一种用于诊断皮肤利什曼病和内脏利什曼病的新型全利什曼原虫环介导等温扩增（Loopamp）检测法：系统评价与荟萃分析

A novel pan-Leishmania loop-mediated isothermal amplification (Loopamp) assay for diagnosis of cutaneous and visceral leishmaniasis: a systematic review and meta-analysis.

作者信息

Taye Behailu, Gebrie Habtamu, Bogale Alayu, Getu Eyob, Churiso Gemechu

机构信息

Department of Medical Laboratory Science, College of Medicine and Health Science, Dilla University, Dilla, Ethiopia.

出版信息

BMC Infect Dis. 2025 May 19;25(1):718. doi: 10.1186/s12879-025-11091-2.

DOI:10.1186/s12879-025-11091-2

PMID:40383753

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12087146/

Abstract

BACKGROUND

There is an urgent need for accurate and robust point-of-care (PoC) assays for visceral and cutaneous leishmaniasis (VL and CL). The Loopamp™ Leishmania detection kit (Loopamp), a novel loop-mediated isothermal amplification (LAMP) assay, has shown promise for VL and CL diagnosis using Qiagen and simpler boil-and-spin (B&S) DNA extraction methods. But diagnostic performances were inconsistent across studies. This systematic review and meta-analysis aimed to evaluate the pooled sensitivity and specificity of Loopamp for CL and VL diagnosis.

METHODS

A comprehensive search of PubMed, Scopus, EMBASE, and Google Scholar was conducted to identify studies that evaluated the diagnostic performance of Loopamp for VL and CL suspects. Using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2), the methodological qualities of the included studies were evaluated. A bivariate random-effects meta-analysis was performed using R and Stata 14.2.

RESULTS

Ten studies comprising 18 datasets were included. Sensitivity among individual VL studies ranged from 92 to 100%, while specificity varied from 41 to 100%. For CL, sensitivity varied from 48 to 100% and specificity from 31 to 100%. Pooled sensitivity was 96% (95% CI, 94-98%) for VL and 93% (95% CI, 70-99%) for CL. Pooled specificity was 99% (95% CI, 94-100%) for VL and 87% (95% CI, 55-97%) for CL. Subgroup analysis revealed that whole-blood B&S-Loopamp for VL had similar sensitivity (96%, 95% CI: 93-98%) and specificity (99%, 95% CI: 89-100%) to Qiagen-Loopamp.

CONCLUSIONS

Loopamp demonstrated robust diagnostic performance for VL in whole blood, meeting the 95% sensitivity and 99% specificity criteria outlined in the Target Product Profile (TPP). Similar to Loopamp-Qiagen, Loopamp-B&S performed excellently for VL diagnosis and is feasible to deploy in remote endemic areas. Loopamp showed high sensitivity and good specificity for CL diagnosis but fell short of the 95% sensitivity and 90% specificity required for CL PoC tests. Data on CL are limited, and its effectiveness in New World VL patients is unclear. Future research is needed to address this gap.

TRIAL REGISTRATION

CRD42023489463.

摘要

背景

对于内脏利什曼病（VL）和皮肤利什曼病（CL），迫切需要准确且可靠的即时检测（PoC）方法。环介导等温扩增（LAMP）检测试剂盒（Loopamp）是一种新型的环介导等温扩增检测方法，已显示出使用Qiagen和更简单的煮沸离心（B&S）DNA提取方法诊断VL和CL的潜力。但不同研究的诊断性能并不一致。本系统评价和荟萃分析旨在评估Loopamp诊断CL和VL的合并敏感性和特异性。

方法

全面检索PubMed、Scopus、EMBASE和谷歌学术，以确定评估Loopamp对VL和CL疑似病例诊断性能的研究。使用诊断准确性研究质量评估-2（QUADAS-2）对纳入研究的方法学质量进行评估。使用R和Stata 14.2进行双变量随机效应荟萃分析。

结果

纳入了10项研究，共18个数据集。VL个体研究的敏感性范围为92%至100%，特异性从41%至100%不等。对于CL，敏感性从48%至100%不等，特异性从31%至100%不等。VL的合并敏感性为96%（95%CI，94-98%），CL为93%（95%CI，70-99%）。VL的合并特异性为99%（95%CI，94-100%），CL为87%（95%CI，55-97%）。亚组分析显示，用于VL的全血B&S-Loopamp与Qiagen-Loopamp具有相似的敏感性（96%，95%CI：93-98%）和特异性（99%，95%CI：89-100%）。

结论

Loopamp在全血中对VL显示出强大的诊断性能，符合目标产品概况（TPP）中概述的95%敏感性和99%特异性标准。与Loopamp-Qiagen类似，Loopamp-B&S在VL诊断中表现出色，并且在偏远流行地区部署是可行的。Loopamp对CL诊断显示出高敏感性和良好的特异性，但未达到CL PoC检测所需的95%敏感性和90%特异性。关于CL的数据有限，其在新大陆VL患者中的有效性尚不清楚。需要进一步的研究来填补这一空白。