Dataset Information

Accuracy of Two Point-of-Care Tests for Rapid Diagnosis of Bovine Tuberculosis at Animal Level using Non-Invasive Specimens.

ABSTRACT: Bovine tuberculosis (BTB) testing in cattle requires a significant investment of time, equipment, and labor. Novel, rapid, cheaper and accurate methods are needed. The Alere Determine TB lipoarabinomannan antigen (LAM-test) is a World Health Organization-endorsed point-of-care urine test designed to detect active TB disease in humans. The Lionex Animal TB Rapid Test (Lionex-test) is a novel animal specific TB diagnostic blood test. An animal level analysis was performed using urine (n?=?141) and milk (n?=?63) samples from depopulated BTB-suspected cattle to test the accuracy of the LAM-test when compared to results of positive TB detection by any routine BTB tests (BOVIGAM, necropsy, histology, culture, PCR) that are regularly performed by the United States Department of Agriculture (USDA). The agreement between the urine LAM-test and USDA standard tests were poor at varying testing time points. The same milk samples did not elicit statistically significant agreement with the Lionex-test, although positive trends were present. Hence, we cannot recommend the LAM-test as a valid BTB diagnostic test in cattle using either urine or milk. The Lionex-test's production of positive trends using milk samples suggests larger sample sizes may validate the Lionex-test in accurately diagnosing BTB in cattle using milk samples, potentially providing a quick and reliable field test for BTB.

SUBMITTER: Kelley HV

PROVIDER: S-EPMC7096388 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Publications

Accuracy of Two Point-of-Care Tests for Rapid Diagnosis of Bovine Tuberculosis at Animal Level using Non-Invasive Specimens.

Kelley Holden V HV Waibel Sarah M SM Sidiki Sabeen S Tomatis-Souverbielle Cristina C Scordo Julia M JM Hunt W Garret WG Barr N N Smith R R Silwani Sayeed N SN Averill James J JJ Baer Susan S Hengesbach Janet J Yildiz Vedat O VO Pan Xueliang X Gebreyes Wondwossen A WA Balada-Llasat Joan-Miquel JM Wang Shu-Hua SH Torrelles Jordi B JB

Scientific reports 20200325 1

Bovine tuberculosis (BTB) testing in cattle requires a significant investment of time, equipment, and labor. Novel, rapid, cheaper and accurate methods are needed. The Alere Determine TB lipoarabinomannan antigen (LAM-test) is a World Health Organization-endorsed point-of-care urine test designed to detect active TB disease in humans. The Lionex Animal TB Rapid Test (Lionex-test) is a novel animal specific TB diagnostic blood test. An animal level analysis was performed using urine (n = 141) and ...[more]

PMID: 32214170

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Project description:Accuracy of new or alternative diagnostic tests is typically estimated in relation to a well-standardized reference test referred to as a gold standard. However, for bovine tuberculosis (bTB), a chronic disease of cattle, affecting animal and public health, no reliable gold standard is available. In this context, latent-class models implemented using a Bayesian approach can help to assess the accuracy of diagnostic tests incorporating previous knowledge on test performance and disease prevalence. In Uruguay, bTB-prevalence has increased in the past decades partially because of the limited accuracy of the diagnostic strategy in place, based on intradermal testing (caudal fold test, CFT, for screening and comparative cervical test, CCT, for confirmation) and slaughter of reactors. Here, we evaluated the performance of two alternative bTB-diagnostic tools, the interferon-gamma assay, IGRA, and the enzyme-linked immunosorbent assay (ELISA), which had never been used in Uruguay in the absence of a gold standard. In order to do so animals from two heavily infected dairy herds and tested with CFT-CCT were also analyzed with the IGRA using two antigens (study 1) and the ELISA (study 2). The accuracy of the IGRA and ELISA was assessed fitting two latent-class models: a two test-one population model (LCA-a) based on the analysis of CFT/CFT-CCT test results and one in-vitro test (IGRA/ELISA), and a one test-one population model (LCA-b) using the IGRA or ELISA information in which the prevalence was modeled using information from the skin tests. Posterior estimates for model LCA-a suggested that IGRA was as sensitive (75-78%) as the CFT and more sensitive than the serial use of CFT-CCT. Its specificity (90-96%) was superior to the one for the CFT and equivalent to the use of CFT-CCT. Estimates from LCA-b models consistently yielded lower posterior Se estimates for the IGRA but similar results for its Sp. Estimates for the Se (52% 95%PPI:44.41-71.28) and the Sp (92% 95%PPI:78.63-98.76) of the ELISA were however similar regardless of the model used. These results suggest that the incorporation of IGRA for detection of bTB in highly infected herds could be a useful tool to improve the sensitivity of the bTB-control in Uruguay.

Project description:BackgroundBovine tuberculosis (BTB) today primarily affects developing countries. In Africa, the disease is present essentially on the whole continent; however, little accurate information on its distribution and prevalence is available. Also, attempts to evaluate diagnostic tests for BTB in naturally infected cattle are scarce and mostly complicated by the absence of knowledge of the true disease status of the tested animals. However, diagnostic test evaluation in a given setting is a prerequisite for the implementation of local surveillance schemes and control measures.Methodology/principal findingsWe subjected a slaughterhouse population of 954 Chadian cattle to single intra-dermal comparative cervical tuberculin (SICCT) testing and two recently developed fluorescence polarization assays (FPA). Using a Bayesian modeling approach we computed the receiver operating characteristic (ROC) curve of each diagnostic test, the true disease prevalence in the sampled population and the disease status of all sampled animals in the absence of knowledge of the true disease status of the sampled animals. In our Chadian setting, SICCT performed better if the cut-off for positive test interpretation was lowered from >4 mm (OIE standard cut-off) to >2 mm. Using this cut-off, SICCT showed a sensitivity and specificity of 66% and 89%, respectively. Both FPA tests showed sensitivities below 50% but specificities above 90%. The true disease prevalence was estimated at 8%. Altogether, 11% of the sampled animals showed gross visible tuberculous lesions. However, modeling of the BTB disease status of the sampled animals indicated that 72% of the suspected tuberculosis lesions detected during standard meat inspections were due to other pathogens than Mycobacterium bovis.Conclusions/significanceOur results have important implications for BTB diagnosis in a high incidence sub-Saharan African setting and demonstrate the practicability of our Bayesian approach for diagnostic test evaluation.

Dataset Information

Accuracy of Two Point-of-Care Tests for Rapid Diagnosis of Bovine Tuberculosis at Animal Level using Non-Invasive Specimens.

Publications

Accuracy of Two Point-of-Care Tests for Rapid Diagnosis of Bovine Tuberculosis at Animal Level using Non-Invasive Specimens.

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