Abstract
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Diagnostic Performance of a Kit for Detection of Mycobacterium tuberculosis Complex and Nontuberculous Mycobacteria
by Nan Young Lee, Soon Hee Chang, Yu Kyung Kim, Kyung Eun Song, Ji Yeon Ham, Jae Hee Lee, Eon Jeong Nam
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Background: The rapid distinction between Mycobacterium tuberculosis complex (MTBC) and nontuberculous mycobacteria (NTM) is crucial for the clinical management of patients with suspected mycobacterial infections. The accurate identification of NTM is also important, because NTM species have different clinical implications. NeoPlex™ TB/NTM detection kit (Genematrix Inc., Seongnam, South Korea) (NeoPlex) can simultaneously detect five major NTM species separately as well as MTBC or NTM differentially. This study aimed to validate the diagnostic performance of the NeoPlex assay in detecting Mycobacterium species.
Methods: Two hundred and fifty liquid media samples for acid-fast bacilli culture based on the results from Real-Q MTB & NTM kit (BioSewoom Inc., Seoul, South Korea) (Real-Q) assay were collected from January through November 2024. The samples were tested using Neoplex to detect MTBC/NTM. Identification of NTM isolates from 100 NTM-positive samples was conducted using the NeoPlex assay. The results obtained from the NeoPlex assay were then compared with those previously obtained through the Real-Q assay for MTBC/NTM detection, as well as with those from the AdvanSureTM Mycobacteria GenoBlot Assay (LG Life Sciences, Seoul, South Korea) (GenoBlot assay) and direct gene sequencing for identification of NTM isolates.
Results: Both positive and negative results were concordant in 100 MTBC samples, resulting in a 100% concordance rate. One hundred and fifty samples for NTM detection also revealed a 100% concordance rate between two assays in positive and negative results. For the identification of NTM isolates, out of 100 NTM-positive cases, 93 matched the GenoBlot assay with a 93% concordance rate. Direct gene sequencing for NTM species identification confirmed the match in three more cases among the discrepant cases, eventually bringing the diagnostic accuracy of NTM identification by the NeoPlex assay to 96%.
Conclusions: This study showed that the NeoPlex assay is a precise test that can accurately detect MTBC/NTM whilst simultaneously distinguishing five major NTM species in a single multiplex real-time PCR with 96% accuracy compared to the GenoBlot assay and direct gene sequencing for NTM species identification.
DOI: 10.7754/Clin.Lab.2025.250354
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