Unassayed control reagents for in vitro molecular diagnostic assays.
Used to monitor assay or device performance and functionality as well as identify deviations from the desired performance.
For Research Use Only. Not for use in diagnostic procedures.
RED Controls stands for:
Real. Contain whole inactivated pathogen that monitors the total process of extraction, amplification and detection. They are tested in the same manner as a real patient sample.
Economical. Ready to use liquid controls that are stored at 2-8 C and have a 2 year expiry. Multi pathogen configurations reduce the number of QC tests performed. Simply test a single use vial as you would a patient sample. No need to thaw or reconstitute.
Diagnostic. Whether you perform a lab developed test or a licensed commercial assay, the repetitive use of a 3rd party control provides an unbiased assessment of the performance of the testing process and confidence in your results.
The use of 3rd party controls help to meet the requirements and recommendations of laboratory accreditation standards.
ISO 15189:2012 Medical Laboratories – Requirements for quality and competence
ISO 15189 220.127.116.11, Note 2
“Use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.”
CLSI C24-A3, Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition, 6.2.1 “. . . quality control materials should be different from the calibrator materials to ensure that the QC procedure provides an independent assessment of the measurement procedure’s performance in its entirety, including the procedure for calibration of the measurement.”