Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System
U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of In Vitro Diagnostic Device Evaluation and Safety Division of Immunology and Hematology Devices
Food and Drug Administration
Center for Devices and Radiological Health
Office of In Vitro Diagnostic Device Evaluation and Safety
Division of Immunology and Hematology Devices
- ACOG Practice Bulletin No. 83: Management of Adnexal Masses. Obstetrics & Gynecology. 110(1):201-214, July 2007.
- Kondratovich M., Yousef WA. Evaluation of accuracy and optimal cutoff of diagnostic devices in the same study. Joint Statistical Meeting. 2005. ASA Section on Statistics in Epidemiology; p.2547-2551.
- Gostout BS, Brewer MA. Guidelines for Referral of the Patient with an Adnexal Mass. 2006. Clinical Obstetrics and Gynecology 49(3): 448-459.
3 Biggerstaff, B.J. Comparing diagnostic tests: a simple graphic using likelihood ratios. Statistics in Medicine 2000, 19: 649-663.
4 PPV depends on a positive likelihood ratio (PLR) and prevalence of malignancy, and NPV depends on negative likelihood ratio (NLR) and prevalence. For a comparison of two tests within the same population, comparison of PPV and NPV is equivalent to comparison of PLR and NLR.