Validating Real-Time Polymerase Chain Reaction (PCR) Assays

For many years, the development of assays took place in the laboratories where the test was required. Whilst more and more commercially developed tests have become available, novel assays continue to be developed in academic hospital laboratories. Although commercial kits are more expensive than LDTs, they enable the rapid introduction of assays, with the advantage of being CE marked or FDA approved. However, this approval does not necessarily guarantee the rigorous validation of the assay. Furthermore, commercial assays have to be commercially attractive, which is unlikely for small-scale, specialist tests targeting rarely occurring infectious pathogens and thus there will continue to be a need for laboratory-developed tests.