Newborn Screening

Brief Description

https://dph.georgia.gov/NBS

Laboratory Unit

Newborn Screening

Methodology

Tandem Mass Spectrometry (MSMS)

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 metabolic screens 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 an individual envelope for each specimen card.
  • Newborn Screening Dried Bloodspot Specimen (DBS) shall be completed 24 hours after birth, as follows:
    • All information requested on the NBS Card shall be legibly and accurately collected.
    • Specimens of the baby's blood shall be collected and placed on the DBS 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.
  • NBS01 Dried Blood Spot Specimen Collection for Newborn Screening, 7th ed, 2021, https://clsi.org/standards/products/newborn-screening/documents/nbs01/
  • Video training for bloodspot collection: https://dph.georgia.gov/NBS

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 of collection.
  • The NBS Card shall be sent within 24 hours to the Department's Public Health Laboratory, using a courier service that ensures next business day delivery and allows the tracking of the package. A copy of the completed NBS Card shall be maintained with the baby's clinical records.
  •  If an NBS Card does not reach the Public Health Laboratory within ten (10) days after the blood sample was drawn, the submitter shall repeat this process and submit a new Card for that baby.

Acceptable Specimen Type(s)

  • Infants:
    • Collect on infants 24-72 hours of age and preferably on a protein diet.
  • Early discharge:
    • If the infant is discharged earlier than 24 hours after birth or before a 24-hour period of protein feeding, a specimen should still be collected.  The parents should be informed in writing the child should be retested by one week of age.
  •  Preterm Low Birth Weight and or sick infants:
    • Infants who weigh less than 2500 grams should be retested when the child is four weeks of age.  Collect the first specimen 24 hours after protein feeding or 48 hours after birth.  If the infant is transferred to a Special Care Baby Unit (i.e., NICU) prior to collection of a newborn screening specimen, a specimen should be collected upon admission and prior to initiation of any treatment (e.g., transfusion, parenteral nutrition, or antibiotics).  A second specimen should be collected 48 – 72 hours after birth, and ideally at least 24 hours after any transfusion.  A third specimen should be collected 28 days after birth or at discharge, whichever occurs first.  For more information, see “Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns”, CLSI Document I/LA31-A, Vol. 28, No. 34. If the infant is to be transfused, collect a specimen before the transfusion regardless of the age.  If the child is less than 24 hours old, collect a second sample 24 hours after the last transfusion and a third sample 4-6 months after the last transfusion.

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

  • Heparin
  • Anticoagulant
  • Antiseptics

Result Reported

3-4 business days

Fees

$80.40

LOINC

54089-8