Please note: This is a Sole Source Notification. The Minnesota Department of Health intends to enter an agreement with Qiagen for the purchase of reagents for the NBS lab's assay for Severe Combined Immunodeficiency (SCID), Spinal Muscular Atrophy (SMA), and to validate a new addition to the Newborn Screening testing panel Congenital Cytomegalovirus (CMV). This has been deemed a single source, as purification and elution solutions are only available from Qiagen. These are the only reagents that work with the currently validated CF method and SMA and SCID assays and are needed to validate CMV assay. Different reagents would require a new method validation and would not be compatible with all three assays which have different requirements for the DNA extraction. Qiagen also confirmed that they do not have any authorized distributors for these products.
