|The IONA® test||Detection rate (sensitivity)*||False Positive Rate (FPR)*|
|Trisomy 21 (Down’s syndrome)||99%||0.03%|
|Trisomy 18 (Edwards’ syndrome)||92%||0.03%|
|Trisomy 13 (Patau’s syndrome)||100%||0.02%|
* Clinical Performance of the IONA® test in over 20,000 patient samples
Fetal sex determination has an accuracy rate of >99% and is available for singleton and monochorionic twin pregnancies.
This is only available in regions that allow fetal sex determination.
The IONA® test has a re-draw rate of <0.5%.
The IONA® test is a CE marked in vitro diagnostic product and as such the IONA® clinical validation study(1) has formed part of the Technical File that has been reviewed by a Notified Body. A recent independent study(2) performed at Kings College, London showed the IONA® test detected 100% of the trisomies, with 0% false positives, present in the 242 blinded maternal blood samples.
IONA® test publications - open access
- Ultrasound Obstet Gynecol. 2015 Oct 23. DOI: 10.1002/uog.15791. Clinical evaluation of the IONA® test: a non-invasive prenatal screening test for Trisomy 21, 18 and 13. Papageorghiou A, Khalil A, Forman M, Hulme R, Mazey R, Mousa HA, Johnstone ED, McKelvey A, Cohen KE, Risley M, Denman W, Kelly B.
- Ultrasound Obstet Gynecol. 2015 Dec 28. DOI: 10.1002/uog.15749. The IONA® test for first-trimester detection of trisomy 21, 18 and 13. Poon LC, Dumidrascu-Diris D, Francisco C, Fantasia I, Nicolaides KH.
- Fetal Diagnosis and Therapy. 2017 Feb 8. Doi: 10.1159/000455025. The IONA® Test: Development of an Automated Cell-Free DNA-Based Screening Test for Fetal Trisomies 13, 18, and 21 That Employs the Ion Proton Semiconductor Sequencing Platform. Crea F, Forman M, Hulme R, Old R.W, Ryan D, Mazey R, Risley M.D
|June 2016||Side-by-side comparison of the NIFTY test and IONA® test for Non-Invasive Prenatal Testing (NIPT)||FMF World Congress|
|July 2016||the IONA® test - update on dynamic Fetal Fraction||ISPD 2016|
|March 2017||Bridging the non-invasive prenatal testing gap: accessing private screening in an NHS teaching hospital||BMFMS 2017|
|June 2017||Use of Maternal Age or First Trimester Screening risk results in the estimation of trisomy risk in an NIPT||FMF 2017|
|April 2018||THE SAFE TEST: Performance of non-invasive prenatal screening (NIPS) for high-risk pregnancies in the Southwest Thames Region||BMFMS 2018|