simpli-COLLECT™ HPV COLLECTION KIT
Empowering women, Optimizing Lab workflow
For in vitro diagnostic use. Rx only.
How can your solution help without adding complexity to clinical workflows?
simpli-COLLECT HPV Collection Kit by Abbott is a clinically validated, FDA-approved self-collection kit for HR HPV testing that enables women to collect their own vaginal sample in a clinical setting, and is compatible with the Alinity m HR HPV assay. As self-collection becomes increasingly supported by evolving clinical guidelines, simpli-COLLECT helps expand access to personalized cervical cancer screening and advance the future of preventive women’s health.
EACH KIT CONTAINS
- One Alinity m sample tube
- One specimen collection swab
simpli-COLLECT HPV Collection Kit tested for ease of use
External human factors study demonstrated that simpli-COLLECT HPV Collection Kit is easy to use, and the instructions are easy to follow.
Study participants
21 participants from four geographically distinct sites in the U.S.
*The critical task success rate is generated from a separate CE human factors study using the same product; Abbott data on file.
How simpli-COLLECT Supports patients, clinicians, and labs
Clinically validated for sample stability with zero physician assistance
- Zero hands-on time required by physicians to prepare a self-collected sample
- Dry swab minimizes risk of contamination or spillage during transport to lab
Streamlined operational workflow for laboratories
- Fully automated pre-analytics with Alinity mp and easy transfer to Alinity m
- Single tube for both collection and processing helps minimize waste and human error
Supports broader access to testing while meeting evolving guidelines
- Self-collection in a doctor’s office broadens access to care for women by making sample collection more convenient and less intimidating
- Extended genotype reporting with our assay delivers evidence-based risk stratification, enhancing patient management practices
Confidence in results
- Clinical data demonstrate comparable sensitivity and specificity between vaginal and cervical samples
- Human factors study demonstrated >97% patients found instructions easy to follow
- Built-in cellular control of our assay ensures sample adequacy—especially important for self-collection
Self-collection aligns with evolving clinical guidelines
USPSTF
In Dec 2024, the U.S. Preventive Service Task Force (USPSTF) released a draft update to its cervical cancer screening recommendations. For the first-time, self-collected HPV samples—when collected in clinical settings—were recognized as an acceptable screening option.2
ASCCP
In Feb 2025, under the Enduring Guidelines framework, the American Society for Colposcopy and Cervical Pathology (ASCCP) released the first major clinical guidance supporting the use of self-collected vaginal samples for HPV testing.3
How simpli-collect™ optimizes your workflow
*Upgrade kit (LN 09N65-007) required for Alinity mp to process dry swabs using the simpli-COLLECT HPV Collection Kit. The manual process is to uncap the sample tube, resuspend the sample with 2.5 mL Alinity m Specimen Buffer Kit II, and recap the sample tube. After vortexing, place on Alinity m for sample processing with the Alinity m HR HPV assay.
EXPANDING CHOICE IN SELF-COLLECTION
Rovers Evalyn® Brush is an alternative FDA-approved self-collection device compatible with the Alinity m HR HPV assay, providing flexible options for personalized care.
INTENDED USE
The simpli-COLLECT HPV Collection Kit is intended for the self-collection and transportation of vaginal swab specimens for testing with the Alinity m HR HPV assay.
Refer to the Alinity m HR HPV assay package insert for additional information.
The simpli-COLLECT HPV Collection Kit is not intended for home use.
LIMITATIONS OF THE PROCEDURE
- Optimal performance of this kit requires appropriate specimen collection, handling, preparation, and storage (refer to the Specimen Collection Procedures and Appendix A sections of the package insert).
- This kit should only be used to self-collect vaginal swab specimens. Refer to the Alinity m HR HPV assay package insert for more information.
- The self-collected vaginal swab specimen application is limited to health care facilities where support and counseling is available to explain the procedures and precautions.
- Pregnant women should not use the simpli-COLLECT HPV Collection Kit.
WARNINGS AND PRECAUTIONS
- Follow all instructions in the simpli-COLLECT HPV Collection Kit package insert.
- Warnings and precautions for the Alinity m HR HPV Assay are provided in the Alinity m HR HPV AMP Kit package insert.
LEARN MORE ABOUT ABBOTT MOLECULAR’S SIMPLI-COLLECT HPV COLLECTION KIT
Talk to your Molecular sales representative to learn more.
Explore
Alinity m HR HPV assay
View the Alinity m HR HPV assay page to learn more about our end-to-end HPV testing portoflio.
Alinity mp
See how this pre-analytical system can help you automate tedious tasks for your HPV workflow.
Alinity m
Learn more about the Alinity m analyzer and how it can help transform your molecular lab to achieve measurably better healthcare performance.
REFERENCES
- National Cancer Institute Cancer Trends Progress Report. Cervical Cancer Screening. https://progressreport.cancer.gov/detection/cervical_cancer. Accessed Sep 2025,
- U.S. Preventive Task Force, Cervical Cancer Screening Draft Recommendation.
- American Society for Colposcopy and Cervical Pathology. New Guidelines Released for Self-Collected HPV Screening. Press release, February 21, 2025