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Evaluation Process:

If evaluations are to be performed a process must be followed.

Information on the kit or assay can be obtained from the manufacturer. Manufacturers usually have a large amount of information available. While this information is confidential and will not be shared with all laboratories if a regulatory process is in place, the information will be made available to the reference laboratory.

  • Examination of this information may save performing a full evaluation.
  • If a full evaluation is to proceed a protocol will need to be written.
  • The protocol must include how many samples will be examined and a calculation to verify that the evaluation will be statistically valid.
  • An evaluation panel is selected. Suitable samples to form the evaluation panel are assembled. Appropriate documentation is carried out.

    Performing the testing

  • This may be conducted at a single centre or by multiple sites.
  • The data should be assembled carefully and checked carefully.
  • The testing should all include the use of QC samples. This is particularly important if multiple laboratories are performing the testing. A QC sample will assure that the inter laboratory variability can be assessed.