Kim Keun Ju, Chang Yunhee, Yun Seung Gyu, Nam Myung-Hyun, Cho Yunjung
Department of Laboratory Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul 02841, Republic of Korea.
Department of Biomedical Laboratory Science, Kyungnam College of Information & Technology, Busan 47011, Republic of Korea.
Microorganisms. 2024 Dec 26;13(1):26. doi: 10.3390/microorganisms13010026.
Accurate and timely diagnosis of mycobacterial infections, including complex (MTBC) and nontuberculous mycobacteria (NTM), is crucial for effective disease management.
This study evaluated the performance of the NeoPlex TB/NTM-5 Detection Kit (NeoPlex assay, Seongnam, Republic of Korea), a multiplex real-time PCR assay that incorporates melting curve analysis, compared with the line-probe assay (LPA). The NeoPlex assay could simultaneously detect and differentiate MTBC from five other NTM species: , , , , and . A total of 91 acid-fast bacillus culture-positive samples, comprising 36 MTBC and 55 NTM isolates, were collected from the Korea University Anam Hospital.
The NeoPlex assay successfully detected nucleic acids in 87 of the 91 isolates (95.6%). Notably, it identified additional mycobacterial nucleic acids not detected by the LPA in eight isolates. These findings were confirmed via DNA sequencing. The assay had 100% sensitivity and specificity for , , , NTM, and MTBC, whereas it had 100% specificity and sensitivity of 90.9% and 75.0% for and , respectively.
These results highlight the potential of the NeoPlex assay to enhance rapid and accurate diagnosis of mycobacterial infections, particularly in settings in which prompt treatment initiation is essential.
准确及时地诊断分枝杆菌感染，包括复合型结核分枝杆菌（MTBC）和非结核分枝杆菌（NTM），对于有效的疾病管理至关重要。
本研究评估了NeoPlex TB/NTM-5检测试剂盒（NeoPlex检测法，韩国城南）的性能，这是一种结合熔解曲线分析的多重实时聚合酶链反应检测法，并与线性探针检测法（LPA）进行了比较。NeoPlex检测法能够同时检测MTBC并将其与其他五种NTM菌种：[具体菌种1]、[具体菌种2]、[具体菌种3]、[具体菌种4]和[具体菌种5]区分开来。从韩国大学安岩医院收集了总共91份抗酸杆菌培养阳性样本，其中包括36份MTBC分离株和55份NTM分离株。
NeoPlex检测法成功检测出了91份分离株中的87份（95.6%）的核酸。值得注意的是，它在8份分离株中鉴定出了LPA未检测到的额外分枝杆菌核酸。这些发现通过DNA测序得到了证实。该检测法对[具体菌种1]、[具体菌种2]、[具体菌种3]、NTM和MTBC的敏感性和特异性均为100%，而对[具体菌种4]和[具体菌种5]的特异性为100%，敏感性分别为90.9%和75.0%。
这些结果凸显了NeoPlex检测法在增强分枝杆菌感染快速准确诊断方面的潜力，尤其是在必须迅速开始治疗的情况下。
