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首页> 外文期刊>PLOS Neglected Tropical Diseases >Validation of SYBR green I based closed tube loop mediated isothermal amplification (LAMP) assay and simplified direct-blood-lysis (DBL)-LAMP assay for diagnosis of visceral leishmaniasis (VL)
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Validation of SYBR green I based closed tube loop mediated isothermal amplification (LAMP) assay and simplified direct-blood-lysis (DBL)-LAMP assay for diagnosis of visceral leishmaniasis (VL)

机译：基于SYBR green I的闭管环介导的等温扩增（LAMP）分析和简化的直接血液裂解（DBL）-LAMP分析在内脏利什曼病（VL）诊断中的验证

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Author summary Definitive diagnosis of visceral leishmaniasis(VL) by demonstration of amastigotes by microscopy is invasive and risky. Serology based diagnosis using rK39 rapid diagnostic test(RDT) has excellent sensitivity of~97% when combined with clinical symptoms but is inconclusive for detection of active infection and relapses due to persistence of anti-leishmanial antibodies. The developed SYBR Green I based closed tube LAMP assay overcomes these constraints and further, direct blood lysis (DBL)-LAMP, makes it more suitable for field application. The study involved validation of LAMP assay at two endemic sites in India, on a total of 179 VL patients confirmed by rK39 RDT and/ or microscopy and 88 controls. The assay was highly sensitive (98.32%) and specific (96.59%). Further, DBL-LAMP assay yielded a sensitivity and specificity of 93.05% and 100%, respectively. In conclusion, the study has validated the field potential of LAMP assay for diagnosis of VL which will provide momentum to ongoing VL elimination in the Indian subcontinent (ISC).
机译：作者摘要显微镜下通过显示变形虫可明确诊断内脏利什曼病（VL）是侵入性的，并且具有风险。使用rK39快速诊断测试（RDT）进行的基于血清学的诊断与临床症状结合时具有〜97％的出色灵敏度，但由于抗利什曼抗体的持续存在，尚无法确定活动性感染和复发。基于SYBR Green I的封闭管LAMP测定技术克服了这些限制，而且直接血液裂解（DBL）-LAMP更适合现场应用。该研究涉及在印度的两个地方性站点上对LAMP测定法的验证，该研究共对经rK39 RDT和/或显微镜确认的179名VL患者和88名对照进行了验证。该测定法是高度敏感的（98.32％）和特异性（96.59％）。此外，DBL-LAMP分析的灵敏度和特异性分别为93.05％和100％。总而言之，该研究验证了LAMP测定法在VL诊断中的现场潜力，这将为印度次大陆（ISC）正在进行的VL消除提供动力。

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