Evaluation of rapid diagnostic tests

Because of the ongoing shortage of laboratories in the countries of the African “meningitis belt,” the only way of implementing bedside diagnostics that can be used by non-specialist health workers is to develop rapid diagnostic tests that are simple and cheap to use. A rapid diagnostic test for serogroup A, C, W135 and Y meningococci, in the form of reagent strips, has been developed by the Institut Pasteur and the CERMES. The test was initially assessed in the laboratory and then under field conditions in Niger. In order to complete the evaluation of the test, it has been suggested that a study also be carried out in Burkina Faso and in Mali.

The development of the protocol was supervised by the AMP team. All of the trial tools (such as collection tools and consent forms) have been finalised.

All administrative and ethical authorisations have been obtained. The authorisation of the Clinical Research Committee was given in October 2008. The authorisation of the Committee of the Centre Muraz in Burkina Faso was given on 31 December 2007 for one year and amendment 1 was submitted in August 2008 to extend the period authorised for the start. The agreement of the Ministry of Health has been obtained. The agreement of the ethical committee in Mali was obtained in February 2007. The agreement with the sponsor has been signed.

The sample size for the test will be 300 CSF samples from patients with suspected meningitis in Burkina Faso and 300 CSF samples from similar patients in Mali.