Harmony Test with GP advice
Harmony Test London with NO NEED to pay for an Ultrasound as well if you don’t need one.
After a lot of thought, We have Changed our NIPT Test from Harmony to the Illumina VeriSeq® NIPT solution V2 assay as our Doctors feel it is superior.
Illumina VeriSeq NIPT solution V2 assay.
The Illumina Blood test (Non Invasive Prenatal Testing) analyses cell free DNA circulating in a pregnant mother’s blood. From this, it will give one of the most accurate screening approaches to estimating the risk of a foetus having a common chromosomal abnormality, called a Trisomy. This occurs when there are 3 copies of a particular chromosome instead of the usual 2. As this is a blood test from the pregnant mother, there is no risk of harm to the foetus.
The test is also capable of testing for the gender of your child, if required.
Why Do our Doctors think the Illumina VeriSeq is superior to the Harmony?:
- Better detection rates for all 3 trisomies (> 99%) – Harmony is 99% for trisomy 21, 97% for trisomy 17 & 93% for trisomy 13.
- Only 1% of samples will fail in processing – Harmony has a 4% failure rate.
- Shorter turnaround times (Usually 3 – 4 working days) – Harmony is 5 – 7 working Days.
- PPV (positive predictive value) same as Harmony Test.
- American originated test analysed by the largest NIPT Lab in the UK (TDL Genetics) – one of the only Labs with UKAS accreditation for NIPT testing (same as Harmony test) – other laboratories often do not have UKAS accreditation for NIPT testing.
|Illumina VeriSeq Blood Test Only|
(Includes discussion with your doctor and signing your consent forms)
[You have to be AT LEAST 10 weeks’ gestational age – we will need ultrasound scan proof to proceed with your blood test]
|* = £15 Surcharge for Weekend appointment|
|We would always encourage you to have an ultrasound scan immediately prior to the Illumina VeriSeq blood test. Missed miscarriages commonly occur before 12 weeks gestation and you may not want the heartache of having a result from the harmony test if this has occurred. We are unable to provide any refunds in these circumstances.|
To be eligible for the Illumina VeriSeq blood test, patients MUST BE at least 10 weeks’ gestational age. They can have a singleton or twin pregnancy resulting from natural conception or IVF using your own egg or a donor egg. Foetal sexing is also now available for twin pregnancies, but patients who are pregnant with more than one foetus are NOT eligible for the Illumina Prenatal Test with X and Y analysis.
In the very rare instance (less than 1% chance) that the laboratory cannot find enough foetal cell free DNA in your blood to perform an analysis, we will repeat your test free of charge. HOWEVER, if they cannot find enough cell free DNA the second time too, the Lab will not repeat the test a third time and you will be given a refund of £255 (that is, the GP Surgery will retain the remainder as an administrative fee).
For the above reason – Please make sure you have your Nuchal scan and NT blood tests with your NHS hospital and don’t rely on definitely getting a result from your Harmony test. Furthermore, the positive predictive value (see below) is based on your Nuchal/ NT blood test result, so it is very important for you to have it done.
You are paying for Trisomy 21/18/13 testing. The Laboratory offers foetal sex testing and the sex chromosome aneuploidy panel testing as additional complimentary investigations. Hence if results from the latter two are inconclusive, they will not repeat them for you free of charge.
Conditions tested for:
Trisomy 21 (Down Syndrome) – This may be associated with moderate to severe intellectual disabilities and may cause other organ defects.
Trisomy 18 (Edwards Syndrome) and Trisomy 13 (Patau Syndrome) – This is associated with a high rate of miscarriage. Babies that do survive are born with severe brain abnormalities as well as other birth defects.
Sex chromosome analysis – The sex chromosomes (X & Y) determine if we are male or female. The Illumina VeriSeq blood test evaluates X and Y chromosome sequences, providing information on foetal sex and sex chromosome aneuploidy.
The Illumina VeriSeq blood test is not intended nor validated for diagnosis or detection of mosaicism, partial trisomy, or translocations.
Accuracy of Results:
The Illumina VeriSeq Prenatal blood test has a very high accuracy rate of detection of foetuses with Trisomy 21, Trisomy 18 and Trisomy 13. Please be aware that some X and Y chromosomal abnormalities may have a much lower accuracy rate of detection. X and Y analysis provides a high accuracy for foetal sex.
It is important to be aware that if the test results show a high risk of having Trisomy 21, 18 or 13 or sex chromosome conditions, it does not automatically mean that the foetus definitely has one of these conditions, but it is highly likely. Hence, in the event of a ‘high risk’ (or positive) result, we would recommend follow up testing via an invasive method (such as amniocentesis) after discussion with your obstetrician.
Similarly, a low risk (or negative) result does not automatically mean that the foetus definitely does not have the above conditions, but it is unlikely to do so. However, there is still a very small risk that not all Trisomy foetuses will be detected.
Please continue to have all your normal scans as usual and interpret all readings in context of your risk factors and family risks.
The Advertising Standards Authority (ASA) has made a ruling on false advertising for prenatal testing. TDL Genetics have provided the Positive Predictive Value (PPV) figures required and these are Available here.
Positive predictive value (PPV), the probability that a positive test result is a true positive, depends on both test performance and the prevalence of the condition in a given population.
The population-based PPV in the table was determined in a large prospective study of a first trimester routine-screening population. PPV will be higher in high-risk populations.
Clinical factors such as family history and results of other screening may influence the PPV for an individual patient.
If you weigh more than 100kg – It is best for you to wait for at least 20 weeks pregnancy to do the Illumina VeriSeq test.
You will NOT be eligible for the Illumina VeriSeq test if:
1> You have received an organ transplant.
2> You have received a Bone marrow transplant.
3> You have metastatic cancer.
4> If you have a Vanishing Twin pregnancy – the release of cell-free DNA from the trophoblast of the perished embryo leads to inaccurate results.
How long before I get my results:
Approximately 3 to 4 days. Please be aware – we are a third party using TDL Genetics to analyse your blood test. Any delays (which are extremely rare) will necessitate you contacting them directly to discuss your concerns. Please see below for their contact details.
Repeat Blood testing:
Very rarely (in 1% of cases), there is not enough foetal DNA in the maternal blood sample taken and we may have to repeat the maternal blood test. There will be no extra charge for this.
Who analyses the blood test:
Illumina, USA – This is now analysed by their UK partner (The Doctors Laboratory, in Central London) – Hence the quicker turnaround time.
For further understanding of the Illumina VeriSeq NIPT solution V2 assay – please click on this link for more useful information.
For more details – please visit the TDL Website for more useful information.