Module CC-04 · Version 1.0
Sensitivity, Specificity, and Specimen Interference
A method's ability to detect a measurand and a test's ability to diagnose a condition are two different questions, and a flagged or unflagged specimen does not settle either one by itself. Limit of blank, limit of detection, and limit of quantitation differ from diagnostic sensitivity, specificity, and predictive value. Hemolysis, biotin, and heterophile antibody interference can require a defensible next step for a discordant result.
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Who this module is for
MLS and MLT students transitioning to bench practice, and new bench technologists who need a shared vocabulary for analytical versus diagnostic performance and specimen interference.
Learning objectives
- Distinguish analytical sensitivity and selectivity from diagnostic sensitivity and specificity
- Recognize interference as a method-specific effect rather than a property of the patient alone
- Select an appropriate verification step when hemolysis, icterus, lipemia, biotin, heterophile antibodies, or another interferent is suspected
How completion works
Mark every required section done and answer every knowledge check in those sections correctly. The final save completes the module automatically.
Sources
12 sources
1. 42 CFR 493.1252, Standard: Test systems, equipment, instruments, reagents, materials, and supplies, and 42 CFR 493.1253, Establishment and verification of performance specifications, Code of Federal Regulations, Title 42, Part 493, Subpart K.
Source note · federal regulation
2. CLSI EP07, Interference Testing in Clinical Chemistry, current edition, Clinical and Laboratory Standards Institute.
Source note · consensus standard
3. CLSI EP17, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, current edition, Clinical and Laboratory Standards Institute.
Source note · consensus standard
4. CLSI EP37, Supplemental Tables for Interference Testing in Clinical Chemistry, current edition, Clinical and Laboratory Standards Institute.
Source note · consensus standard
5. CLSI C56, Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis, current edition, Clinical and Laboratory Standards Institute.
Source note · consensus standard
6. CLSI Harmonized Terminology Database, entries for analytical specificity, selectivity, and cross-reactivity, Clinical and Laboratory Standards Institute.
Source note · consensus standard
7. U.S. Food and Drug Administration, Testing for Biotin Interference in In Vitro Diagnostic Devices, Guidance for Industry, October 2020.
Source note · federal regulation
8. U.S. Food and Drug Administration, Biotin Interference with Troponin Lab Tests, In Vitro Diagnostics safety communication.
Source note · federal regulation
9. U.S. Food and Drug Administration, 510(k) premarket notification decision summaries documenting high-dose hook effect and heterophile/endogenous antibody interference study design for cleared immunoassays.
Source note · manufacturer labeling
10. Sensitivity, Specificity, and Predictive Value, in Clinical Methods: The History, Physical, and Laboratory Examinations, 3rd edition, NCBI Bookshelf.
Source note · peer-reviewed literature
11. Performance Measures, in Assessment of Cancer Screening: A Primer, NCBI Bookshelf.
Source note · peer-reviewed literature
12. Peer-reviewed comparative studies establishing hemolysis, icterus, and lipemia interference thresholds across clinical chemistry analyzer platforms, including studies of thresholds for 35 chemistry assays and body-fluid analyte panels on differing analyzer systems.
Source note · peer-reviewed literature