The Harmony Prenatal Test, NIPT
The Harmony Prenatal Test is a non invasive prenatal test (NIPT) that assesses the risk of Chromosomal Trisomies, mainly 21,18 and 13 by analysing cell free DNA (cfDNA) in maternal blood in pregnancy. It has been long established that a blood sample taken from the mother at any time from early pregnancy can be analysed for cell free fetal DNA, which is essentially a marker in the mother’s blood of the DNA of the baby. The result of the simple blood test (Harmony), taken at 10 weeks or later, is predictive to more than 99% in Downs syndrome, 98% of Edwards syndrome and 80% of Patau’s syndrome which will significantly reduce the need for invasive testing by CVS or amniocentesis. This is wonderful news for pregnant mothers because it abolishes the risk of miscarriage of the pregnancy due to these invasive procedures. It is important that an ultrasound scan is performed just before the blood test to confirm the pregnancy, and to check that the mother is not carrying twins or more. The Harmony test can be used to check twins as long as it is not an egg donation pregnancy. The Harmony can now be used if the pregnancy is conceived with donated egg. The result of the Harmony is predictive to more than 99% in Down’s syndrome babies.
The Harmony Test now is one of the most predictive and accurate non invasive tests to predict the chance of a chromosomal abnormality in a pregnancy (greater than 99% for Down’s Syndrome. For the last ten years or so the majority of Obstetricians have been using the results of the Nuchal Translucency (NT), Scan to advise pregnant women and their partners on their risk of having a baby with Downs syndrome, or other abnormalities. The Nuchal Translucency Scan looks at the skin fold on the back of the baby’s neck at about 12 weeks. This has been further refined by looking at the nose bone of the baby with an additional blood test to identify two pregnancy hormones. This is the combined test and has achieved a predictive value of about 92%. Women with a high risk have an option to proceed to chorionic villous sampling (CVS) or amniocentesis. These are invasive tests that carry a miscarriage risk of about 1:100 i.e. 1% over and above the natural incidence of miscarriage in the background population. Fortunately this is not the case now that the Harmony blood test has become available.
The Harmony Test may be chosen by any mother who wants extra reassurance about the normality of her pregnancy can have the test. Women who may need it are those who are anxious about their baby having a chromosomal abnormality such as Downs, Edwards or Patau's syndrome, older women (particularly over 40 years) and those who have already had a chromosomally abnormal pregnancy often opt for the test. Those who are at particular risk of miscarriage should they have an amniocentesis or chorionic villous sample also find the test very attractive as it avoids an invasive procedure. It is helpful for those who have had a previous sex chromosome abnormality such as Turners syndrome or cystic hygromas.
If a mother chooses The Harmony Test, She has to read and sign a consent form and sign a form for data release. An ultrasound scan is always is firstly performed to confirm pregnancy and estimate the number of foetuses.
The Harmony Test is a simple blood test from the vein in the pregnant mother's arm like any other blood test. There is no risk from having the test. Two tubes need to be fully filled and the blood bottles are immediately packaged and sent to The Doctors Laboratory in London, UK, for dispatch to California in the US of America.
The Harmony test result is usually available within 12-14 days. There is a 0.33 chance that no DNA is obtained. i.e. a redraw of 5-10%. This is not a positive or negative test: it is an unsuccessful test. An offer of a repeat test is made free of charge. This is usually successful.
The Result of The Harmony Test is expressed as a probability. It is a super screening test and not a diagnostic test. And the only diagnostic test is either Amniocentesis or Chorionic villous sampling A result form of a normal test is shown below. A good test result gives a risk of a chromosomal problem of less than 1:10000. A bad result gives a risk of 1:2. A risk of 1:2 requires an amniocentesis or chorionic villous sampling depending on the clinical situation. The couple are counselled about this by our Senior Staff at the Brayford Studio Lincolnshire at Lincoln, UK.
The Harmony Test is currently from £500.99 including the ultrasound scan.
After The Harmony Test result, depending on how many weeks pregnant, you will still have the opportunity to have a 12 week scan at The Brayford Studio Lincolnshire or with the NHS. The focus of the 12 week scan will change as you will already have the result of the Down’s syndrome test, so the 12 week scan will look at the baby in detail for structural abnormalities (these may exist without a chromosomal abnormality). You will still have the opportunity to have the later scans, such as the 20 weeks scan, as before. If the Harmony test is negative then it is important that the person conducting the 12 week scan is aware of this. If the test is positive then you should return to The Brayford studio Lincolnshire at Lincoln or your Local NHS Hospital for further counselling.
The Harmony Test will not detect any structural abnormalities such as Spina Bifida, heart defects and IUGR i.e. a poorly growing baby will only be seen on scans and often not until later scans. These scans should still be undertaken.
The Harmony Test has been developed by Ariosa Diagnostics www.ariosadx.com and is quality controlled by Ariosa Diagnostics.
The Harmony Test is now available at The Brayford Studio Lincolnshire at Lincoln.
- The only Clinic in Lincolnshire offering this test
- 30 - 45 minutes per appointment
- Evening and Sunday appointments available
- Detailed ultrasound scan included
- Cases can be discussed with our senior staff if necessary
- Price : From £500.99 including ultrasound scan.
|Singleton Pregnancy||From £500.99|
|Blood test only||From £399.99|
|Blood Test + Scan||From £499.99|
Call us to book your appointment:
The Brayford Studio Lincolnshire.
Tel: 01522 683347
We are open, every day, 24hours a day
Harmony Test is a:
Non-Invasive Prenatal Test- NIPT
Appointments every day including Sunday.
Access to senior staff opinion.
Ultrasound scan included.
9-14 days for result.
Sex chromosome analysis available.
For more information please visit the link below