Field test of a novel detection device for Mycobacterium tuberculosis antigen in cough

BMC Infectious Diseases

Technical Advance

Kebede Amena¹  Ato Tesfaye¹  Ruth McNerney²  Beyene A Wondafrash³  Elaine M McCash⁴  Nicol J Murray⁴ 

[1] Adama Hospital, PO BOX 611, Oromia 04, Nazareth, Ethiopia;Department of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, Keppel Street, WC1E 7HT, London, UK;Department of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, Keppel Street, WC1E 7HT, London, UK;Adama Hospital, PO BOX 611, Oromia 04, Nazareth, Ethiopia;Rapid Biosensor Systems Ltd, Babraham Hall, CB22 3AT, Babraham, Cambridge, UK;

关键词: Tuberculosis;    Pulmonary Tuberculosis;    Acid Fast Bacillus;    Smear Microscopy;    Sputum Smear Microscopy;   

DOI  :  10.1186/1471-2334-10-161

 received in 2009-11-17, accepted in 2010-06-08,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundTuberculosis is a highly infectious disease that is spread from person to person by infected aerosols emitted by patients with respiratory forms of the disease. We describe a novel device that utilizes immunosensor and bio-optical technology to detect M. tuberculosis antigen (Ag85B) in cough and demonstrate its use under field conditions during a pilot study in an area of high TB incidence.MethodsThe TB Breathalyzer device (Rapid Biosensor Systems Ltd) was field tested in the outpatient clinic of Adama Hospital, Ethiopia. Adults seeking diagnosis for respiratory complaints were tested. Following nebulization with 0.9% saline patients were asked to cough into a disposable collection device where cough aerosols were deposited. Devices were then inserted into a portable instrument to assess whether antigen was present in the sample. Demographic and clinical data were recorded and all patients were subjected to chest radiogram and examination of sputum by Ziehl-Nielsen microscopy. In the absence of culture treatment decisions were based on smear microscopy, chest x-ray and clinical assessment. Breathalyzer testing was undertaken by a separate physician to triage and diagnostic assessment.ResultsSixty individuals were each subjected to a breathalyzer test. The procedure was well tolerated and for each patient the testing was completed in less than 10 min. Positive breath test results were recorded for 29 (48%) patients. Of 31 patients with a diagnosis of tuberculosis 23 (74%; 95% CI 55-87) were found positive for antigen in their breath and 20 (64%; 95% CI 45-80) were smear positive for acid fast bacilli in their sputum. Six patients provided apparent false positive breathalyzer results that did not correlate with a diagnosis of tuberculosis.ConclusionsWe propose that the breathalyzer device described warrants further investigation as a tool for studying exhalation of M. tuberculosis. The portability, simplicity of use and speed of the test device suggest it may also find use as a tool to aid early identification of infectious cases. We recommend studies be undertaken to determine the diagnostic sensitivity and specificity of the device when compared to microbiological and clinical indicators of tuberculosis disease.

【 授权许可】

CC BY   
© McNerney et al; licensee BioMed Central Ltd. 2010