Table 3.
Sensitivity and Specificity | First-Tier Tests Alone | Modified 2-Tiered Testing Protocols |
Conventional 2-Tiered Testing |
||||
---|---|---|---|---|---|---|---|
WCS EIA | C6 | VlsE CLIA | WCS EIA f/b C6 EIA | WCS EIA f/b VlsE CLIA |
VlsE CLIA f/b C6 EIA | WCS EIA f/b IgM/IgG WBs | |
Sensitivity, % | |||||||
Acute-phase EM (n = 55) | 49 [.02] | 65 [<.0001] | 55 [.003] | 38 [.22] | 36 [.30] | 54 [.003] | 25 |
Convalescent-phase EM (n = 47) | 77 [.05] | 81 [.01] | 72 [.13] | 72 [.13] | 66 [.40] | 72 [.13] | 55 |
Specificity, % | |||||||
Overall (n = 1277) | 97.4 [<.0001] | 98.4 [.02] | 98.1 [.003] | 99.5 [1.00] | 99.5 [1.00] | 99.3 [.63] | 99.5 |
Bracketed numbers represent the P values for the comparison with conventional 2-tiered testing.
Abbreviations: CLIA, chemiluminescence immunoassay; EIA, enzyme immunoassay; EM, erythema migrans; f/b, followed by; IgG, immunoglobulin G; IgM, immunoglobulin M; VlsE, variable major protein-like sequence, expressed; WB, Western blot; WCS, whole-cell sonicate.