Centers for Disease Control and Prevention. Clinical Laboratory Improvement Amendments (CLIA). Available at:
http://wwwn.cdc.gov/clia/. CDC web page - last reviewed on January 16, 2024. Accessed February 20, 2024.
Clinical and Laboratory Standards Institute (CLSI). Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. 3rd ed. CLSI document EP5-A3 CLSI; 2014. (Revised October 2018.)
Clinical and Laboratory Standards Institute (CLSI). Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline. 4th ed. CLSI document C24. CLSI; 2016. (Revised February 2017.)
Clinical and Laboratory Standards Institute (CLSI). User Verification of Precision and Estimation of Bias; Approved Guideline. 3rd ed. CLSI document EP15-A3. CLSI; 2014. (Revised November 2022.)
McPherson RA, Pincus MR, eds. Henry's Clinical Diagnosis and Management by Laboratory Methods. 24th ed. Elsevier; 2021.
Monaghan TF, Rahman SN, Agudelo CW, et al. Foundational statistical principles in medical research: Sensitivity, specificity, positive predictive value, and negative predictive value. Medicina (Kaunas). 2021;57(5):503. Published 2021 May 16. doi:10.3390/medicina57050503
Rifai N, Chiu RWK, Young I, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 9th ed. Elsevier; 2023.
Shreffler J, Huecker MR.
Diagnostic Testing Accuracy: Sensitivity, Specificity, Predictive Values and Likelihood Ratios. [Updated 2023 Mar 6]. Online; In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK557491/Trull YL, Rogers MW, Levtzow CB, Henderson MPA, McCudden CR, Willis MS. Quality management in the clinical laboratory - Method evaluation. In: Bishop ML, Fody EP, Van Siclen C, Mistler JM, Moy M, eds. Clinical Chemistry Principles, Procedures, Correlations. 9th ed. Jones & Bartlett Learning; 2022: Chapter 3.
Turgeon ML. Clinical Laboratory Science. 9th ed. Elsevier; 2022.
Westgard JO. Basic QC Practices. 4th ed. Madison, WI: Westgard QC, Inc; 2016.
World Health Organization (WHO). Laboratory Quality Management Handbook. CDC and CLSI; 2011.