Evaluation of Anyplex™ II MTB/MDR kit’s performance to rapidly detect isoniazid and rifampicin resistant Mycobacterium tuberculosis from various clinical specimens

Abstract

To determine the accuracy of multiplex real-time PCR (Anyplex™ II MTB/MDR kit) in detecting Isoniazid (INH)-and Rifampin (RIF)-resistant Mycobacterium tuberculosis strains from various clinical specimens. The performance of Anyplex™ II MTB/MDR kit in detecting INH-and RIF-resistant M. tuberculosis compared to the conventional drug susceptibility tests by Mycobacterial Growth Indicator Tube (MGIT). A total of 430 clinical samples had positive results for M. tuberculosis from both Anyplex™ II MTB/MDR kit assay and mycobacterial cultures by MGIT method. When compared to MGITs, the sensitivity and specificity of Anyplex™ II MTB/MDR kit in detecting INH-resistant TB were 85.71% and 99.75%, respectively. For the detection of MDR-TB, the sensitivity and specificity of the test were 82.35% and 99.76%, respectively. The positive predictive values and negative predictive values to detect INH-resistant TB were 96.77% and 98.75%, respectively. Anyplex™ II MTB/MDR kit can be used to rapidly detect isoniazid and rifampicin resistances. It has a high sensitivity, specificity and PPV in detecting INH-resistant TB and MDR-TB. This test can be used as an alternative test to Xpert MTB/ RIF because it can rapidly detect both INH-resistant TB and RIF-resistant TB.

Temporal trend of drug-resistant tuberculosis among Thai children during 2006–2021

“…In this study, discrepant results between genotypic and phenotypic methods were observed in the Hr-TB cases, indicating that not all drug-resistant genes can be detected by multiplex real-time PCR (Anyplex TM II MTB/MDR Detection). However, this multiplex real-time PCR still had high sensitivity, specificity, PPV, and NPV for Hr-TB (85.3%, 99.5%, 93.5, and 97.2%, respectively) ( Chumpa et al., 2020 ). The most common mutations for Hr-TB were located in katG and inhA promoter regions, with other mutations reported in aphC, fabG1 , and furA genes ( Seifert et al., 2015 ).…”

“…The phenotypic DST for isoniazid (H), rifampicin (R), ethambutol (E), and streptomycin (S) was performed using the MGIT 960 DST method Global Laboratory Initiative, 2014 . Furthermore, the MTBC and genotypic drug resistance were directly identified in clinical specimens using the Anyplex™ II MTB/MDR Detection assay, targeting katG and inhA (for isoniazid resistance) and rpoB (for rifampicin resistance), according to the manufacturer's instructions (from 2014) ( Chumpa et al., 2020 ).…”

Diagnostic performance of the Anyplex MTB/NTM real-time PCR in detection of Mycobacterium tuberculosis complex and nontuberculous mycobacteria from pulmonary and extrapulmonary specimens

“…These include the Conformite Europeenne (CE)-marked commercial assays such as Anyplex MTB/NTM real-time detection assay (Anyplex MTB/NTM) (Seegene Inc., Republic of Korea) [ 9 ] and FDA-approved tests such as Xpert MTB/RIF (Cepheid, USA) [ 10 , 11 ]. Some NAATs can not only detect MTBC organisms but also detect gene mutations associated with TB drug resistance such as Xpert MTB/RIF assay detecting rifampicin resistance ( rpoB gene) and Anyplex II MTB/MDR detection [ 12 , 13 ] and GenoType MTBDRplus [ 14 , 15 ] detecting both rifampicin resistance and isoniazid resistance ( inhA and katG genes).…”

Evaluation of an in-house loop-mediated isothermal amplification for Mycobacterium tuberculosis detection in a remote reference laboratory, Thailand

“…Recently, an Anyplex plus MTB/NTM assay (Seegene, South Korea) has been introduced and is a Conformite Europeenne (CE) marked, which can be used for in vitro diagnostic purposes 5 . This multiplex real-time PCR system has been used widely in Thailand due to its potential to detect and differentiate MTB and NTM directly from clinical specimens at the same time and the semi-automated platform also offers the ability to detect both isoniazid and rifampicin in the same tube of the next step 6 . The loop-mediated isothermal amplification (LAMP) is a novel nucleic acid amplification test (NAAT) reported for the first time in the year 2000 7 .…”