Baumeister Carl, Verschoor Jan, Ueckermann Veronica, Molatseli Mosa, Sesing Thoriso, Khuboni Nomthandazo, Fourie Bernard
Department of Biochemistry, Genetics and Microbiology, Faculty of Natural & Agricultural Sciences, University of Pretoria, Pretoria, South Africa.
MARTI TB Diagnostics, Pretoria, South Africa.
Biomark Med. 2025 Aug;19(16):769-782. doi: 10.1080/17520363.2025.2548196. Epub 2025 Sep 4.
This study assessed electro-impedimetric detection (EIS-MARTI) of anti-mycolate antibodies (AMAb) in TB patients before, during, and after treatment, compared to sputum culture (MGIT) as the gold standard.
A prospective pilot study enrolled 15 confirmed TB patients and 73 healthy controls at a Pretoria hospital (2016-2017). A prospective monitoring study followed 25 confirmed TB patients over 6 months of treatment at a Pretoria clinic (2019-2020) to evaluate biomarker behavior. Outcomes were analyzed using descriptive statistics, wherein diagnostic accuracy and predictive values were assessed by ROC curve analysis.
EIS-MARTI detected 14/15 true TB-positive cases independent of HIV co-infection and 68/73 true TB-negatives in the pilot study. In the monitoring study, EIS-MARTI correlated with culture in 7/8 cases at treatment end, but not during the first 2 months.
AMAbs arise independently of HIV co-infection in active TB, recede during treatment, and are rapidly detected by a hand-held EIS-MARTI device. While suitability for treatment monitoring remains uncertain, EIS-MARTI shows promise for rapid, accurate TB diagnosis and confirming cure.
本研究评估了结核患者在治疗前、治疗期间和治疗后的抗霉菌酸抗体(AMAb)的电阻抗检测(EIS-MARTI),并与作为金标准的痰培养(MGIT)进行比较。
一项前瞻性试点研究在比勒陀利亚一家医院(2016 - 2017年)招募了15名确诊的结核病患者和73名健康对照。一项前瞻性监测研究在比勒陀利亚一家诊所(2019 - 2020年)对25名确诊的结核病患者进行了为期6个月的治疗随访,以评估生物标志物的行为。使用描述性统计分析结果,其中通过ROC曲线分析评估诊断准确性和预测值。
在试点研究中,EIS-MARTI检测出14/15例真正的结核病阳性病例,与是否合并HIV感染无关,以及73例中的68例真正的结核病阴性病例。在监测研究中,EIS-MARTI在治疗结束时与培养结果在8例中的7例相关,但在最初2个月内不相关。
在活动性结核病中,抗霉菌酸抗体独立于HIV合并感染产生,在治疗期间消退,并可通过手持式EIS-MARTI设备快速检测到。虽然其用于治疗监测的适用性仍不确定,但EIS-MARTI在快速、准确的结核病诊断和确认治愈方面显示出前景。