What is PaternitySafe?

PaternitySafe® is a non-invasive prenatal paternity test that helps determine the baby's biological father while the pregnancy is ongoing. The test is based on examining the baby's cell-free DNA fragments naturally present in the mother's blood and comparing the resulting genetic profile with that of the alleged father. This procedure does not interfere with the environment in which the baby is located; no invasive intervention such as amniocentesis or chorionic villus sampling is required.
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Why is it done?

The PaternitySafe test makes it possible to assess biological paternity during pregnancy, without waiting for the baby to be born.

Traditional prenatal paternity tests may require sampling from the amniotic fluid or placenta. These procedures are invasive and are performed only with appropriate medical indications. In the PaternitySafe test, however, a blood sample is taken from the expectant mother and a buccal swab sample is taken from the alleged father.

Therefore, the test:

• Does not interfere with the environment in which the mother and baby are located.

• Does not require surgical or interventional sampling.

• Allows paternity to be assessed safely during pregnancy.

How Does It Work?

01

Plasma is separated from the expectant mother's blood

02

The cell-free DNA of the mother and baby in the plasma is examined

03

The DNA is analyzed using Next-Generation Sequencing.

04

It is compared with the DNA in the buccal swab sample taken from the alleged father

05

A paternity assessment is made based on the genetic match obtained.

When can it be done?

Although the brochure states that fragments of the baby's DNA can be detected in the mother's blood from the early stages of pregnancy, for the PaternitySafe test it is recommended that the blood sample be taken from the expectant mother at 10 weeks of gestation at the earliest .

It is appropriate for the gestational age to be confirmed by ultrasound or a doctor's assessment.

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How Is It Done?

  • Approximately 3 mL of blood sample is taken from the expectant mother.

  • A buccal swab sample is taken from the alleged father.

What are the advantages?

It is non-invasive

It does not require sampling from the amniotic fluid or placenta. Therefore, the environment in which the baby is located is not entered for the purpose of the test.

Can be performed in early pregnancy

The test can be performed from the recommended gestational week onward, without waiting for the baby to be born.

Advanced technology is used

The small amount of the baby's DNA in the mother's blood is examined using Next-Generation Sequencing and advanced bioinformatic methods.

Offers high accuracy

The test's sensitivity and specificity are above 99%, so paternity results are reported with high reliability.

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How are the results reported?

At the end of the test, one of two results is usually given; if the proportion of the baby's DNA is low, a result may not be possible and a new blood sample may be requested.

  • Paternity Confirmed

    The alleged father cannot be excluded as the baby's biological father. When the genetic characteristics match, the result can be reported with a paternity probability of over 99.9% .

  • Paternity Excluded

    No genetic match is found, and it is concluded that the alleged father is not the biological father.

How long does it take to get the result?

The laboratory analysis time is usually 15 working days.

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What should be considered before the test?

The following about the expectant mother:
- Gestational age,
- Whether it is a singleton or multiple pregnancy,
- Whether she has recently had a blood transfusion,
- History of organ or bone marrow transplantation,
- Whether the pregnancy resulted from a donor egg,
- History of a vanishing twin
must be reported to the laboratory. These situations may affect the distribution of DNA in the mother's blood and may require a separate assessment of the test's applicability.

Before the buccal swab is taken from the alleged father, he may be required not to eat, drink, smoke or chew gum for the period specified by the laboratory.

Why is the mother's sample needed?

The mother's blood contains DNA fragments belonging to both the mother and the baby. Knowing the mother's genetic characteristics helps to identify the baby's portion more accurately.

Therefore, the test is performed not only with the sample taken from the alleged father but together with the expectant mother's blood sample.

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What if there is more than one alleged father?

If there is more than one alleged father, each person can be tested separately. If the alleged fathers are close relatives of one another, the laboratory must be informed. Particularly when the alleged fathers are brothers, father and son, or close male relatives, genetic similarity may be higher, so additional analysis may be required.
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