How indicative are laboratory tests of actual field performance?
By using blood samples from field locations, including samples subjected to high temperatures, the blinded laboratory evaluation closely approximated real-life conditions. However, variations in test performance among the RDT samples used for the evaluation was often noted and it is expected that there will also be variations in different production lots (each lot typically contains some 20,000-40,000 tests). For these reasons, an ongoing programme of global comparative testing is important as are programmes of “lot” testing at country or regional level in order to maintain quality assurance and control. Under the auspices of the joint test evaluation programme, WHO/WPRO, TDR and FIND have established a lot testing programme.
