title: Field evaluation of a blood based test for active tuberculosis in endemic settings.
abstract: Over 9 million new active tuberculosis (TB) cases emerge each year from an enormous pool of 2 billion individuals latently infected with Mycobacterium tuberculosis (M. tb.) worldwide. About 3 million new TB cases per year are unaccounted for, and 1.5 million die. TB, however, is generally curable if diagnosed correctly and in a timely manner. The current diagnostic methods for TB, including state-of-the-art molecular tests, have failed in delivering the capacity needed in endemic countries to curtail this ongoing pandemic. Efficient, cost effective and scalable diagnostic approaches are critically needed. We report a multiplex TB serology panel using microbead suspension array containing a combination of 11 M.tb. antigens that demonstrated overall sensitivity of 91% in serum/plasma samples from TB patients confirmed by culture. Group wise sensitivities for sputum smear positive and negative patients were 95%, and 88%, respectively. Specificity of the test was 96% in untreated COPD patients and 91% in general healthy population. The sensitivity of this test is superior to that of the frontline sputum smear test with a comparable specificity (30-70%, and 93-99%, respectively). The multiplex serology test can be performed with scalability from 1 to 360 patients per day, and is amenable to automation for higher (1000s per day) throughput, thus enabling a scalable clinical work flow model for TB endemic countries. Taken together, the above results suggest that well defined antibody profiles in blood, analyzed by an appropriate technology platform, offer a valuable approach to TB diagnostics in endemic countries.
authors.affiliation: College of Earth and Environmental Sciences, University of the Punjab, Lahore, Pakistan.
authors.forename: Aasia
authors.initials: A
authors.lastname: Khaliq
authors.affiliation: Department of Pathology and Laboratory Medicine, University of California, Davis, California, United States of America.
authors.forename: Resmi
authors.initials: R
authors.lastname: Ravindran
authors.affiliation: Department of Computer Science, School of Science and Engineering, Lahore University of Management Sciences, Lahore, Pakistan.
authors.forename: Syed Fahadulla
authors.initials: SF
authors.lastname: Hussainy
authors.affiliation: Department of Pathology and Laboratory Medicine, University of California, Davis, California, United States of America.|Department of Chemistry, California State University, Fresno, California, United States of America.
authors.forename: Viwanathan V
authors.initials: VV
authors.lastname: Krishnan
authors.affiliation: Gulab Devi Chest Hospital, Lahore, Pakistan.
authors.forename: Atiqa
authors.initials: A
authors.lastname: Ambreen
authors.affiliation: Department of Pathology, Allama Iqbal Medical College, Lahore, Pakistan.
authors.forename: Noshin Wasim
authors.initials: NW
authors.lastname: Yusuf
authors.affiliation: Department of Pathology, Allama Iqbal Medical College, Lahore, Pakistan.
authors.forename: Shagufta
authors.initials: S
authors.lastname: Irum
authors.affiliation: Gulab Devi Chest Hospital, Lahore, Pakistan.
authors.forename: Abdul
authors.initials: A
authors.lastname: Rashid
authors.affiliation: Gulab Devi Chest Hospital, Lahore, Pakistan.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Jamil
authors.affiliation: Department of Computer Science, School of Science and Engineering, Lahore University of Management Sciences, Lahore, Pakistan.
authors.forename: Fareed
authors.initials: F
authors.lastname: Zaffar
authors.affiliation: College of Earth and Environmental Sciences, University of the Punjab, Lahore, Pakistan.
authors.forename: Muhammad Nawaz
authors.initials: MN
authors.lastname: Chaudhry
authors.affiliation: NextGen In Vitro Diagnostics, New Delhi, India.
authors.forename: Puneet K
authors.initials: PK
authors.lastname: Gupta
authors.affiliation: School of Biological Sciences, University of the Punjab, Lahore, Pakistan.
authors.forename: Muhammad Waheed
authors.initials: MW
authors.lastname: Akhtar
authors.affiliation: Department of Pathology and Laboratory Medicine, University of California, Davis, California, United States of America.
authors.forename: Imran H
authors.initials: IH
authors.lastname: Khan
mesh_terms: D000328:Adult; D005260:Female; D006403:Hematologic Tests / Q000379:methods*; D006801:Humans; D008297:Male; D009169:Mycobacterium tuberculosis / Q000276:immunology; D010949:Plasma / Q000382:microbiology; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods; D013183:Sputum / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000097:blood* / Q000175:diagnosis* / Q000382:microbiology; D055815:Young Adult