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The increase in travelers and refugees combined with global warming may soon lead to the development of tropical diseases such as Schistosoma or Strongyloides infections in some European countries.
Those intestinal parasites may persist for decades with subclinical infections or low-grade disease with nonspecific manifestations. In the presence of immunosuppression, strongyloidiasis can rapidly evolve into life-threatening disseminated disease, whereas chronic schistosomiasis can lead to complications causing future morbidity and death.
Currently in France, an update of diagnostic tests reimbursed for those tropical diseases is ongoing to fully cover diagnostic needs.
Our aim was to assess the clinical relevance of tests used in schistosomiasis’ or strongyloidiasis’ diagnosis and include the most relevant in the national list of reimbursed tests.
The assessment involves a critical analysis of national and international guidelines identified by a systematic literature search, and stakeholders’ views.
This work identifies several autochthonous outbreaks of those diseases in France; such as urogenital schistosomiasis that occurred in Corsica, in summer 2013. Also it enlightens the increase of strongyloides serological tests performed in the past years. Those facts prove the potential development of those infections in Europe.
It underlines that, serology is the first diagnostic test line for most cases and is more sensitive than stool microscopy which represents however the final diagnostic investigation to confirm the intestinal infection.
It confirms the main indications of those two diagnostic tools.
It relies on a tropical infectious disease expert network including the French army health service. They have brought further clarification of diagnostic tests clinical relevance for travelers or autochthonous cases.
This new use of Health Technology Assessment has allowed updating and listing the relevant diagnostic tools which might be crucial to better follow those diseases and it may help the health system to face the increase of tropical infections.
Since the 1990s in France, based on contemporary French consensus conferences, for Hepatitis B (HBV) or Hepatitis C (HCV), diagnosis is acknowledged when detection of Hepatitis B surface antigen or anti-HCV antibody is positive on a 1st test line and further replicated on an independent blood sample.
The replication was introduced to alleviate the low performance of immunoassay and avoid false positive results.
Currently, the Haute Autorité de santé (HAS) is managing an update of diagnostic tests reimbursed for HBV and HCV to fully cover diagnostic needs.
Our aim is to assess the clinical relevance of this repetition.
The assessment involves a critical analysis of national and international guidelines identified by a systematic literature search, and stakeholders’ views (professionals and public authorities).
Since the 1990s, new tools were introduced (that is, polymerase chain reaction (PCR) for diagnosis and follow-up), and performances were improved for both enzyme immunoassay tests and PCR. Despite those change, replications are still performed nowadays in France.
Neither guidelines nor stakeholders’ contributions mentioned any replication tests’ clinical relevance.The Ministry of Health confirms that replications have not any legal basis contrary to HIV diagnosis procedures. Also the French National agency for health products safety confirms there are neither technological pitfalls nor reagent vigilance signals involving HBV or HCV in vitro diagnostic tests. Furthermore, after 1st line positive results, a second blood sample is always collected to test other markers such as HBV DNA or HCV RNA which represent the best 2nd proof of infection.
This work has enlightened a lack of clinical relevance for the replication of the same serological makers’ detection. It may obliterate soon this French medical dogma. This work has illustrated that short assessment based on critical guideline analysis linked with stakeholders’ views allows a rapid answer without assessment quality reduction. This HAS work will contribute to medical practice rationalization and cost reduction.
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