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How accurate is the Vanadis NIPT test for Trisomy Screening?

 

Condition

Sensitivity

(95% CI)

Specificity

(95% CI)

 

Positive Predictive Value (PPV)

Negative Predictive Value (NPV)

T21a

>99 %

(95.5-100%)

>99%

(98.3-99.8%)

 

98.8%

>99%

T18b

91.7%

(77.5-98.2%)

>99%

(99.2-99.9%)

 

91.7%

>99%

T13b

>99%

(69.2-100%)

 

>99%

(99.5-100%)

 

90.9%

>99%

a = based 747 patient samples

b = based on 1035 patient samples

 

95% Confidence Interval (CI) – In 95% of samples tested the sensitivity or specificity of the test will be within the reported range

 

Sensitivity -   The ability of the Vanadis NIPT test to identify the condition in pregnancies affected by the condition

 

Specificity -  The ability of the Vanadis NIPT test to correctly identify pregnancies not affected by the condition

 

PPV -  The number of truly positive/affected pregnancies that were reported as positive by the Vanadis NIPT test

 

NPV -  The number of truly negative/unaffected pregnancies that were reported as negative by the Vanadis NIPT test