title: Fast and efficient detection of tuberculosis antigens using liposome encapsulated secretory proteins of Mycobacterium tuberculosis.
abstract: OBJECTIVE
  A rapid and efficient diagnostic test was developed for the detection of Mycobacterium tuberculosis antigens in serum samples of active tuberculosis (TB) and extrapulmonary TB patients via a liposomal agglutination-based method.
  
  
  METHODS
  A rapid card test has been developed to facilitate the recognition of high-affinity binding rabbit raised purified culture filtrate protein antibodies coupled on the surface of activated liposomal preparation. In the presence of TB antigens, the polyclonal antibodies bound to the liposomal particles demonstrate a visible agglutination reaction.
  
  
  RESULTS
  The developed assay was simple, rapid, reliable, sensitive, and specific as a diagnostic test for the detection of antigens in serum samples of clinically confirmed cases of TB within 4-5 minutes' duration. The test was evaluated at different hospitals, medical colleges, and pathology centers, and involved 1483 participants. This investigation was conducted to detect the presence of these antigens during the period of active growth of the microorganism in serum samples for pulmonary TB and processed tissue biopsy for other extrapulmonary TB. Results obtained using this test were compared with acid-fast bacilli smear and culture results.
  
  
  CONCLUSIONS
  Our study demonstrated that the newly developed liposome tuberculosis antigen card test detected antigens in our study population with approximately 97.48% sensitivity and 95.79% specificity. This is the first study to report the liposomal encapsulation of culture filtrate proteins from M. tuberculosis for diagnostic application.
authors.affiliation: Catalysis and Peptide Research Unit, School of Health Sciences, University of KwaZulu-Natal, Durban, South Africa; School of Environmental Biology and Centre for Biotechnology Studies, University of Awdhesh Pratap Singh, Rewa 486001, Madhya Pradesh, India. Electronic address: Tiwari@ukzn.ac.za.
authors.forename: Dileep
authors.initials: D
authors.lastname: Tiwari
authors.affiliation: Department of Biosciences, Jamia Millia Islamia, New Delhi 110025, India; Research and Scientific Studies Unit, College of Nursing and Allied Health Sciences, Jazan University, Jazan 45142, Saudi Arabia.
authors.forename: Shafiul
authors.initials: S
authors.lastname: Haque
authors.affiliation: Department of Biotechnology, Immunodiagnostic Division, Vanguard Diagnostic Pvt. Ltd., Delhi 110020, India.
authors.forename: Ram P
authors.initials: RP
authors.lastname: Tiwari
authors.affiliation: Research and Scientific Studies Unit, College of Nursing and Allied Health Sciences, Jazan University, Jazan 45142, Saudi Arabia.
authors.forename: Arshad
authors.initials: A
authors.lastname: Jawed
authors.affiliation: Catalysis and Peptide Research Unit, School of Health Sciences, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Thavendran
authors.initials: T
authors.lastname: Govender
authors.affiliation: Catalysis and Peptide Research Unit, School of Health Sciences, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Hendrik G
authors.initials: HG
authors.lastname: Kruger
mesh_terms: D000372:Agglutination Tests; D000906:Antibodies; D000942:Antigens, Bacterial / Q000097:blood / Q000276:immunology* / Q000302:isolation & purification*; D003955:Diagnostic Tests, Routine / Q000379:methods; D006801:Humans; D006867:Hydrolases / Q000276:immunology; D008081:Liposomes / Q000737:chemistry / Q000276:immunology*; D009169:Mycobacterium tuberculosis / Q000276:immunology*; D014376:Tuberculosis / Q000175:diagnosis* / Q000276:immunology* / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis / Q000276:immunology / Q000382:microbiology
chemical_list: D000906:Antibodies; D000942:Antigens, Bacterial; D008081:Liposomes; C072681:Mycobacterium tuberculosis antigens; D006867:Hydrolases; C527647:HsaD protein, Mycobacterium tuberculosis
keywords: Active tuberculosis; Antigen; Liposome; Mycobacterium tuberculosis H(37)Rv; Secretory protein antibody