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.