Okong'o-Odera E A, Wamachi A, Kagai J M, Kurtzhals J A, Githure J I, Hey A S, Were J B, Koech D K, Mitema E S, Kharazmi A
Kenya Medical Research Institute, Nairobi.
Trans R Soc Trop Med Hyg. 1993 Jul-Aug;87(4):423-4. doi: 10.1016/0035-9203(93)90023-j.
Two soluble antigens from Leishmania donovani of 116 kDa and 70 kDa molecular mass, and a soluble mixture of crude antigens, were used in an enzyme-linked immunosorbent assay (ELISA) for the detection of visceral leishmaniasis (VL) in the field, and compared with the direct agglutination test (DAT). The tests were carried out on 8 VL patients, 34 normal individuals from an area endemic for the disease, and 68 former visceral leishmaniasis patients 1-5 years after treatment. The 70 kDa ELISA and the DAT had a sensitivity and specificity of 100% (95% confidence interval 63-100%), while the 116 kDa ELISA and the soluble crude antigen ELISA were 37.5% (9-76%) and 50% (16-84%) sensitive, respectively. When using ELISA (116 kDa or 70 kDa), 68-69% of sera tested 1-2 years, and 92-94% of sera tested 5 years, after treatment were negative. In contrast, when DAT or ELISA with crude antigen were used, the negativity rate was 31% 1-2 years, and 53% 5 years, after treatment. DAT was therefore not an accurate test for diagnosis in the field. The use of the 70 kDa antigen in ELISA was an accurate alternative to DAT in the detection of VL.
使用来自杜氏利什曼原虫的两种分子量分别为116 kDa和70 kDa的可溶性抗原以及粗抗原的可溶性混合物,进行酶联免疫吸附测定(ELISA)以检测现场的内脏利什曼病(VL),并与直接凝集试验(DAT)进行比较。对8例VL患者、34名来自该病流行地区的正常个体以及68例治疗后1至5年的既往内脏利什曼病患者进行了检测。70 kDa ELISA和DAT的敏感性和特异性均为100%(95%置信区间63 - 100%),而116 kDa ELISA和可溶性粗抗原ELISA的敏感性分别为37.5%(9 - 76%)和50%(16 - 84%)。使用ELISA(116 kDa或70 kDa)时,治疗后1至2年检测的血清中有68 - 69%为阴性,治疗后5年检测的血清中有92 - 94%为阴性。相比之下,使用DAT或粗抗原ELISA时,治疗后1至2年的阴性率为31%,治疗后5年的阴性率为53%。因此,DAT并非现场诊断的准确检测方法。在ELISA中使用70 kDa抗原是检测VL时替代DAT的准确方法。