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Título:
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Performance of the TB-LAMP diagnostic assay in reference laboratories: Results from a multicentre study
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Autores:
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Pham, Thu Hang ;
Peter, Jonathan ;
Mello, Fernanda C. Q. ;
Parraga, Tommy ;
Lan, Nguyen Thi Ngoc ;
Nabeta, Pamela ;
Valli, Eloise ;
Cáceres, Tatiana ;
Dheda, Keertan ;
Dorman, Susan E. ;
Hillemann, Doris ;
Gray, Christen M. ;
Perkins, Mark D.
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Tipo de documento:
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texto impreso
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Editorial:
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Elsevier, 2018-11-30T22:50:35Z
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Nota general:
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info:eu-repo/semantics/restrictedAccess
https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
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Idiomas:
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Inglés
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Palabras clave:
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Editados por otras instituciones
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Artículos
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Artículos en revistas indizadas
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Resumen:
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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.
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En línea:
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http://doi.org/10.1016/j.ijid.2018.01.005
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