Congenital Hypothyroidism (CH) by AutoDELFIA Neonatal TSH Assay

DataValue
Method Solid Phase Two-Site Fluoroimmunometric Assay
CPT Code 84443
Testing Scope Detection of elevated levels of TSH from clinical specimens.
Preferred Specimen Heel stick dried blood spots collected on FDA-approved filter paper (Perkin Elmer 226 Ahlstrom) at 24-48 hours of age and at 10-14 days of age.
Specimen Container Specimen collection kit comes with a biohazard flap to cover the blood when dried for about 4 hours and placed in an envelope for shipment.
Specimen Identification All information fields on the kit must be completely filled out. Each kit has a unique serial number and barcode.
Special Instructions After air-drying for 4 hours, send specimen for overnight delivery within 24 hours after collection.
Shipping Requirements Do not place specimen in a zipper bag without desiccant.
Do not expose to direct sunlight, excessive humidity or high temperature.
Note Steroids, Dopamine and/or anticoagulant EDTA will interfere with the assay.
Sample Rejection Criteria
  • Quantity not sufficient (QNS)
  • Not evenly saturated
  • Diluted/Discolored/Contaminated
  • Repetitive/Overlapping Blood Spots
  • Clotted/Layered/Oversaturated
  • Damaged
  • Separated/Serum Rings
  • Too Old (>14 days from collection)
Turnaround Time Normal result within 24-36 hours.
Presumptive positive result within 48-72 hours.