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The need for controls…
Is your lab achieving consistent, reliable results? IVD Research, Inc. offers an extensive line of external controls and quality control (QC) panels to help aid in tracking the reliability of an assay. External controls and quality control panels are used in clinical laboratories to monitor processes to assure test systems are performing according to the manufacturer’s specifications. The use of these controls complies with the requirements of Good Laboratory Practice (GLP), CLIA and various regulatory agencies overseeing the operations of clinical laboratories. Our products can provide you with an in-house method of evaluation to ensure your lab is achieving consistent, reliable results.
Frequently Asked Questions
Who uses external controls and QC panels?
Any clinical lab which uses immunodiagnostic assays to evaluate the presence of analyte specific antigens or antibodies.
When should external controls and QC panels be used?
External controls and QC panels should be used during clinical study site qualifications, product development and manufacturing, new product or testing method introductions and evaluations as well as while participating in proficiency test programs.
What is the difference between external controls and QC panels?
The QC panel is an expansion of the external controls and is therefore most widely used to validate new test methods or to evaluate a new lot of an assay. External controls are typically included during each run of an assay to aid in tracking drift and run-to-run variation.
How are external controls and QC panels stored?
Most external controls and QC panels offered by IVD Research, Inc. requires storage at ≤-15 ºC.
Material List
External controls are sold as single vials and contain 1.5ml of prediluted, ready to use material. In some cases, external controls are provided at 0.5ml of undiluted material.
QC panels are sold as a set and contain 10 vials, each containing 0.5ml of undiluted material. Within each set are varying degrees of reactive (positive) specimens as well as a non-reactive (negative) specimen.
