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 |
|