Development of a proof of concept immunochromatographic lateral flow assay for point of care diagnosis of Mycobacterium tuberculosis

BMC Research Notes

Timothy Mark Doherty¹  Peter Andersen⁴  Karin Weldingh⁴  Ida Rosenkrands⁴  Ismail Ceyhan⁵  Jose M Delgado²  Jose R González²  Arantxa Cortés²  Lawrence K Yamuah³  Menberwork Chanyalew³  Martha Zewdie³  Kidist Bobosha³  Abraham Aseffa³  Markos Abebe³  Liya Wassie³ 

[1] Current address: GlaxoSmithKline, Nykær 68, Copenhagen, Denmark;Vircell, S.I., 18320 Santa Fe, Granada, Spain;Armauer Hansen Research Institute, P.O. Box: 1005, Jimma Road, Addis Ababa, Ethiopia;Department of Infectious Disease Immunology, Statens Serum Institute, 5 Artillertivej, DK-2300, Copenhagen S, Denmark;Refik Saydam National Institute of Hygiene, Cemal Gürsel Cad. No: 18, Sihhiye, Turkey

关键词: ELISA;    Diagnosis;    Serology;    Antigen;    TB;    Antibody;    IgG;   

Others  :  1142643
DOI  :  10.1186/1756-0500-6-202

 received in 2012-09-05, accepted in 2013-05-15,  发布年份 2013

【 摘 要 】

Background

Despite major public health initiatives and the existence of efficacious treatment regimes, tuberculosis (TB) remains a threat, particularly in resource-limited settings. A significant part of the problem is the difficulty of rapidly identifying infected individuals, and as a result, there has been renewed interest in developing better diagnostics for infection or disease caused by Mycobacterium tuberculosis. Many of the existing tools, however, have limitations such as poor sensitivity or specificity, or the need for well-equipped laboratories to function effectively. Serodiagnostic approaches in particular have long drawn attention, due to their potential utility in large field studies, particularly in resource-poor settings. Unfortunately none of the serodiagnostic approaches have so far proven useful under field conditions.

Results

We screened a large panel of antigens with serodiagnostic potential by ELISA and selected a subpanel that was strongly and broadly recognised by TB patients, but not by controls. These antigens were then formulated into a simple immuno-chromatographic lateral flow assay format, suitable for field use, and tested against panels of plasma and blood samples from individuals with different clinical status (confirmed TB patients, household contacts, and apparently healthy community controls), recruited from Ethiopia (a highly TB-endemic country) and Turkey (a TB meso-endemic country). While specificity was good (97-100% in non TB-endemic controls), the sensitivity was not as high as expected (46-54% in pulmonary TB, 25-29% in extra-pulmonary TB).

Conclusions

Though below the level of sensitivity the consortium had set for commercial development, the assay specifically identified M. tuberculosis-infected individuals, and provides a valuable proof of concept.

【 授权许可】

   
2013 Wassie et al.; licensee BioMed Central Ltd.

【 图 表 】

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