دورية أكاديمية
أعرض في EDS

Simplified molecular diagnosis of visceral leishmaniasis: Laboratory evaluation of miniature direct-on-blood PCR nucleic acid lateral flow immunoassay.

التفاصيل البيبلوغرافية
العنوان: Simplified molecular diagnosis of visceral leishmaniasis: Laboratory evaluation of miniature direct-on-blood PCR nucleic acid lateral flow immunoassay.
المؤلفون: van Dijk NJ; Amsterdam University Medical Centre, Department of Medical Microbiology and Infection Prevention, Experimental Parasitology, Amsterdam, the Netherlands.; Amsterdam Institute for Infection and Immunity, Infectious Diseases Programme, Amsterdam, the Netherlands., Hagos DG; Amsterdam University Medical Centre, Department of Medical Microbiology and Infection Prevention, Experimental Parasitology, Amsterdam, the Netherlands.; Amsterdam Institute for Infection and Immunity, Infectious Diseases Programme, Amsterdam, the Netherlands.; College of Health Sciences, School of Medicine, Department of Medical Microbiology and Immunology, Mekelle University, Mekelle, Ethiopia., Huggins DM; Amsterdam University Medical Centre, Department of Medical Microbiology and Infection Prevention, Experimental Parasitology, Amsterdam, the Netherlands., Carrillo E; WHO Collaborating Centre for Leishmaniasis, National Center for Microbiology, Instituto de Salud Carlos III, Majadahonda (Madrid), Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC-ISCIII), Madrid, Spain., Ajala S; Amsterdam University Medical Centre, Department of Medical Microbiology and Infection Prevention, Experimental Parasitology, Amsterdam, the Netherlands., Chicharro C; WHO Collaborating Centre for Leishmaniasis, National Center for Microbiology, Instituto de Salud Carlos III, Majadahonda (Madrid), Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC-ISCIII), Madrid, Spain., Kiptanui D; Kacheliba Sub-County Hospital, Kacheliba, West Pokot County, Kenya., Solana JC; WHO Collaborating Centre for Leishmaniasis, National Center for Microbiology, Instituto de Salud Carlos III, Majadahonda (Madrid), Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC-ISCIII), Madrid, Spain., Abner E; Kacheliba Sub-County Hospital, Kacheliba, West Pokot County, Kenya., Wolday D; Department of Biochemistry and Biomedical Sciences, McMaster University, Hamilton, Canada., Schallig HDFH; Amsterdam University Medical Centre, Department of Medical Microbiology and Infection Prevention, Experimental Parasitology, Amsterdam, the Netherlands.; Amsterdam Institute for Infection and Immunity, Infectious Diseases Programme, Amsterdam, the Netherlands.
المصدر: PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2024 May 07; Vol. 18 (5), pp. e0011637. Date of Electronic Publication: 2024 May 07 (Print Publication: 2024).
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't; Evaluation Study
اللغة: English
بيانات الدورية: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101291488 Publication Model: eCollection Cited Medium: Internet ISSN: 1935-2735 (Electronic) Linking ISSN: 19352727 NLM ISO Abbreviation: PLoS Negl Trop Dis Subsets: MEDLINE
أسماء مطبوعة: Original Publication: San Francisco, CA : Public Library of Science
مواضيع طبية MeSH: Leishmaniasis, Visceral*/diagnosis , Leishmaniasis, Visceral*/parasitology , Leishmania donovani*/genetics , Leishmania donovani*/isolation & purification , Sensitivity and Specificity*, Humans ; Immunoassay/methods ; Leishmania infantum/genetics ; Leishmania infantum/isolation & purification ; Polymerase Chain Reaction/methods ; Spain ; Molecular Diagnostic Techniques/methods ; Female ; Male ; Adult ; Adolescent ; Child ; Young Adult ; Middle Aged ; Africa, Eastern ; DNA, Protozoan/genetics ; DNA, Protozoan/blood ; Child, Preschool
مستخلص: Background: Diagnosis of visceral leishmaniasis (VL) in resource-limited endemic regions is currently based on serological testing with rK39 immunochromatographic tests (ICTs). However, rK39 ICT frequently has suboptimal diagnostic accuracy. Furthermore, treatment monitoring and detection of VL relapses is reliant on insensitive and highly invasive tissue aspirate microscopy. Miniature direct-on-blood PCR nucleic acid lateral flow immunoassay (mini-dbPCR-NALFIA) is an innovative and user-friendly molecular tool which does not require DNA extraction and uses a lateral flow strip for result read-out. This assay could be an interesting candidate for more reliable VL diagnosis and safer test of cure at the point of care.
Methodology/principle Findings: The performance of mini-dbPCR-NALFIA for diagnosis of VL in blood was assessed in a laboratory evaluation and compared with the accuracy of rK39 ICTs Kalazar Detect in Spain and IT LEISH in East Africa. Limit of detection of mini-dbPCR-NALFIA was 650 and 500 parasites per mL of blood for Leishmania donovani and Leishmania infantum, respectively. In 146 blood samples from VL-suspected patients from Spain, mini-dbPCR-NALFIA had a sensitivity of 95.8% and specificity 97.2%, while Kalazar Detect had a sensitivity of 71.2% and specificity of 94.5%, compared to a nested PCR reference. For a sample set from 58 VL patients, 10 malaria patients and 68 healthy controls from Ethiopia and Kenya, mini-dbPCR-NALFIA had a pooled sensitivity of 87.9% and pooled specificity of 100% using quantitative PCR as reference standard. IT LEISH sensitivity and specificity in the East African samples were 87.9% and 97.4%, respectively.
Conclusions/significance: Mini-dbPCR-NALFIA is a promising tool for simplified molecular diagnosis of VL and follow-up of treated patients in blood samples. Future studies should evaluate its use in endemic, resource-limited settings, where mini-dbPCR-NALFIA may provide an accurate and versatile alternative to rK39 ICTs and aspirate microscopy.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2024 van Dijk et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
References: PLoS Negl Trop Dis. 2018 Mar 1;12(3):e0006277. (PMID: 29494596)
Vet J. 2009 Nov;182(2):356-8. (PMID: 18603455)
J Clin Microbiol. 2005 Dec;43(12):5973-7. (PMID: 16333084)
J Clin Microbiol. 2011 Nov;49(11):3892-904. (PMID: 22042830)
PLoS Negl Trop Dis. 2014 Jun 26;8(6):e2869. (PMID: 24968313)
Cochrane Database Syst Rev. 2014 Jun 20;(6):CD009135. (PMID: 24947503)
J Clin Microbiol. 2018 Jun 25;56(7):. (PMID: 29695527)
PLoS Negl Trop Dis. 2013 Sep 26;7(9):e2441. (PMID: 24086782)
Trop Med Int Health. 2001 Feb;6(2):108-13. (PMID: 11251906)
J Mol Diagn. 2018 Jan;20(1):78-86. (PMID: 29056574)
J Clin Microbiol. 2014 Sep;52(9):3147-55. (PMID: 24829226)
PLoS Negl Trop Dis. 2020 Oct 8;14(10):e0008741. (PMID: 33031382)
Antimicrob Agents Chemother. 2015 Jan;59(1):1-14. (PMID: 25367913)
Parasit Vectors. 2018 May 2;11(1):273. (PMID: 29716641)
Microorganisms. 2021 Apr 05;9(4):. (PMID: 33916346)
Transfusion. 2001 Sep;41(9):1100-6. (PMID: 11552065)
Am J Trop Med Hyg. 2014 Jan;90(1):33-39. (PMID: 24218406)
Clin Infect Dis. 2021 Sep 7;73(5):775-782. (PMID: 33580234)
BMC Infect Dis. 2021 Nov 17;21(1):1166. (PMID: 34789175)
J Parasit Dis. 2020 Jun;44(2):253-272. (PMID: 32419743)
J Trop Med. 2022 Apr 11;2022:3569704. (PMID: 35449755)
Clin Infect Dis. 2012 Nov 15;55(10):1312-9. (PMID: 22942208)
Front Cell Infect Microbiol. 2021 Apr 26;11:670759. (PMID: 33981632)
BMC Infect Dis. 2020 Dec 11;20(1):946. (PMID: 33308170)
Microbiol Spectr. 2023 Jun 15;11(3):e0335422. (PMID: 37014253)
PLoS Negl Trop Dis. 2012;6(5):e1665. (PMID: 22666514)
Parasit Vectors. 2022 Jan 24;15(1):34. (PMID: 35073980)
Am J Trop Med Hyg. 2009 Jun;80(6):929-34. (PMID: 19478251)
PLoS Negl Trop Dis. 2020 Mar 25;14(3):e0008139. (PMID: 32210438)
J Clin Microbiol. 2004 Nov;42(11):5249-55. (PMID: 15528722)
Vet Sci. 2022 Jul 27;9(8):. (PMID: 36006301)
Biomed Res Int. 2019 Jul 24;2019:8240784. (PMID: 31428648)
Malar J. 2023 Mar 17;22(1):98. (PMID: 36932372)
Trans R Soc Trop Med Hyg. 1992 Sep-Oct;86(5):505-7. (PMID: 1475815)
المشرفين على المادة: 0 (DNA, Protozoan)
تواريخ الأحداث: Date Created: 20240507 Date Completed: 20240507 Latest Revision: 20240509
رمز التحديث: 20240509
مُعرف محوري في PubMed: PMC11075898
DOI: 10.1371/journal.pntd.0011637
PMID: 38713648
قاعدة البيانات: MEDLINE
الوصف
تدمد:1935-2735
DOI:10.1371/journal.pntd.0011637