ABSTRACT
The widespread perception of the effectiveness of applying tests based on the detection of antibodies against foot-and-mouth disease (FMD) viral non-capsid proteins (NCPs) to assess virus circulation irrespective of vaccination triggered the demand for international standards to evaluate the comparative performance of the upcoming assays against the OIE Index test developed at the Pan American Foot-and-Mouth Disease Center, PAHO/WHO. To this end, a panel was developed composed of 34 cattle sera from animals with an unambiguous exposed/infected status, covering serotypes O, A and C, obtained either under experimental conditions or from the field in regions with different epidemiological situations. Reference values in the Index test and their reproducibility in other laboratories, data on stability as well as results in four other commercial kits and one in house test were obtained. The characteristics of the panel which comprise adequate preparation following international guidelines, a broad range of antibody reactivity, proper stability and the ability to assess comparative diagnostic sensitivity, make it suitable as a reference standard to evaluate if tests equivalent to the OIE Index method are used in support of FMD control programs and by trading partners, and also whether they maintain their standards of diagnostic performance.
Subject(s)
Antibodies, Viral/blood , Cattle Diseases/immunology , Foot-and-Mouth Disease Virus/immunology , Foot-and-Mouth Disease/immunology , Immunoassay/standards , Immunoassay/veterinary , Viral Nonstructural Proteins/immunology , Animals , Cattle , Cattle Diseases/diagnosis , Cattle Diseases/virology , Foot-and-Mouth Disease/diagnosis , Foot-and-Mouth Disease/virology , Foot-and-Mouth Disease Virus/classification , Reagent Kits, Diagnostic , Reference Standards , Reproducibility of Results , VaccinationABSTRACT
The threat of using biological material for ago-bioterrorist ends has risen in recent years, which means that research and diagnostic laboratories, biological agent banks and other institutions authorised to carry out scientific activities have had to implement biosafety and biosecurity measures to counter the threat, while carrying out activities to help prevent and monitor the accidental or intentional introduction of exotic animal diseases. This article briefly sets outthe basic components of biosafety and biosecurity, as well as recommendations on organisational strategies to consider in laboratories that support agro-bioterrorist surveillance and prevention programs.
Subject(s)
Bioterrorism/prevention & control , Laboratories/standards , Safety/standards , Security Measures/standards , Specimen Handling/standards , Animals , Biological Warfare/prevention & control , Disaster Planning , Emergencies , Humans , Risk AssessmentABSTRACT
En este estudio, se examinó la efectividad del uso del polipéptido 3D recombinante, obtenido en su forma nativa en una prueba de IDGA (IDGA-3D), para uso en la detección de anticuerpos específicos de infección con VFA, independientemente de la condición de vacunación. Los resultados indican que en relación a la tradicional prueba de IDGA-VIAA, la IDGA 3D ofrece, particularmente cuando se evalúan sueros de bajo título, un método más consistente, con especificidad comparable, y por lo menos la misma sensibilidad. Ninguno de los antígenos ofreció una ventaja particular con respecto a la definición de las bandas de precipitación. El reemplazo del VIAA por la proteína 3D recombinante tiene considerables atracciones, dado que proporciona un suministro ilimitado de material inocuo, económico, de fácil purificación y consistente, eliminando la presencia potencial de antígenos no específicos de células BHK o componentes de la cápside del VFA.
Subject(s)
Foot-and-Mouth Disease , DNA-Directed RNA Polymerases , RNA, Viral , Immunodiffusion , Foot-and-Mouth Disease VirusABSTRACT
Foot-and-mouth disease (FMD) recombinant non-capsideal viral antigens 3A, 3B, 2C, 3D and 3ABC were assessed individually in an indirect enzyme-linked immunosorbent assay (I-ELISA) for their ability to screen for persistent infection-specific antibodies in cattle, regardless of vaccination condition. Results of sequential serum samples from non-vaccinated animals with experimentally induced persistent infection, and their correlation with virus isolation, indicated that the polypeptides 3A, 3B and 3ABC showed the most adequate characteristics for further field studies. Reliable performance of the I-ELISA with the selected antigen 3ABC was indicated by the distinct patterns observed for the frequency distribution values of naive and true positive samples. For regularly vaccinated livestock, a clear negative profile was proved in samples from regions without recent history of FMD. In contrast, at 90 and 900 days post-outbreak, coexistence of a positive and a negative population was established. These findings indicated that, irrespective of vaccination, the test allowed a classification of the herd-disease status. A high degree of agreement was observed between I-ELISA-3ABC and EITB results for clearly reactive and non-reactive sera. For samples with reactivity values close to that of the cut-off, the EITB profiles upheld the definition of the infection condition. On this basis, screening by I-ELISA-3ABC, together with confirmation of suspect or positive samples by EITB is proposed as an adequate and accurate approach for large-scale epidemiological surveillance.
Subject(s)
Antibodies, Viral/blood , Aphthovirus/immunology , Cattle Diseases/epidemiology , Foot-and-Mouth Disease/epidemiology , Vaccination/veterinary , Viral Vaccines/immunology , Animals , Cattle , Cattle Diseases/diagnosis , Cattle Diseases/virology , Enzyme-Linked Immunosorbent Assay/methods , Foot-and-Mouth Disease/diagnosis , Foot-and-Mouth Disease/virology , Immunoblotting/methods , Population Surveillance , Recombinant Proteins/immunology , Sensitivity and Specificity , Serologic Tests , Viral Nonstructural Proteins/genetics , Viral Nonstructural Proteins/immunologyABSTRACT
The authors describe the method used in Argentina for quantification of risk in controls of the potency and innocuity of foot and mouth disease vaccine. Quantitative risk analysis is a relatively new tool in the animal health field, and is in line with the principles of transparency and equivalency of the Sanitary and Phytosanitary Agreement of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT: now World Trade Organisation [WTO]). The risk assessment is presented through a description of the steps involved in manufacturing the vaccine, and the controls performed by the manufacturer and by the National Health Animal Service (Servicio Nacional de Sanidad Animal: SENASA). The adverse situation is considered as the lack of potency or innocuity of the vaccine, and the risk is estimated using a combination of the Monte Carlo simulation and the application of a Bayesian model.
