Case definition | Assay | Design | N (studies); N(2×2 tables); N(cases); N(controls) | Sensitivity (95 % CI) | Specificity (95 % CI) | Heterogeneity | Quality and Study Design |
---|---|---|---|---|---|---|---|
Erythema migrans | In-house ELISA | Case-control, Healthy controls | 6, 10, 451, 658 | 0•41 (0•25 to 0•60) | 0•97 (0•95 to 0•98) | IgG lower sensitivity than IgM. Other sources of heterogeneity were not found. | Study quality did not influence the accuracy |
In-house IB | 3, 3, 182, 380 | 0•52 (0•38 to 0•65) | 0•98 (0•94 to 0•99) | ||||
Commercial ELISA | 13, 32, 874, 2509 | 0•54 (0•44 to 0•65) | 0•93 (0•90 to 0•95) | ||||
Commercial IB | 3, 5, 161, 289 | 0•58 (0•49 to 0•67) | 0•86 (0•75 to 0•93) | ||||
Two-tiered tests | 2, 7, 125, 190 | range 0•12 to 0•64 | range 0•67 to 0•96 | ||||
Lyme neuroborreliosis | In-house ELISA | Case-control, Healthy controls | 6, 9, 277, 649 | 0•69 (0•60 to 0•76) | 0•88 (0•72 to 0•97) | IgM and IgG have similar sensitivity and specificity, IgG has a higher accuracy. Recombinant tests perform best. More recent studies perform better than earlier studies. | If serology was not part of the reference standard, then specificity was lower. |
(serum) | In-house IB | 5, 8, 253, 445 | 0•69 (0•57 to 0•80) | 0•93 (0•86 to 0•97) | |||
Commercial ELISA | 11, 28, 484, 2920 | 0•81 (0•70 to 0•89) | 0•94 (0•91 to 0•96) | ||||
Commercial IB | 2, 4, 33, 286 | 0•81 (0•57 to 0•94) | 0•92 (0•88 to 0•95) | ||||
 | Two-tiered tests | 1, 5, 15, 100 | range 0•41 to 0•87 | range 0•88 to 0•94 | |||
(csf) | Any ELISA | Case-control, Cross-reacting controls | 6, 9, 385, 261 | 0•74 (0•38 to 0•93) | 0•96 (0•85 to 0•99) | ||
(serum + csf) | Specific AI test | 7, 10, 458, 380 | 0•86 (0•63 to 0•95) | 0•94 (0•85 to 0•97) | |||
Lyme neuroborreliosis | Any ELISA or IB (in serum) | Cross-sectional study | 6, 12, 282, 412 | 0•78 (0•53 to 0•92) | 0•78 (0•40 to 0•95) | Sensitivity similar for IgG and IgM; specifcity higher for IgG. No other sources of heterogeneity. |  |
Specific AI test (in serum and CSF) | 4, 4, 102, 118 | 0•79 (0•34 to 0•97) | 0•96 (0•64 to 1•00) | ||||
Lyme arthritis | All ELISA | Case-control, Healthy controls | 8, 26, 160, 1112 | Median0•96 Interquartile range 0•93 to 1•00 | Median 0•94 Interquartile range 0•91 to 0•97 | IgM a much lower sensitivity than IgG. No other sources of heterogeneity. | Study quality did not influence the accuracy |
Acrodermatitis | All ELISA | Case-control, Healthy controls | 10, 27, 256, 1415 | 0•97 (0•94 to 0•99) | 0•95 (0•88 to 0•98) | IgM a much lower sensitivity than IgG. No other sources of heterogeneity. | Study quality did not influence the accuracy |
Lyme borreliosis (unspecified) | In-house ELISA | Case-control, Healthy controls | 4, 7, 115, 215 | 0•85 (0•71 to 0•93) | 0•98 (0•93 to 0•99) | Tests assessing both IgM and IgG have highest sensitivity; specificity not very variable. Recombinant tests and more recent studies perform worse. | If serology was not part of the reference standard, then accuracy was lower. |
In-house IB | 2, 4, 98, 126 | 0•63 (0•33 to 0•86) | 0•97 (0•93 to 0•99) | ||||
Commercial ELISA | 10, 43, 658, 815 | 0•70 (0•52 to 0•83) | 0•95 (0•89 to 0•98) | ||||
Commercial IB | 1, 4, 26, 62 | 0•29 (0•07 to 0•68) | 0•96 (0•90 to 0•98) | ||||
Lyme borreliosis (unspecified) | Any ELISA or IB | Cross-sectional study | 5, 14, 226, 914 | 0•77 (0•48 to 0•93) | 0•77 (0•46 to 0•93) | IgM lowest sensitivity, but highest specificity; no other sources investigated. |  |