Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.
Clin Microbiol Infect. 2012 Jan;18(1):81-5. doi: 10.1111/j.1469-0691.2011.03540.x. Epub 2011 Jul 1.
Antibody detection is a safely applied method at the wide scale in diagnosis of visceral Leishmaniasis (VL). In order to further advance serodiagnosis, the rK28 antigen has been recently introduced as a candidate for diagnosis of VL. We evaluated the sensitivity and specificity of the rK28 antigen in a micro-ELISA format in comparison to the rk39 antigen. The test was conducted on 252 parasitologically confirmed VL cases, 103 endemic healthy controls, 95 non-endemic healthy controls, 88 other infectious disease and 53 follow-up cases. Of 252 parasitologically confirmed VL cases, 251 cases were reported positive by rK28 antigen, yielding 99.6% sensitivity (95% CI, 0.97-0.99), which was similar to the sensitivity of rK39 ELISA (99.6%) (95% CI, 0.97-0.99). Specificity of the rK28 antigen in non-endemic and endemic healthy controls was 100% (95% CI 0.96-1) and 94.17% (95% CI, 0.88-0.97), respectively. In 88 different diseases, specificity was 95.45% (95% CI, 0.84-0.96). With the rK39 antigen, specificity of non-endemic and endemic controls and different diseases was 100% (95% CI 0.96-1), 92.23% (95% CI 0.85-0.96) and 96.59% (95% CI 0.90-0.98), respectively. Our results show that rK39 and rK28 antigens have similar sensitivity and specificity and rK28 can also be used as a serodiagnostic tool in the endemic population of Bihar.
抗体检测是一种广泛应用于内脏利什曼病（VL）诊断的安全方法。为了进一步推进血清诊断，rK28 抗原最近被引入作为 VL 诊断的候选抗原。我们在微 ELISA 格式中评估了 rK28 抗原与 rk39 抗原相比的敏感性和特异性。该测试在 252 例寄生虫学确诊的 VL 病例、103 例地方性健康对照、95 例非地方性健康对照、88 例其他传染病和 53 例随访病例中进行。在 252 例寄生虫学确诊的 VL 病例中，251 例 rK28 抗原报告为阳性，敏感性为 99.6%（95%CI，0.97-0.99），与 rK39 ELISA 的敏感性（99.6%）相似（95%CI，0.97-0.99）。rK28 抗原在非地方性和地方性健康对照中的特异性为 100%（95%CI 0.96-1）和 94.17%（95%CI 0.88-0.97）。在 88 种不同疾病中，特异性为 95.45%（95%CI 0.84-0.96）。使用 rK39 抗原，非地方性和地方性对照以及不同疾病的特异性分别为 100%（95%CI 0.96-1）、92.23%（95%CI 0.85-0.96）和 96.59%（95%CI 0.90-0.98）。我们的结果表明，rK39 和 rK28 抗原具有相似的敏感性和特异性，rK28 也可以作为比哈尔邦地方性人群的血清学诊断工具。
