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A failed NIPS (NIPT) test result may lead to unnecessary patient redraws and/or diagnostic procedures, an issue often compounded by increasedmaternal weight. MaterniT 21 PLUS has a very high success rate inpatients with elevated maternal weight:
Some NIPSs (NIPTs) have a success rate as low as 72.5% (27.5%corresponding failure rate) in patients weighing over 200 lbs.2
97.6%
success rate at 200-225lbx
The MaterniT 21 PLUS test offers very low published and commercial non-reportable rates for trisomies 13, 18, and 21.
The MaterniT 21 PLUS test has been validated in clinical studies that tested samples from more than 2,100 pregnant women. The table below shows values for aneuploid samples in patients across four clinical studies, and accuracy for fetal sex within an additional publication.
Positive results | Sensitivity | Specificity |
---|---|---|
210 of 212 - trisomy 213,4 | 99.1% | 99.9% |
59 of 59 - trisomy 184 | > 99.9% | 99.6% |
11 of 12 - trisomy 134 | 91.7% | 99.7% |
8 of 8 multiple gestations: 7 of trisomy 21 | 1 of trisomy 138 | > 99.9% detection rate | |
Fetal sex9 | 99.4% accuracy | |
25 of 26 combined sex chromosome aneuploidies10 | 96.2% | 99.7% |
In a high-risk group, MaterniT 21 PLUS showed a positive predictive value greater than 97.9% for trisomy 21.11