Development and validation of an immunoperoxidase antigen detection test for improved diagnosis of rabies in Indonesia

Autor: Chris Morrissy, Brian J. Shiell, John Allen, Gary Beddome, Wojtek P. Michalski, Jean Payne, Yul Fitria, Meng Yu, John Bingham, Andrea Certoma, Ian A. Gardner, Ibnu Rahmadane, A. Colling, Susanne L Wilson, Grantley R. Peck
Jazyk: angličtina
Rok vydání: 2017
Předmět:
0301 basic medicine
RNA viruses
Veterinary medicine
Viral Diseases
Research Facilities
Physiology
medicine.disease_cause
Pathology and Laboratory Medicine
Biochemistry
0403 veterinary science
Fats
Geographical Locations
Immunoenzyme Techniques
Zoonoses
Immune Physiology
Medicine and Health Sciences
Medical diagnosis
Antigens
Viral

Mammals
Immune System Proteins
Immunoperoxidase
lcsh:Public aspects of medicine
Eukaryota
Brain
04 agricultural and veterinary sciences
Lipids
Test (assessment)
Infectious Diseases
Veterinary Diseases
Medical Microbiology
Viral Pathogens
Viruses
Vertebrates
Rabbits
Pathogens
Research Laboratories
Research Article
Neglected Tropical Diseases
Gene Expression Regulation
Viral

medicine.medical_specialty
lcsh:Arctic medicine. Tropical medicine
Asia
040301 veterinary sciences
lcsh:RC955-962
Rabies
Immunology
Oceania
Research and Analysis Methods
Microbiology
Antibodies
03 medical and health sciences
Rabies Virus
Viral Proteins
Dogs
medicine
Animals
Humans
Medical physics
Direct fluorescent antibody
Microbial Pathogens
business.industry
Fitness for purpose
Rabies virus
Public Health
Environmental and Occupational Health

Organisms
Biology and Life Sciences
Proteins
Reproducibility of Results
lcsh:RA1-1270
Gold standard (test)
medicine.disease
Tropical Diseases
030104 developmental biology
Nucleoproteins
Indonesia
Amniotes
People and Places
Lyssavirus
Veterinary Science
Immunization
Reagent Kits
Diagnostic

business
Government Laboratories
Zdroj: PLoS Neglected Tropical Diseases
PLoS Neglected Tropical Diseases, Vol 11, Iss 11, p e0006079 (2017)
ISSN: 1935-2735
1935-2727
Popis: Rabies continues to pose a significant threat to human and animal health in regions of Indonesia. Indonesia has an extensive network of veterinary diagnostic laboratories and the 8 National laboratories are equipped to undertake diagnostic testing for rabies using the commercially-procured direct fluorescent antibody test (FAT), which is considered the reference (gold standard) test. However, many of the Indonesian Provincial diagnostic laboratories do not have a fluorescence microscope required to undertake the FAT. Instead, certain Provincial laboratories continue to screen samples using a chemical stain-based test (Seller’s stain test, SST). This test has low diagnostic sensitivity, with negative SST-tested samples being forwarded to the nearest National laboratory resulting in significant delays for completion of testing and considerable additional costs. This study sought to develop a cost-effective and diagnostically-accurate immunoperoxidase antigen detection (RIAD) test for rabies that can be readily and quickly performed by the resource-constrained Provincial laboratories. This would reduce the burden on the National laboratories and allow more rapid diagnoses and implementation of post-exposure prophylaxis. The RIAD test was evaluated using brain smears fixed with acetone or formalin and its performance was validated by comparison with established rabies diagnostic tests used in Indonesia, including the SST and FAT. A proficiency testing panel was distributed between Provincial laboratories to assess the reproducibility of the test. The performance of the RIAD test was improved by using acetone fixation of brain smears rather than formalin fixation such that it was of equivalent accuracy to that of the World Organisation for Animal Health (OIE)-recommended FAT, with both tests returning median diagnostic sensitivity and specificity values of 0.989 and 0.993, respectively. The RIAD test and FAT had higher diagnostic sensitivity than the SST (median = 0.562). Proficiency testing using a panel of 6 coded samples distributed to 16 laboratories showed that the RIAD test had good reproducibility with an overall agreement of 97%. This study describes the successful development, characterisation and use of a novel RIAD test and its fitness for purpose as a screening test for use in provincial Indonesian veterinary laboratories.
Author summary In Indonesia, veterinary diagnostic laboratories conduct tests for rabies on brain samples from animals suspected of being infected with rabies virus. National laboratories use internationally recommended tests for rabies virus that require expensive materials and equipment. Remote and smaller Provincial laboratories use a simpler older-generation chemical stain test that is less costly to perform but is also highly inaccurate resulting in many rabies-infected brains returning false negative test results. Brain samples that give negative results at a Provincial laboratory are then transported to a National laboratory for retesting to confirm the diagnosis. This results in additional costs and time delays and creates the need for a more effective, lower cost rabies test that Provincial laboratories can effectively use. This paper describes the development of one such test that is of comparable accuracy to the internationally recommended test for detecting rabies in brain and does not require expensive equipment to perform.
Databáze: OpenAIRE