Classic view of this page
Noninvasive prenatal testing
Clinical Genetic Test
Help
offered by
Genome-Nilou Lab
View lab's test page
LinkOut
GTR Test Accession: Help GTR000597286.1
NYS CLEP
Last updated in GTR: 2022-01-10
View version history
Last annual review date for the lab: 2023-02-06 Past due LinkOut
At a Glance
Test purpose: Help
Screening
Conditions (1): Help
Aneuploidy
Chromosomal regions/ Mitochondria (1): Help
Chromosome13,18,21,X,Y
Methods (1): Help
Molecular Genetics - Targeted variant analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Pregnant women
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Genome-Nilou Lab
View lab's website
View lab's test page
Test short name: Help
NIPT
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
Lab contact: Help
Shahram Savad, PhD, MD, Lab Director
Mostafa Iranpour, Administrator
m.iranpour@sbmu.ac.ir
Contact Policy: Help
Post-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
How to Order: Help
Order URL
Test development: Help
Manufactured (research use only; not FDA-reviewed)
Informed consent required: Help
Yes
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test Order Code, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Chromosomal regions/Mitochondria Help
Total chromosomal regions/mitochondria: 1
Chromosomal region/Mitochondrion Associated condition
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
Targeted variant analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Ion Torrent Proton
Clinical Information
Test purpose: Help
Screening
Target population: Help
Pregnant women
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
According to ACMG guidelines

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided.
Recommended fields not provided:
Clinical validity, Clinical utility, Are family members with defined clinical status recruited to assess significance of VUS without charge?, Will the lab re-contact the ordering physician if variant interpretation changes?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
98-99% for aneuploidy 95% for fetal sex determination
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
No
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: Not Applicable
NYS CLEP Approval: Help
Number: 8417
Status: Approved
Additional Information
Practice guidelines:
Consumer resources:

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in 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.