Abstract：
BACKGROUND: Detection of spliced leader (SL)-RNA allows sensitive diagnosis of gambiense human African trypanosomiasis (HAT). We investigated its diagnostic performance for treatment outcome assessment.
METHODS: Blood and cerebrospinal fluid (CSF) from a consecutive series of 97 HAT patients, originating from the Democratic Republic of the Congo, were prospectively collected before treatment with acoziborole, and during 18 months of longitudinal follow-up after treatment. For treatment outcome assessment, SL-RNA detection was compared with microscopic trypanosome detection and CSF white blood cell count. The trial was registered under NCT03112655 in clinicaltrials.gov.
RESULTS: Before treatment, respectively 94.9% (92/97; CI 88.5-97.8%) and 67.7% (65/96; CI 57.8-76.2%) HAT patients were SL-RNA positive in blood or CSF. During follow-up, one patient relapsed with trypanosomes observed at 18 months, and was SL-RNA positive in blood and CSF at 12 months, and CSF positive at 18 months. Among cured patients, one individual tested SL-RNA positive in blood at month 12 (Specificity 98.9%; 90/91; CI 94.0-99.8%) and 18 (Specificity 98.9%; 88/89; CI 93.9-99.8%).
CONCLUSIONS: SL-RNA detection for HAT treatment outcome assessment shows ≥98.9% specificity in blood and 100% in CSF, and may detect relapses without lumbar puncture.
BACKGROUND: The DiTECT-HAT project is part of the EDCTP2 programme, supported by Horizon 2020, the European Union Funding for Research and Innovation (grant number DRIA-2014-306-DiTECT-HAT).
METHODS: Blood and cerebrospinal fluid (CSF) from a consecutive series of 97 HAT patients, originating from the Democratic Republic of the Congo, were prospectively collected before treatment with acoziborole, and during 18 months of longitudinal follow-up after treatment. For treatment outcome assessment, SL-RNA detection was compared with microscopic trypanosome detection and CSF white blood cell count. The trial was registered under NCT03112655 in clinicaltrials.gov.
RESULTS: Before treatment, respectively 94.9% (92/97; CI 88.5-97.8%) and 67.7% (65/96; CI 57.8-76.2%) HAT patients were SL-RNA positive in blood or CSF. During follow-up, one patient relapsed with trypanosomes observed at 18 months, and was SL-RNA positive in blood and CSF at 12 months, and CSF positive at 18 months. Among cured patients, one individual tested SL-RNA positive in blood at month 12 (Specificity 98.9%; 90/91; CI 94.0-99.8%) and 18 (Specificity 98.9%; 88/89; CI 93.9-99.8%).
CONCLUSIONS: SL-RNA detection for HAT treatment outcome assessment shows ≥98.9% specificity in blood and 100% in CSF, and may detect relapses without lumbar puncture.
BACKGROUND: The DiTECT-HAT project is part of the EDCTP2 programme, supported by Horizon 2020, the European Union Funding for Research and Innovation (grant number DRIA-2014-306-DiTECT-HAT).
摘要：
背景：剪接前导序列（SL）-RNA的检测可以灵敏地诊断冈比亚人非洲锥虫病（HAT）。我们调查了其用于治疗结果评估的诊断性能。
方法：连续97例HAT患者的血液和脑脊液（CSF），源自刚果民主共和国，在用acoziborole治疗前前瞻性收集，以及治疗后18个月的纵向随访。对于治疗结果评估，将SL-RNA检测与显微镜锥虫检测和CSF白细胞计数进行比较。该试验已在clinicaltrials.gov上根据NCT03112655注册。
结果：治疗前，分别有94.9%(92/97;CI88.5-97.8%)和67.7%(65/96;CI57.8-76.2%)的HAT患者在血液或CSF中SL-RNA阳性。随访期间,一名患者在18个月时观察到锥虫复发，在12个月时血液和脑脊液中SL-RNA呈阳性，18个月时脑脊液呈阳性。在治愈的患者中，1例患者在第12个月(特异性98.9%;90/91;CI94.0-99.8%)和18个月(特异性98.9%;88/89;CI93.9-99.8%)时在血液中检测到SL-RNA阳性。
结论：用于HAT治疗结果评估的SL-RNA检测显示血液中的特异性≥98.9%，CSF中的特异性≥100%，并且可以在没有腰椎穿刺的情况下发现复发。
背景：DiTECT-HAT项目是EDCTP2计划的一部分，由Horizon2020支持，欧盟研究与创新资助（资助编号DRIA-2014-306-DiTECT-HAT）。
方法：连续97例HAT患者的血液和脑脊液（CSF），源自刚果民主共和国，在用acoziborole治疗前前瞻性收集，以及治疗后18个月的纵向随访。对于治疗结果评估，将SL-RNA检测与显微镜锥虫检测和CSF白细胞计数进行比较。该试验已在clinicaltrials.gov上根据NCT03112655注册。
结果：治疗前，分别有94.9%(92/97;CI88.5-97.8%)和67.7%(65/96;CI57.8-76.2%)的HAT患者在血液或CSF中SL-RNA阳性。随访期间,一名患者在18个月时观察到锥虫复发，在12个月时血液和脑脊液中SL-RNA呈阳性，18个月时脑脊液呈阳性。在治愈的患者中，1例患者在第12个月(特异性98.9%;90/91;CI94.0-99.8%)和18个月(特异性98.9%;88/89;CI93.9-99.8%)时在血液中检测到SL-RNA阳性。
结论：用于HAT治疗结果评估的SL-RNA检测显示血液中的特异性≥98.9%，CSF中的特异性≥100%，并且可以在没有腰椎穿刺的情况下发现复发。
背景：DiTECT-HAT项目是EDCTP2计划的一部分，由Horizon2020支持，欧盟研究与创新资助（资助编号DRIA-2014-306-DiTECT-HAT）。
