Peace of mind during your pregnancy
EVITA TEST COMPLETE is the only risk free Non-Invasive-Prenatal-Test (NIPT) that in detail examines all the fetal chromosomes in whole fetal cells. The test can be taken during pregnancy from week 10+0 up to 14+6 days.
As for now EVITA TEST is only available in Denmark.
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Peace of mind during your pregnancy
EVITA TEST COMPLETE is the only risk free Non-Invasive-Prenatal-Test (NIPT) that in detail examines all the fetal chromosomes in whole fetal cells. The test can be taken during pregnancy from week 10+0 up to 14+6 days.
As for now EVITA TEST is only available in Denmark.
Step-by-step guide to the EVITA TEST COMPLETE
Contact your preferred clinic to book an appointment for a blood test. This can be done anywhere from week 10+0 days until week 14+6 days of pregnancy.
The blood sampling will be completed at the clinic. The blood sample is then processed and analyzed by ARCEDI, and the results evaluated by an experienced clinical geneticist.
Your test results will most often be ready within 12 working days, from the date of the test.
A) Most EVITA TEST COMPLETE results are normal and you receive the test results by phone from the clinic. A short report is also mailed to you.
B) In the rare event that the results indicate an abnormality in the fetal DNA, you will be called by the clinic, who will guide you through the findings and talk you through the next steps.
EVITA TEST COMPLETE’s laboratory analysis is ISO 15189 accredited by DANAK under registration number 1049 to medical examination.
Choose your clinic and book an appointment
If you want to book an appointment for an EVITA TEST COMPLETE, choose one of our partner clinics nearby.
How EVITA TEST COMPLETE works
Watch the video to learn about the technology behind EVITA TEST COMPLETE.
EVITA TEST COMPLETE vs. traditional NIPTs
Watch how EVITA TEST COMPLETE differs from traditional NIPTs in detecting genetic abnormalities prenatally.
Get familiar with EVITA TEST COMPLETE and our partner clinics
Read more about EVITA TEST on our social media
Accuracy and confidence with EVITA TEST COMPLETE
- Complete fetal DNA screening based on whole and pure fetal cells.
- Screening for abnormalities in all chromosomes: both in number of chromosomes and for disease causing variations within all chromosomes.
- Test accuracy unaffected by maternal DNA, BMI and malignancies – which challenges traditional NIPT tests based on fragments of circulating DNA.
- Only available NIPT test in the private market where all steps in the process from blood test to genetic reporting takes place within Denmark.
- Provides accurate gender identification.
Want to know more about EVITA TEST COMPLETE and other NIPT tests?
EVITA TEST COMPLETE versus other NIPTs
EVITA TEST COMPLETE is a cell-based Non-Invasive Prenatal Test. There are other types of tests called cell-free Non-Invasive Prenatal Test which are available on the market today, but EVITA TEST COMPLETE is the only one that:
- Is based on the analysis of whole and pure fetal cells with the complete fetal genome.
- Screens the entire genome for aneuploidies and any pathogenic (disease causing) deletions and dulpications as small as 1 million base pairs (Mb)* in size in .¤
- Additionally, it screens selected regions associated with known syndromes for even smaller pathogenic deletions and duplications ≥ 0.4 Mb.¤
- Can be used by all pregnant women regardless of their own genetics or BMI.
The differences between the various prenatal test types can be seen below.
* Human chromosomes come in different sizes, the largest being Chromosome 1 (249 Mb), and the smallest Chromosome 21 (54 Mb)
¤ These syndromes are from the DECIPHER database (Grade 1), and are reported according to the Danish national prenatal reporting guidelines.
Sensitivity and specificity
EVITA TEST COMPLETE has been developed together with researchers from Aarhus University Hospital. Between 2018 and 2023 a clinical validation study was conducted in the Central Denmark Region on 344 pregnancies.
The results are published in the journal; Prenatal Diagnosis: How does cell-based NIPT perform against chorionic villus sampling and cell-free NIPT in detecting trisomies and copy number variations? A clinical study from Denmark.
Based on this published data, and on recent unpublished data, sensitivity and specificity have been calculated for EVITA TEST COMPLETE:
- Sensitivity is a measure of how many with abnormal genetics are correctly identified as abnormal in the test.
- Specificity is a measure of how many with normal genetics are correctly identified as normal in the test.
Syndromes EVITA TEST COMPLETE screens for
EVITA TEST COMPLETE screens all fetal chromosomes for aneuploidies (gain or loss of a complete chromosome eg. Downs syndrome is caused by an extra copy of chromosome 21) and deletion and duplication syndromes, also called copy number variations (CNVs), where parts of a chromosome are duplicated or deleted. Fortunately, deletion and duplication syndromes are rare, but can occur anywhere within the different chromosomes. Some deletions and/or duplications are more frequent and have a syndrome named after them, while others are rarer and often de novo (new) but can still be serious.
EVITA TEST COMPLETE tests for aneuploidies and any pathogenic (disease causing) deletions and dulpications as small as 1 million base pairs (Mb)* in size in .¤
Additionally, smaller pathogenic deletions and duplications ≥ 0.4 Mb in selected regions associated with known syndromes are reported.¤
* Human chromosomes come in different sizes, the largest being Chromosome 1 (249 Mb), and the smallest Chromosome 21 (54 Mb)
¤ These syndromes are from the DECIPHER database (Grade 1), and are reported according to the Danish national prenatal reporting guidelines.
Genomewide, pathogenic copy number variations
- > 1 Mb for deletions
- > 1 Mb for duplications
Number errors (loss or increase of an entire chromosome)
All aneuploidies on the autosomal chromosomes – i.e. chromosomes 1-22.
For example:
- Trisomy 21 – Downs syndrome
- Trisomy 18 – Edwards syndrome
- Trisomy 13 – Pataus syndrome
Number errors of the sex chromosomes
For example:
- X0 – Turner syndrome
- XXY – Klinefelters syndrome
- XYY – Jacobs syndrome
Selected deletions and duplications (≥ 0.4 Mb) in regions associated with known syndromes
For example:
- Prader-Willi syndrome (type 2)
- Angelman syndrome (type 2)
- Williams syndrome
- 1p36 microdeletion syndrome
- Cri-du-chat Syndrome (5p deletion)
- Wolf-Hirschhorn syndrome
- 22q11 deletion syndrome (Velocardiofacial / DiGeorge syndrome)
- Smith-Magenis syndrome
- 2q33.1 deletion syndrome
- 2q37 monosomy
- Sotos syndrome
- 9q subtelomeric deletion syndrome
- Potocki-Shaffer syndrome
- ATR-16 syndrome
- Rubinstein-Taybi syndrome
- Miller-Dieker syndrome (MDS)
- NF1-microdeletion syndrome
- 17q21.31 recurrent microdeletion syndrome (Koolen de Vries syndrome)
- 22q13 deletion syndrome (Phelan-Mcdermid syndrome)
Test restrictions
EVITA TEST COMPLETE is not yet a diagnostic test, it is a screening test like the other NIPT tests. Thus, a positive test finding of an anomaly needs to be confirmed with a followup invasive diagnostic test. A positive screening result means that a fetus has a high risk of having a specific genetic chromosomal abnormality. Consequently, any medical decisions regarding the screening test results should only be taken after a discussion with a medical doctor or specialist health care professional.
In a small number of maternal blood samples (5%), not enough fetal cells can be found to carry out the chromosome examination. In this case, a new blood test (within the gestational age of 10+0 -14+6) is offered. After this point, the number of samples where a chromosome examination of the fetus cannot be completed drops to 2%. If still unsuccessful at this point in time a refund is provided.
EVITA TEST COMPLETE cannot be used to test for:
- Monogenic diseases (mutation in a single gene, e.g. cystic fibrosis)
- Mosaicism (a small fraction of cells in the placenta or fetus have a chromosomal abnormality)
- Polyploidy (more than two of each kind of chromosomes)
- Balanced translocations (exchange of chromosomal material between two different chromosomes, but the total amount of the chromosomes is unchanged)
- Uniparental disomy (UPD) (two copies of a chromosome are inherited from only one parent)
Pricing
Our partner clinics will be happy to inform about pricing when you call to book your test appointment. See the list of clinics below.
Still got questions?
If you want to know more about the test, simply visit our frequently asked questions page, where our expert team is ready to answer your questions.