U.S. flag

An official website of the United States government

GTR Home > Tests > STAT Chromosome Analysis, Peripheral Blood

Performance Characteristics

Availability

Help

  • Entire test performed in-house

Analytical Validity

Help

Final result minimal band resolution is 550 bands; band resolution lower for STAT preliminary result. Preliminary STAT chromosome result based on 5 cell evaluation will be called to the ordering provider within 48-72 hours from time the specimen was received by the lab. Final written result is issued after 20 metaphase cells are analyzed to identify numerical and structural chromosome abnormalities and can detect mosaicism down to 20% of cells at 95th confidence interval. Mosaicism study (50-cell extended cell count evaluation) available, which can detect mosaicism down to 6% of cells at 95th confidence interval.

Citations

Not provided

Proficiency Testing (PT)

Is proficiency testing performed for this test? Help
Yes
Method used for proficiency testingHelp
Formal PT program
PT ProviderHelp
College of American Pathologists, CAP

FDA Regulatory Clearances of the Test

Help
FDA Category Designation
Not Applicable

Practice guidelines

  • ACMG, 2021
    Chromosomal microarray analysis, including constitutional and neoplastic disease applications, 2021 revision: a technical standard of the American College of Medical Genetics and Genomics (ACMG)
  • NSGC, 2021
    National Society of Genetic Counselors Position Statement: Prenatal Cell-Free DNA Screening
  • ACMG, 2016
    Noninvasive prenatal screening for fetal aneuploidy, 2016 update: a position statement of the American College of Medical Genetics and Genomics
  • ESHG/ASHG, 2015
    Non-invasive prenatal testing for aneuploidy and beyond: challenges of responsible innovation in prenatal screening.
  • NSGC, 2013
    Noninvasive prenatal testing/noninvasive prenatal diagnosis: the position of the National Society of Genetic Counselors. (Replaced by NSCG, 2021 Statement)
  • ACMG, 2013
    ACMG statement on noninvasive prenatal screening for fetal aneuploidy. (See 2016 Update)
  • ICFMM, 2013
    Position Statement from the Italian College of Fetal Maternal Medicine: Non-invasive prenatal testing (NIPT) by maternal plasma DNA sequencing.
  • NSGC, 2013
    NSGC practice guideline: prenatal screening and diagnostic testing options for chromosome aneuploidy.

Consumer resources

IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.