![]() As with any test, false-positive or false-negative results do occur. Pregnancy management decisions should not be based on the results of a cfDNA test alone. ![]() QNatal is a “screening” test, not a diagnostic test therefore, all positive for increased risk results should be followed by genetic counseling and further diagnostic testing and procedures, when clinically indicated. QNatal Advanced is not recommended before 10 weeks gestation due to a significantly increased risk of a failed result. This test does not assess the risk of fetal anomalies such as neural tube defects or ventral wall defects. In addition, if selected as an option, QNatal Advanced can screen for certain microdeletions (ie, 22q 5p 1p36 15q 11q 8q and 4p) that may cause birth defects, and/or for fetal sex. * QNatal® Advanced is a cell-free DNA test that screens for increased risk of certain fetal chromosomal abnormalities that may cause birth defects, including Trisomy 21 (Down Syndrome), Trisomy 18, Trisomy 13, and certain sex chromosome abnormalities (ie, 45,X 47,XXY 47,XXX and 47,XYY). (Some authors affiliated with Quest Diagnostics) An automated, non-invasive prenatal screening assay (NIPS) for trisomy 21, 18, 13 in singleton and twin gestations. ![]() doi:10.1002/mgg3.545 (Some authors affiliated with Quest Diagnostics) Prenatal cell-free DNA screening for fetal aneuploidy in pregnant women at average or high risk: results from a large US clinical laboratory. Guy C, Haji-Sheikhi F, Rowland CM, et al.Systematic evidence-based review: The application of noninvasive prenatal screening using cell-free DNA in general-risk pregnancies. Rose NC, Barrie ES, Malinowski J, et al.Screening for Fetal Chromosomal Abnormalities: ACOG Practice Bulletin, Number 226. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins-Obstetrics, Committee on Genetics, Society for Maternal-Fetal Medicine.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 (ie, 45,X 47,XXY 47,XXX and 47,XYY in the aggregate), and 75.0% for microdeletions (ie, 22q 5p 1p36 15q 11q 8q and 4p in the aggregate).* The results demonstrated strong analytical sensitivity and specificity for trisomy 21, 18, and 13. 1 The American College of Medical Genetics and Genomics (ACMG) states that noninvasive prenatal cell-free DNA screening is “the most effective screening test” for trisomies 13, 18, and 21 “in singleton and twin gestations.” 2Ī published clinical study 3 examined the performance of the QNatal Advanced test in a population of pregnant women that included both those at average and those at high risk. 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 (ie, screening for the trisomies and sex chromosome abnormalities) or diagnostic testing, regardless of maternal age. Reliable for detecting recent drug use, especially marijuana. Quantisal™ tests a variety of drugs in oral fluid including amphetamine, methamphetamines (including MDMA and its metabolite), cocaine (metabolite), marijuana (THC), opiates (codeine, morphine, hydrocodone, hydromorphone, 6-AM (heroin), oxycodones (oxycodone, and oxymorphone), and PCP.This test can be used for all pregnant women.Positive results are confirmed, reviewed, and typically reported within 72 hours of receipt. Testing is performed the day it arrives at our laboratory, with negative screening results reported within a day. Specimen collection with the Quantisal™ collector typically takes about 5-10 minutes. This also decreases the likelihood of the sample being rejected as "quantity not sufficient" and thereby reducing the time and expense associated with a second collection. The patented collection device with built-in sample adequacy indicator window shows the collector that a sufficient quantity of oral fluid has been provided.
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