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评估乳胶凝集试验(KAtex)在检测HIV-利什曼原虫合并感染患者尿液中利什曼原虫抗原的应用:对诊断及治疗后随访的价值

Evaluation of a latex agglutination test (KAtex) for detection of Leishmania antigen in urine of patients with HIV-Leishmania coinfection: value in diagnosis and post-treatment follow-up.

作者信息

Riera C, Fisa R, Lopez P, Ribera E, Carrió J, Falcó V, Molina I, Gállego M, Portús M

机构信息

Laboratori de Parasitologia, Facultat de Farmàcia, Universitat de Barcelona, Avenida Joan XXIII s/n, 08028, Barcelona, Spain,

出版信息

Eur J Clin Microbiol Infect Dis. 2004 Dec;23(12):899-904. doi: 10.1007/s10096-004-1249-7.

DOI:10.1007/s10096-004-1249-7
PMID:15599651
Abstract

The usefulness of antigen detection in urine as an alternative tool for diagnosis of leishmaniasis and post-treatment follow-up in patients with Leishmania-HIV coinfection was evaluated with a latex agglutination test (KAtex; Kalon Biological, UK). Forty-nine HIV-infected patients with visceral leishmaniasis were included in the study. Antigen detection in urine (ADU) was positive in 42 of 49 (sensitivity, 85.7%) samples obtained during a primary episode. After treatment, a follow-up study in 23 patients was performed by simultaneous ADU and culture of peripheral blood mononuclear cells in 148 determinations. The two methods gave concordant results in 94 cases, 38 of which were positive and 56 negative. In five cases, ADU was negative and culture of peripheral blood mononuclear cells was positive: two of these cases corresponded to clinical relapses. In 49 cases, culture of peripheral blood mononuclear cells was negative and ADU was positive. In the absence of clinical symptoms, the detection of parasite antigens in 71 of 130 (54.6%) urine samples was not associated with clinical disease. The Kaplan-Meier estimates of the probability of relapse at 6, 12, 18, and 24 months were 16% (95%CI, 15-17%), 20% (95%CI, 18-22%), 31% (95%CI, 27-35%), and 71% (95%CI, 52-89%), respectively, in patients with a positive ADU result. In contrast, when ADU was negative, the probability of relapse was 5% at 6 months (95%CI, 2-8%) (only 2 of 11 patients who relapsed had a negative test). ADU by KAtex is appropriate for primary diagnosis of visceral leishmaniasis, for monitoring the efficacy of treatment, and for detection of subclinical infection.

摘要

采用乳胶凝集试验(KAtex;英国Kalon Biological公司)评估了尿液抗原检测作为利什曼病诊断及利什曼原虫与人类免疫缺陷病毒(HIV)合并感染患者治疗后随访的替代工具的有效性。49例感染HIV且患有内脏利什曼病的患者纳入本研究。在初次发作期间采集的49份样本中,42份(敏感性85.7%)尿液抗原检测(ADU)呈阳性。治疗后,对23例患者进行了随访研究,共进行了148次ADU检测及外周血单个核细胞培养。两种方法在94例中结果一致,其中38例为阳性,56例为阴性。5例中,ADU为阴性但外周血单个核细胞培养为阳性:其中2例与临床复发相对应。49例中,外周血单个核细胞培养为阴性但ADU为阳性。在无临床症状的情况下,130份尿液样本中有71份(54.6%)检测到寄生虫抗原,但与临床疾病无关。ADU结果呈阳性的患者在6、12、18和24个月时复发概率的Kaplan-Meier估计值分别为16%(95%CI,15 - 17%)、20%(95%CI,18 - 22%)、31%(95%CI,27 - 35%)和71%(95%CI,52 - 89%)。相比之下,当ADU为阴性时,6个月时复发概率为5%(95%CI,2 - 8%)(复发的11例患者中仅2例检测为阴性)。KAtex的ADU适用于内脏利什曼病的初步诊断、监测治疗效果及检测亚临床感染。

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