Interpretation: Among those who had a positive screening test, the probability of disease was 11.8. It has not been cleared or approved by the Food and Drug Administration. Positive predictive value focuses on subjects with a positive screening test in order to ask the probability of disease for those subjects. These are the metrics that are citedi.e., often as percentages, although sometimes as decimal fractions, and preferably with accompanying 95 confidence. This test was developed, and its performance characteristics determined, by LabCorp. Sensitivity a / ( a + c) × 100 Specificity d / ( b + d) × 100 Positive predictive value ( PPV) a / ( a + b) × 100 Negative predictive value ( NPV) d / ( c + d) × 100.
Pregnancy management decisions, including termination of the pregnancy, should not be based on the results of this test alone. The results of this testing, including the benefits and limitations, should be discussed with a qualified health care provider. The ability to report results may be impacted by maternal body mass index (BMI), maternal weight, and/or maternal systemic lupus erythematosus (SLE). Positive predictive value of a test/investigation is defined as the proportion of patients with positive results being truly diseased. cfDNA testing may not accurately identify fetal triploidy, balanced rearrangements, or the precise locations of subchromosomal duplications or deletions these may be detected by prenatal diagnosis with CVS or amniocentesis. Such investigations may lead to a diagnosis of maternal chromosomal or subchromosomal abnormalities, which on occasion may be associated with benign or malignant maternal neoplasms. cfDNA testing for whole chromosome abnormalities (including sex chromosomes) and for subchromosomal abnormalities could lead to the potential discovery of both fetal and maternal genomic abnormalities that could have minor or no clinical significance.Įvaluating the significance of a positive or nonreportable test result may involve both invasive prenatal testing and additional studies on the mother.
A patient with a positive or high risk score test result should be referred for genetic counseling and tests are not intended to identify pregnancies at risk for neural tube defects or ventral wall defects. Cell-free DNA (cfDNA) testing does not replace the accuracy and precision of prenatal diagnosis with CVS or amniocentesis. While the results of these tests are highly accurate, discordant results, including inaccurate fetal sex prediction, may occur due to placental, maternal, or fetal mosaicism or neoplasm vanishing twin prior maternal organ transplant or other causes.
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