Tri- Gene Test

Traditional screening misses the diagnosis of Down's syndrome in 10-35% cases with a false positive rate of 5-7%, making the mother undergo unnecessary invasive tests that can cause 0.5- 1% fetal loss.

Tri- Gene is a prenatal diagnosis/screening test without risk and high accuracy and also avoid invasive test.

Comparison of Traditional Screening and Diagnosis Technologies:

Method Non/Invasive Pregnancy(W) Risk & Detection Rate
First-Trimester Serum Screening Non/Invasive 11/13 65%?70% Detection Rate
Second-Trimester Serum Screening Non/Invasive 15/19 69%/81% Detection Rate
Fetal Nuchal Translucency (NT) Non/Invasive 11/13 64%/70% Detection Rate
Serum Integrated Screen Non/Invasive 11/13 & 15/19 85%/88% Detection Rate
Serum integrated screen + NT Non/Invasive 11/13 & 15/19 94%/96% Detection Rate
Amniocentesis Invasive 16/21 0.5/1% Miscarriage Permission Required
Chorionic villi aspiration sampling (CVS) Invasive 10/13 1/2% Miscarriage Permission Required
Percutaneous umbilical blood sampling (PUBS) Invasive 18/24 1/2% Miscarriage Permission Required
Tri- Gene Non/Invasive 12- 24 No Miscarriage Risk >99% Detection Rate


Accuracy: The test detects >99% of pregnancies affected by Down syndrome. The false positive rate is <1%.
Testing Period: The test can be done between 12 weeks to 24 weeks of gestation.
Sample Needed: Only 5ml maternal peripheral blood is needed.
Reporting Time: The report is available within 2 weeks in 90% cases.

Advantages:

  • Non-Invasive: only 5 mL maternal peripheral blood is needed. Therefore, there is no risk of intrauterine infection and miscarriage.
  • Highly Accurate: 100% sensitivity and 99.9% specificity.
  • Early-Test: can be performed at the early pregnancy (~12 weeks), which allows early detection for a better clinical decision.
  • Report: available within 2 weeks.
  • Inclusivity: All chromosomal aneuploidies could be detected in one test.

Applications:

  • Those that wish to have non-invasive fetal aneuploidies test for trisomy21, 18 and 13.
  • Those whose age is 35 or above and does not choose to receive invasive prenatal tests.
  • Those whose serum biochemical tests and ultrasound examinations suggest high risk of chromosome aneuploidies at the first and second trimester.
  • Those that has contraindication of invasive prenatal testing, such as placenta previa, risks of miscarriage, HBV infection and HIV infection, etc.
  • Those that received IVF, or previously suffered from habitual abortion.