Assay and method for determining newborn risk for sudden infant death syndrome

摘要

An assay and method for screening newborns to determine risk of Sudden Infant Syndrome is described. The assay and method is based on the detection of elevated IgM-anti-IgG (MAG) levels in newborns' serum within the first year of birth. In particular, it has been discovered that elevated MAG levels indicate an increased risk of Sudden Infant Death Syndrome (SIDS).PPIn a preferred embodiment of the invention, an ELISA is utilized in which a first binding agent having specific affinity for IgM is used to capture and separate IgM antibodies from the newborn's blood sample. A second binding agent having specific affinity for IgG which has been separated from the sample eluant by complexing with MAG, is then used in conjunction with an enzyme conjugate to indirectly determine the amount of MAG in the newborn's blood. The MAG level is then compared to a cut-off which is selected to separate out approximately 4% of the newborns which have the highest MAG levels. These newborns are designated "high risk" and are recommended for more testing and/or monitoring.