IONA Test -Advanced NIPT Solution for Clinical Laboratories
The IONA test is a non-invasive prenatal screening test to estimate the risk of a fetus having Trisomy 21, Trisomy 18 or Trisomy 13. The test can also be used to determine the sex of the fetus.
Excellent Support
- CE-IVD: no tech transfer required, no hidden costs
- World class technical support including CPD accredited workflow training
- Verified and validated - so you don’t have to
- Backup service laboratory
Robust and Reliable
- >99% detection and <1% false positive rate
- Highly scalable workflow to match your demands
- Low re-draw rate <0.5%
- Measures fetal fraction, requiring ≥2%
Fast and Easy to Use
- 3 day turnaround time
- IONA® Software for analysis - trusted and reliable reporting
- Premaitha Workflow Manager for complete paper-free sample tracking
The IONA test is an advanced prenatal screening test which is offered to pregnant women to estimate the risk that their fetus may be affected with Trisomy 21 (Down’s syndrome), Trisomy 18 (Edwards’ syndrome) or Trisomy 13 (Patau’s syndrome). The test can also be used for fetal sex determination if required.
The IONA® test is a complete CE-IVD product for laboratories wishing to offer their own in-house non-invasive prenatal testing (NIPT) service. It is suitable for use from 10 gestational weeks for singleton or twin pregnancies.
The analysis is performed on cell-free placental DNA from a maternal blood sample, using Next Generation Sequencing technology, with test results available with a turnaround time of just 3 days. By offering this service locally, laboratories can broaden their offering and provide pregnant women fast, reliable results that reduce the need for invasive tests, which reduces the associated stress and anxiety for expectant parents.
Quality Control and Fetal Fraction
The IONA test has been optimised to deliver the most accurate results while simultaneously keeping the number of sample failures due to low fetal fraction at a minimum. This is achieved by using a unique approach of two fetal fraction evaluations. All samples must have at least ≥2% fetal fraction. In addition, all samples at risk of a false negative or false positive result are evaluated using our proprietary dynamic fetal fraction assessment. This adapts the level of required fetal fraction for the sample to the quality of the sequencing data. Unlike other NIPT methods, the IONA test has a very low re-draw rate of <0.5%.
Please note that the IONA test is not available for sale in the United States