Unique NIPT tests that integrate mothers' carrier screening in one single blood draw
Over one million pregnant women in Asia have undergone the triSure NIPT to ensure a safe and non-invasive prenatal screening starting from the 9th week of pregnancy. This groundbreaking test not only examines numerical abnormalities across the 23 pairs of fetal chromosomes, but it also integrates information about carrier genes from mothers. These carrier genes include those related to Thalassemia, enabling obstetricians to make early interventions when necessary. With triSure NIPT, expectant mothers can rest assured that their baby's health is being closely monitored, providing peace of mind during this crucial phase of pregnancy.
triSure - Non-invasive prenatal testing (NIPT)
The story of triSure - Gene Solutions' comprehensive NIPT (Non-invasive Prenatal Testing) solutions for all OBGYNs and pregnant women. triSure NGS-based screening products line covers from fetus basic trisomy, mother's carrier integration to single-gene disorders, with validated notable accuracy and unique post-test support.
The uniqueness of triSure algorithm and technical process.
- triSure assay with integrated mothers’ recessive diseases procedure is validated by peer-reviewed publication.(*)
- triSure is the NIPT test that reduces the need for amniocentesis, 25 times more than other biochemical tests.(**)
- The triSure algorithm uniquely distinguishes between fetal and maternal DNA, aiding in the recognition of maternal mosaicism and fetal abnormalities to enhance test accuracy and minimize false positive cases.(***)
(*) International publication “Establishing and validating non-invasive prenatal testing procedure for foetal aneuploidies in Vietnam”. (**) Published in the Vietnamese Medical Journal “Investigate positive predictive values of NIPT triSure noninvasive prenatal test in medical practice” by Patricia AT, et al (2016); “Noninvasive prenatal testing in the general obstetric population: clinical performance and counselling considerations in over 85,000 cases”, Prenatal Diagnosis, 36, 237 243 & Petersen AK, et al. (2017). “PPV estimates for cell-free noninvasive prenatal screening from data of a large referral genetic diagnostic laboratory”, Am J Obstet Gynecol; 217:691. e1-6. (***) International publication “Reducing false positive rate of foetal monosomy X in non invasive prenatal testing using a combined algorithm to detect maternal mosaic monosomy X”.
Benefits of trisure NIPT
Early screening for serious and common birth defects in the fetus as well as common recessive genetic diseases for mothers.
Performed at nine weeks or more of pregnancy and is recommended as the first test for pregnant women.
Sensitivity and specificity >99% can replace biochemical tests such as double test.
Early screening for timely intervention or a better pregnancy management plan, appropriate delivery management, postnatal care and preparation for the next pregnancy.
Testing scope of trisure NIPT
Numerical chromosome abnormalities in the foetus
Down
Edwards
Patau
Turner
Klinefelter
Rare trisomies
Monogenic recessive diseases from the mother
Alpha thalassemia
Frequency of Vietnamese carriers: 1/22
Beta thalassemia
Frequency of Vietnamese carriers: 1/32
Milk allergy (Galactose metabolism disorder)
Frequency of Vietnamese carriers: 1/416
G6PD Deficiency
Frequency of Vietnamese carriers: 1/36
Protein intolerance (Phenylketonuria)
Frequency of Vietnamese carriers: 1/60
Cholestatic jaundice due to citrin deficiency
Frequency of Vietnamese carriers: 1/32
Male sexual differentiation disorder due to deficiency of 5-alpha reductase enzyme
Frequency of Vietnamese carriers: 1/45
Pompe disease (glycogen-storage disease type 2)
Frequency of Vietnamese carriers: 1/52
Wilson's disease (disorder of copper metabolism)
Frequency of Vietnamese carriers: 1/110
Testing process
Pre-test counselling
Blood collection and extracellular DNA separation
Sequencing of cell-free DNA
Counting-base analysis
Returning results and post-test counselling
Compared to biochemical screening
There is a 25-fold reduction in unnecessary amniocentesis
Only 3 of every 100 positive cases are abnormal, with the remaining 97 cases being amniocentesis.
Biochemical test
There are 97 abnormal cases for every 100 positive cases, minimizing inappropriate amniocentesis.
triSure NIPT
Published in the Vietnam Medical Journal "Determining the positive predictive value of the noninvasive prenatal test NIPT in medical practice."
Missed cases are reduced by 15 times (false negatives)
85% detection rate
(for every 100 cases, 15 cases are missed)
Biochemical test
99% detection rate
(for every 100 cases, less than 1 case is missed)
triSure NIPT