Molecular Quality Controls

Resources

Accreditation Requirements Emphasize Use of Independent Quality Controls

Regulation Subsection Quote
CAP Microbiology Checklist
2015
MIC.63262
Daily QC - Molecular-based Testing
Controls are run at least daily, or more frequently if specified in manufacturer's instructions, laboratory procedure, or the CAP Checklist, for molecular-based quantitative and qualitative tests.
CAP Microbiology Checklist
2015
Quality Control Introduction
page 80
Qualitative molecular tests typically include positive and negative controls and, in some instances, a sensitivity control to show that low level target is detectable.
EP12-A2 Vol. 28 No.3 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline 2nd Edition (3/3/2008) 7.1 Controls Appropriate QC materials are required to ensure consistent candidate method performance ... For many qualitative tests, the daily use of a negative and positive control is sufficient, while some qualitative candidate methods may require more frequent testing on controls.

Some qualitative tests produce numerical results that can be monitored like quantitative method controls to assess test performance.
CLSI. Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions. 3rd ed. C24. Approved Guidelines; 2006. 9 Interlaboratory QC Programs Participation in an interlaboratory program provides an effective mechanism to complement external quality assessment (proficiency survey) programs. Consequently, a laboratory should actively participate in interlaboratory QC programs when such programs are available.
CAP Molecular Pathology Checklist
2015
MOL.34024
Calibrator Preparation
Calibrators and controls are prepared separately.
CLSI. Molecular Diagnostic Methods for Infectious Diseases. 3rd ed. CLSI report MM03. Wayne, PA: Clinical and Laboratory Standards Institute; 2015 8.4 Control Materials Throughout the development, optimization, production, and implementation phases, stable QC materials are essential for functional assessment of each components and the total system.

Known positive and negative control specimens are needed for developing and optimizing new or modified methods to be used as, or in, clinical laboratory test systems.
... ... ...
CAP Molecular Pathology Checklist
2015
MOL.34516
Qualitative Cut-Off
For qualitative tests that use a cut-off value to distinguish positive from negative, the cut-off value is established initially, and verified with every change in lot or at least every six months.
CLSI. Molecular Diagnostic Methods for Infectious Diseases. 3rd ed. CLSI report MM03. Wayne, PA: Clinical and Laboratory Standards Institute; 2015. 8.8 Quality Assurance for Implementation of Molecular Diagnostic Tests In the United States, the Centers for Medicare & Medicaid Services requires that the following be performed at least one time on each day that patient specimens are assayed or examined:
•For each qualitative procedure, include a negative and positive control material.
•For each test system that has an extraction phase, include two control materials, including one that is capable of detecting errors in the extraction process
CLSI. Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions. 3rd ed. C24. Approved Guidelines; 2006. 6.2.1 Relation to Calibrators 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.
CLSI. Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions. 3rd ed. C24. Approved Guidelines; 2006. Abstract
Page i
… this guideline is intended for use by a healthcare laboratory to provide a QC procedure that employs control materials that are independent and external to a reagent kit, an instrument, or analytical system.
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