Diagnostic tools are the key to understanding virus ecology, disease epidemiology, and pathology in hosts and dead end hosts. They are also a major gateway for clinical interventions to be transformed from mere symptomatic relief to virus-specific treatment.
The viruses targeted by our consortium are not among the best-studied. Their zoonotic nature as well as the fact that they occur mostly outside temperate, highly industrialised countries keeps them out of the attention of the medical industry. As a consequence, de-novo development, improvement, and extension of these methods are up to academic and public health / veterinary facilities. The laboratory-based, experimental surroundings in which diagnostic tools for viruses such as CCHFV, RVFV, WNV, and their like are developed brings along a large diversity of protocols and fundamentally different approaches in chemical and/or biological formulations. Sometimes, experimental protocols may vary not only between laboratories, but even between researchers in the same laboratory. As a consequence, laboratory results cannot be compared, contributing a level of uncertainty to derivative datasets (e.g., surveillance data). Clearly, standardisation of methods is needed.
Another topic in diagnostics is the provision of protocols to less developed settings. Those laboratories that have diagnostic tools at hand, even though they may not be well comparable, are able to operate in their own fashion. However, especially those laboratories that are entitled to provide data for surveillance in affected, endemic regions may lack the resources or the expertise to maintain proper technology. These laboratories are in urgent need of improvement of their technological status. Clearly, the protocols and other resources they receive should be absolutely free of controversy, in that they should have gone through a first stage of standardisation already. Then they can easily be installed, and training on agreed methods can be provided by multiple "donating" partners.
Finally, although facilities such as the many national reference centres contributing in our consortium, are highly resprected for their expert status and tradition in operating, there is sometimes a dearth of hard facts that characterises or scales their performance for non-experts. If this is true for the most well respected facilities, this is even more the case for "newcomers" or "outsiders" who may have been entitled to objectify their performance but lack the means to do so. External quality assurance (EQA) is the best approach to putting laboratory performance of many facilities on a common denominator. At the same time, it identifies shortcomings and areas that can be improved, specifically for each participating laboratory. It also provides important research material for laboratories to practice and improve their methods on. We will organise EQA studies according to the long standing experience of some of our partners.
In detail, this section of the project will address and accomplish the following tasks:
A. A repository of diagnostic capacities
- An electronic list of the types of assays in consortium labs, together with standard operation practice (SOP) documentation
- An electronic list of the testing capacities (throughput, types of samples, sources of samples), as well as your function in your country´s public health/verterinary/food safety infrastructure
- An electronic list of reference material that can be shared with others for diagnostic controls
B. Assessment of diagnostic proficiency
- An external quality assurance (EQA) study on RT-PCR detection of CCHFV and RVFV will be conducted. We will send around inactivated, lyophilised virus.
- A follow-up study on an earlier West Nile RT-PCR EQA study will be conducted in the same manner.
- A combined serological EQA study will be completed, allowing any established serological method – we will send around sera of humans and animals.
C. Disseminating the best assays from EQA
- RT-PCR: centrally-ordered oligonucleotides will be pre-tested and assembled together with controls and SOP documentation, and will be distributed through the consortium (for all three viruses)
- Serology: IFA-slides or pre-coated EIA plates, together with controls and SOP documentation, will be distributed through the consortium (for all three viruses)
