Abass Elfadil, Mansour Durria, Abdalla Zaki, Altaher Hassan, Sliman Mootaz, Osman Hussam, Babiker Rabie Ali, Salah Mohamed, Omer Elmohaned, Elamin Elwaleed, Visekruna Alexander, Steinhoff Ulrich, Mahdavi Rouzbeh
Department of Clinical Laboratory Science, College of Applied Medical Sciences, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Ahfad Biomedical Research Laboratory (ABRL), School of Health Sciences, Ahfad University for Women, Omdurman, Sudan.
PLoS Negl Trop Dis. 2025 Apr 8;19(4):e0012905. doi: 10.1371/journal.pntd.0012905. eCollection 2025 Apr.
This study enrolled 107 VL suspects who attended a health centre in Gedaref between October 2022 and June 2023. Diagnostic accuracy was assessed by comparing the performance of the new index test (INgezimLeishma-CROM) with the comparator test (IT-LEISH) and parasitological examination as reference standard.
Of 107 VL suspects screened by parasitological examination, 77 VL patients were smear positive and 30 were smear negative. Independent serological testing of these patients using INgezim Leishma-CROM showed a sensitivity of 98.7% [95% CI 92.23-99.97] and specificity of 92.5% [95% CI 75.71-99.09]. For IT-LEISH, both sensitivity [95% CI 84.39-97.20] and specificity [95% CI 75.71-99.09] were 92.5%. INgezim Leishma-CROM demonstrated increased diagnostic accuracy (97.2%) compared to IT-LEISH RDT (92.5%). Both RDTs gave positive results in 2 cases from the smear negative group that were previously treated for VL. All other non-VL cases (malaria, typhoid, brucellosis) were negative in both RDTs, showing 100% specificity, while VL patients co-infected with malaria were positive in both tests. Within the smear-negative group, 3 VL symptomatic cases that had been previously treated but still show clinical signs were all positive with INgezim Leishma-CROM but only 2 cases were positive with IT-LEISH.
本研究纳入了2022年10月至2023年6月期间在加达里夫一家健康中心就诊的107名内脏利什曼病疑似患者。通过将新的指标检测（英吉兹姆利什马-色谱法）与对照检测（IT-利什曼病检测）的性能进行比较，并以寄生虫学检查作为参考标准，来评估诊断准确性。
在107名经寄生虫学检查筛查的内脏利什曼病疑似患者中，77名患者涂片呈阳性，30名患者涂片呈阴性。使用英吉兹姆利什马-色谱法对这些患者进行独立血清学检测，结果显示敏感性为98.7%[95%置信区间92.23 - 99.97]，特异性为92.5%[95%置信区间75.71 - 99.09]。对于IT-利什曼病检测，敏感性[95%置信区间84.39 - 97.20]和特异性[95%置信区间75.71 - 99.09]均为92.5%。与IT-利什曼病快速诊断检测（92.5%）相比，英吉兹姆利什马-色谱法显示出更高的诊断准确性（97.2%）。两种快速诊断检测在涂片阴性组中先前接受过内脏利什曼病治疗的2例病例中均给出阳性结果。所有其他非内脏利什曼病病例（疟疾、伤寒、布鲁氏菌病）在两种快速诊断检测中均为阴性，显示出100%的特异性，而合并感染疟疾的内脏利什曼病患者在两种检测中均为阳性。在涂片阴性组中，3例先前接受过治疗但仍有临床症状的内脏利什曼病有症状病例，英吉兹姆利什马-色谱法检测均为阳性，但IT-利什曼病检测只有2例阳性。
