12.2.1.2. Experimental specificity

The specificity of the PCR assay is then tested experimentally, using inclusivity and exclusivity tests.

  • Inclusivity tests
    Inclusivity tests assess the robustness of an assay, i.e. its ability to detect genetically diverse isolates. The PCR assay is evaluated against a panel of samples representing the full range of genetic diversity of the virus in question. This diversity is determined beforehand through phylogenetic analysis of bio-geographic isolates (see section 12.2.1.1.).
  • Exclusivity tests
    Exclusivity tests assess the specificity of an assay, i.e. its ability to detect only the virus in question, and not any other viruses. The PCR assay is evaluated against a panel of viruses unrelated to the virus being tested, but which are found in the same environment or ecological area as the virus being tested.