- Who will carry out the Harmony Prenatal Test?
- How accurate is the Harmony Prenatal Test?
- Who should have the Harmony NIPT?
- When should I have the Harmony NIPT?
- What is involved in the Harmony Prenatal Test?
- How is Harmony different to other blood tests for Down’s Syndrome?
- What anomalies does the Harmony Prenatal Test check for?
- Does the Harmony NIPT pick up all anomalies?
- How will I receive my results of the Harmony NIPT?
- When will I get the results of my Harmony NIPT?
- What does a “low risk” result mean?
- What does a “High Risk” result mean?
- Can I have the Harmony Prenatal Test when I am expecting twins?
- I’m expecting a baby through IVF, can I get the Harmony Prenatal test?
- How many guests can I bring with me?
- Do I need to bring anything with me?
- Do I need a full bladder for my scan?
- How do I pay?
- Should I still attend my hospital scans?
- What are the limitations of the Harmony NIPT?
- What if an abnormality is found?
1.) Who will carry out the Harmony Prenatal Test?
Your appointment will be performed by one of our fully qualified healthcare professionals.
You will receive your results in a report sent to your email.
The Harmony test is available at our Glasgow clinic.
2.) How accurate is the Harmony Prenatal Test?
Harmony’s DNA-based technology correctly identifies Down syndrome in more than 99% of cases. By comparison, traditional blood tests can miss as many as 15% of Down syndrome cases in pregnant women. Harmony also has detection rates of 97.4% for Edwards syndrome and 93.8% for Patau’s syndrome.
Harmony is also much less likely than traditional tests to give you a false-positive result, meaning there is much less chance your doctor would recommend follow-up invasive testing, such as amniocentesis or CVS.
3.) Who should have the Harmony NIPT?
We offer the Harmony test to all pregnant women, anybody who would like extra reassurance about their pregnancy is welcome to come to one of our clinics for a test. The test is not aimed at over 35’s, although the risk of Down’s syndrome does increase with maternal age most cases of Down’s syndrome occur in women under 35.
The Harmony test is validated for pregnant women of all ages both under and over the 35 year age group.
Those who are anxious about having a baby with a chromosomal abnormality such as Down’s syndrome, Edwards syndrome or Patau’s syndrome, or who have previously had pregnancies with chromosomal abnormalities often opt for the test. Also any pregnancies who are at risk of miscarriage should they have CVS or amniocentesis also tend to opt for this option as there is a lower false positive rate which mean less chance of needing an invasive procedure.
4.) When should I have the Harmony NIPT?
You can have the test as early as 10 weeks of pregnancy, or at any point after this.
Harmony is available at our Glasgow clinic.
5.) What is involved in the Harmony Prenatal Test?
You will initially have an ultrasound performed by one of our qualified sonographers or midwife sonographers, this is to confirm that the gestational age is 10 weeks or over, and also to confirm that there is an on-going pregnancy and to check for multiple babies.
You will then be asked to return for a blood test where 2 tubes of blood will be taken from your arm, which will then be sent for lab testing.
6.) How is Harmony different to other blood tests for Down’s Syndrome?
Harmony can provide clear and early results; the test can be carried out as early as 10 weeks gestation.
Harmony uses a unique method which targets and analyses DNA at specific locations, with extensive quality control of this technique Harmony can achieve over 99% accuracy and a false positive rate less than 0.1% in comparison to conventional trisomy screening tests which have a false positive rate of 5% which means that there are a much higher amount of patients being sent for unnecessary invasive tests.
7.) What anomalies does the Harmony Prenatal Test check for?
Harmony is aimed at picking up trisomy’s 21,18 & 13. The detection rate for Down’s syndrome is greater than 99%, for Edwards syndrome is 97.4% and for Patau’s syndrome is 93.8%.
There is also the option to have the sex chromosomes evaluated, this option tests for conditions caused by having a missing or an extra copy of X or Y chromosomes including Turners and Klinefelter syndromes*.
*This option is only available in singleton pregnancies.
8.)Does the Harmony NIPT pick up all anomalies?
No, the Harmony test does not pick up all anomalies, it is specific to picking up trisomies 21,18, 13, X and Y. Having a low risk result does not mean that your baby will not have any other anomalies or genetic disorders.
9.) How will I receive my results of the Harmony NIPT?
Your results will be sent to you in a report to the email address that you provide us with. If any of your results come back as high risk we will provide you with an appointment with our Healthcare Professionals who will explain everything to you, a report of the results will also be sent to your own healthcare provider.
10.) When will I get the results of my Harmony NIPT?
Once the blood reaches the lab the turnaround time is 5 working days, we aim to have the results to you in 7 working days from the day of your test.
11.) What does a “LOW RISK” result mean?
If the Harmony test shows a “LOW RISK” result (risk less than 1 in 10,000), this means your baby is unlikely to have a chromosome problem involving chromosomes 21, 13, 18, X or Y. However the Harmony test is specific to trisomys 21, 18, 13, X and Y and does not detect all cases of chromosome abnormalities or genetic defects.
There is less than 1% failure rate with Harmony, this means that a low risk result you still have 0.04% chance of the foetus having a trisomy 21, 18, 13 , X or Y. You should only proceed with the test on the basis that you understand the failure rate and false positive rate of the test.
12.) What does a “HIGH RISK” result mean?
If the Harmony test shows a “HIGH RISK” result for a chromosome problem involving chromosomes 21, 13, 18, X or Y, this means that it is extremely likely that your baby has one of these defects. We will send your report on to your healthcare provider who will recommend that you have a diagnostic testing, either chorionic villus sampling (cvs) or amniocentesis to confirm this diagnosis.
There is a 0.06% false positive rate, which means that in 0.06% of “HIGH RISK” results there is no abnormality. You should only proceed with this test on the basis that you understand and accept this.
13.) Can I have the Harmony Prenatal Test when I am expecting twins?
Yes, the Harmony Prenatal Test can be used in twin pregnancies, however is not suitable in cases of a vanishing twin or where there are more than 2 foetuses.
For Twin pregnancies the Sex chromosome analysis can only be carried out to test the foetal sex; a MALE result may apply to either 1 or both foetuses, a FEMALE result will apply to both foetuses.
Harmony with Monosomy X or sex chromosome aneuploidy panel cannot be requested in twin pregnancies.
14.) I’m expecting a baby through IVF, can I get the Harmony Prenatal test?
Yes. In most cases, the Harmony test can be used in pregnancies conceived through in vitro fertilization (IVF).
15.) How many guests can I bring with me?
You can bring 2 guests along with you to have the Harmony prenatal test. The Harmony test is available at our Glasgow clinic.
16.) Do I need to bring anything with me?
Please ensure that you bring your antenatal records when you attend for your Harmony NIPT appointment so that we can contact your health professionals if necessary.
17.) Do I need a full bladder for my scan?
If you are coming for the test between 10 and 12 weeks of pregnancy we recommend that you attend with a full bladder. This is because at this stage of pregnancy the uterus is small and full bladder pushes the uterus up and gives a clearer picture of the foetus.*
*Scar and adipose tissue can also make it more difficult to get a clear picture of the foetus, in these cases a full bladder is also advantageous.
18.) How do I pay?
Payment for the Harmony prenatal test will be taken when you attend for the dating scan and can be made by cash, credit/debit card. Cheques are not accepted.
19.) Should I still attend my Hospital appointments?
Yes. Harmony prenatal test should be regarded as an additional test and is not part of your routine antenatal care. It is important that you attend all your hospital appointments.
20.) What are the limitations of the Harmony NIPT?
The Harmony NIPT is not intended or validated for diagnosis or detection of mosacism, partial trisomy or translocations. Certain rare biological conditions may also affect the accuracy of the test. Limited numbers of aneuploidy twin and egg donor pregnancies have been evaluated because these conditions are rare. Results for twin pregnancies reflect the probability that the pregnancy involves at least one affected foetus. For twin pregnancies male results apply to one or both foetuses.
Not all trisomy foetuses will be detected. Some trisomy foetuses may have LOW RISK results. Some non-trisomy foetuses may have a HIGH RISK results. False negative and false positive results are possible. A LOW RISK result does not guarantee an unaffected pregnancy due to the screening limitations of the test. Harmony provides a risk assessment, not a diagnosis and results should be considered in the context of other clinical criteria. It is recommended that a HIGH RISK result be confirmed through diagnostic test such as amniocentesis or CVS.
If there is not enough foetal DNA collected in the blood the Harmony test will be unable to provide a result. There are two samples of blood taken for this reason, if there is not enough foetal DNA in the first tube then the second tube will then be tested. If there is still not enough foetal DNA in the second tube you will be asked at this stage if you would like to come back to have a redraw, where again 2 more samples will be taken and tested. In cases where there is not enough foetal DNA in the samples this will delay the result for you. We aim to have the results of the 2 sample tubes to you within 10 working days, you will then be contacted at this point to see if you would like to go ahead with the redraw, if so it can be up to 10 further working days before you can expect a result.
21.) What if an abnormality is found?
If your results are returned as “HIGH RISK” we will arrange an appointment with our Healthcare Professionals who will explain the results to you and answer an questions that you may have. We will also write a report and send it to your healthcare professional. We would recommend that you also make an appointment with your healthcare professional to discuss you options of having a diagnostic test such as amniocentesis or CVS.