NIPT Harmony Test
What is the Harmony Test?
The harmony test is a new non-invasive prenatal screening test (NIPT) which can be performed from 10 weeks gestation.
The test is a simple blood test taken from the mother which is then analysed for fetal cell-free DNA (cfDNA). cfDNA is the result of the natural breakdown of fetal cells and can be found in the mothers blood. cfDNA can be tested to identify more than 99% of babies with Down’s syndrome (Trisomy 21), 98% of babies with Edwards syndrome (Trisomy 18) and 80% of babies with Patau’s syndrome (Trisomy 13).
Why choose the Harmony test?
The Harmony test is now one of the most predictive and accurate non-invasive tests available to predict the chance of your baby having a chromosomal abnormality.
If the test result shows a low probability result for a chromosomal abnormality, then your baby will have a probability of less than 1 in 10,000.
If the test result shows a high probability result, then the probability that your baby has a chromosomal abnormality is greater than 99%.
A high probability result does not mean your baby definitely has a chromosomal abnormality although it is highly likely. For this reason, an invasive procedure such amniocentesis or chorionic villus sampling (CVS) would be recommended following a high probability Harmony result.
Current screening tests (Nuchal Translucency scan) have a false positive rate (that is, the results suggest a problem when the baby is in fact healthy) of around 4%. The Harmony test has a false positive rate of 0.1%. This reduction in the false positive rate reduces the number of women offered invasive testing, using chorionic villus sampling (CVS) or amniocentesis. Both of these procedures carry around a one in 100 risk of causing a miscarriage.
How is the test performed?
An ultrasound scan is always performed prior to your blood test. This will ensure you are at the correct gestation (over 10 weeks).
Your scan and blood test will be discussed and if you wish to proceed we will take your blood sample.
Your blood sample will be packaged and sent to the laboratory based in London, collections from the clinic by Royal Mail are at 9.00am so you sample will be sent the day after you have had your bloods taken – you are welcome to take you pack to a post office with a later collection time if you wish.
Can I find out the Gender of my baby?
The test is primarily used for the detection of Trisomy 21,18 and 13, however you can request X and Y analysis providing over 99% accuracy for your baby’s gender.
This option is also available for twin pregnancies.
A female result for a twin pregnancy will apply to both babies, a male result will apply to either one or both babies.
Sex Chromosome conditions
The Harmony test can also assess the risk of sex chromosome conditions XXX, XYY, XXYY, XXY and a missing X chromosome in a girl (Turner Syndrome). This option will be discussed at your appointment to determine whether requesting this is right for you. This option is not available for twin pregnancies.
When do I get my results?
The results are typically available in 3-5 working days from receipt of the sample in the laboratory in London.
There is a 3% chance there is insufficient fetal DNA in the sample to provide a result. In this case you will be offered a second blood test at no extra charge. If the test is unsuccessful and we are unable to provide a result a partial refund will be made of £295
You will be contacted by telephone when the results have been received at Babyvision. The results will also be posted to you.
What is the cost of the Harmony test?
The total cost, inclusive of your scan, consultation, blood test and laboratory fees – £399
What do I do after my test?
If you have a low risk result you should still attend your 12 week NHS scan and advise that the Harmony test has been performed.
If you have a high risk result we will inform your booking hospital and arrange a referral for further testing.
Are there problems this test will not detect?
Yes. Structural abnormalities for example Spina Bifida and heart defects can not be detected with the Harmony test. You will still be required to attend your 12 and 20 week scans (plus any additional scans which may be arranged for you by your hospital).
Further information can be found by following www.ariosadx.com
Antenatal Results and Choices ARC