抄録
The procedure for 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 under resource-limited conditions such as microscopy centers in developing countries. The study was conducted to evaluate the clinical performance of this method in point of care setting. The performance was compared with those of smear microscopy and a liquid culture, in a hospital laboratory in Haiti, which is considered to be a representative facility for implementing this method. The sensitivity, based on the culture-positivity was 86% (95% Confidence interval: 81.3 – 90.8%) and that based on the smear-negative and culture-positive finding was 51% (38.7 – 63.5%). The specificity based on the specimens 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 detected by adding the LAMP-TB method to routine smear microscopy in the field settings of Haiti. In addition, it was suggested that LAMP-TB could be performed by local technicians after only short-term training.
