Diagnostic Viability of Umbilical Cord Specimens

DESCRIPTION (provided by applicant): The current "best practices" procedure for diagnosing the in utero drug exposure of fetuses is testing the newborn's meconium for the presence of drugs. Meconium is difficult to collect and in 8-20% of births in the U.S. the meconium is released into the amniotic fluid pre-birth due to some type of fetal distress. While drugs may have induced this fetal distress it is unlikely that these infants will be tested for drug exposure due to lack of available meconium for testing. Under Phase I funding we studied the feasibility of substituting umbilical cord for meconium in fetal drug testing. Umbilical cord is readily available at every birth event and is easily collected. During the Phase I study we screened 118 matched meconium/umbilical cord samples with immunoassays specific for amphetamines, opiates, cocaine metabolites, cannabinoids, and phencyclidine (PCP) (NIDA-5 panel). The meconium samples were tested and reported out as routine clinical samples. Umbilical cord extracts were prepared, screened for the same drugs, and the results compared to the screening data for the respective meconium samples. Cutoffs for the umbilical cord screening tests were determined by ROC analyses of the data. Agreement between meconium and umbilical cord for amphetamine screening was 96.6%; for opiates was 94.9%; for cocaine metabolites was 99.2%; for cannabinoids was 90.7%; and for PCP was 100% for negatives (no PCP positive samples were obtained). Having established feasibility of umbilical cord testing in these Phase I studies, we now propose to extend these studies in Phase II to optimize and develop for production testing the umbilical cord extraction and assay procedures. We will screen by drug group-specific immunoassays and analyze by gas chromatography/mass spectrometry (GC/MS), the gold standard in drug testing, a large sampling (1000) of umbilical cord specimens from potentially drug- exposed neonates obtained from various socio-economic and ethnic populations at several birthing sites in the U.S. The data obtained will be used to establish drug screening cutoffs having optimum sensitivity and specificity. The umbilical cord screening and gold standard GC/MS assays will be validated and a marketing plan will be developed to introduce these assays into the drug testing arena. Testing of umbilical cord specimens will simplify drug testing of newborns, will allow testing of those infants suffering fetal distress, and will provide the potential to intervene for a greater population of drug-exposed babies.