Use of Test
The HPV Test is a qualitative multiplex assay that provides detection of 14 high-risk HPV types, as well as specific genotyping information for HPV Types 16 and 18. The method used by WSLH is cobas® 4800 by Roche (Indianapolis, IN).
Container identification may be affixed with a label or hand-printed and MUST include: full legal name of patient, DOB, DOS and specimen source.
Speculum should be warmed and rinsed in saline solution; no lubricant should be used. Obtain an adequate sampling from the cervix using one of the methods below:
- Insert the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix.
- Push gently, and rotate the broom in a clockwise direction five (5) times.
- Immediately and vigorously swirl the cell contents into the ThinPrep® vial, swirling the brush around the bottom of the vial at least 10 times for at least 10 seconds.
- Insert the central bristles of the brush into the endocervical canal so that the bottom of the brush is visible at base of os.
- Rotate the brush in a clockwise direction ¼-½ turn. NOTE that over-rotating may cause excessive bleeding leading to an unsatisfactory Pap test.
- Immediately and with some force, vigorously swirl and twirl the brush against the edges of the vial at least 10 times for at least 10 seconds.
- Using a plastic spatula, insert the small end of the spatula into the ectocervix
- Rotate the spatula one full turn in a clockwise direction
- Quickly place the spatula into the vial and forcefully swish in the liquid against the vial 10 times for at least 10 seconds
PLEASE NOTE: Make sure vial is properly closed to prevent spilling or leakage.
WSLH cytology requisition form #141 must include:
- Patient’s full legal names
- Full address, especially if patient has third-party insurance (commercial or government)
- Clinic medical record number, if available
- Date of birth
- Date of collection
- Specimen source
- Clinician’s name, clinic address, phone and fax number
- Date of last menstrual period (LMP)
- Pertinent clinical history
- Result of previous Pap test, and HPV test if available
- Payment information
#16 ThinPrep® Pap Kit
#16 ThinPrep® Pap Kit with Broom
HPV Detected or Not Detected for the cocktail and 16/18. When detected, genotype 16 and 18 will be specifically reported as Detected or Not Detected.
- Not Detected: None of the 16 HRHPV viral types have been detected.
- Detected: At least one of the 16 HRHPV viral types have been detected
- HPV 16 and 18 detection will follow this result.
- Unsatisfactory: The specimen lacked the minimal requirements to successfully assess HPV detection.
- Do not collect specimen during menses.
- Endocervical collection methods not recommended for use on pregnant patients. The test does not sample from the endometrium.
- The cobas® 4800 HPV Test is a valuable but imperfect screening test for HPV-related cancer and its precursors. Both false negative and false positive results may occur. Positive results should be confirmed with additional studies as clinically indicated.
- Findings must be correlated with history and other test results.
- Specimens that do not meet basic requirements of cell volumes may be non-diagnostic and rendered unsatisfactory.
- When HPV is ordered as part of co-testing with ThinPrep® Pap Test processing, HPV is run after the Pap Test processing. Uncommonly, all of the cells and liquid may be used for the Pap Test. If there is less than 2mL left, HPV testing will not be performed.
PLEASE NOTE: Results may be delayed or the sample rejected if pertinent and/or required information needs clarification or is missing.
Specimen Submission Requirements
This kit is intended for collection and shipment of cervico-vaginal (gynecologic) specimens for analysis of pre-malignant or malignant disease. This kit is NOT SUITABLE for collection of specimens for chlamydia or other infectious diseases.
Contents of kit:
- 1 ThinPrep® vial
- Absorbent paper
- Biohazard bag
- Cytobrush and spatula or cytobroom
- Styrofoam mailers
- Mailing Labels
- Write patient’s full name, DOB and DOS on ThinPrep® vial.
- Complete WSLH requisition form #141.
- Collect specimen and transfer to vial.
PLEASE NOTE: Close vial cap tightly and check for possible leakage.
- Wrap absorbent paper around the ThinPrep® vial
- Place the vial in a biohazard bag
- Place the completed requisition form in the sleeve of the biohazard bag
- Label the styrofoam mailer with the following:
- Your laboratory/clinic’s address
- WSLH Cytology Department address
- Diagnostic specimen label
- Shipping label: 49 CFR 173.4
- Place the bag in a styrofoam mailer
PLEASE NOTE: The specimen does not need to be refrigerated or packed with ice.