scope:

This standard specifies requirements and recommendations for maternal serum aspects of prenatal screening for neural tube defects (NTDs) and trisomy 21 (T21) (Down syndrome [DS]) and incorporates ultrasound measurements to ensure that screening methods and quality control procedures are carried out to a high standard. It offers guidance that may be used by manufacturers and clinical laboratories that provide prenatal screening services. This document also addresses the standards that should be maintained by manufacturers and by laboratories and clinicians when providing screening services used to evaluate pregnancies and risks of fetal disease.

This document intends to strike a balance between being sufficiently specific to be clear but not too prescriptive, allowing laboratory directors to use their professional judgment in setting policy.

The intended users of this standard are manufacturers, diagnostic laboratories, regulatory agencies, and public health authorities involved in providing or regulating prenatal screening services used to evaluate pregnancies and risks of fetal disease.