Comparison of the Accuracy of Two Different Molecular Tests for the Diagnosis of Tuberculous Lymphadenitis Using Core Needle Biopsy Specimens: A Diagnostic Accuracy Study.

Abstract

PurposeTo evaluate the diagnostic accuracy of the CapitalBio Mycobacterium real-time polymerase chain reaction assay (CapitalBio test) testing of core needle biopsy (CNB) specimens for tuberculous lymphadenitis (TBL) and to compare it with Xpert MTB/RIF.MethodsWe retrospectively analyzed the medical data on patients with suspected peripheral TBL. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of the CapitalBio test, Xpert MTB/RIF, and parallel test (positive result for either of these two tests) were calculated to evaluate their diagnostic efficacy compared with the final clinical diagnosis.ResultsThe study included 114 patients. For diagnosing TBL using CNB samples, the sensitivity, specificity, PPV, NPV, and AUC were 65.0%, 100.0%, 100.0%, 28.6%, and 0.83, respectively, for the CapitalBio test; 72.0%, 100.0%, 100.0%, 33.3%, and 0.86, respectively, for Xpert MTB/RIF; and 82.0%, 100.0%, 100.0%, 43.8%, and 0.91, respectively, for the parallel test.ConclusionThe accuracy of the CapitalBio test and Xpert MTB/RIF for diagnosing TBL using CNB specimens was moderate, while the sensitivity and NPV of these two tests were relatively low. The diagnostic accuracy of the CapitalBio test was slightly lower than that of Xpert MTB/RIF, but the difference between the two was not statistically significant. Parallel test might improve the diagnostic accuracy but not substantially over a single test.