marker Free-d (hCG) has been shown to independently identify a substantially greater number of cases of Down's syndrome than total hCG. The highest level of detection efficiency [up to 80% for trisomy 21 in early gestational weeks (less than 17 weeks)] has been achieved by combining maternal age and the biochemical markers AFP and Free-d (hCG).4 This latest observation has been confirmed by several independent studies. S • IO . ! 1The concept of using multiple markers to detect congenital disorders is a relatively new methodology requiring high level statistical computations and computer support. Additionally, linking the evaluation of both AFP and Free-d (hCG) in a single maternal serum sample raises the intriguing prospect of being able to measure both analytes simultaneously. This prospect.is enhanced i...