Evaluation of selected commercial kits for rapid detection of Influenza A and testing their suitability in laboratories in resource-constrained countries
Friedrich-Loeffler-Institut, Federal Research Institute of Animal Health, Isle of Riems
Emerging zoonotic animal viral diseases such as highly pathogenic avian influenza (HPAI) H5N1 or the Pandemic H1N1 2009, which has been circulating in human and pig populations world wide since 2009, are of general rising public concern as they constitute a great threat not only to the economy of affected countries, particularly in the developing world, but also to global public health.
In some developing countries capacity and resources for disease detection are limited, often meaning that a final and/or confirmative diagnosis fails as a result of deficiencies in laboratory biosafety or sophisticated (molecular biological) laboratory equipment. However, to respond promptly with control measures, a rapid laboratory diagnosis is critical. Taking this gap into account a huge industry offers diagnostic kits that ‘in theory’ rapidly detect specific animal diseases. Being cheap and easy to obtain and operate without the need of sophisticated equipment, those diagnostic kits might well offer great potential for use in laboratories in resource-constrained settings. On the other hand, if they have not been validated in a scientific manner they might not have sufficient diagnostic specificity and sensitivity. If not properly validated there may be a danger of obtaining false-positive or false-negative results from those “ready-to-go” kits which may result in inappropriate decisions in disease management.
A new Offlu-funded project that started in December 2010 at the Friedrich-Loeffler-Institut (FLI) aims at improving the diagnostic capacities of veterinary laboratories of least or less developed countries. In a first step some new commercially available diagnostic kits for rapid and easy detection of Influenza A will be scientifically evaluated at the FLI focussing on diagnostic sensitivity and specificity. Once proven that those kits are working well, a second evaluation is planned to take place in a less well-resourced veterinary laboratory. This has the advantage of checking whether the kits are running equally well under limited conditions while training the lab staff in the application of techniques for critical evaluation including result interpretation of test kits that might be feasible to use.
A timeframe of 13 months is planned for the project operation.