Noninvasive prenatal testing in routine clinical practice--an audit of NIPT and combined first-trimester screening in an unselected Australian population

Aust N Z J Obstet Gynaecol. 2016 Feb;56(1):22-8. doi: 10.1111/ajo.12432.

Abstract

Background: There are limited data regarding noninvasive prenatal testing (NIPT) in low-risk populations, and the ideal aneuploidy screening model for a pregnant population has yet to be established.

Aims: To assess the implementation of NIPT into clinical practice utilising both first- and second-line screening models.

Materials and methods: Three private practices specialising in obstetric ultrasound and prenatal diagnosis in Australia offered NIPT as a first-line test, ideally followed by combined first-trimester screening (cFTS), or as a second-line test following cFTS, particularly in those with a calculated risk between 1:50 and 1:1000.

Results: NIPT screening was performed in 5267 women and as a first-line screening method in 3359 (63.8%). Trisomies 21 and 13 detection was 100% and 88% for trisomy 18. Of cases with known karyotypes, the positive predictive value (PPV) of the test was highest for trisomy 21 (97.7%) and lowest for monosomy X (25%). Ultrasound detection of fetal structural abnormality resulted in the detection of five additional chromosome abnormalities, two of which had high-risk cFTS results. For all chromosomal abnormalities, NIPT alone detected 93.4%, a contingent model detected 81.8% (P = 0.097), and cFTS alone detected 65.9% (P < 0.005).

Conclusions: NIPT achieved 100% T21 detection and had a higher DR of all aneuploidy when used as a first-line test. Given the false-positive rate for all aneuploidies, NIPT is an advanced screening test, rather than a diagnostic test. The benefit of additional cFTS was the detection of fetal structural abnormalities and some unusual chromosomal abnormalities.

Keywords: NIPT; cell-free DNA; chromosome abnormality; prenatal; screening; ultrasound.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aneuploidy
  • Australia
  • Chromosome Disorders / diagnosis*
  • Chromosomes, Human, Pair 13
  • Chromosomes, Human, Pair 18
  • Chromosomes, Human, X
  • Chromosomes, Human, Y
  • Down Syndrome / diagnosis
  • False Positive Reactions
  • Female
  • Genetic Testing / methods*
  • Genetic Testing / statistics & numerical data
  • Humans
  • Maternal Serum Screening Tests / methods*
  • Maternal Serum Screening Tests / statistics & numerical data
  • Medical Audit
  • Predictive Value of Tests
  • Pregnancy
  • Pregnancy Trimester, First*
  • Prospective Studies
  • Sex Chromosome Aberrations
  • Trisomy / diagnosis
  • Trisomy 13 Syndrome
  • Trisomy 18 Syndrome
  • Ultrasonography, Prenatal / methods*
  • Ultrasonography, Prenatal / statistics & numerical data