Harmony Prenatal Test £400
The Harmony NIPT test is available at Miracle Inside Diagnostic services from week 10 of pregnancy and is designed to give you peace of mind when you need it most. Our service includes the Harmony blood test and a scan, allowing you to see your baby, in the comfort of our first-class facilities.
Developed in the USA by Ariosa Diagnostics, the Harmony Test is a non-invasive blood test for pregnant women from 10 weeks of pregnancy. It has a 99% detection rate for Down Syndrome and will also identify most cases of Edward Syndrome and Patau Syndrome.
To Contact us for more information to know about these blood test call 📞 01138301371 to speak with the Healthcare Professional
Who is it suitable for?
The Harmony Test is suitable for any pregnant woman with a singleton or twin pregnancy (except donor twin pregnancy).
- Safe, this test poses no risk for your baby.
- Quick and simple blood test drawn from the mother’s arm.
Typically the test is useful for the following patients:
- Women over 35 who are concerned about their age-related risk of Down Syndrome and other Trisomies.
- Women under 35 who want a safe, reliable, early and accurate test for Down Syndrome
- Women who have an increased risk or “High Risk” result from a Combined Test or Nuchal Translucency scan but wish to avoid unnecessary CVS or amniocentesis and their risk of miscarriage.
- Women who have an increased risk or “High Risk” result from a Triple test or Quad test but wish to avoid unnecessary CVS or amniocentesis and their risk of miscarriage.
- Women with a previous pregnancy with a baby with Down Syndrome, Patau Syndrome or Edward Syndrome
- The test is not suitable for multiple pregnancies with donor eggs.
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What does it test for?
- Trisomy 21 is the most common trisomy at the time of birth. Also called Down Syndrome, it is associated with moderate to severe intellectual disabilities and may also lead to digestive disease and congenital heart defects and other malformations.
- Trisomy 18 (Edwards Syndrome) and Trisomy 13 (Patau Syndrome) are associated with a high rate of miscarriage. These babies are born with severe brain abnormalities and often have congenital heart defects as well as other birth defects. Most affected individuals die before or soon after birth and very few survive beyond the first year of life.
Can it tell my baby’s sex?
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.
The test will also be able to determine the baby’s sex in most cases, with an accuracy of about 99% which is additional Optional Extra.
Sex Chromosome conditions - Optional extra
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) A female fetus with a single X chromosome. These babies have a high risk of miscarriage and heart problems.
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. Harmony test also can detect Sex Aneuploidies* X, Y ( Monosomy X - Turner syndrome: X0, Triple X syndrome: XXX, Klinefelter syndrome: XXY, Jacobs syndrome: XYY, XXYY syndrome )
22q11.2 deletion Screening - Optional extra
TDL Genetics are now offering 22q11.2 deletion screening as an additional optional Extra in the Harmony prenatal test menu. 22q11.2 deletion is the underlying cause of conditions described as DiGeorge Syndrome and velocardiofacial syndrome (VCFS) .This option will be discussed at your appointment to determine whether requesting this is right for you.
How accurate is the Harmony prenatal test?
Verified clinical data from our genetics laboratory states that:
- Down Syndrome >99% (0.1% false positive rate)
- Edwards Syndrome >97% (0.1% false positive rate)
- Patau Syndrome 80% (0.1% false positive rate)
Detection and false-positive rates are calculated on a risk cut-off of 1/100.
Fetal sex reporting (detection of the Y chromosome) has an accuracy of greater than 99%.
What does a HIGH RISK result mean?
A HIGH RISK result is indicative of a high risk for a trisomy. The test identifies more than 99% of fetuses with trisomy 21, 98% of fetuses with trisomy 18, and 80% of fetuses with trisomy 13. After the test, the number of women required to have a CVS or an amniocentesis is less than 1%. It is important to note that if the test results show there is a HIGH risk that the fetus has trisomy 21, 18 or 13 it does not mean that the fetus definitely has one of these defects, although it is highly likely. For this reason, in the event of a high risk (or positive) result, follow-up testing by an invasive procedure is recommended.
What does a LOW RISK result mean?
In the same way, if the test results show that there is a LOW RISK that the fetus has trisomy 21, 18 or 13 it is unlikely that the fetus has one of these defects. However, there is a very small risk that not all trisomy fetuses will be detected. All results should be interpreted by a clinician in the context of clinical and familial data: patients should continue with their usual scan appointments following testing.
How long will it take to get results? Reasons for failed Test?
Typically within 7 working days but occasionally (3% of tests which are done) if there is not enough fetal DNA less than 4 % in the original blood sample then a repeat blood test may be required within a week of the original test at no extra cost.
The relative proportion of cell-free fetal DNA is reduced in women with a high BMI as they have more of their own cell-free DNA circulating in their blood. Low fetal fractions of less than 4% will lead to a failure of the NIPT test or render a false negative result. some of the Reasons for low fetal fractions include testing too early in the pregnancy, sampling errors, maternal obesity, and fetal abnormality.
Are there any risks to the pregnancy from the Harmony Test?
No. The testing is non-invasive: it involves taking a blood sample from the mother. The pregnancy is not put at risk of miscarriage, or from other adverse outcomes that are associated with invasive testing procedures such as CVS or amniocentesis.
Are NIPT Tests available on the NHS Treatment?
NHS will only provide a Combined test or Quadruple blood screening test with the blood test to indicate the likelihood that your baby has Down’s Syndrome only if there is a risk considered HIGH, only then the patients will then be offered an invasive test called an Amniocentesis or chorionic villus sampling (CVS). Both these test procedures carry a High risk of miscarriage, that's is why most parents are going for the NIPT test. NIPT screening test carries no risk to Mum or Baby infant with the results arriving in 7 working days.
The NHS is currently unable to provide this test due to the costs involved, although most private healthcare professionals recommend it for the Peace of mind.
The very earliest you can have a scan to test for a Baby’s Gender Reveal is around 16 weeks and the NHS don’t tend to provide gender confirmation until 20 weeks. A NIPT test can be performed from as early as 10 weeks, with the results arriving in 7 working days.
What do about my Regular NHS 12 weeks scan and NT measurements scans?
If you are having NIPT Test or you have got negative or Low-risk result on the Non-Invasive Prenatal Test you should still attend and not miss your regular 12 week NHS scan and the NT measurements.
- We will require details of your GP / Health Care Professional, which may be requested prior to or at the time of the scan.
- This scan requires access to the area of interest, therefore it is recommended to wear loose clothing to facilitate this process.
- Blood results require interpretation and All results should be shared with your regular healthcare professional / GP / Fertility specialist.
- All of our first line ultrasound scans & health Blood tests are optional. You must be at least 16 years old and you should have no existing medical condition or treatment pending that relates to the scan/blood test you are booking. If you are in any doubt about having any type of test, you should consult your GP.
- Genetic counselling is not provided as part of this Blood test Services. Customers regular Healthcare professional / GP / Fertility specialist is responsible for ensuring appropriate counselling provided to the patient.
Are there conditions 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
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