Newborn Screening Notice of Cyctic Fibrosis Testing Delays
AUSTIN, April 13, 2016 - The Texas Newborn Screening (NBS) Laboratory received notification that some reagents used to identify mutations as part of the Cystic Fibrosis (CF) newborn screen have been recalled by the manufacturer due to potential false positive results. Effective April 1, 2016, our laboratory has temporarily ceased reporting abnormal results of CF Mutation Panel based on in house testing. Specimens may be forwarded to a reference laboratory for CF DNA testing until our laboratory can re‐establish the full testing. There will be no additional cost to submitters.
All previously reported CF DNA results are considered accurate and not affected by this recall.
What specimens may be affected?
ONLY second screen specimens with an elevated IRT or first screen specimens with an elevated IRT for which the laboratory has not received the second screen within 30 days after birth.
How does this impact newborn screening test results?