| Autor: |
Thu Hang Pham, Jonathan Peter, Fernanda C.Q. Mello, Tommy Parraga, Nguyen Thi Ngoc Lan, Pamela Nabeta, Eloise Valli, Tatiana Caceres, Keertan Dheda, Susan E. Dorman, Doris Hillemann, Christen M. Gray, Mark D. Perkins |
| Jazyk: |
angličtina |
| Rok vydání: |
2018 |
| Předmět: |
|
| Zdroj: |
International Journal of Infectious Diseases, Vol 68, Iss , Pp 44-49 (2018) |
| Druh dokumentu: |
article |
| ISSN: |
1201-9712 |
| DOI: |
10.1016/j.ijid.2018.01.005 |
| Popis: |
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. Keywords: Mycobacterium tuberculosis, Polymerase chain reaction, Clinical trials |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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