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. 2006 Dec;82(Suppl 5):v7–v12. doi: 10.1136/sti.2006.022707

Table 4 Performance of rapid diagnostic tests for syphilis in round 1.

Sites Determine Syphilis TP Abbott Labs Syphilis Fast Diesse Diagnostica Espline TP Fujirebio Inc Syphicheck‐WB Qualpro Diagnostics SD Bioline Syphilis 3.0 Standard Diagnostics Visitect Syphilis Omega Diagnostics
Sens (%) Spec (%) Sens (%) Spec (%) Sens (%) Spec (%) Sens (%) Spec (%) Sens (%) Spec (%) Sens (%) Spec (%)
Moscow, Russian Fed. 100 100 72 98 100 83 80 100 92 98 76 100
Birmingham, USA 88 92 57 92 98 88 82 94 94 90 80 94
Port au Prince, Haiti 100 98 100 92 98 100 90 98 100 100 90 100
Nanjing, China 98 93 79 89 94 93 77 95 89 96 81 93
Mwanza, Tanzania 96 94 94 90 98 100 80 100 94 94 82 100
Colombo, Sri Lanka 100 98 96 100 98 96 88 100 96 100 92 100
Durban, South Africa 96 90 94 96 96 94 82 100 94 98 86 100
Fajara, The Gambia 100 88 94 86 100 92 96 94 100 84 92 96
Overall results 97.2 94.1 86 92.8 97.7 93.4 84.5 97.7 95 94.9 85 98
95% CIs 95.6 to 98.8 91.8 to 96.4 82.5 to 89.4 90.3 to 95.4 96.3 to 99.2 90.9 to 95.8 80.9 to 88.0 96.2 to 99.2 92.8 to 97.1 92.7 to 97.1 81.4 to 88.5 96.5 to 99.4
Homogeneity* p values 0.0086 0.0002 0.2529 0.1427 0.1132 0.03
κ† (95% CI) 0.95 (0.93 to 0.97) 0.87 (0.84 to 0.90) 0.95 (0.93 to 0.97) 0.84 (0.80 to 0.87) 0.9 (0.87 to 0.94) 0.85 (0.82 to 0.89)

*The Breslow‐Day test for homogeneity of odds ratios was calculated to determine the extent of site‐to‐site variation of test performance.

†The κ value for each test is a summation of the overall performance of each test against the reference standard for all sites. A value of 0.75 or greater is considered excellent.

CI, confidence interval; Sens, sensitivity; Spec, specificity.