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Niops pitfalls of interpreting Niipps results is a challenge we need to address because NIPS is increasingly taking place womenn the involvement of genetic counselors in pretest or post-test counseling. Womsn is real concern that patients are making pregnancy decisions based on screening tests with the misunderstanding that NIPS is diagnostic. I write this as call to the NIPS labs to change their reporting practices to better emphasize the screening nature of this technology. Providing some positive predictive value estimates would be tremendously helpful as we try to make sense of NIPS results for our patients.
While it may be difficult to provide individualized risk assessment, a general table of how prior probability impacts individual test performance would be beneficial for interpretation. Furthermore, eliminating language from the reports that suggests these tests are diagnostic and giving more transparency to ways in which performance data are calculated would also be welcome changes. As genetic counselors, we strive to ensure informed decision-making for the clients we see. Key to informed decision-making is an understanding of the limitations of this evolving technology. As fellow patient advocates, I hope the genetic counseling community will join me in requesting increased accountability and responsible reporting on the part of the labs regarding NIPS.
nipos I would like to acknowledge Evan Stoll, retired GAO data analyst for his contributions to this piece. Conclusions The experience of using NIPS in clinical practice confirms that wojen results cannot be considered diagnostic. Pre-test counseling should emphasize this. Diagnostic genetic testing should always be offered following abnormal NIPS results. The fragments are most frequently base pairs in length [ 12 ] and derive mostly from apoptotic cells [ 2 ]. During pregnancy, placental cytotrophoblastic cells are shed into maternal circulation and contribute to the cfDNA pool in the maternal bloodstream [ 3 ].
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Non-invasive prenatal nippx NIPS for fetal chromosome abnormalities is based on either massively parallel sequencing [ 5 — 11 ] or analysis of single nucleotide polymorphism SNP patterns [ 1213 ] from cfDNA in maternal serum. Very high sensitivity Somewhat lower sensitivities and specificities are seen when screening for trisomy 18 T18trisomy 13 T13and the sex chromosome aneuploidies SCAs: Although sensitivity and specificity are important performance metrics, positive predictive value PPV and negative predictive value NPV become more clinically relevant after results have returned. Performance was evaluated by calculating standard metrics such as PPV.
Underlying biological causes for discordant results were determined where possible. Some discordant or unusual cases are described in detail.
Benefits and limitations of using NIPS in clinical practice and recommendations for follow-up of abnormal results are discussed. Patient age at delivery, gestational age at screening, indication for screening, and maternal serum screen results nipos extracted from outpatient clinic notes. Pregnancy outcomes were extracted from delivery summaries. Fetal ultrasound results were extracted from radiology records; diagnostic wwomen test results were extracted from cytogenetics records; and NIPS results Older women nipps extracted from laboratory records.
Patients with normal NIPS results typically declined prenatal diagnostic genetic testing. If not already completed, maternal serum alpha-fetoprotein AFP and fetal anatomy ultrasound were recommended, and the patient was referred back to her primary obstetrical provider for routine care. Patients with abnormal NIPS results were offered high-resolution fetal ultrasound interpreted by either a UWMC perinatologist or a UWMC radiologist specializing in fetal anatomical imaging, genetic counseling, and prenatal diagnostic genetic testing via chorionic villus sampling CVS or amniocentesis.
When the latter was declined, postnatal testing was recommended. Maternal chromosome analysis was added to our recommendations several months after we started to offer NIPS. Normal NIPS results were defined as concordant when either diagnostic genetic test results matched the screen results or, for patients declining prenatal diagnostic genetic testing and delivering at UWMC, when normal pregnancy outcome was confirmed by review of delivery records.