Identify Appropriate QC Materials

CLSI (C24-A3, Section 6.2) suggests the following considerations when selecting control materials:

• The control material should share common characteristics with the intended patient sample types.
• To minimize the amount of testing required when a lot change occurs the laboratory should purchase a large enough volume of control materials. If practical, at least a one year supply is recommended.
• Upon opening, the control material should demonstrate stability over the claimed shelf life.
• The vial to vial variance should be much less than the expected variance of the procedure being tested.
• To verify proper performance over the measuring range, the control material should consist of a sufficient number of levels and concentrations.

Note: Local government regulations might specify a minimum number of control levels for particular testing protocols

• The control material should contain the analyte to be tested in concentrations at the clinically relevant levels that might be seen in patient samples.