Diagnostic performance of enzyme-linked immnosorbent assays for diagnosing paratuberculosis in cattle: a meta-analysis

To evaluate the diagnostic accuracy of two commercial ELISA tests (Allied- and CSL-ELISA) for the diagnosis of Mycobacterium paratuberculosis in cattle, Meta-analysis using English language papers published during 1990-2001 was performed. Diagnostic odds ratios (DOR) were analyzed using regression analysis together with summary receiver operating characteristic (ROC) curves. The difference in diagnostic performance between the two ELISA systems was evaluated by using linear regression. Publication bias was assessed by funnel plot and linear regression. The pooled sensitivity and specificity were 44% (95% CI, 38 to 51) and 98% (95% CI, 96 to 99) for the random-effect model. The DOR between studies was heterogeneous. The area under the fitted ROC curve (AUC) was 0.72 for the unweighted and 0.77 for the weighted model. Maximum joint sensitivity and specificity for the unweighted and weighted model from their summary ROC curve were 70% and 75%, respectively. Based on the fitted model, at a specificity of 95%, sensitivity was estimated to be 52% for the unweighted and 57% for the weighted model. From the final multivariable model study characteristic, the country was the only significant variable with an explained component variance of 13.3%. There were no significant differences in discriminatory power, sensitivity, and specificity between the two ELISA tests. The overall diagnostic accuracy of two commercial ELISA tests was moderate, as judged by the AUC, maximum joint sensitivity and specificity, and estimates from the fitted model and clinical usefulness of the tests for screening program is limited because of low sensitivity and heterogeneous of DOR. It is, therefore, recommended to use ELISA tests as a parallel testing with other diagnostic tests together to increase test sensitivity in the screening program.