Will women feel that combined first-trimester screening is an inferior test if they cannot afford NIPT?.Will women not see the need for a first-trimester scan?.Will providers undertake independent advertising?.Will women be adequately informed and counselled?.Many concerns are emerging already and must be addressed as this test is incorporated into clinical practice: 2 NIPT has not been validated as yet for multiple pregnancies, although some companies still offer the test for twins and higher order multiples. There is also a percentage of tests that fail to yield a result, usually because of low fetal DNA fraction (when 90%, but is expensive. 7 A karyotype will provide diagnostic information, reveal an unbalanced translocation and provide more information for mosaic cases. The false-positive rate is low but significant and, therefore, invasive testing is always recommended to confirm a positive result. In addition, if the patient requests analysis of the sex chromosomes, the test shows the sex of the fetus and some sex chromosome abnormalities. The result is available within 10–14 days and reports a risk assessment for trisomy 21, 18 and 13. All samples are sent offshore to America or China at a cost to the patient of $500–1400, depending on the provider. Pregnant women who elect to have NIPT can have a blood test from 10 weeks gestation. These large trials confirm similar high detection rates and low false-positive rates for the test in a general obstetric population. There have now been five clinical trials evaluating NIPT in a population of low- and high-risk women from China, the United Kingdom and the United States.
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