Evaluation of the diagnostic performance of the MiniDock MTB Test for rapid tuberculosis detection

doi:10.19982/j.issn.1000-6621.20250022

Abstract

Abstract:

Objective: To assess the diagnostic performance of the MiniDock MTB Test (hereafter referred to as “MiniDock”) for the rapid detection of tuberculosis (TB). Methods: A prospective study was conducted at three clinical sites in Guangdong Province—Dongguan Sixth People’s Hospital, Shantou Institute of Tuberculosis Prevention and Control, and Shenzhen Nanshan Center for Chronic Disease Control. Between May and August 2024, consecutive patients with suspected pulmonary TB who met the inclusion criteria were enrolled. Relevant clinical data were collected. Sputum specimens were subjected to Ziehl-Neelsen smear microscopy, solid culture on L?wenstein-Jensen medium, GeneXpert MTB/RIF (Xpert), and MiniDock testing, all performed by trained laboratory personnel. Results: A total of 213 patients with suspected pulmonary TB were enrolled. The positivity rates for smear microscopy, solid culture on L?wenstein-Jensen medium, Xpert, and MiniDock were 22.07% (47/213), 36.62% (78/213), 32.86% (70/213), and 36.62% (78/213), respectively. When clinical diagnosis was used as the reference standard, MiniDock achieved a sensitivity of 47.24% (77/163) and specificity of 98.00% (49/50), while Xpert showed a sensitivity of 42.94% (70/163) and specificity of 100.00% (50/50). Using culture as the reference, MiniDock yielded a sensitivity of 84.62% (66/78) and specificity of 91.11% (123/135), whereas Xpert demonstrated a sensitivity of 78.21% (61/78) and specificity of 93.33% (126/135). Agreement analysis between the two methods indicated a high level of concordance, with a Kappa coefficient of 0.88. Conclusion: The MiniDock MTB Test demonstrated robust diagnostic performance, with high sensitivity and specificity for TB detection, and showed strong concordance with the results of the Xpert assay.

Key words: Mycobacterium tuberculosis, Nucleic acid amplification techniques, Diagnosis, differential, Comparative study

CLC Number:

Wu Zhuhua, Wang Yong, Lai Xiaoyu, Ji Liwei, Chen Ruiming, LYU Chunfang, Xu Liuyue, Guo Huixin, Chen Yuhui, Liang Hongdi, Liu Shengyuan, Zhong Xinguang, Chen Xunxun. Evaluation of the diagnostic performance of the MiniDock MTB Test for rapid tuberculosis detection[J]. Chinese Journal of Antituberculosis, 2025, 47(5): 577-581. doi: 10.19982/j.issn.1000-6621.20250022

Figures/Tables 2

References 12

[1]	Ismail N, Nathanson CM, Zignol M, et al. Achieving universal access to rapid tuberculosis diagnostics. BMJ Glob Health, 2023, 8(5): e012666. doi:10.1136/bmjgh-2023-012666.
[2]	García-Basteiro AL, DiNardo A, Saavedra B, et al. Point of care diagnostics for tuberculosis. Pulmonology, 2018, 24(2): 73-85. doi:10.1016/j.rppnen.2017.12.002. pmid: 29426581
[3]	Xiao Z, Liu X, Kang X, et al. Rapid and accurate detection of SARS-CoV-2 using the RHAM technology. Sci Rep, 2023, 13(1): 22798. doi:10.1038/s41598-023-49733-7.
[4]	中华人民共和国国家卫生和计划生育委员会. WS 288—2017 肺结核诊断. 结核与肺部疾病杂志, 2024, 5(4): 376-378. doi:10.19983/j.issn.2096-8493.2024022.
[5]	赵雁林, 逄宇. 结核病实验室检验规程. 北京: 人民卫生出版社, 2015.
[6]	Bagcchi S. WHO’s Global Tuberculosis Report 2022. Lancet Microbe, 2023, 4(1):e20. doi:10.1016/S2666-5247(22)00359-7.
[7]	Hong JM, Lee H, Menon NV, et al. Point-of-care diagnostic tests for tuberculosis disease. Sci Transl Med, 2022, 14(639): eabj4124. doi:10.1126/scitranslmed.abj4124.
[8]	Dheda K, Ruhwald M, Theron G, et al. Point-of-care diagnosis of tuberculosis: past, present and future. Respirology, 2013, 18(2): 217-232. doi:10.1111/resp.12022. pmid: 23190246
[9]	Esmail A, Randall P, Oelofse S, et al. Comparison of two diagnostic intervention packages for community-based active case finding for tuberculosis: an open-label randomized controlled trial. Nat Med, 2023, 29(4): 1009-1016. doi:10.1038/s41591-023-02247-1. pmid: 36894651
[10]	Parsons LM, Brosch R, Cole ST, et al. Rapid and simple approach for identification of Mycobacterium tuberculosis complex isolates by PCR-based genomic deletion analysis. J Clin Microbiol, 2002, 40(7): 2339-2345. doi:10.1128/JCM.40.7.2339-2345.2002.
[11]	Mcevoy CR, Falmer AA, Gey van Pittius NC, et al. The role of IS 6110 in the evolution of Mycobacterium tuberculosis. Tuberculosis (Edinb), 2007, 87(5):393-404. doi:10.1016/j.tube.2007.05.010.
[12]	Yang N, Zhang H, Han X, et al. Advancements and applications of loop-mediated isothermal amplification technology: a comprehensive overview. Front Microbiol, 2024, 15: 1406632. doi:10.3389/fmicb.2024.1406632.

检测方法	临床诊断(例)		合计 (例)	敏感度 (%,95%CI)	特异度 (%,95%CI)	阳性预测值 (%,95%CI)	阴性预测值 (%,95%CI)
检测方法	结核	非结核	合计 (例)	敏感度 (%,95%CI)	特异度 (%,95%CI)	阳性预测值 (%,95%CI)	阴性预测值 (%,95%CI)
MiniDock				47.24 (39.57~54.91)	98.00 (94.08~100.00)	98.72 (96.20~100.00)	36.30 (28.16~44.44)
阳性	77	1	78
阴性	86	49	135
合计	163	50	213
Xpert				42.94 (35.52~50.36)	100.00 (100.00~100.00)	100.00 (100.00~100.00)	34.97 (27.04~42.90)
阳性	70	0	70
阴性	93	50	143
合计	163	50	213
抗酸杆菌染色涂片				28.83 (22.20~35.46)	100.00 (100.00~100.00)	100.00 (100.00~100.00)	30.12 (22.89~37.35)
阳性	47	0	47
阴性	116	50	166
合计	163	50	213
固体培养				47.85 (40.14~55.56)	100.00 (100.00~100.00)	100.00 (100.00~100.00)	37.04 (28.82~45.26)
阳性	78	0	78
阴性	85	50	135
合计	163	50	213

检测方法	痰培养(例)		合计 (例)	敏感度 (%,95%CI)	特异度 (%,95%CI)	阳性预测值 (%,95%CI)	阴性预测值 (%,95%CI)
检测方法	阳性	阴性	合计 (例)	敏感度 (%,95%CI)	特异度 (%,95%CI)	阳性预测值 (%,95%CI)	阴性预测值 (%,95%CI)
MiniDock				84.62 (75.83~90.65)	91.11 (85.57~94.64)	84.62 (75.83~90.65)	91.11 (85.57~94.64)
阳性	66	12	78
阴性	12	123	135
合计	78	135	213
Xpert				78.21 (68.37~85.92)	93.33 (88.33~96.18)	87.14 (78.43~92.54)	88.11 (82.19~92.01)
阳性	61	9	70
阴性	17	126	143
合计	78	135	213

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