Table 4: The sensitivity, 95% confidence intervals (CI) and delta values of the Project IVDs in a known positive and a presumed antibody status positive specimen panel. The specimens were selected by PHE on screening reactivity in this IVD followed by a positive Viramed IgG immunoblot #Interpretive criteria Europe excluding German FDR No. of Specimens positive panel (Equivocal as PAS positive panel (Equivocal as Equivocal results (%) negative) negative) Known PAS Sensitivity % 95% CI Sensitivity % 95% CI Known PAS δ Positive Positive Positive Positive Novatec Novalisa 94 87–98 1.91 100 95–100 1 0 DiaSorin Liaison 95 88–98 N/A 99 93–100 2 1 CLIA Trinity Biotech 80 71–87 1.2 73 62–81 7 4 ELISA Euroimmun 78 68–85 0.97 94 86–97 8 2 Immunetics C6 IgG 100* 95–100 4.03 100 95–100 0 0 100 95 Viramed IgG IB 9 5 89* 81–94 N/A 87 79–93 Euroimmun 99 94–100 N/A 100 95–100 N/A N/A Euroline IB Trinity Biotech IB 33 24–43 N/A 66 56–75 6 15 # Mikrogen IgG IB 77 67–85 N/A 93 85–97 14 4 Seramun SeraSpot 87 78–93 N/A 100 95–100 5 0
Table 4: The sensitivity, 95% confidence intervals (CI) and delta values of the Project IVDs in a known positive and a presumed antibody status positive specimen panel. No. of Specimens positive panel (Equivocal as negative) PAS positive panel (Equivocal as negative) Equivocal results (%) Known Positive PAS Positive Sensitivity % 95% CI δ Sensitivity % 95% CI Known Positive PAS Positive Novatec Novalisa 100 95 94 87–98 1.91 100 95–100 1 0 DiaSorin Liaison CLIA 95 88–98 N/A 99 93–100 2 1 Trinity Biotech ELISA 80 71–87 1.2 73 62–81 7 4 Euroimmun 78 68–85 0.97 94 86–97 8 2 Immunetics C6 IgG 100* 95–100 4.03 100 95–100 0 0 Viramed IgG IB 89* 81–94 N/A 87 79–93 9 5 Euroimmun Euroline IB 99 94–100 N/A 100 95–100 N/A N/A Trinity Biotech IB # 33 24–43 N/A 66 56–75 6 15 Mikrogen IgG IB 77 67–85 N/A 93 85–97 14 4 Seramun SeraSpot 87 78–93 N/A 100 95–100 5 0 The specimens were selected by PHE on screening reactivity in this IVD followed by a positive Viramed IgG immunoblot #Interpretive criteria Europe excluding German FDR
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