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|
|False positive No.||1||1||0|
|False negative No.||0||0||0|
|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%|