• Medicalport Tunççevik Hospital, Kurtuluş St., No: 70, Kyrenia
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Why choose PrenatalSafe for a NIPT test ?

Europe’s broadest and most reliable NIPT test panel

 

Next-generation CE-IVD Technology + Proprietary CE-IVD NIPT FLOW™ Algorithm

  1. In studies conducted on 71,740 pregnancies, sensitivity and specificity >99.9% have been proven.
  2. High resolution: coverage of 50 million reads (test accuracy increases as the number of reads increases).
  3. High detection at low levels: high accuracy with low cfDNA amounts (FF: 2%) (enabling testing at an earlier gestational age).
  4. Low no-result rate (<0.1%) (allowing diagnosis without the need for invasive procedures such as amniocentesis).
  5. PrenatalSafe® has the lowest false-negative rate, with 0% false negatives reported in published clinical studies.
  6. The PrenatalSafe® test is performed in a laboratory with ISO 17025 and ISO 15189 accreditation, over 20 years of prenatal diagnostic experience, and more than 200,000 genetic tests performed annually.
  7. PrenatalSafe® is prescribed by thousands of gynecologists worldwide.
  8. To date, PrenatalSafe® is the only NIPT that screens both genome-wide chromosomal abnormalities and serious fetal genetic diseases in a single test.
  9. Unlike other commercially available NIPT tests, PrenatalSafe® offers a free Rh(D) test (RhSafe).
  10. Free counseling service provided by a team of 11 genetic specialists.

 

 

Performance

Condition

Sensitivity (95% CI)

Specificity (95% CI)

Trisomy 21

99.54%

99.92%

Trisomy 18

100%

99.97%

Trisomy 13

100%

99.99%

X0 (Turner syndrome)

98.11%

99.98%

XXX, XXY, XYY

100%

100%

Rare autosomal aneuploidies

100%

100%

Deletions and duplications

100%

99.99%

Microdeletions*

83.33%

99.99%
  1. Common trisomies were analyzed in more than 70,000 samples.
  2. Sex chromosome aneuploidies were analyzed in more than 65,000 samples.
  3. Other anomalies were investigated in more than 40,000 samples.

*The only test with published scientific data on microdeletions.

 

 

Genetic Science in the Service of Clinical Practice

  1. Compliance with UNI EN ISO 15189:2013 (the only accredited laboratory in Italy for NIPT)
  2. CE-IVD certified technology
  3. Advisory team of 11 genetic specialists
  4. Authorization for UN3373 biological sample transport
  5. Sample traceability
  6. Comprehensive insurance coverage