Test code(s) 92777

References

  1. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Obstetrics, Committee on Genetics, Society for Maternal-Fetal Medicine. Screening for Fetal Chromosomal Abnormalities: ACOG Practice Bulletin, Number 226. Obstet Gynecol. 2020;136(4):e48-e69. doi:10.1097/AOG.0000000000004084 
  2. Rose NC, Barrie ES, Malinowski J, et al. Systematic evidence-based review: The application of noninvasive prenatal screening using cell-free DNA in general-risk pregnancies. Genet Med. 2022; 24(7):1379-1391. doi:10.1016/j.gim.2022.03.019
  3. Guy C, Haji-Sheikhi F, Rowland CM, et al. Prenatal cell-free DNA screening for fetal aneuploidy in pregnant women at average or high risk: results from a large US clinical laboratory. Mol Genet Genomic Med. 2019;7(3):e545. doi:10.1002/mgg3.545 (Some authors affiliated with Quest Diagnostics)
  4. Anderson B, Zhang K, Nguyen Q, et al. An automated, non-invasive prenatal screening assay (NIPS) for trisomy 21, 18, 13 in singleton and twin gestations. Int J Gynaecol Obstet. 2015;131(Suppl 5):E264. (Some authors affiliated with Quest Diagnostics)

 

 

* 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). 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. This test does not assess the risk of fetal anomalies such as neural tube defects or ventral wall defects. QNatal Advanced is not recommended before 10 weeks gestation due to a significantly increased risk of a failed result.

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. Pregnancy management decisions should not be based on the results of a cfDNA test alone. As with any test, false-positive or false-negative results do occur. The positive predictive value of the screening test varies by genetic marker and may be lower for rare conditions. Performance data for the QNatal Advanced may be obtained by contacting Quest Diagnostics at 1.866.GENE.INFO (1.866.436.3463).

 

QNatal Advanced is a laboratory-developed test that has been developed and validated pursuant to the Clinical Laboratory Improvements Amendments of 1988 (CLIA), and as such it has not been reviewed by FDA.

 


This FAQ is provided for informational purposes only and is not intended as medical advice. A physician’s test selection and interpretation, diagnosis, and patient management decisions should be based on the physician’s education, clinical expertise, and assessment of the patient.

 

Document FAQS.167 Version: 3

Version 3: Effective 05/17/2024 to present

Version 2: Effective 05/09/2023 to 05/17/2024

Version 1: Effective 12/19/2019 to 05/09/2023

Version 0: Effective 10/28/2015 to 12/19/2019