CLSI ILA25
Maternal Serum Screening
This CLSI document provides guidance on maternal serum screening, including key serum and ultrasound markers, risk calculation, and outcome evaluation. It supports laboratories and clinicians in ensuring accurate screening and reporting for prenatal risk assessment.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute document I/LA25-A2—Maternal Serum Screening; Approved Standard—Second Edition is written for clinical laboratorians who participate in prenatal screening for open neural tube defects and trisomy 21 (Down syndrome) involving alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), unconjugated estriol (uE3), inhibin A, and/or pregnancy-associated plasma protein-A (PAPP-A) measurements, as well as for clinicians and manufacturers who have a direct interest in the tests. First-trimester screening (including nuchal and ultrasound measurements) and integrated first- and second-trimester screening are emphasized. The standard is intended to present necessary considerations: preanalytical, analytical, and postanalytical (preexamination, examination, and postexamination); and to ensure the reliability of the tests, including the risk calculation, the outcome evaluation, and the accuracy of the information management. If properly applied, the five biochemical determinations and the risk calculations can contribute constructively to the field of prenatal screening and to the welfare of pregnant women and the fetus.
Many new options are available since publication of I/LA25-A, including testing in the first trimester, in the second trimester, and testing that combines both the first and second trimester.
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.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This document is available in electronic format only.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
Clinical and Laboratory Standards Institute document I/LA25-A2—Maternal Serum Screening; Approved Standard—Second Edition is written for clinical laboratorians who participate in prenatal screening for open neural tube defects and trisomy 21 (Down syndrome) involving alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), unconjugated estriol (uE3), inhibin A, and/or pregnancy-associated plasma protein-A (PAPP-A) measurements, as well as for clinicians and manufacturers who have a direct interest in the tests. First-trimester screening (including nuchal and ultrasound measurements) and integrated first- and second-trimester screening are emphasized. The standard is intended to present necessary considerations: preanalytical, analytical, and postanalytical (preexamination, examination, and postexamination); and to ensure the reliability of the tests, including the risk calculation, the outcome evaluation, and the accuracy of the information management. If properly applied, the five biochemical determinations and the risk calculations can contribute constructively to the field of prenatal screening and to the welfare of pregnant women and the fetus.
Many new options are available since publication of I/LA25-A, including testing in the first trimester, in the second trimester, and testing that combines both the first and second trimester.
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.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
This document is available in electronic format only.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.