INTRODUCTION

Controls are used in all clinical laboratories to monitor the analytical process and to assure that the test reagents and systems are performing according to the specifications of the manufacturers of those test reagents and systems. The use of controls complies with the requirements of Good Laboratory Practice (GLP), the CLIA, and the various regulatory agencies overseeing the operation of clinical laboratories.

The initial question regarding controls, therefore, is no longer whether to use them, but which type to choose. The traditional option has been to select from the various off the shelf controls to find the one that best fits the overall needs of the laboratory. This option meets some requirements while other requirements are left unaddressed. The possibility of having a control customized to fit the individual needs of the laboratory has not been an option in the past. Scantibodies Laboratory, Inc. now offers this option.

IN THIS BRIEF...

• The need for controls
• Limitations of typical general purpose controls
• Limitations of kit controls
• Limitations of pooled patient serum for controls
• The function of controls
• What are custom controls?
• Who is a potential candidate for custom controls?
• Why should one buy a custom control?
• Possible analytes in custom controls
• Product configuration
• Packaging configuration
• Testing performance on custom controls
• Summary