title: Accuracy of LAMP-TB Method for Diagnosing Tuberculosis in Haiti.
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.
authors.affiliation: RESULTS Japan.
authors.forename: Taijin
authors.initials: T
authors.lastname: Kaku
authors.forename: Fujihiko
authors.initials: F
authors.lastname: Minamoto
authors.forename: Richard
authors.initials: R
authors.lastname: D'Meza
authors.forename: Willy
authors.initials: W
authors.lastname: Morose
authors.forename: Jacque
authors.initials: J
authors.lastname: Boncy
authors.forename: Josette
authors.initials: J
authors.lastname: Bijou
authors.forename: Harry
authors.initials: H
authors.lastname: Geffrard
authors.forename: Miki
authors.initials: M
authors.lastname: Yoshida
authors.forename: Toru
authors.initials: T
authors.lastname: Mori
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001431:Bacteriological Techniques / Q000379:methods; D005260:Female; D006205:Haiti; D006801:Humans; D008297:Male; D008853:Microscopy / Q000379:methods; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D014376:Tuberculosis / Q000175:diagnosis*