Methods manual for laboratory quality control testing of malaria RDTs
This manual provides methods that will allow production of samples or relatively consistent antigen content and quality for testing malaria RDTs. These samples are intended to detect inadequacies in the lower limit of detection of parasites that are likely to result in mis-diagnoses with a clinical impact in the field. Extrapolation of laboratory results to field use assumes that storage in the field is sufficiently similar to storage of RDTs in the laboratory prior to testing, and that parasites of a similar species and strain (similar antigen) are present.
These methods are therefore suitable for testing product lots after purchase before and during deployment in the field, to ensure that the product lots fulfils basic criteria for operational use.