Classification | Cause of false negative RDT result |
---|---|
Product design or quality | Poor detection sensitivity of a RDT product due to poor specificity, affinity, or insufficient quantity of antibodies used in the RDT |
Poor visibility of test bands due to high background colour on the test | |
Incorrect instructions for use | |
Transport or storage conditions | Antibody degradation due to poor durability to heat or to incorrect transport or storage |
Parasite factors | Variation in the amino acid sequence of the epitope targeted by the monoclonal antibody |
Parasites lacking the target antigens or expressing reduced levels of the target antigens | |
Operator factors | Operator error in preparing the RDT, performing the test, or interpreting the result |
Host parasite density | Very low parasite densities/target antigen concentrations |
Prozone effect (hyperparasitemia/antigen overload) |