Article

Sample Collection for Cervical Cancer Screening programs

Cervical cancer screening programs can help to eliminate cervical cancer

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.
 

Roche Cell Collection Medium with Brush
Roche Cell Collection Medium with Brush
HPV self-sampling – a new bridge to connect women to life-saving screening programs

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.

Roche Cell Collection Medium, a proven choice for sample storage, transportation and processing
 
  • The Roche Cell Collection Medium, together with the  cobas® 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® 6800/8800 Systems and  cobas® 4800 System.

  • With the  cobas® 4800 System, 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.

Roche Cell Collection Medium - Intended Use
Roche Cell Collection Medium is designed for the preservation and transport of cells to be used in molecular testing and/or for the preparation of cytology slides.
Roche Cell Collection Medium with Brush
Systems Compatibility

Roche Cell Collection Medium can be used with the following Roche systems & Assays according to the Roche product Instructions for Use and the Roche Operator’s Manual or User Guide.

  • cobas® HPV test

  • cobas® 4800 System

  • cobas® 6800/8800 Systems

  • cobas p 480 instrument

  • cobas® prime Pre-analytical System

  • CINtec® PLUS Cytology test
  • Pap Cytology

Additionally, cellular specimens collected in Roche Cell Collection Medium can be processed for cytology using:

  • Hologic ThinPrep® T2000 system

  • Hologic ThinPrep® T5000 system

cobas prime Pre-analytical System
Addressing the need for automated, pre-analytic sample processing

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.

Compatibility: cobas® HPV Test for use on the cobas® 6800/8800 Systems

View Full Table

Compatibility: cobas® HPV Test for use on the cobas® 6800/8800 Systems

  CE-IVD U.S.
  ThinPrep
PreservCyt®†
Solution
Roche Cell
Collection
Medium
SurePath
Preservative
Fluid
ThinPrep
PreservCyt®†
Solution
 Roche Cell
Collection
Medium
SurePath
Preservative
Fluid
ASC-US triage - -
Co-testing (Pap Cytology with HPV testing) - -
Primary HPV Screening - -
CINtec® PLUS Cytology - -

Compatibility: cobas® HPV Test on cobas® 4800 System

View Full Table

Compatibility: cobas® HPV Test on cobas® 4800 System

  CE-IVD U.S.
  ThinPrep
PreservCyt®†
Solution
Roche Cell
Collection
Medium
SurePath
Preservative
Fluid
ThinPrep
PreservCyt®†
Solution
 Roche Cell
Collection
Medium
SurePath
Preservative
Fluid
ASC-US triage -
Co-testing (Pap Cytology with HPV testing) -
Primary HPV Screening -
CINtec® PLUS Cytology - -

Ordering Information

View Full Table

Ordering Information

Material Number

Product name1

Package size

08779040190 Cervical Collection Brush (sterile & single packed) 100 brushes
08399832190 Cervical Collection Brush (bulk) 500 brushes
09032932190 Copan FLOQSwabs® for vaginal self-collection, 552C.801,2 600 swabs
07994745190 Roche Cell Collection Medium 20 ml Vial 250 vials
07994753190 Roche Cell Collection Medium 945 ml Bottle (bulk solution) 4 bottles
07994788190 Dispenser for 945 ml Bottle 1 piece
06913512001 42mm Replacement Cap (automated, cobas® p 480 instrument) 384 pieces / blister pack
08037230190 42mm Replacement Cap (manual/loose, grey cap) 250 pieces / bag
  1. Not all products or accessories are available in all countries.
  2. Used for vaginal self-collection