This test can be used for all pregnant women. The American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal-Fetal Medicine (SMFM) recommend that all women should be offered the option of aneuploidy screening or diagnostic testing for fetal genetic disorders, regardless of maternal age.1 The American College of Medical Genetics and Genomics (ACMG) states that there is strong evidence that noninvasive prenatal screening can replace conventional screening for trisomies 13, 18, and 21, regardless of maternal age.2
A published clinical study3 on the performance of the QNatal Advanced test in a population of pregnant women that included both those at average and those at high risk demonstrated excellent analytical sensitivity and specificity for trisomy 21, 18, and 31. The positive predictive value (PPV) was 98.1% for trisomy 21, 88.2% for trisomy 18, 59.3% for trisomy 13, 69.0% for sex-chromosome aneuploidies, and 75.0% for microdeletions. Overall, the PPV for fetal aneuploidies was 87.2%; sensitivity was 97.9% and specificity was 99.9%.