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Table 1 Possible causes of false negative RDT results

From: Plasmodium falciparum parasites lacking histidine-rich protein 2 and 3: a review and recommendations for accurate reporting

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)