simpli-COLLECT™ HPV COLLECTION KIT
Empowering women, Optimizing Lab workflow
For in vitro diagnostic use.
How can our solution help without adding complexity to laboratory workflows?
simpli-COLLECT HPV is a clinically validated, CE-marked dry swab for HPV testing that enables women to collect their own vaginal sample at home or 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 PERFORMS COMPARABLE TO CLINICIAN-COLLECTED SAMPLE
Overall percentage agreement between clinician-collected cervical sample and self-collected vaginal samples using simpli-COLLECT: 90.4%
AGREEMENT BETWEEN SELF-COLLECTED VAGINAL SPECIMENS USING SIMPLI-COLLECT AND CLINICIAN-COLLECTED CERVICAL SPECIMENS
How simpli-COLLECT Supports patients, clinicians, and labs
SUPPORTS BROADER ACCESS TO CERVICAL SCREENING AND EXTENDED HPV GENOTYPING
- Self-collection at home or in a doctor's office broadens access to care for women by making sample collection more convenient and less intimidating
- In combination with the Alinity m HR HPV assay, it provides access to extended genotyping, enhancing patient management practices
Confidence in results
- Clinical data demonstrate comparable sensitivity and specificity between vaginal self-collected and cervical clinician-collected samples
- Built-in cellular control of our assay ensures sample adequacy—especially important for self-collection
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
Validated for Sample Stability
- Stable performance under varying external conditions*
- Dry swab minimizes risk of contamination or spillage during transport to lab
*Abbott data on file
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 in Alinity m Specimen Buffer Kit II, and recap 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 CE-Marked self-collection device compatible with the Alinity m HR HPV assay, providing flexible options for personalized care.
AGREEMENT BETWEEN SELF-COLLECTED VAGINAL SPECIMENS USING EVALYN BRUSH AND CLINICIAN-COLLECTED CERVICAL SPECIMENS
INTENDED USE
The simpli-Collect HPV Collection Kit is intended for the self-collection and transport of vaginal swab specimens for testing with the Alinity m HR HPV assay. Swab specimens may be collected and prepared for transport in a healthcare or non-healthcare environment by a lay user.
The collected specimens are intended to be tested on the automated Alinity m System; refer to the Alinity m HR HPV assay package insert for additional information.
The intended users for the simpli-COLLECT HPV Collection Kit are lay users, and laboratory and healthcare professionals.
LIMITATIONS
- Optimal performance of this kit requires appropriate specimen collection, handling, preparation, and storage. Refer to the Alinity m HR HPV package insert for additional information.
- This kit should only be used to collect vaginal swab samples. Refer to the patient instructions for use and the Alinity m HR HPV (List No. 09N15-092) package insert for additional information.
- Pregnant women should not use the simpli-COLLECT HPV Collection Kit.
WARNINGS
- Follow all instructions in the package insert.
- Do not send the simpli-COLLECT HPV Collection Kit to the patient if the kit is damaged. Discard unused or damaged kits in accordance with local, regional, and national regulations.
- Do not send the simpli-COLLECT HPV Collection Kit to the patient if the kit is beyond its expiration date.
- Wear disposable gloves while handling specimens and wash hands thoroughly afterward. Use of protective eyewear is recommended.
- Decontaminate and dispose of all specimens, reagents, and other potentially contaminated materials in accordance with local, regional, and national regulations.
Talk to your molecular sales representative to learn more
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View the Alinity m HR HPV assay page to learn more about our end-to-end HPV testing portoflio.
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REFERENCES
- L Bruni, B Serrano, E Roura, L Alemany, M Cowan, R Herrero, M Poljak, R Murillo, N Broutet, LM Riley, S de Sanjose. Cervical cancer screening programmes and age-specific coverage estimates for 202 countries and territories worldwide: a review and synthetic analysis. Lancet Global Health. 2022. https://doi.org/10.1016/S2214-109X(22)00241-8