Maurya R, Singh R K, Kumar B, Salotra P, Rai M, Sundar S
Infectious Diseases Research Laboratory, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, 6 SK Gupta, Nagar, Lanka, Varanasi 221 005, India.
J Clin Microbiol. 2005 Jul;43(7):3038-41. doi: 10.1128/JCM.43.7.3038-3041.2005.
This study was done to evaluate PCR with Ld1 primers for the diagnosis of Indian visceral leishmaniasis (VL) and to assess its role in prediction of the disease outcome. The PCR assay was performed with DNA isolated from the peripheral blood of parasitologically confirmed cases of VL before the initiation of treatment, just after the end of treatment, and at 3 and 6 months of follow-up. The pretreatment PCR result was positive for 100 of 101 patients (sensitivity, 99%; confidence interval [CI], 94 to 100%). None of the 150 negative controls tested were PCR positive (specificity, 100%; CI, 96.8 to 100%). Of 60 patients who were treated at our center, 51 (85%; CI, 73 to 93%) became negative immediately after treatment and continued to be negative at 3 and 6 months of follow-up. At the 3-month follow-up, two of the remaining nine patients were PCR positive, making 58 (96.7%; CI, 87 to 100%) patients PCR negative. At the 6-month follow-up, all patients became PCR negative. One patient who was PCR negative immediately after the end of treatment relapsed 11 months later. This limited prospective study with VL patients suggests that the PCR assay is a highly sensitive and specific (99% and 100%, respectively) tool for the diagnosis of VL. In the majority of patients, it can identify a successful disease outcome; however, its translation into the field setting remains a major challenge.
本研究旨在评估使用Ld1引物的聚合酶链反应（PCR）用于诊断印度内脏利什曼病（VL），并评估其在预测疾病转归中的作用。PCR检测使用从经寄生虫学确诊的VL病例治疗开始前、治疗刚结束时以及随访3个月和6个月时的外周血中分离的DNA进行。101例患者中100例治疗前PCR结果为阳性（敏感性99%；置信区间[CI]，94%至100%）。150个阴性对照检测均无PCR阳性结果（特异性100%；CI，96.8%至100%）。在本中心接受治疗的60例患者中，51例（85%；CI，73%至93%）治疗后立即转为阴性，随访3个月和6个月时仍为阴性。在3个月随访时，其余9例患者中有2例PCR阳性，58例（96.7%；CI，87%至100%）患者PCR阴性。在6个月随访时，所有患者PCR均为阴性。1例治疗结束后立即PCR阴性的患者在11个月后复发。这项对VL患者的有限前瞻性研究表明，PCR检测是诊断VL的高度敏感和特异（分别为99%和100%）的工具。在大多数患者中，它可以确定疾病转归良好；然而，将其应用于现场环境仍然是一项重大挑战。
