Overview
Starting with the controls means confirming that required run and specimen controls meet the assay's pass criteria before interpreting or releasing patient molecular results.
Classification
| Control type | Protects against |
|---|---|
| Positive control | Failed detection / false negatives from assay failure |
| Negative / no-template | Contamination / false positives |
| Internal / process | Inhibition, extraction, or process failure |
Morphologic Features
Not applicable, this entry covers molecular interpretation workflow, not morphologic identification.
Laboratory Characteristics
- Control criteria are assay- and SOP-defined
- Instrument green status does not replace control review
- Ct/Cq on an invalid run is not a clinical answer
Reference Intervals
Not applicable as a numeric interval. Pass/fail thresholds for controls are defined by the validated assay procedure.
Clinical and Laboratory Significance
Control-first review is the gate that protects both detected and not-detected reports. Without valid controls, patient amplification patterns must not be released as clinical results.
Differential Considerations
Before reading patient targets, exclude failed positive, negative, or internal controls; unacceptable specimens; and incomplete runs. Do not salvage an invalid run by informal judgment.
Comparison Tables
Controls-first checkpoints
| Statement | Safe understanding | Unsafe shortcut |
|---|---|---|
| Strong patient curve | Still requires passed controls | Release despite failed controls |
| Blank patient target + failed IC | May be invalid/inhibited, follow SOP | Report as negative |
| Review order | Specimen → controls → targets | Targets first, controls later |
Classification Frameworks
Not applicable . World Health Organization (WHO) disease classifications do not define molecular control-review workflow.
Laboratory Notes
- Always start with specimen acceptability and control validity
- Failed controls → hold and follow procedure
- Invalid ≠ negative
References
Authoritative textbooks, guidelines, and reviews supporting this reference entry. Verify reference intervals, critical limits, and reflex criteria against institutional protocols and current guideline editions.
Textbooks
- McPherson RA, Pincus MR. Henry's Clinical Diagnosis and Management by Laboratory Methods. 24th ed. Elsevier; 2021. (Molecular diagnostics chapters, verify current edition.)
- Buckingham L. Molecular Diagnostics: Fundamentals, Methods, and Clinical Applications. 3rd ed. F.A. Davis; 2019. (Verify current edition.)
CLSI and Professional Guidelines
- Clinical and Laboratory Standards Institute (CLSI). Consult current CLSI molecular method documents available through your laboratory, document numbers and editions change; do not treat any single CLSI title as universal.
- Institutional molecular laboratory SOPs, assay manufacturer instructions for use (IFU), and locally adopted accreditation requirements. Always verify current local practice.
Frequently Asked Questions
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