Enzygnost* Anti-HBc monoclonal - Medcorp

Tab. 3 SpecificityThe specificity studies performed at four independent centres (T, J, R, W) yielded the followingdata:Sample panel Number of sample Initially reactive Retest reactive(T) Normal negative sera 480 2 1(J) Normal negative sera 1943 17 12Normal negativeplasmas 494 4 2(R) Normal negative sera 731 0 0(W) Normal negative 2468 28 9sera/plasmasTab. 4 ReproducibilityThe studies on intra-assay reproducibility performed at two independent centres (T, Tr) yieldedthe following data:Sample Repeats Ratio % CV(T) 1 20 1.531 8.72 20 1.012 13.63 20 0.689 8.0(Tr) 1 15 1.559 5.02 15 1.079 3.93 15 0.951 5.4The studies on inter-assay reproducibility performed at three independent centres (T, J, Tr)yielded the following data:Sample Repeats Ratio % CV(T) 1 10 1.689 8.52 10 1.090 10.73 10 0.844 11.2(J) 1 10 1.878 4.72 10 1.329 11.53 10 1.109 15.3(Tr) 1 7 1.373 5.62 7 0.940 12.03 7 0.705 10.8Ratio = absorbance / cut-offOUWE G13 C0541 (879) CS/R 9