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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
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01af/12087146/a76afd3b1d52/12879_2025_11091_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01af/12087146/b32eeae59870/12879_2025_11091_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01af/12087146/dfef41b87e25/12879_2025_11091_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01af/12087146/7d34cffa670b/12879_2025_11091_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01af/12087146/874e07fe2e44/12879_2025_11091_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01af/12087146/a76afd3b1d52/12879_2025_11091_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01af/12087146/b32eeae59870/12879_2025_11091_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01af/12087146/dfef41b87e25/12879_2025_11091_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01af/12087146/7d34cffa670b/12879_2025_11091_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01af/12087146/874e07fe2e44/12879_2025_11091_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01af/12087146/a76afd3b1d52/12879_2025_11091_Fig5_HTML.jpg

相似文献

[1]
A novel pan-Leishmania loop-mediated isothermal amplification (Loopamp) assay for diagnosis of cutaneous and visceral leishmaniasis: a systematic review and meta-analysis.

BMC Infect Dis. 2025-5-19

[2]
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[3]
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[4]
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[6]
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[7]
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[8]
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[9]
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[10]
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本文引用的文献

[1]
Evaluation of Loopamp Leishmania detection kit for the diagnosis of cutaneous leishmaniasis in Ethiopia.

Parasit Vectors. 2024-10-15

[2]
Evaluation of Less Invasive Sampling Tools for the Diagnosis of Cutaneous Leishmaniasis.

Open Forum Infect Dis. 2024-2-28

[3]
Comparison of the Diagnostic Performances of Five Different Tests in Diagnosing Visceral Leishmaniasis in an Endemic Region of Ethiopia.

Diagnostics (Basel). 2024-1-11

[4]
Real Time PCR-based diagnosis of human visceral leishmaniasis using urine samples.

PLOS Glob Public Health. 2022-12-29

[5]
Gauging the skin resident Leishmania parasites through a loop mediated isothermal amplification (LAMP) assay in post-kala-azar dermal leishmaniasis.

Sci Rep. 2022-10-27

[6]
Visceral Leishmaniasis: Epidemiology, Diagnosis, and Treatment Regimens in Different Geographical Areas with a Focus on Pediatrics.

Microorganisms. 2022-9-21

[7]
Cutaneous Leishmaniasis: A 2022 Updated Narrative Review into Diagnosis and Management Developments.

Am J Clin Dermatol. 2022-11

[8]
Development of a chimeric protein based on a proteomic approach for the serological diagnosis of human tegumentary leishmaniasis.

Appl Microbiol Biotechnol. 2021-9

[9]
Utility of the Loop-Mediated Isothermal Amplification Assay for the Diagnosis of Visceral Leishmaniasis from Blood Samples in Ethiopia.

Am J Trop Med Hyg. 2021-7-26

[10]
Emergent canine visceral leishmaniasis in Argentina: Comparative diagnostics and relevance to proliferation of human disease.

PLoS Negl Trop Dis. 2021-7

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