TrisoNIM®


The non-invasive prenatal screening test

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Revolutionising prenatal diagnosis

Maternal blood fetal DNA test to detect chromosomal abnormalities associated with Down's, Edwards' or Patau syndromes. By using Next-Generation Sequencing (NGS) and applying the NIFTY® algorithm, this test estimates the risk of presenting these diseases with a reliability of more than 99%. It also provides information about other genetic alterations and the sex of the fetus.

At NIMGenetics we are committed to quality in all our processes. We have obtained the ENAC - ISO 15189 accreditation for fetal aneuploidy screening (chromosomes 13, 18, 21, X and Y), as well as for maternal blood fetal sex determination through massive parallel sequencing (NGS). Our management system is also certified by Bureau Veritas, in accordance with the requirements of the ISO 9001:2015 Standard, for providing diagnostic genetic testing services in pre-analytical, analytical and post-analytical stages for the specialities of genomics, non-invasive prenatal testing and molecular diagnostics.

TRISONIM® ADVANCE

  • Analyses all chromosomes.
  • Detects fetal trisomies 21, 13 and 18.
  • Provides information on the most common sex chromosome aneuploidies and the sex of the fetus.
  • Tests for 3 microdeletion syndromes: 1p36, 2q33.1 and 5p (cri-du-chat).
  • BGI results software (NIFTY) with CE marking for trisomy 21.
  • Detailed fetal fraction calculation, using a double algorithm and discarding samples with less than 3.5% fetal fraction, in accordance with international recommendations.

What requirements must patients fulfil to undergo TrisoNIM® Advance?

  • Be at least 10 weeks pregnant, confirmed by ultrasound.
  • Single pregnancy.
  • Invasive diagnosis not clinically indicated.

Turnaround time: 7 working days from receipt of the sample.
Reference: PRE1002

Please remember to attach the Informed Consent Form to the sample, which you will find on the right.

TRISONIM® TWIN

  • Detects fetal trisomies 21, 13 and 18, although these cannot be attributed to individual fetus.
  • Provides information on the sex of the fetus, but if a Y chromosome is detected, the test cannot determine the sex of each twin fetus.
  • BGI results software (NIFTY) with CE marking for trisomy 21.
  • Detailed fetal fraction calculation, using a double algorithm and discarding samples with less than 3.5% fetal fraction, in accordance with international recommendations.

What requirements must patients fulfil to undergo TrisoNIM® Twin?

  • Be at least 10 weeks pregnant, confirmed by ultrasound.
  • Twin pregnancy (two fetus).
  • Invasive diagnosis not clinically indicated.

Turnaround time: 7 working days from receipt of the sample.
Reference: PRE1009

Please remember to attach the Informed Consent Form to the sample, which you will find on the right.

Vanishing twin
Due to the uncontrolled fetal DNA produced by a vanishing twin, if one of the fetus is lost*, we do not recommend performing any TrisoNIM® tests except in the following situation:

  • Loss of one of the fetus before the eighth week of pregnancy and provided that at least eight weeks have passed since loss of the embryonic sac was confirmed by ultrasound. If these requirements are met, the TrisoNIM® Advance, TrisoNIM® Premium and TrisoNIM® Excellence tests can be performed.

 

*Fetal loss: disappearance of the gestational sac must always be confirmed by ultrasound.

TRISONIM® PREMIUM

  • Analyses all chromosomes.
  • Detects fetal trisomies 21, 13 and 18.
  • Provides information on the most common sex chromosome aneuploidies and the sex of the fetus.
  • Tests for 7 microdeletion syndromes: 1p36, 1q32-q41 (Van der Woude), 2q33.1, 5p15 (cri-du-chat), 10p14-13 (DiGeorge 2), 11q23-qter (Jacobsen) and 16p12-p11.
  • BGI results software (NIFTY) with CE-IVD marking for trisomy 21.
  • Detailed fetal fraction calculation, using a double algorithm and discarding samples with less than 3.5% fetal fraction, in accordance with international recommendations.

What requirements must patients fulfil to undergo TrisoNIM® PREMIUM?

  • Be at least 10 weeks pregnant, confirmed by ultrasound.
  • Pregnant with a single fetus.
  • Invasive diagnosis not clinically indicated.

Turnaround time: 5 working days from receipt of the sample.
Reference: PRE1001

Please remember to attach the Informed Consent Form to the sample, which you will find on the right.

TRISONIM®  EXCELLENCE

  • Analyses all chromosomes.
  • Detects fetal trisomies 21, 13 and 18.
  • Provides information on the most common sex chromosome aneuploidies and the sex of the fetus.
  • Tests for 38 microdeletion syndromes with a 5Mb resolution.
  • BGI results software (NIFTY) with CE-IVD marking for trisomy 21.
  • Detailed fetal fraction calculation, using a double algorithm and discarding samples with less than 3.5% fetal fraction, in accordance with international recommendations.

What requirements must patients fulfil to undergo TrisoNIM®  EXCELLENCE?

  • Be at least 10 weeks pregnant, confirmed by ultrasound.
  • Pregnant with a single fetus.
  • Invasive diagnosis not clinically indicated.

Turnaround time: 8 working days from receipt of the sample.
Reference:  PRE1005

Please remember to attach the Informed Consent Form to the sample, which you will find on the right.

TRISONIM®  NEOSEQ

  • Analyses all chromosomes.
  • Detects fetal trisomies 21, 13 and 18.
  • Provides information on the most common sex chromosome aneuploidies and the sex of the fetus.
  • Tests for 38 microdeletion syndromes with a 5Mb resolution.
  • Analyses 2038 pathogenic and likely pathogenic variants located in 18 genes, associated with 27 dominant monogenic disorders.
  • BGI results software (NIFTY) with CE-IVD marking for trisomy 21.
  • Detailed fetal fraction calculation, using a double algorithm and discarding samples with less than 3.5% fetal fraction, in accordance with international recommendations.

What requirements must patients fulfil to undergo TrisoNIM®  NEOSEQ?

  • Be at least 12 weeks pregnant, confirmed by ultrasound.
  • Pregnancies over 22 weeks will require a special informed consent form.
  • Pregnant with a single fetus.
  • Not suitable for egg donation.
  • Invasive diagnosis not clinically indicated.

Turnaround time: 15 working days from receipt of the sample.
Reference:  PRE1005

Please remember to attach the Informed Consent Form to the sample, which you will find on the right.

Any doubts?








     

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