RDT Performance issues Index

Causes for poor performance of RDT tests 1. Selection and procurement of MDTs (a) Quality of test design/production. Historically there was significant variation of performance between tests and batches, this has been greatly improved with the WHO pre-qualification testing program that requires a minimum standard of performant, however users are still advised to check the performance of their selected test (see WHO testing information ref 2 above) (b) Lot variability. Variability between different production batches has been observed and should be considered if RDT performance is less good than expected. 2. Stability and storage issues (a) RDTs typically have a shelf-life of 18–24 months providing storage is appropriate. (b) Tests can suffer degradation if stored in inappropriate heat or humidity: generally tests are stable in the range 2–30°C or higher, but these limits may be exceeded in many countries, and continuous product refrigeration to the point of use may not be guaranteed in developing countries. 3. Operator training (a)Problems in test usage may include inappropriate placement of test reagents or blood sample on RDT. (b)Poor interpretation of faint lines. (c) Inadequate training or reference materials