Sample Collection for Cervical Cancer Screening programs

Cervical cancer, although nearly 100% preventable, remains one of the most common cancers and causes of cancer-related deaths in women across the globe – especially in low-and middle-income countries. 

Over the years, the world has experienced a transition from conventional or liquid based cytology based screening programs to a molecular based screening program also known as primary HPV screening. This new screening method improves existing or newly implemented screening programs with a more sensitive way of testing and therefore identifies women earlier who may have an increased risk of developing cervical cancer. 

However, the majority of cervical cancer cases are found in women who are unscreened or underscreened. There are many reasons women cannot or do not participate in a cervical cancer screening program – and Roche is addressing some of these barriers by expanding its portfolio offering to include a claim for self-sampling.
 

HPV Self Sampling provides women around the world an opportunity to participate in screening programs by collecting their own specimens, following detailed collection instructions provided by a healthcare worker. Depending on local regulations, this may require for example a visit to a local clinic or a healthcare worker visiting remote areas where they explains the self-sampling procedure.

Despite their geographic location or their access to screening programs, some women are more likely to participate in HPV screening when given the option to collect their sample in a private setting. 

With this claim extension we are now able to reach these women and provide an alternative solution to clinicians collected a women’s specimen.

Roche Cell Collection Medium

The Roche Cervical Cancer Portfolio performs with multiple media types, including Roche Cell Collection Medium. Roche Cell Collection Medium is a liquid-based cytology collection solution that provides long-term stability for cervical specimens including vaginal specimens that are collected via self-collection. It is designed for the preservation and transport of cells to be used in molecular testing and/or the preparation of cytology slides, supporting the entire cervical cancer screening workflow.

Please check with your local Roche representative about product availability in your area; some products may not be available in all countries.

• The Roche Cell Collection Medium, together with the cobas^® 5800/6800/8800 Systems and cobas^® 4800 System, increases lab efficiency while minimizing human error, contamination, and process time of samples.

• Provides flexibility to screen and triage when using cobas^® HPV test and CINtec^® PLUS Cytology.

• Validated for use with the fully automated cobas^® 5800/6800/8800 Systems and cobas^® 4800 System.

• With the cobas^® 4800 & 5800 Systems, samples can be processed directly from the Roche Cell Collection Medium vials.

• Each stabilised sample vial contains 20 ml volume to perform multiple tests.

• The Roche Cell Collection Medium is validated for suspension of vagina self-collected specimens, but has not been validated for cytology assessment with vaginal self-collected specimens.

For automated processing of cervical samples to prepare them for analysis, cobas^® HPV tests are compatible with workflow options on the cobas p 480 instrument, and cobas^® prime Pre-analytical System.

The cobas^® prime Pre-analytical System is is the first and only solution capable of automatically preparing the variety and volume of samples received for molecular diagnostic testing. The fully automated system consolidates, integrates and standardizes the pre-analytical process to streamline and simplify lab operations. cobas^® prime is designed to automate all common pre-analytical steps, including vortexing, decapping, aliquoting, barcode labeling, reagent addition and heating. The complete end-to-end pre-analytical solution also features cross-contamination control of molecular samples, including samples from women's health, microbiology and virology disease areas for use in diagnostic testing. The system features track-connectable modular configurations with one workflow for multiple sample types, end-to-end automation with predictable lab turnaround time, and IT integration with sample and test tracking.

The features for cobas^® prime Pre-analytical System bring tremendous value to labs by providing an innovative, high-throughput option for testing consolidation and efficiency. This is especially important in HPV testing and screening applications that involve complex sample preparation workflows.

The cobas^® prime Pre-analytical System is now commercially available in the United States and markets accepting the CE mark.