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Diagnosis of tuberculosis in an Indian population by an indirect ELISA protocol based on detection of Antigen 85 complex: a prospective cohort study.

ABSTRACT: BACKGROUND: Diagnosis of tuberculosis (TB) remains problematic despite many new advanced diagnostic methods. A reliable and rapid diagnostic test, which could be performed in any standard pathology laboratory, would help to obtain definitive early diagnoses of TB. In the present study we describe a prospective evaluation for demonstrating Antigen (Ag) 85 complex in the sera from TB patients. METHODS: Indirect ELISA, employing monoclonal antibodies (mAb) against the purified Ag 85 complex, was used to demonstrate Ag 85 complex in sera from TB patients. Serum samples were obtained from 197 different groups of patients: confirmed TB {n = 24}, clinically diagnosed TB {n = 104}, disease controls {n = 49} and healthy controls {n = 20}. Receiver operating curve (ROC) was used to calculate the cut off value and comparison between TB and non-TB groups were done by the chi-square test. RESULTS: The indirect ELISA method, using an mAb against Ag 85 complex, yielded 82% sensitivity (95% confidence interval [CI] 67 to 93%) and 86% specificity (95% CI, 57 to 98%) for the diagnosis of TB. The serum positivities for Ag 85 complex in cases of confirmed and clinically diagnosed TB patients were 96% (23/24) and 79% (82/104) respectively, while the positivity for patients in the non-tuberculosis group was 14% (10/69). CONCLUSION: The detection of Ag 85 complex in sera from TB patients by indirect ELISA using mAb against purified Ag 85 complex gives a reliable diagnosis and can be used to develop an immunodiagnostic assay with increased sensitivity and specificity.

SUBMITTER: Kashyap RS

PROVIDER: S-EPMC1933431 | biostudies-literature | 2007

REPOSITORIES: biostudies-literature

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Diagnosis of tuberculosis in an Indian population by an indirect ELISA protocol based on detection of Antigen 85 complex: a prospective cohort study.

Kashyap Rajpal S RS Rajan Anju N AN Ramteke Sonali S SS Agrawal Vijay S VS Kelkar Sanjivani S SS Purohit Hemant J HJ Taori Girdhar M GM Daginawala Hatim F HF

BMC infectious diseases 20070710

<h4>Background</h4>Diagnosis of tuberculosis (TB) remains problematic despite many new advanced diagnostic methods. A reliable and rapid diagnostic test, which could be performed in any standard pathology laboratory, would help to obtain definitive early diagnoses of TB. In the present study we describe a prospective evaluation for demonstrating Antigen (Ag) 85 complex in the sera from TB patients.<h4>Methods</h4>Indirect ELISA, employing monoclonal antibodies (mAb) against the purified Ag 85 co ...[more]

PMID: 17620147

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Project description:The precision by which animal diseases are diagnosed affects our ability to make informed decisions with regards to animal health management, from a clinical and economic perspective. Lameness is a major health condition in dairy cattle. The underlying causes of lameness include bovine digital dermatitis (BDD), which is reported as one of the main causes of infectious lameness in dairy cattle. Presently, the gold standard for BDD diagnosis in dairy cattle is visual inspection of lifted hooves-a labour intensive and subjective method. Research has suggested that Treponema spp. are the main pathogens associated with the establishment of BDD. We explored the potential of indirect enzyme-linked immunosorbent assay (ELISA) as a diagnostic serological tool in the identification of cows at different stages of BDD. Additionally, we evaluated the predictive power of this diagnostic tool on the future occurrence of BDD lesions. A total of 232 cows from three farms were used in the study. Serum samples and hoof health data were collected at three time points: ~ 30 days pre-calving, around calving, and approximately 30 days post-calving. The mean absorbance from the ELISA test was compared across different clinical presentations of BDD as assessed by visual inspection of the hooves according to the M-stage classification system. A transition model was developed to estimate the probability of lesion occurrence in time t + 1 based on the spectrophotometer (absorbance) reading in time t. The mean absorbance reading for both IgG1 and IgG2 anti-Treponema antibodies was associated with disease presence-apart from M4.1 lesions, animals with no lesions had a lower mean when compared to animals with lesions regardless of the score. Additionally, the mean absorbance reading of animals with active lesions was higher when compared to animals with no lesions. However, the anti-Treponema antibody assays failed to identify disease presence in a consistent manner. Moreover, indirect ELISA readings were not a predictor of the future occurrence of BDD lesions. In conclusion, although the levels anti-Treponema antibodies were associated with disease presence, the ELISA test failed to detect disease unequivocally and had no predictive value in the future occurrence of BDD lesions.

Dataset Information

Diagnosis of tuberculosis in an Indian population by an indirect ELISA protocol based on detection of Antigen 85 complex: a prospective cohort study.

Publications

Diagnosis of tuberculosis in an Indian population by an indirect ELISA protocol based on detection of Antigen 85 complex: a prospective cohort study.

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