Ninalia 3 (T13 T18 T21)

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Eurofins Biomnis code

NINA3

Synonyms
  • cfDNA
  • DPNI
  • Ninalia
  • NIPT
Specialty

Genetics

Clinical significance

Noninvasive prenatal testing (NIPT) based on cell-free DNA analysis from maternal blood is a screening test; it is not diagnostic. Test results must not be used as the sole basis for diagnosis. Further confirmatory testing is necessary prior to making any irreversible pregnancy decision. NIPT detects trisomies 21, 18, and 13 in both singleton and twin pregnancies. The VeriSeq NIPT Solution v2 is an in vitro diagnostic test (CE-IVD) intended for use as a screening test for the detection of trisomies 21, 18, and 13 from maternal peripheral whole blood specimens in pregnant women of at least 10 weeks gestation. Performance in Singleton Pregnancies: - Trisomy 21: Sensitivity >99,99%; Specifity 99,90% - Trisomy 18: Sensitivity >99,99%; Specifity 99,90% - Trisomy 13: Sensitivity >99,99%; Specifity 99,90% Performance in Twin Pregnancies: - Trisomy 21: Sensitivity 96,4%; Specifity 99,9% - Trisomy 18: Sensitivity 95,7%; Specifity >99,9% - Trisomy 13: Sensitivity 93,6%; Specifity >99,9%Due to even lower prevalence, data for higher-order pregnancies (triplets or higher) were insufficient to establish appropriate statistical models to estimate accuracy of aneuploidy detection.

Preanalytics
  • A tube specifically for this analysis : No
Further information

Enclose the specific B39-INTGB request form : DPNI
Sample must be forwarded to Eurofins Biomnis within 5 days maximum
Straight away after blood draw, mix blood by gentle inversion (10 times minimum)
ALWAYS attach the specific information form, the 1st trimester ultrasound report, the consent form dated and signed by the clinician and the patient.

Documents to download
Methodology

New generation sequencing

Turnaround time

5 business days (Monday to Friday upon receipt at Eurofins Biomnis)

Testing Laboratory

Contact(s)
Customer Care