Examinarea clinică a testului NIFTY

The clinical validation study of our NIFTY test has been finished by a multi-centered collaboration. This non-invasive screening for fetal aneuploidies has shown over 99% consistency with the result of the golden standard of the prenatal diagnosis, karyotyping. 3464 NIFTY test in phase I clinical validation with fetal karyotyping analysis indicated that it is highly accurate. Table 1 shows the comparative results of our NIFTY test of trisomies 21, 18 and 13 with fetal karyotyping analysis.
In 2009-2011, we peformed the phase II clinical test on 11105 patients. The result strongly proved that NIFTY test is highly sensitive and accurate.

Trisomy 21 Trisomy 18 Trisomy 13
NIFTY positive 189 64 10
Karyotyping Positive 188 63 10
False positive No. 1 1 0
False negative No. 0 0 0
Sensitivity 100% 100% 100%
Specificity 99.97% 99.97% 100%
False Positive Rate 0,03% 0,029% 0,00%
Fasle Negative Rate 0,00% 0,00% 0,00%
Positive Predictive Rate 99,49% 98,44% 100%