Newborn Screening

Brief Description

Newborn screening (NBS) identifies potentially serious and life-threatening conditions within the first days of a newborn’s life.  Most babies appear healthy and show no signs of illness right after birth.

Laboratory Unit

Newborn Screening

Methodology

Tandem Mass Spectrometry (MS/MS), Immunoassay, High Performance Liquid Chromatography (HPLC) and Molecular.

Specimen Collection

  • Blood Collection on Filter Paper:
    • Form 3491 is a FDA-licensed medical collection device. It consists of a form and an attached filter paper strip for collection of the specimen. A pre-addressed UPS envelope is available for hospitals. Form 3491 and the pre-addressed envelope can be ordered from: Laboratory Services and Supply, 1749 Clairmont Road, Decatur, GA 30033, (phone: 404-327-7928). Store forms upright in a cool, dry area. When submitting to the GPHL, use only the material supplied. The forms currently in use include a protective wrap-around cover for the filter paper, and do not require individual envelopes.
  • Newborn Screening Dried Bloodspot Specimen (DBS) shall be collected at ≥24 to 48 of age, as follows:
    • All information requested on the NBS card shall be legible and accurately completed.
    • Specimens of the infant's blood shall be collected and placed on the NBS card in accordance with the current edition of the Georgia Newborn Screening Program Policy and Procedure Manual and allowed to dry for at least three hours.
  • Specimen Collection Training Resources: 

Storage/Transport

  • Dried blood samples can be maintained at room temperature (15-30 °C) in the envelopes during transit for no more than 24 hours following collection.
  • The NBS card shall be sent within 24 hours to the GPHL using a courier service that ensures next business day delivery and allows tracking of the package. A copy of the completed NBS card shall be maintained with the infant's clinical records. 
  • If a NBS card does not reach the GPHL within ten (10) days of collection, the submitter shall repeat this process and submit a new card for that infant.

Acceptable Specimen Type(s)

  • Infants:
    • Collect the initial dried blood spot specimen at ≥24 to 48 hours of age. 
  • Early discharge: 
    • If the infant is discharged before 24 hours of age, collect a specimen prior to discharge, and collect a repeat specimen at 48–72 hours of age to identify potential false-positive results caused by early screening. 
  •  There are additional screening considerations and schedules for the following Special Populations: 
    • Infants Unlikely to Survive 
    • NICU or Special Care Baby Unit (SCBU) 
    • Transferred Infants 
    • Transfusions/Blood Products/ECMO 
    • Parenteral Nutrition 
    • NPO/IV Fluids Only 
    • Older Infants/Children 
  • Please review the Georgia Newborn Screening Policy and Procedure Manual for Timing for Special Populations.

Test Request

Form 3491 is an FDA-licensed medical collection device.

Possible Results

  • Normal
  • Abnormal
  • Unsatisfactory
  • Inconclusive

Reference Range

Normal

Unacceptable Conditions

  • Capillary or venous blood samples
  • Incomplete Saturation
  • Specimen abraded
  • Layered, clotted, or supersaturated
  • Diluted, discolored, or contaminated
  • Serum rings
  • Blood on overlay cover
  • Expired form
  • Damaged form
  • Incomplete patient information/labeling
  • Wet forms

Interfering Substances

  • Anticoagulant (Heparin and others)
  • Antiseptics 
  • Total parenteral nutrition (TPN)

Result Reported

3-4 business days

Fees

$96.13

LOINC

54089-8