Clinical application of Mycobacterium RT-PCR assay using various specimens for the rapid detection of lymph node tuberculosis: A diagnostic accuracy study.

Abstract

To evaluate the diagnostic accuracy of the Capital Bio Mycobacterium real-time polymerase chain reaction assay Capital Bio assay for lymph node (LN) tuberculosis (LNTB), and to further compare the effect of different types of LN specimens on the detection capability of the test. We retrospectively analyzed the medical records of LNTB patients who met the inclusion criteria. The sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve of Capital Bio assay were calculated to evaluate its diagnostic accuracy compared with the final clinical diagnosis as reference standard. Three hundred sixty-four patients were included in the study. The overall sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve of the Capital Bio assay for LNTB were 74.4%, 100.0%, 100.0%, 34.9%, and 0.87, respectively. For the pus specimens, these values for Capital Bio assay were 93.2%, 100.0%, 100.0%, 27.3%, 0.97, respectively. For the core needle biopsy specimens, these values were 65.9%, 100.0%, 100.0%, 33.3%, and 0.83, respectively. For the fine-needle aspiration specimens, these values were 60.0%, 100.0%, 100.0%, 53.9%, and 0.80, respectively. For the tissue, these values were 59.3%, 100.0%, 100.0%, 33.3%, 0.80, respectively. The Capital Bio assay had good effective for the diagnosis of LNTB. Compared to LN fine-needle aspiration and core needle biopsy specimens and tissue specimens, pus specimens were more suitable for molecular testing and had the best diagnostic efficacy.