Raheem T Y, Ojo O, Adenipekun E O, Olalekan A O, Oluwadun A, Iwalokun B A
Molecular Biology & Biotechnology Division, Nigerian Institute of Medical Research, Lagos, Nigeria.
Department of Medical Microbiology & Parasitology, Olabisi Onabanjo University, Sagamu-Ogun State, Nigeria.
J Immunoassay Immunochem. 2021 Sep 3;42(5):543-558. doi: 10.1080/15321819.2021.1911812. Epub 2021 Apr 25.
This study assessed the performance of SD Bioline MPT64 immunochromatographic test for the identification of complex (MTBC) in Nigeria.A total of 157 mycobacterial isolates, comprising 120 (76.4%) MTBC (, 112; , 5; , 3) and 37 (23.6%) non-tuberculous mycobacteria (NTM) isolates from patients attending six DOTS centers in Lagos between June 2012 and July 2014 were analyzed. All the isolates were grown on Bactec MGIT960 liquid media and identified in parallel by the conventional method and MPT64 immunochromatographic test. Discrepant results were resolved using the line probe assay.The comorbid disease rates for HIV and type 2 diabetes were 20.9% and 8.2%, respectively. Compared to the conventional method, SD Bioline MPT64 identified 117 MTBC isolates correctly, producing a sensitivity of 97.5% (95% CI, 92.9-99.2) at a shorter growing median time of 11 days compared to 26 days by the conventional method. The three undetected MTBC were confirmed by the line probe assay to be strains. The test also identified all the NTM correctly producing a specificity of 100% (95% CI, 90.7-100).This study supports the integration of SD Bioline TB MPT64 antigen test into diagnostic workflow for rapid MTBC case identification in Nigeria.
本研究评估了SD Bioline MPT64免疫层析试验在尼日利亚鉴定结核分枝杆菌复合群（MTBC）的性能。对2012年6月至2014年7月期间在拉各斯六个直接观察治疗（DOTS）中心就诊患者的157株分枝杆菌分离株进行了分析，其中包括120株（76.4%）MTBC（结核分枝杆菌，112株；牛分枝杆菌，5株；非洲分枝杆菌，3株）和37株（23.6%）非结核分枝杆菌（NTM）分离株。所有分离株均在Bactec MGIT960液体培养基上生长，并同时采用传统方法和MPT64免疫层析试验进行鉴定。使用线性探针分析解决不一致的结果。HIV和2型糖尿病的合并疾病率分别为20.9%和8.2%。与传统方法相比，SD Bioline MPT64正确鉴定了117株MTBC分离株，灵敏度为97.5%（95%CI，92.9 - 99.2），中位生长时间较短，为11天，而传统方法为26天。通过线性探针分析确认未检测到的三株MTBC为菌株。该试验还正确鉴定了所有NTM，特异性为100%（95%CI，90.7 - 100）。本研究支持将SD Bioline TB MPT64抗原试验纳入诊断工作流程，以在尼日利亚快速鉴定MTBC病例。
