Evaluation of the Clinical Usefulness of the Xeniss Rapid TB kit for the Diagnosis of Tuberculosis

Park, Seung Kyu; Lee, Woo Chul; Hwang, Soo Hee; Kwon, Eun Si; Lee, Hung Soon; Lee, Duk Hyoung

Abstract

BACKGROUND: The rapid diagnostic tests for tuberculosis are needed to facilitate early treatment of tuberculosis and prevention of Mycobacterium tuberculosis transmission. The Xeniss Rapid TB kit is a rapid, card-based immunochromatographic test for the detection of antibodies directed against M. tuberculosis antigens including antigen 5(38-kDa antigen). The objective of this study was to evaluate the performance of the Xeniss Rapid TB kit for the diagnosis of active tuberculosis with serums from patients, asymptomatic healthy and close contact controls. METHOD: 188 patients with active tuberculosis were tested; 177 with pulmonary tuberculosis(18 with combined pleurisy), and 11 with extrapulmonary tuberculosis. The control groups were composed of 82 close contacts and 57 healthy adults. Study subjects were drawn from one national tuberculosis hospital for patients and close contacts, and another private hospital for healthy adults in Masan city, Korea. The Xeniss Rapid TB kit(Xeniss Life Science Co., Ltd., Seoul, Korea) was evaluated by using serum samples according to the instructions of the manufacturer by an investigator masked to the clinical and microbiological status of the study subjects.
RESULTS
The diagnostic sensitivity of the Xeniss Rapid TB kit was 73.9% in patients and specificities were 73.2% and 93.0% in close contact and healthy adults respectively. The positive predictive value in patients was 84.2% and the negative predictive value in controls was 85.8%.
CONCLUSIONS
This study shows that the Xeniss Rapid TB test is a simple and fast method to diagnose active TB. The results of the sensitivity and specificites suggest that serodiagnosis using this point of care testing(POCT) device would be valuable and advantageous for screening tuberculosis in the clinical field.