Universidad Peruana Cayetano Heredia

Feasibility and Operational Performance of Tuberculosis Detection by Loop-Mediated Isothermal Amplification Platform in Decentralized Settings: Results from a Multicenter Study

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dc.contributor.author Gray, Christen-M.
dc.contributor.author Katamba, Achilles
dc.contributor.author Narang, Pratibha
dc.contributor.author Giraldo, Jorge
dc.contributor.author Zamudio Fuertes, Carlos Eduardo
dc.contributor.author Joloba, Moses
dc.contributor.author Narang, Rahul
dc.contributor.author Paramasivan, C. N.
dc.contributor.author Hillemann, Doris
dc.contributor.author Nabeta, Pamela
dc.contributor.author Amisano, Danielle
dc.contributor.author Alland, David
dc.contributor.author Cobelens, Frank
dc.contributor.author Boehme, Catharina-C.
dc.date.accessioned 2019-02-06T14:45:34Z
dc.date.available 2019-02-06T14:45:34Z
dc.date.issued 2016
dc.identifier.uri https://hdl.handle.net/20.500.12866/5075
dc.description.abstract Currently available nucleic acid amplification platforms for tuberculosis (TB) detection are not designed to be simple or inexpensive enough to implement in decentralized settings in countries with a high burden of disease. The loop-mediated isothermal amplification platform (LAMP) may change this. We conducted a study in adults with symptoms suggestive of TB in India, Uganda, and Peru to establish the feasibility of using TB-LAMP (Eiken Chemical Co.) in microscopy laboratories compared with using smear microscopy against a reference standard of solid and liquid cultures. Operational characteristics were evaluated as well. A total of 1,777 participants met the eligibility criteria and were included for analysis. Overall, TB-LAMP sensitivities among culture-positive samples were 97.2% (243/250; 95% confidence interval [CI], 94.3% to 98.2%) and 62.0% (88/142; 95% CI, 53.5% to 70.0%) for smear-positive and smear-negative TB, respectively, but varied widely by country and operator. Specificities ranged from 94.5% (446/472; 95% CI, 92.0% to 96.4%) to 98.0% (350/357; 95% CI, 96.0% to 99.2%) by country. A root cause analysis identified high temperatures, high humidity, and/or low reaction volumes as possible causes for false-positive results, as they may result in nonspecific amplification. The study was repeated in India with training focused on vulnerable steps and an updated protocol; 580 participants were included for analysis. Specificity in the repeat trial was 96.6% (515/533; 95% CI, 94.7% to 97.9%). To achieve acceptable performance of LAMP at the microscopy center level, significant training and infrastructure requirements are necessary. en_US
dc.language.iso eng
dc.publisher American Society for Microbiology
dc.relation.ispartofseries Journal of Clinical Microbiology
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Adolescent en_US
dc.subject Adult en_US
dc.subject Aged en_US
dc.subject Aged, 80 and over en_US
dc.subject Female en_US
dc.subject Humans en_US
dc.subject India en_US
dc.subject Male en_US
dc.subject Middle Aged en_US
dc.subject Molecular Diagnostic Techniques/methods en_US
dc.subject Nucleic Acid Amplification Techniques/methods en_US
dc.subject Peru en_US
dc.subject Sensitivity and Specificity en_US
dc.subject Tuberculosis/diagnosis en_US
dc.subject Uganda en_US
dc.subject Young Adult en_US
dc.title Feasibility and Operational Performance of Tuberculosis Detection by Loop-Mediated Isothermal Amplification Platform in Decentralized Settings: Results from a Multicenter Study en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1128/JCM.03036-15
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#1.06.01
dc.relation.issn 1098-660X


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