title: Detection of active tuberculosis by an MPB-64 transdermal patch: a field study.
abstract: The mycobacterial antigen MPB-64 was formulated for delivery in a transdermal patch and used as a diagnostic skin test reagent to detect active tuberculosis (TB) in patients attending a clinic in Manila, The Philippines. The MPB-64 Transdermal Patch was applied to 62 patients, 49 with sputum-positive active disease and 13 who had completed TB chemotherapy, and to 28 non-TB but tuberculin-positive controls. The results were read at 72 h. The sensitivity of the Transdermal Patch was 87.8%, with an efficacy of 92.9% and a specificity of 100%. The 13 TB patients who had completed 6 months of TB chemotherapy showed different reactions to the MPB64 patch test: those who had completed chemotherapy < 4 months before testing were positive; 50% of patients who completed chemotherapy 5 months previously were positive; and those who had completed chemotherapy 7 and 8 months before were negative. All the non-TB controls with positive tuberculin tests were negative to the MPB-64 Transdermal Patch, even at the highest protein dose tested. This test may be a useful method to distinguish active TB patients from TB-infected but asymptomatic individuals. Moreover, the MPB64 Transdermal Patch may be useful to monitor successful chemotherapy.
authors.affiliation: Sequella Inc., Rockville, Maryland 20850, USA.
authors.forename: R M
authors.initials: RM
authors.lastname: Nakamura
authors.forename: L
authors.initials: L
authors.lastname: Einck
authors.forename: M A
authors.initials: MA
authors.lastname: Velmonte
authors.forename: K
authors.initials: K
authors.lastname: Kawajiri
authors.forename: C F
authors.initials: CF
authors.lastname: Ang
authors.forename: C E
authors.initials: CE
authors.lastname: Delasllagas
authors.forename: C A
authors.initials: CA
authors.lastname: Nacy
mesh_terms: D000942:Antigens, Bacterial; D001426:Bacterial Proteins; D016022:Case-Control Studies; D003937:Diagnosis, Differential; D006801:Humans; D010328:Patch Tests / Q000379:methods; D012680:Sensitivity and Specificity; D013997:Time Factors; D014374:Tuberculin Test; D014376:Tuberculosis / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology
chemical_list: D000942:Antigens, Bacterial; D001426:Bacterial Proteins; C080865:MPB64 protein, Mycobacterium