For in vitro diagnostic use. Rx Only
simpli-COLLECT™ HPV Collection
Study demonstrated that simpli-COLLECT™ HPV Collection Kit is easy to use, and the instructions are easy to follow.³
Study Participants
21 participants from four geographically distinct sites in the U.S.
simpli-COLLECT™ HPV Collection Kit User Rating
Test Information:
- Test code: M525-4
- Test name: Alinity simpli-COLLECT HPV EXTENDED GENOTYPE (Self Collect)
- Specimen Requirement: simpli-COLLECT HPV Collection Kit
simpli-COLLECT™ HPV Collection Kit Intended Use⁴
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
FOR IN VITRO DIAGNOSTIC USE
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
*Study evaluated cellular material lost in liquid-based cervical cytology samples
References
- Perspectives of Human Papillomavirus Self‑Sampling for Cervical Cancer Screenings and Opportunities for Education, Journal of Cancer Education, January 2025.
- simpli-COLLECT HPV Collection Kit package insert, 53-608542/R1.
- Abbott data on file.
- Alinity m HR HPV Assay package insert, 53-608175/R2.
