simpli-COLLECT HPV

CAUTION

DO NOT touch the white tip of the swab or lay the swab down. If the white tip is touched or the swab is laid down or dropped, your results may not be accurate. You need to request a new simpli-COLLECT™ HPV Collection Kit.

Avoid touching the blue top of the Alinity m Pierceable Cap to prevent potential contamination.

Warnings and precautions

Do not use the simpli-COLLECT™ HPV Collection Kit if the package is damaged or if the seal is broken. Discard unused or damaged kits in accordance with local, state, and federal regulations.
Do not use the simpli-COLLECT™ HPV Collection Kit beyond its expiration date.
Use only the orange shaft swab provided in the simpli-COLLECT™ HPV Collection Kit for collecting swab specimens. The swab must remain in the Alinity m Sample Tube after specimen collection. Do not place multiple swabs in the Alinity m Sample Tube.
The simpli-COLLECT™ HPV Collection Kit isa single use device. Reuse of the device or patient contact with a previously used swab could potentially expose the patient to infectious organisms.
Avoid touching the blue top of the Alinity m Pierceable Cap to prevent potential contamination.
Ensure that the Alinity m Pierceable Cap seals tightly to prevent potential contamination.
Follow the specimen collection procedures. Remove the cap before placement of the specimen collection swab into the transport tube. Do not push a specimen collection swab through the cap.

Limitations of procedure

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.

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.