Đề tài Development of Improved Capability in SupporCattle and Pigs - Milestone 10

Ministry of Agriculture & Rural Development Competency Assessment Report§ Development of Improved Capability in Support of National Biosecurity for the Surveillance and Control of Foot & Mouth Disease in Cattle and Pigs Milestone 10 Competency assessment of laboratory staff and field veterinarians in Sub-DAHs: Increased awareness and implementation of recommended practices by farmers in target areas Chris Morrissy § Milestone 10 Resubmission, June 2010 1 Table of Contents 1. Institute Information ____________________________________________ 2 2. Project Abstract _______________________________________________ 3 3. Executive Summary ____________________________________________ 3 4. Progress to date _______________________________________________ 4 4.1 Implementation Highlights [Competency Assessment]____________ 4 5. Conclusions __________________________________________________ 7 2 1. Institute Information Project Name CARD FMD [072/04VIE] Vietnamese Institution Regional Animal Health Centre (RAHO-6) Ho Chi Minh City South Vietnam Vietnamese Project Team Leader Dr Dong Manh Hoa Australian Organisation Australian Animal Health Laboratory [AAHL] Private Bag 24 Geelong, VIC 3220 Australia Australian Personnel Mr Chris Morrissy Date commenced 01/06/2005 Completion date (original) 01/06/2008 Completion date (revised) Reporting period Project 3 year Reporting Period Contact Officer(s) In Australia: Team Leader Name: Mr Chris Morrissy Telephone: +61 3 5227 5000 Position: Supervisor Mammalian Virology Fax: +61 3 5227 5555 Organisation Australian Animal Health Laboratory [AAHL] Private Bag 24 Geelong, VIC 3220, Australia Email: [email protected] In Australia: Administrative Contact Name: Mr Christopher Morrissy Telephone: +61 3 5227 5434 Position: Patents Contracts Officer Fax: +61 3 5227 5555 Organisation Australian Animal Health Laboratory [AAHL] Private Bag 24 Geelong, VIC 3220 Australia Email: christopher.morrissy@csi ro.au In Vietnam Name: Dr Dong Manh Hoa Telephone: + 84 8 8568220 Position: Director Fax: + 84 8 8569050 Organisation Regional Animal Health Centre (RAHO-6) Ho Chi Minh City South Vietnam Email: [email protected] 3 2. Project Abstract The aims of this project were to develop capacity for FMD surveillance and diagnosis at both a laboratory and field level within the wider animal health network in Vietnam. Improved diagnostic capacity will facilitate early detection and identification of FMD enabling better disease control. Specifically, successful capacity development at regional laboratories will enable quality assured laboratory capability for FMDV diagnosis and serology. This will be applied to the investigation of FMDV serotypes currently in circulation and the reason underlying on-going FMD vaccine failures in Vietnam. In addition, the successful establishment of an effective laboratory network for the diagnosis and control of FMD will provide a greater understanding of FMD epidemiology and will facilitate the coordination and implementation of effective vaccination control strategies via the wider animal health network in Vietnam. 3. Executive Summary Significant progress has been made in relation to both achievement in the laboratory and realisation in the field of Milestone 10 objectives. Specifically, this project has successfully achieved capacity development in relation to the establishment of quality assured FMD diagnostics at multiple laboratories in Vietnam. Throughout the course of this project both the quality of field data and the integrity of specimen submissions showed continuous improvement. This is an excellent example of successful capability development and quality assurance in the laboratory being the driving force behind more effective training and education of field veterinarians in relation to FMD management practices in the field. This greater integration and coordination within the entire FMD animal health network in Vietnam has resulted in both effective capability and capacity to perform serological surveillance studies and related quality assured FMD laboratory diagnostic tests. In relation to sustainability, this project has successfully established all of the core competencies required within the wider animal health network for the successful implementation of on-going FMD serosurveillance studies. This will significantly aid the DAH gain a better understanding of both the numbers of animals exposed to FMD and already has generated important data in relation to vaccination coverage in the field. As a result of successful capacity development, and subsequent quality assurance of implemented FMD diagnostic tests, both the RAHO-6 and NCVD laboratories have achieved FMD Reference Laboratory status in Vietnam. Specifically, the RAHO-6 laboratory has quality assured FMD diagnostic capability using all of the tests available for the diagnosis of FMD - equivalent to tests used by AAHL and other international reference laboratories. This was confirmed following on-site appraisal by AAHL personnel and further substantiated following both IQC and ECQ using an FMD proficiency test panel from both AAHL and also the Regional Reference Laboratory in Thailand. In a wider context, RAHO-4, RAHO-7 and NAVETCO also have the capability to perform FMD ELISAS for the detection of antigen and antibody giving these laboratories the capability to diagnose FMD. In relation to the integration of FMD diagnostics within the wider animal health network, since its inception the RAHO-6 epidemiology section have been highly proactive in engaging and training provincial veterinarians and field staff. Proof of this was the dramatic improvement in sample and data collection at RAHO-6 during the course of this project. However, the other collaborating laboratories have no epidemiology staff (such as at NCVD) and this inherently results in lower quality field data. This represents a fundamental limitation in relation to the realisation of long- term project objectives in some regions of Vietnam. 4 4. Progress to Date [In relation to Milestone 10 Deliverables] 4.1 Implementation Highlights [Competency Assessment] An overview of training activities conducted at AAHL and both on-site training and appraisal by AAHL personnel in Vietnam were outlined in earlier Milestone Reports. In this “Competence Appraisal” report details of competence assessment and appraisal are given in relation to each of the Milestone deliverables. In addition, each of the specific comments made by the Referees in the earlier Milestone 10 Appraisal Report are addressed and further substantiated. • Training manuals for veterinarians and farmers This milestone will be split into two parts. Firstly, training manuals specifically targeted for field veterinarians and secondly technical standard operating procedures and data collection sheets for laboratory-based veterinarians and related personnel. • Training manuals [Field-based] The AAHL Scientific Coordinator has inputted into the OIE / FAO “Outbreak Investigation Manual” which represents perhaps the most detailed and comprehensive training resource for livestock veterinarian network members. This manual is targeted primarily at field veterinarians and focuses on both FMD and CSF. It is intended as a guide to assist field veterinarians to investigate and manage disease outbreaks and on effective relationship management with both farmers in the field and also laboratory personnel. This step-by-step guide is supported by background information on why outbreaks occur; the epidemiology and clinical signs; reporting procedures; sample collection; laboratory submission and control measures. This manual has been used by the OIE/FAO for several field veterinarian disease investigation training workshops in Vietnam. Although currently still at the “Draft” stage with the OIE / FAO Sub-Committee the manual will be published in due course. • Training manuals [Laboratory-based] Details of training inputs both at AAHL and on-site training and appraisal by AAHL personnel in Vietnam have been detailed in earlier Milestone reports. In relation to FMD diagnostics and capacity development, the following AAHL standard operating procedures and methods were successfully established in the collaborating laboratories under their in-house quality assurance systems. Specifically, a quality system was implemented in each laboratory for FMD diagnostics, which included standardised methods, IQC and record keeping compliance. The results of inter- laboratory comparisons and EQA will be detailed later in this Milestone report. • RAHO-6 and the NCVD laboratories have established quality assured FMD cell culture, virus isolation, virus neutralisation and FMD RT-PCR procedures based on the following AAHL SOPs  Cell culture procedures [SOP 13-4-85]  Isolation of FMDV from animal samples [SOP 13-4-14]  Molecular Diagnosis: FMDV Assays [SOP 13-4-80-9] 5 • RAHO-4 and RAHO-7 laboratories have also attained quality assured capability for FMD diagnosis based on the following AAHL SOPs  Ag ELISA (detection of antigen) • Antigen ELISA [SOP 13-4-88]  Serology by ELISA for post-vaccination surveillance • FMDV C-ELISA [SOP 13-4-89] • FMDV LP-ELISA [SOP13-4-13] These SOPs have been modified for use under local conditions and facilities and have been successfully implemented. For example, at RAHO-6 quality assurance in the form of standard cover sheets, result sheets and IQC record keeping forms were included in Appendix 1 of the earlier Milestone 3 Report [National Reference Laboratory and Regional Laboratories operational and effective]. Additional substantiation in relation to FMD laboratory diagnostic capability can be provided on request. In a wider context, details in relation to on-going quality assurance appraisal and the results of EQA are as follows: • Results of laboratory comparisons and EQA Following technology transfer and capacity development from AAHL a quality system for FMD diagnostics was successfully implemented in each laboratory. In-house quality assurance initially comprised standardised methods and reference reagents supplied by AAHL. Quality assurance was assessed following on-site appraisal by AAHL personnel and further confirmed using EQA from both AAHL and the FMD Regional Reference Laboratory in Thailand. The EQA results were as follows: • Quality assurance was further confirmed following EQA using a proficiency test [PT] panel o The RAHO-6 results testing using PT panels from AAHL for the LP ELISA are given in Attachment 1. o The RAHO-6 results testing using PT panels from the RRL in Thailand for both the LP ELISA and Ag ELISA are given in Attachment 2 • Quality Assurance of the genotyping of FMD isolates performed at RAHO-6 were subsequently confirmed following transfer of samples and additional sequence analysis conducted by the FMD World Reference Laboratory (WRL). The results from the EQA clearly attest to the on-going quality assurance of the FMD diagnostic assays currently in use in Vietnam. • Target farmers knowledge and FMD management practices assessed and changes documented The “Outbreak Investigation Manual” detailed earlier also represents a significant resource to all relevant stakeholders. However, additional resources have been produced to facilitate the acquisition of necessary field data to facilitate the assessment, monitoring and appraisal of FMD management practices in Vietnam. Specifically, these resources were designed to enable DAH to gain a better understanding of the numbers of animals exposed to FMD, vaccination coverage and both improved sample and data collection. 6 Specifically, the following approaches have been implemented to gain a greater understanding and to appraise FMD management practices in the field in Vietnam. o Improved diagnostic and surveillance sample collection and concomitant on-the-job training of DAH field and epidemiology staff • An example of the serum sampling record sheets distributed to field veterinarian and epidemiologists to facilitate serological surveillance of FMD vaccine usage in the field in Vietnam is given in Attachment 3 o Disease investigation protocols established in collaboration with FAO GF-TADS project and SEAFMD • An example of the “outbreak survey” form to help field veterinarians collect necessary information in the event of a FMD outbreak is given in Attachment 4 The use of such forms ensure that important information in relation to vaccines used etc. are recorded and available to laboratory and DAH to ensure effective surveillance and management of disease outbreaks in the field in Vietnam. In addition, having such standardised documents facilitates professional interaction between field veterinarians and laboratory personnel and results in an increase in number of samples submitted to the laboratory for serotyping by ELISA. This will give DAH a better understanding of the circulating serotypes of FMD viruses in Vietnam. The improvement in sample collection also facilitated virus isolation from field samples. This has not been possible prior to the initiation of this project and has subsequently enabled rapid genotyping of FMD virus isolates to be performed. • Competency assessment of RHAC-HCHC staff as trainers of regional laboratory staff and field veterinarians As a result of successful capacity development and quality assurance compliance both RAHO-6 and NCVD have been recognised as FMD Reference laboratories in Vietnam. This was achieved through the use of on-site appraisal by the AAHL Scientific Coordinator and the use of PT panels from both AAHL and the Regional Reference Laboratory in Thailand. As part of their reference laboratory function, RAHO-6 provides training and advice to other regional laboratories and DAH personnel. The competence and professionalism of RAHO-6 staff was further substantiated by their highly effective training and mentoring of DAH field personnel in relation to proper sample collection for surveillance and the implementation of field surveys for the management of disease outbreaks as detailed earlier. In relation to the presentations mentioned in the initial Milestone 10 submission the following presentations have been attached to the Milestone 10 resubmission: o MS 10 Attachment 5 [SEAFMD Labnet 2010 Meeting] o MS 10 Attachment 6 [OIE Subcom 2010 Meeting] o MS 10 Attachment 7 [SEAFMD LMWG 2008 Meeting] In addition, although details of ELISA methods and worksheets had been included in the earlier Milestone 3 report, an example of a completed FMD LP ELISA worksheet is given in Attachment 10. All other attachments specifically mentioned by the Referee in the earlier Milestone 10 Appraisal Report have been included elsewhere in this Milestone 10 Report. 7 5. Conclusions This project has successfully achieved objectives through the establishment of quality assured FMD diagnostic capacity within the network of veterinary laboratories in Vietnam. Of particular significance, both the HCMC [RAHO-6] and Hanoi [NCVD] laboratories have attained FMD Reference Laboratory status and continue to provide FMD diagnostic support and training to other regional laboratories in the network. Proficiency testing has confirmed quality assurance in relation to the range of FMD diagnostic tests established. In addition, on-going IQC and EQC using reference reagents and PT panels provided by AAHL and other external Reference Laboratories will ensure future quality assurance and sustainability at other regional laboratories in Vietnam. This project also highlighted the need for on-going training of field veterinarians in the collection of data and the identification of procedures to ensure the correct information is obtained from the farmer. This has been greatly facilitated by the range of data collection and survey questionnaires produced by RAHO-6. On-going training of DAH field and epidemiology staff has led to improved knowledge and a much greater appreciation of processes needed for disease investigation. In particular, the requirement for much closer integration and greater two-way communication between laboratory and field personnel was highlighted. In the case of RAHO-6 closer integration and communication has already resulted in much- improved sample and data collection. The resultant FMD diagnostic capacity and both improved and coordinated specimen collection in the field has increased the number of FMD outbreaks identified in Vietnam. In addition, proper sample collection has facilitated the collection of samples suitable for virus isolation and subsequent genotyping by RT-PCR. For example, the use of cell culture for the growth of FMDV at RAHO-6 has allowed sequencing results to be obtained quickly. This is currently used as a decision tool in relation to identifying the serotypes of FMD circulating in Vietnam and the selection of the correct vaccine for use on a region-by-region basis. FMD cell culture capability has also allowed the production locally of key reagents required for FMD diagnostics such as FMD ELISA antigen. For example, RAHO-6 is producing their own FMD antigen and supplying other laboratories such as NCVD, RAHO-4 and RAHO-7. This will ensure future sustainability in relation to FMD Ag- ELISA capabilities in Vietnam. In addition, the ability to grow FMDV in cell culture has allowed RAHO-6 to establish the FMD virus neutralisation test (VNT) which can be used to detect antigenic changes in FMDV field isolates. This facilitates the early detection of antigenic changes, which may reduce vaccine effectiveness. This project has increased the diagnostic capability of Vietnamese laboratories to diagnose FMD and to characterise FMDV field isolates. This allows the laboratories to determine the FMD serotype in circulation and to confirm the correct vaccine serotype is in use in the field. The laboratories’ ability to genotype FMD isolates also helps identify the source of the outbreak and facilitates better control and prevention of FMD. This project has also highlighted the importance of an integrated lab-to-field animal health network and has already resulted in increased vaccine coverage in some provinces. This has resulted in an ever-decreasing incidence of FMV outbreaks in the South of Vietnam compared to central and North Vietnam.