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===Broad feature set of a pathology information management solution=== | |||
* automated reflex testing: | |||
* adjunctive testing: Adjunctive testing is testing "that provides information that adds to or helps interpret the results of other tests, and provides information useful for risk assessment."<ref name="SegensAdjunct11">{{cite web |url=https://medical-dictionary.thefreedictionary.com/adjunct+test |title=adjunct test |work=Segen's Medical Dictionary |date=2011 |accessdate=05 September 2020}}</ref> A common adjunctive test performed in [[cytopathology]] is HPV testing.<ref name="FDANewApproaches19">{{cite web |url=https://www.fda.gov/media/122799/download |title=New Approaches in the Evaluation for High-Risk Human Papillomavirus Nucleic Acid Detection Devices |author=U.S. Food and Drug Administration |publisher=U.S. Food and Drug Administration |date=08 March 2019 |accessdate=05 September 2020}}</ref><ref name="StolerAdjunctive15">{{cite book |chapter=Chapter 9: Adjunctive Testing |title=The Bethesda System for Reporting Cervical Cytology |author=Stoler, M.H.; Raab, S.S.; Wilbur, D.C. |editor=Nayar, R.; Wilbur, D. |publisher=Springer |pages=287–94 |year=2015 |doi=10.1007/978-3-319-11074-5_9 |isbn=9783319110745}}</ref> The FDA described this as such in 2003, specifically in regards to expanding the use of the Digene HC2 assay as an adjunct to cytology<ref name="FDANewApproaches19" />: | |||
<blockquote>In women 30 years and older, the HC2 High-Risk HPV DNA test can be used with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.</blockquote> | |||
Some vendors of pathology information management solutions allow users to manually add an adjunctive test to a primary pathology test, or in some cases this may be enabled as part of an automated reflex testing process. However, ensure that any such solution is capable of feeding any adjunctive test results into the final report, along with the results from the primary tests. Using adjunctive HPV test results as an example, the report should optimally include details such as assay name, manufacturer, the HPV types it covers, results, and any applicable educational notes and suggestions.<ref name="StolerAdjunctive15" /> | |||
Revision as of 14:35, 5 September 2020
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Sandbox begins below
Broad feature set of a pathology information management solution
- automated reflex testing:
- adjunctive testing: Adjunctive testing is testing "that provides information that adds to or helps interpret the results of other tests, and provides information useful for risk assessment."[1] A common adjunctive test performed in cytopathology is HPV testing.[2][3] The FDA described this as such in 2003, specifically in regards to expanding the use of the Digene HC2 assay as an adjunct to cytology[2]:
In women 30 years and older, the HC2 High-Risk HPV DNA test can be used with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
Some vendors of pathology information management solutions allow users to manually add an adjunctive test to a primary pathology test, or in some cases this may be enabled as part of an automated reflex testing process. However, ensure that any such solution is capable of feeding any adjunctive test results into the final report, along with the results from the primary tests. Using adjunctive HPV test results as an example, the report should optimally include details such as assay name, manufacturer, the HPV types it covers, results, and any applicable educational notes and suggestions.[3]
- ↑ "adjunct test". Segen's Medical Dictionary. 2011. https://medical-dictionary.thefreedictionary.com/adjunct+test. Retrieved 05 September 2020.
- ↑ 2.0 2.1 U.S. Food and Drug Administration (8 March 2019). "New Approaches in the Evaluation for High-Risk Human Papillomavirus Nucleic Acid Detection Devices". U.S. Food and Drug Administration. https://www.fda.gov/media/122799/download. Retrieved 05 September 2020.
- ↑ 3.0 3.1 Stoler, M.H.; Raab, S.S.; Wilbur, D.C. (2015). "Chapter 9: Adjunctive Testing". In Nayar, R.; Wilbur, D.. The Bethesda System for Reporting Cervical Cytology. Springer. pp. 287–94. doi:10.1007/978-3-319-11074-5_9. ISBN 9783319110745.
