Harmony NIPT & Dating Ultrasound Scan
Non Invasive Prenatal Test
When can I have this?
Harmony Test Criteria:
What is the Harmony Test?
The harmony test is one of the latest and leading DNA based non-invasive prenatal screening blood test with incredibly high sensitivity for estimating the risk of a fetus with Downs syndrome (a congenital disorder arising from chromosomal defect causing various physical and mental disability).
The harmony test is regarded as the most accurate screening tests available for Down’s syndrome as compared to other traditional tests such as combined screening, which is currently the main method of screening for Down’s syndrome offered in the mainstream NHS.
What is Down's syndrome?
Down’s syndrome, also known as Trisomy 21, is a congenital disorder arising from a chromosomal defect during fetal development which causes various physical and mental disabilities. Down’s syndrome is typically not inherited – it’s a simple the result of a one-off genetic change in the sperm of egg. In every pregnancy, there is a small chance of having a child with Down’s syndrome, but the likelihood increases with the age of the mother.
How is the Harmony test performed and analysed?
The Harmony blood test involves taking a blood sample from the mother, just like a routine blood test. The mother must be at least 10 weeks into her pregnancy.
The blood sample is sent and analysed in a specialist laboratory where next-generation sequencing technology, coupled with advanced bioinformatics analysis will detect free-floating fetal DNA (cfDNA), which is a marker in the mother’s blood of baby’s DNA. The resultant information will be generated into a detailed risk analysis report.
This is a relatively new highly accurate alternative to the Downs Syndrome Screening Service provided by the NHS. It has been reported that 1 in 30 women can be given a high result with the NHS combined screening and are advised to undergo an invasive testing such as amniocentesis or chorionic villus sampling (CVS) to determine baby’s chromosomal structure. These procedures carry a 1% risk of miscarriage. NIPT is a perfect risk-free alternative as there is no risk of miscarriage from this non-invasive test.
While the Harmony test or any other NIPT is NOT classed as a diagnostic test like amniocentesis or CVS it will seek to reassure you that you are making the right choices should you need further testing.
What is the primary purpose of this test?
This test is performed to assess the risk of certain chromosomal defects including Trisomy 21 (Down’s syndrome), Trisomy 18, Trisomy 13, X/Y sex chromosomal aneuploidies.
The test can also check the sex of your baby (optional).
A scan is also performed in conjunction with the test to confirm fetal viability, how far along the pregnancy is, and if the mother is having twin or multiple babies. We can also provide an estimated due date.
What if I am having twins?
The Harmony test can be used for twin pregnancy. It can even be used if the pregnancy is conceived with donated eggs.
It can not be performed for triplets/multiple pregnancies.
What problems will this test not detect?
This test will not be able to detect structural abnormalities such as spina bifida, heart defects and growth problems. .
Your blood will be transported to a UK based Harmony Approved pathology laboratory where they will be analysed and reported. Results for your test will be available in 8-12 days due to delays in processing caused by COVID-19.
The Harmony test results take into account your age, pregnancy gestation and the DNA fraction in the blood sample. The results are shown on a report in a graphical format as either “low or high” risk for the different the trisomies.
The Harmony test is a screening test. A screening test is one that is performed to identify those that are at higher risk or more likely to develop a specified disease or condition. It can not however provide confirmation and therefore those identified as having higher risk may need further diagnostic tests. A diagnostic test is a procedure that can identify a specific condition, disease or illness.
This test screens for Down’s syndrome as well as a few other genetic conditions. Therefore this test will give you information about the risk your baby has for these specific conditions.
As with all screening tests, false-positives and false negatives may occur however these are much lower in this test as compared to traditional tests available.
Should you have a high-risk result you have the option for further diagnostic tests such as amniocentesis or chorionic villus sampling.
Does the Harmony blood test ever need to be repeated?
Occasionally there is insufficient fetal DNA in the blood sample obtained from mother to obtain a result. Therefore a repeat sample would be needed to be collected. This occurs in about 2% of tests with overall no result rate of 3% (2% due to insufficient fetal fraction and 1% due to other reasons).
If there is no result from your initial test we would offer one free re-test.
What is Included?
Harmony Blood test including Viability & Dating Ultrasound Scan with a report and any measurements.
How do I Prepare for this Test?
- Please bring your pregnancy book with previous scan results to your appointment as we will not be able to scan you without them.
- All scans are performed to accomplish the main objective only.
- Sometimes at the scan, we may not detect the heartbeat or can visualise the fetus on the screen. In such instances, this could be because it’s too early for the ultrasound scan to detect the pregnancy or could indicate that a miscarriage has occurred. In the event of this happening, please be reassured that our trained staff are on hand to offer advice and guidance on next steps.
- The test can only be performed from 10 weeks gestational age. If the scan determines your pregnancy is earlier than 10 weeks you will be invited to book the Harmony blood test at the next available appointment when you are at least 10 weeks pregnant.
- Single ultrasound scan is included however any additional scans that may be required would be charged at £79 each..
- Gender Determination is based on the Harmony DNA-blood test and is not conducted by ultrasound. There is no additional fee if this option is required.
- This ultrasound scan may involve internal scanning.
- We may require details of your GP / Health Care Professional which will be requested from you before or at the time of your scan.
- Our pregnancy scans do not replace or substitute any scan you have or will have with the NHS / maternity care provider.
We offer a wide range of pregnancy ultrasound scans as well as blood profiles, please feel free to have a look over the complete range by following the quick links below.