Abstract
The procedure of ultra-rapid extraction (PURE) and loop-mediated isothermal amplification for tuberculosis (LAMP-TB) is a simple and rapid manual tuberculosis diagnostic with medium-throughput capability. Because of its simplicity, this method could be useful in resource-limited conditions such as microscopy centers in developing countries. This study was conducted to evaluate the clinical performance of this method in a point-of-care setting. The performance was compared to that of smear microscopy and liquid culture in a hospital laboratory in Haiti, which is considered a representative facility for the implementation of this method. The sensitivity, based on culture-positivity, was 86% (95% confidence interval: 81.3–90.3%) and that based on the smear-negative and culture-positive results was 51% (38.7–63.5%). The specificity based on sample negativity for both smear and culture was 98.4% (96.8–99.2). These results are nearly equivalent to those of a clinical study performed in Japan and are comparable with those of other nucleic acid amplification methods. Thus, approximately 18% more tuberculosis patients could be identified by adding the LAMP-TB method to routine smear microscopy in field settings in Haiti. In addition, it is suggested that local technicians could perform LAMP-TB after only short-term training.
