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?

  •  There may be a delay in reporting the 2nd‐tier CF Mutation Panel results. No delay in reporting of other newborn screening results is expected.

  •  If a specimen is forwarded for CF Mutation Panel testing, a statement of “Final report with CFTR Mutation panel results to follow.” will be included in the Screening Result Note.

  •  When CF Mutation Panel results are available, a revised report that includes the updated results will be sent to the submitting facility and available through the Newborn Screening Web Application.

  •  If the CF DNA results are abnormal, the provider will receive a call from the clinical care coordination nurse to report the results.

    What action should the healthcare submitters take?

    •  Monitor and ensure receipt of a final report with CFTR Mutation panel results. Final results including the CF Mutation Panel may take up to 10 additional days.

    •  Carefully read all screening result notes and follow recommendations accordingly.

    •  Continue to take appropriate actions to follow up on ALL Abnormal newborn screening results.

    •  Contact DSHS NBS Laboratory for any concerns or questions on CF DNA results.

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