Table 3.
Material | Technically valid individual results (n) | Specificity (%)a, b | Sensitivity (%)a, b | One-sided lower confidence limit (%)c |
---|---|---|---|---|
IRMM-359a | 112 | 100 | – | 97.3 |
IRMM-359b | 122 | – | 100 | 97.5 |
IRMM-359c | 125 | – | 100 | 97.6 |
The presence/absence certification (see text for explanation and details) is expressed in either diagnostic specificity (blank material) or diagnostic sensitivity (SEA-containing materials)
aAs defined in the formula depicted in the text and in [18]
bAs determined using the European screening method (ESM) with the VIDAS SET2 detection step and the Ridascreen SET Total detection step. The certified value is based on eight accepted datasets of the ESM with the VIDAS SET2 detection step and seven accepted datasets of the ESM with the Ridascreen SET Total detection step. The certified value is traceable to the SI
cThe lower confidence limit is based on the results of 15 laboratories. It is determined assuming a Poisson distribution [26] with n technically valid (correct) and 0 incorrect results. The value holds for a 95 % level of confidence