Diagnostic Accuracy of Xpert® Mtb / Rif Compared to Microscopy-Based Methods for Diagnosing Tuberculous Lymphadenitis from Fine Needle Aspirates at the Port Moresby General Hospital, Papua New Guinea

@#Data on the accuracy of Xpert® MTB/RIF (Xpert) assay in detecting TB in lymph node aspirates in Papua New Guinea (PNG) is scanty. This study evaluated Xpert performance in diagnosing tuberculous lymphadenitis (TBLN) using lymph node needle aspirates at the Port Moresby General Hospital (PMGH). The objective of the study was to compare Xpert accuracy to acid fast bacilli (AFB) microscopy, cytomorphology, a composite reference test (CRS) and culture. A total of 107 eligible subjects were recruited out of 1080 clinic attendees. Results showed Xpert detected significantly more cases of TBLN than AFB microscopy (66 vs 35; p=0.001). Compared to AFB microscopy Xpert had a sensitivity of 45.4% (95% CI 33.1-58.1), specificity of 87.8% (95% CI 73.8-95.9), positive predictive value (PPV) of 85.7% (95% CI 71.6-93.4) and negative predictive value (NPV) of 50.0%% (95% CI 43.8-56.1). There was no difference between Xpert and cytomorphology (66 vs 60; p=0.5). Compared to cytomorphology Xpert had a sensitivity of 71.6% (95% CI 58.5-82.5), specificity of 51.1% (95% CI 35.7-66.3), PPV of 66.1% (95% CI 58.2-73.2) and NPV of 57.5% (95% CI 45.2-68.9). There was no difference between Xpert and CRS (66 vs 71; p=0.6). Compared to CRS Xpert had a sensitivity of 76.0% (95% CI 64.4- 85.3), specificity of 66.6% (95% CI 49.0-81.4), PPV of 81.8% (95% CI 73.5-87.9) and NPV of 58.4% (95% CI 46.7-69.4). Culture was completed on 24 subjects with positive isolates in 14 giving a culture yield of 58.3%. Of the 24 subjects, Xpert was positive in 21 subjects. There was no difference between Xpert and culture (21 vs 14; p=0.8). Compared to culture Xpert had a sensitivity of 100.0% (95% CI 76.8-100.0), specificity of 30.0% (95% CI 6.6-65.2), PPV of 66.6% (95% CI 57.1-75) and NPV of 100.0%. The results suggest Xpert is more sensitive than AFB microscopy but comparable to cytomorphology and CRS for TBLN diagnosis in the PNG context. Xpert can be used for diagnosing TBLN at PMGH