Evaluation of rapid diagnostic test prototypes detecting Wb123 antibodies in populations with Loa loa

Review status: 
Accepted

Research question

This is a cross-reactivity evaluation of rapid tests detecting Wb123 antibodies. The test should perform similarly in sub-populations of individuals who are positive and negative for other filarial diseases, most importantly Loa loa. This field evaluation will determine the specificity of the tests in two separate populations, those positive and negative for Loa loa, and will be used to inform the product design and the product insert. This evaluation will recruit adults and children from regions that are known to have Loa loa in Cameroon.

 The study’s principal objective is to determine test specificity in individuals who are positive and negative for the filarial worm Loa loa. Secondary objectives are to determine the test specificity in individuals who are positive and negative for Mansonella perstans, and identify failure modes and failure rates of the rapid tests under surveillance conditions.

This is a cross-reactivity evaluation of rapid tests detecting Wb123 antibodies. The test should perform similarly in sub-populations of individuals who are positive and negative for other filarial diseases, most importantly Loa loa. This field evaluation will determine the specificity of the tests in two separate populations, those positive and negative for Loa loa, and will be used to inform the product design and the product insert. This evaluation will recruit adults and children from regions that are known to have Loa loa in Cameroon.

The study’s principal objective is to determine test specificity in individuals who are positive and negative for the filarial worm Loa loa. Secondary objectives are to determine the test specificity in individuals who are positive and negative for Mansonella perstans, and identify failure modes and failure rates of the rapid tests under surveillance conditions.

Study sites

Notes

Total sample size 300