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Performance of the TB-LAMP diagnostic assay in reference laboratories: Results from a multicentre study

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dc.contributor.author Pham, Thu Hang
dc.contributor.author Peter, Jonathan
dc.contributor.author Mello, Fernanda C. Q.
dc.contributor.author Parraga, Tommy
dc.contributor.author Lan, Nguyen Thi Ngoc
dc.contributor.author Nabeta, Pamela
dc.contributor.author Valli, Eloise
dc.contributor.author Caceres, Tatiana
dc.contributor.author Dheda, Keertan
dc.contributor.author Dorman, Susan E.
dc.contributor.author Hillemann, Doris
dc.contributor.author Gray, Christen M.
dc.contributor.author Perkins, Mark D.
dc.date.accessioned 2018-11-30T22:50:35Z
dc.date.available 2018-11-30T22:50:35Z
dc.date.issued 2018
dc.identifier.uri https://hdl.handle.net/20.500.12866/4149
dc.description.abstract OBJECTIVE: To evaluate the diagnostic performance of TB-LAMP, a manual molecular tuberculosis (TB) detection method, and provide comparison to the Xpert MTB/RIF assay. METHODS: In a large multicentre study, two sputum samples were collected from participants with TB symptoms in reference laboratories in Peru, South Africa, Brazil, and Vietnam. Each sample was tested with TB-LAMP. The reference standard consisted of four direct smears, four cultures, and clinical and radiological findings. Individuals negative on conventional tests were followed up after 8 weeks. The Xpert MTB/RIF assay was performed on fresh or frozen samples as a molecular test comparison. RESULTS: A total of 1036 adults with suspected TB were enrolled. Among 375 culture-confirmed TB cases with 750 sputum samples, TB-LAMP detected 75.6% (95% confidence interval (CI) 71.8-79.4%), including 97.9% (95% CI 96.4-99.4%) of smear-positive TB samples and 46.6% (95% CI 40.6-52.7%) of smear-negative TB samples. Specificity in 477 culture-negative participants not treated for TB (954 sputum samples) was 98.7% (95% CI 97.9-99.6%). TB-LAMP test results were indeterminate in 0.3% of cases. CONCLUSIONS: TB-LAMP detects nearly all smear-positive and half of smear-negative TB cases and has a high specificity when performed in reference laboratories. Performance was similar to the Xpert MTB/RIF assay. en_US
dc.language.iso eng
dc.publisher Elsevier
dc.relation.ispartof urn:issn:1878-3511
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Peru en_US
dc.subject Clinical trials en_US
dc.subject Mycobacterium tuberculosis en_US
dc.subject Polymerase chain reaction en_US
dc.subject Adolescent en_US
dc.subject Adult en_US
dc.subject Female en_US
dc.subject Follow-Up Studies en_US
dc.subject Humans en_US
dc.subject Male en_US
dc.subject Young Adult en_US
dc.subject Brazil en_US
dc.subject Tuberculosis en_US
dc.subject Aged en_US
dc.subject Middle Aged en_US
dc.subject Sensitivity and Specificity en_US
dc.subject Aged, 80 and over en_US
dc.subject South Africa en_US
dc.subject Sputum en_US
dc.subject Tuberculin Test en_US
dc.subject Urban Population en_US
dc.subject Vietnam en_US
dc.title Performance of the TB-LAMP diagnostic assay in reference laboratories: Results from a multicentre study en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1016/j.ijid.2018.01.005
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00 es_PE

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