Planned System Maintenance

Background

The clinical significance and inclusion of pregnant persons’ race in prenatal serum screening for fetal trisomy 21 (T21), trisomy 18 (T18), and open neural tube defects (ONTDs) is under debate within the medical community. While some studies support race-based adjustments, recent evidence challenges their validity, highlighting concerns about disease misclassification and the potential for associated healthcare inequities.

Scope

The primary goal of this guideline is to evaluate the evidence supporting the utility of race-based adjustments in prenatal serum screening for fetal aneuploidies and ONTDs. This guideline aims to inform pathologists’ and other healthcare professionals’ decisions regarding the continuation, refinement, or elimination of existing race-based practices to ensure equitable and evidence-based care for pregnant individuals.

Key Questions

The draft overarching question is:

  • In first and second trimester prenatal serum screening for fetal trisomy 21 (T21), trisomy 18 (T18), and open neural tube defects (ONTDs), what is the impact of excluding race/ethnicity-based adjustment—whether in the calculation of individual serum biomarkers or in multivariate risk algorithms—on screening performance and patient-centered outcomes, compared to approaches that include race/ethnicity-based adjustment?

Key Question List

Guideline Information

  • Guideline Status: Complete Recommendations and Draft Manuscript
  • Collaborators: American College of Medical Genetics and Genomics (ACMG); American College of Obstetricians and Gynecologists (ACOG); Association for Diagnostics & Laboratory Medicine (ADLM); International Society for Prenatal Diagnosis (ISPD); Society of Black Pathology (SBP)

Expert Panel Members

  • Ann Moyer, MD, PhD, FCAP, Co-chair
  • Marvin Natowicz, MD, PhD, FACP, FACMG, Co-chair
  • Octavia Peck Palmer, PhD, Co-chair
  • April Adams, MD
  • Allison Allen, MD
  • Dina Greene, PhD
  • Geralyn Messerlian, PhD
  • Christina Pierre, PhD
  • Lesley Souter, PhD
  • Julie Donovan, MLS(ASCP)
  • Marisol Hernandez, MA, MLS

The CAP Pathology and Laboratory Quality Center for Evidence-based Guidelines (Center) develops recommendations related to the practice of pathology and laboratory medicine. Through this work, we and our members continually improve the quality of diagnostic medicine and patient outcomes. For questions, please contact Center@cap.org.

Access the Prenatal Serum Screening Symposium Proceedings

The symposium examined the scientific, clinical, ethical, and operational considerations surrounding the use of race in prenatal serum screening.