Methods manual for product testing of malaria rapid diagnostic tests

Overview

This procedure manual details a protocol for the product testing of antigen-detecting malaria rapid diagnostic tests (RDTs) using samples of frozen parasites prepared for this purpose.

The manual describes a protocol to:

• assess sensitivity and specificity of RDTs against a specimen bank consisting of recombinant antigen, culture-derived parasites and wild-type parasites, and parasite-negative blood samples;
• assess the stability of RDTs at various temperatures;
• describe aspects of RDTs affecting ease of use in the field; and
• record results in a database.

This manual refers to standard operating procedures in the Methods manual for laboratory quality control testing of malaria rapid diagnostic tests, where collection and preparation of the wild-type samples is also described.

The manual is intended only for use in laboratories conducting product testing for the WHO.

Related document

• Methods manual for laboratory quality control testing of malaria RDTs