Comparison of the Genedia MTB/NTM Detection Kit and Anyplex plus MTB/NTM Detection Kit for detection of Mycobacterium tuberculosis complex and nontuberculous mycobacteria in clinical specimens.

Jihoon Kim,Seon Young Kim,Hyun Jin Kim,Sun Hoe Koo,Gye Cheol Kwon,Qute Choi,Yumi Park,Jong Wan Kim

doi:10.1002/jcla.23021

Abstract

BackgroundReal‐time (RT) PCR is a rapid and accurate method that is widely used for the detection of Mycobacterium tuberculosis complex (MTB). The aim of this study was to evaluate and compare the performance of the Genedia MTB/NTM Detection Kit and the Anyplex plus MTB/NTM Detection kit in the detection of MTB and nontuberculous mycobacteria (NTM) in clinical specimens.MethodsFrom October 2017 to February 2018, 236 respiratory specimens and 137 non‐respiratory specimens, from patients with suspected tuberculosis, were examined. AFB smear, culture, and RT‐PCR using the Genedia MTB/NTM Detection kit (Green Cross Medical Science Corp.) and the Anyplex plus MTB/NTM Detection kit (Seegene) were applied. PCR performance in the detection of MTB and NTM was evaluated in relation to culture results and between the two assays.ResultsCulture was positive for MTB in 30 (8.0%) of the 373 specimens and for NTM in 23 (6.2%). The sensitivity and specificity of MTB detection with the Genedia kit were 76.7% and 99.7%, respectively, whereas the Anyplex kit sensitivity and specificity for MTB detection were 86.7% and 97.5%, respectively. Both kits exhibited the same sensitivity (73.9%) for NTM detection, and the specificity was 100% and 99.4% for the Genedia and Anyplex kits, respectively.ConclusionsThe Genedia and Anyplex kits demonstrated high sensitivity and specificity for the detection of MTB and NTM. Both kits have a high concordance rate and can be used more widely in clinical laboratories for the early detection of tuberculosis.

Highlights

Worldwide, tuberculosis (TB) is one of the top 10 causes of death and the leading cause from a single infectious disease
We evaluated the performance of the Genedia Mycobacterium tuberculosis complex (MTB)/non‐ tuberculous mycobacteria (NTM) Detection kit compared with the Anyplex plus MTB/NTM Detection kit
A previous evaluation of the Genedia assay for MTB detection in respiratory samples reported sensitivity and specificity as 81.8% and 99.8%, respectively.[6]

Summary

| INTRODUCTION

Tuberculosis (TB) is one of the top 10 causes of death and the leading cause from a single infectious disease. In 2017, there were an estimated 1.3 million deaths due to TB among HIV‐nega‐ tive people and an additional 300 000 deaths among HIV‐positive people. About 6.4 million new cases of TB were officially notified to the World Health Organization (WHO) via national authorities, TB incidence and mortality rates are gradually decreasing year after year.[1]. The Genedia assay is a real‐time (RT) PCR method targeting IS6110 with TaqMan hydrolysis probes for MTB and the rpoB gene for NTM. In this present study, we evaluated the performance of the Genedia kit using clinical respiratory specimens as well as non‐respi‐ ratory specimens. We compared the results with the Anyplex plus MTB/NTM Detection kit (Seegene)

| MATERIALS AND METHODS

Findings

| DISCUSSION