NEW YORK – Seeking to head off any potential confusion over recommendations issued by other organizations, the American Association for Clinical Chemistry issued new guidance on Monday for the detection of cervical cancer.
The guidance aims to address the "nuanced differences" among three recommendations previously issued by other organizations that may make it difficult for clinicians and labs to determine how best to update their cervical cancer detection strategies, AACC said in a statement.
Titled "Cervical Cancer Detection: Screening, Surveillance, and Diagnosis," the guidance aims to update healthcare and laboratory medicine professionals on the latest advancements, and help them select the most effective cervical cancer detection strategy for their patients, it added.
The guidance also specifically addresses molecular testing for human papillomavirus and the use of self-collected samples, and it provides a laboratory report template to facilitate interpretation of results and clinical decision-making.
The AACC document provides a comparison of three other guidance documents used in clinical practice. These are screening recommendations issued by the US Preventive Services Task Force (USPSTF) in 2018 and by the American Cancer Society (ACS) in 2020, as well as 2019 guidance on histopathology from the American Society for Colposcopy and Cervical Pathology (ASCCP).
AACC noted that there are no randomized trials comparing mortality rates among the screening strategies recommended by these organizations.
"This means that certain decisions about cervical cancer screening should be based on informed discussions with the patient, while other decisions can be made based on what works best for an institution," AACC said.
For example, the use of HPV testing alone for screening — also called primary HPV screening — performs similarly to a co-testing approach using molecular testing and cytology, and it has a lower cost, according to AACC.
"This means that institutions can screen with HPV testing alone if they have an HPV test that is FDA-approved for primary screening, while institutions with one of the other HPV tests can continue to use co-testing," AACC said.
The guidance offers a triage algorithm based on the other organizations' guidance documents. And, it "addresses key questions related to cervical cancer screening and management and introduces the most recently updated screening guidelines, risk-based management for screening and surveillance, as well as methodologies for the diagnosis of cervical cancer," the authors said.
The AACC guidance highlights the two molecular tests cleared by the US Food and Drug Administration for primary HPV screening. These are the Cobas HPV Assay from Roche Molecular Systems, and the BD Onclarity HPV Assay from Becton Dickinson.
In addition, it also highlights three other assays that are approved for reflex testing and co-testing approaches when used in conjunction with cytology. These are the Digene HC2 High-Risk HPV DNA Test from Qiagen, as well as the Cervista HPV HR Assay and Aptima HPV Assay from Hologic.
Regarding self-collected vaginal samples for HPV testing, AACC summarized the literature supporting the method and said that this approach could improve cervical cancer screening in some populations. However, it also noted that self-sampling is not widely used in the US and that the FDA has not yet approved any self-collection methods.
Finally, the guidance also provides an "ideal lab report" template for HPV and cervical cancer testing that is designed to help clinicians quickly review results and make care decisions, AACC said.
Overall, "this guidance document will help clinical laboratorians and clinicians utilize the most recent guidelines for cervical cancer screening, surveillance, and diagnosis," AACC said.