EVITA TEST COMPLETE is the only NIPT test that I recommend to my patients. It is the best risk-free test that also detects minor chromosomal aberrations.

Mette – Doctor

Evita Test Complete

EVITA TEST COMPLETE is the only NIPT test on the market that is cell-based and which examines all chromosomes of the fetus for possible abnormalities. A blood sample from the pregnant woman taken from gestational age 10+0 to 14+6 is analyzed with a specially developed technology, and the results are evaluated by a geneticist. A final result is ready for the parents within twelve working days.

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Model photo

EVITA TEST COMPLETE is the only NIPT test that I recommend to my patients. It is the best risk-free test that also detects minor chromosomal aberrations.

Mette – Doctor (model photo)

EVITA TESTEN

EVITA TEST COMPLETE is the only NIPT test on the market that is cell-based, identifies the sex chromosomes, and examines the 22 chromosome pairs. A blood sample from the expectant mother is analysed using a specially developed technology and the result is reviewed by a clinical geneticist. A final result is ready for the parents within ten working days.

What is analysed in the EVITA TEST COMPLETE?

The EVITA TEST COMPLETE detects changes in chromosome numbers (gains and losses). It examines all chromosomes and reveals both structural and numerical aberrations. EVITA TEST COMPLETE detects microdeletions and microduplications down to a size of 5 megabases. The test examines the chromosomes using comparative genomic hybridization (aCGH).

The test can also accurately identify the sex of the fetus.

New technology behind EVITA TEST COMPLETE

Several variants of Noninvasive prenatal test (NIPT) exist in the market. EVITA TEST COMPLETE is based on a unique technology where whole cells from the fetus are isolated from the pregnant woman’s blood. By isolating the DNA from these circulating fetal cells, one has access to complete genome of the fetus, which can then be analyzed for genetic aberrations. This is called cell-based NIPT.

In the conventional NIPT (also called cell-free NIPT), DNA fragments from the fetus, which circulate in the pregnant woman’s blood, are analyzed. These fragments of fetal DNA originate from apoptotic/broken fetal cells and are analyzed together with the fragments of the pregnant woman’s own DNA in the blood sample. Thus, factors such as the pregnant woman’s BMI and her possible genetic abnormalities can hinder or affect the NIPT results.

Access to the complete genome of the fetus makes it possible to analyze all fetal chromosomes for aneuploidies (loss or increase of the number of whole chromosomes), but also for smaller deletions and duplications of sizes as small as 5 million DNA base pairs. Unlike EVITA TEST COMPLETE, most other cell-free NIPT tests check for common aneuploidies (on chromosomes 13, 18, and 21) and perhaps a smaller group of specific deletion syndromes.

What is unique about EVITA TEST COMPLETE?

  • EVITA TEST COMPLETE is the only NIPT test on the market that is based on the analysis of intact fetal cells circulating in pregnant women’s blood, thus examining the entire fetal genome for chromosomal aberrations.
  • EVITA TEST COMPLETE’ is performed on a blood sample from the pregnant woman taken from gestational age 10+0 to 14+6.
  • EVITA TEST COMPLETE offers the best of both worlds – there is no risk to the fetus and you are guaranteed a picture of all the chromosomes.
  • EVITA TEST COMPLETE examines for aneuploidies and disease-causing deletion and duplication syndromes down to 5 million DNA base pairs in size on all chromosomes.
  • EVITA TEST COMPLETE is accurate and can screen for more chromosomal aberrations than the conventional cell-free NIPT which are based on analysis of fragments of fetal DNA.
  • EVITA TEST COMPLETE is neither affected by the mother’s own genetic abnormalities, nor her BMI.

EVITA TEST COMPLETE is clinically validated in Denmark

EVITA TEST COMPLETE, also called cell-based NIPT (cbNIPT), has been developed together with researchers from Aarhus University Hospital. From 2018 to 2023 a clinical validation study was run in the Central Denmark Region on 344 women.  The results have been published in the journal Prenatal Diagnosis: How does cell-based NIPT perform against chorionic villous sampling and cell-free NIPT in detecting trisomies and copy number variations? A clinical study from Denmark.

Based on these published data, sensitivity and specificity for cbNIPT, EVITA TEST COMPLETE have been calculated:

 

Sensitivity

Specificity

Common trisomies (Chromosomes 13, 18, 21)

100 %  (CI 89-100)

100 % (CI 99-100)

Sex chromosome aneuploides (SCA)

100 % (CI 44-100)

100 % (CI 99-100)

Copy number variations (CNV) down to 5 mio. DNA base pairs in size

100 % (CI 64-100)

99 % (CI 98-100)

Sensitivity is a measure of how many people with abnormal genetics are identified as abnormal in the test. Specificity is a measure of how many people with a normal genetics are identified as normal in the test. CI – Confidence interval

Which syndromes does EVITA TEST COMPLETE screen for?

EVITA TEST COMPLETE screens all fetal chromosomes aneuploidies (change in the number of chromosomes), and deletion and duplication syndromes down to sizes of 5 million DNA base pairs. Deletion and duplication syndromes are fortunately rare but can occur on different chromosomes. Some deletions/duplications are more frequent and have a syndrome named after them, while others are more rare and often new, but can still be serious.

For EVITA TEST COMPLETE, any disease-causing copy number variation over 5 million DNA base pairs in size will be reported. This could be, for example:

Number errors of autosomal chromosomes
 (loss or gain of an entire chromosome)

Number errors of the sex chromosomes

Deletions/duplications*
 (loss or increase of subsets of a 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

For example:

  • Turner’s syndrome (X0)
  • XXY – Klinefelters syndrome
  • XYY syndrome
  • Prader Willi syndrome
  • Angelman syndrome
  • Cat-eye Syndrome
  • 1p36 microdeletion syndrome
  • Cat Cry Syndrome

* These are examples of deletions or duplications over 5 million DNA base pairs in size, but this is not a complete list of deletions/duplications that EVITA TEST COMPLETE can detect. Copy number variations can occur anywhere on the various chromosomes, and EVITA TEST COMPLETE will report any disease-causing copy number variations over 5 million DNA base pairs in size.

Limitations

EVITA TEST COMPLETE is not a diagnostic test

EVITA TEST COMPLETE is a screening test, which means that it does not make a definitive diagnosis. A positive screening result means that your fetus has a high risk of having a specific chromosomal aberration. Hence, all medical decisions should be made after discussion with a doctor or specialist healthcare professional.

Since fetal cells in the pregnant woman’s blood are extremely rare, in a small number of samples (6%) not enough fetal cells can be extracted for chromosomal examination from the first blood draw . If your blood sample is among these 6%, you will be offered a new blood test (free of charge and only within gestational age 10+0-14+6). After second blood sample the number of tests on which chromosomal examination of the fetus can be performed goes up to 98%.

EVITA TEST COMPLETE is currently being investigated, but has not yet been validated for:

  • Twin pregnanciesPolyploidy
    (more than two copies of each chromosome)
  • Balanced translocations
    (exchange of chromosome material between two different chromosomes, but the total amount of chromosomes remains unchanged)
  • Monogenic diseases (mutation in a single gene, e.g. cystic fibrosis)
  • Mosaicism (a small fraction of the cells of the placenta or fetus has a chromosomal aberration)
  • Uniparental disomy (UPD) (two copies of a chromosome are inherited from only one parent)
  • Deletions/duplications below 5 million DNA base pairs in size

How is an EVITA TEST COMPLETE performed?

The EVITA TEST COMPLETE is a quick and easy process for a clinic to carry out. 

EVITA TEST COMPLETE test kit

ARECDI provides clinic with a blood collection kit (EN ISO 13485:2016). The kit contains everything that is needed for blood sampling and shipment of the samples to ARCEDI

Appointment for taking blood sample

The expectant parent(s) make an appointment for EVITA TEST COMPLETE, and the blood sample is drawn from the pregnant woman at the clinic. 

Blood sample sent for analysis

The blood sample is sent to ARCEDI where the sample is processed and DNA isolated from the fetal cells.

Genetic analysis

The Department of Clinical Genetics at Aarhus University Hospital performs genetic analysis, and sends the results to the clinic in the form of a short report.

Results: No aberrations detected

The vast majority of results show no chromososme aberrations and thus a normal results. In such a case the clinic informs the expectant parent(s) via a phone call and a short report. 

Results: Aberrations detected

In the case of any suspected chromosome aberrations, the clinic will guide the expectant parent(s) to an in-depth counselling session with the healtcare specialists.

Test kit delivered

The test kit is delivered to the clinic. The kit will contain everything you need to take the blood sample, as well as the consent form and shipment information.

The blood test

The clinic takes the blood sample from the expectant mother. 30ml of blood is required.

Blood sample sent for analysis

The blood sample is sent to ARCEDI where the sample will be prepared. (DNA will be isolated from the fetal cells).

Genetic analysis

The Department of Clinical Genetics at Aarhus University Hospital will conduct a genetic analysis. The results will be provided to the clinic in the form of a short report.

Results: No aberrations detected

A normal test result is provided by The Department of Clinical Genetics to the referring clinic. The clinic then informs the expectant parents by phone that no chromosome aberrations have been detected and a brief report is sent via email.

Results: Aberrations detected

In the case of any suspected chromosome aberrations, the expectant parents will be informed by the clinic. The parents will be invited to a consultation with a medical specialist at The Department of Clinical Genetics.

When should the test be carried out?

EVITA TEST COMPLETE should be carried out during week 10+0 – 14+6 of pregnancy.

Our experience with EVITA TEST COMPLETE

Læs andres erfaringer med EVITA TEST
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EVITA TEST - Læs andres erfaring
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Læs andres oplevelser med EVITA TEST
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“I recommend the EVITA TEST COMPLETE to all expectant parents who are perhaps concerned about the health and well-being of their fetus. The test is completely risk-free and provides an overview of all of the child’s chromosomes. It’s the only test on the market that provides that level of detail and peace of mind.”

Susan, midwife

“We have previously experienced two miscarriages. Because of that, we were never in doubt that we wanted an EVITA TEST COMPLETE. There is no risk involved with this specific test, and we needed insurance that everything was alright with our baby. The test provided us exactly the security we were longing for. We could continue the pregnancy feeling content that our little boy is healthy.

Sally and Peter, new parents

“The EVITA test is all about peace of mind and feeling content that the child we are expecting is healthy. We have several friends who have experienced complicated pregnancies. These complications resulted in a feeling of insecurity in between the hospital visits. With the EVITA test, we receive the results of the nuchal translucency scan already in week 12. By having the results, we could feel calmer and can be well prepared for the pregnancy.”

Michael og Katrine, young parents

Our experience with EVITA TEST COMPLETE

EVITA TEST GENDER

If the expectant parents only want to know the sex of the fetus, we recommend EVITA TEST GENDER. This test simply requires the clinic to take a blood sample from the expectant mother and the results will be ready in two working days. EVITA TEST GENDER can be performed from week 10 of pregnancy and the results are available from week 12.

Are you our next partner clinic?

If you are interested in becoming a partner clinic for EVITA TEST, please contact ARCEDI by email at: loha@arcedi.com or by phone on: +45 61 71 25 57 and we’ll be happy to answer any questions you may have.