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Validation of laboratory tests for infectious diseases in wild mammals: review and recommendations.

ABSTRACT: Evaluation of the diagnostic sensitivity (DSe) and specificity (DSp) of tests for infectious diseases in wild animals is challenging, and some of the limitations may affect compliance with the OIE-recommended test validation pathway. We conducted a methodologic review of test validation studies for OIE-listed diseases in wild mammals published between 2008 and 2017 and focused on study design, statistical analysis, and reporting of results. Most published papers addressed Mycobacterium bovis infection in one or more wildlife species. Our review revealed limitations or missing information about sampled animals, identification criteria for positive and negative samples (case definition), representativeness of source and target populations, and species in the study, as well as information identifying animals sampled for calculations of DSe and DSp as naturally infected captive, free-ranging, or experimentally challenged animals. The deficiencies may have reflected omissions in reporting rather than design flaws, although lack of random sampling might have induced bias in estimates of DSe and DSp. We used case studies of validation of tests for hemorrhagic diseases in deer and white-nose syndrome in hibernating bats to demonstrate approaches for validation when new pathogen serotypes or genotypes are detected and diagnostic algorithms are changed, and how purposes of tests evolve together with the evolution of the pathogen after identification. We describe potential benefits of experimental challenge studies for obtaining DSe and DSp estimates, methods to maintain sample integrity, and Bayesian latent class models for statistical analysis. We make recommendations for improvements in future studies of detection test accuracy in wild mammals.

SUBMITTER: Jia B

PROVIDER: S-EPMC7649530 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundHealth personnel face challenges in diagnosing vector-borne and other diseases of poverty in urban settings. There is a need to know what rapid diagnostic technologies are available, have been properly assessed, and are being implemented to improve control of these diseases in the urban context. This paper characterizes evidence on the field validation and implementation in urban areas of rapid diagnostics for vector-borne diseases and other diseases of poverty.Main bodyA scoping review was conducted. Peer-reviewed and grey literature were searched using terms describing the targeted infectious diseases, diagnostics evaluations, rapid tests, and urban setting. The review was limited to studies published between 2000 and 2016 in English, Spanish, French, and Portuguese. Inclusion and exclusion criteria were refined post hoc to identify relevant literature regardless of study design and geography. A total of 179 documents of the 7806 initially screened were included in the analysis. Malaria (n = 100) and tuberculosis (n = 47) accounted for the majority of studies that reported diagnostics performance, impact, and implementation outcomes. Fewer studies, assessing mainly performance, were identified for visceral leishmaniasis (n = 9), filariasis and leptospirosis (each n = 5), enteric fever and schistosomiasis (each n = 3), dengue and leprosy (each n = 2), and Chagas disease, human African trypanosomiasis, and cholera (each n = 1). Reported sensitivity of rapid tests was variable depending on several factors. Overall, specificities were high (> 80%), except for schistosomiasis and cholera. Impact and implementation outcomes, mainly acceptability and cost, followed by adoption, feasibility, and sustainability of rapid tests are being evaluated in the field. Challenges to implementing rapid tests range from cultural to technical and administrative issues.ConclusionsRapid diagnostic tests for vector-borne and other diseases of poverty are being used in the urban context with demonstrated impact on case detection. However, most evidence comes from malaria rapid diagnostics, with variable results. While rapid tests for tuberculosis and visceral leishmaniasis require further implementation studies, more evidence on performance of current tests or development of new alternatives is needed for dengue, Chagas disease, filariasis, leptospirosis, enteric fever, human African trypanosomiasis, schistosomiasis and cholera.

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Validation of laboratory tests for infectious diseases in wild mammals: review and recommendations.

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