CLSI I/LA25

Maternal Serum Screening, 2nd Edition

This document addresses the steps required to provide reliable screening and reporting using examples of serum markers currently in common use (AFP, hCG, uE3, inhibin A, PAPP-A). Emphasized is first-trimester screening, in which serum markers used are PAPP-A and hCG , and the main ultrasound marker is nuchal translucency. Outcome evaluation, information management, and calculation of risk are also emphasized.

This document is available in electronic format only.

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Chairholder: Sanda Clejan, PhD

Date of Publication: April 28, 2011

Order Code PDF: CLSI ILA25A2E
ISBN Number: 1-56238-749-9

Order Code Print: print not available

Edition: Second

Pages: 64

CLSI I/LA25 Additional Details

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid of as September 2023. Because of its value to the laboratory community, it is being retained in CLSI’s library.

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CLSI I/LA25 Abstract

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.