Cytology - HPV Primary Protocol
| WSLH Department: | Cytology |
| WSLH Test Code: | 95507 HPV-PROTOCOL |
| Availability: | Monday-Friday |
| Turn-around Time: | 7-10 days |
| Recommended Uses: | Reflex testing: High-risk HPV testing is performed upon the diagnosis of ASCUS. Co-testing: High-risk HPV testing is performed in conjunction with Pap test for patients aged 30 and older. Follow-up testing: High-risk HPV testing may be requested as part of follow-up protocols for patients after an abnormal Pap, abnormal HPV and/or colposcopy and biopsy procedures. Primary testing: High-risk HPV testing is performed as a primary screening test, with reflex Pap testing or colposcopy for abnormal results. NOTE: HPV testing is NOT RECOMMENDED for patients aged 20 and younger. HPV Primary Screening is not recommended for patients under age 24. HPV co-testing or Cytology first testing is recommended for patients with delayed screening onset (older than age 25) and for patients with symptoms such as abnormal bleeding, friable cervix, or cervical abnormalities on examination. |
| Contraindications: | Analyte-specific reagents are used to detect HPV DNA in the female genital tract area and provide information as to the patient risk for the development of cervical cancer. A negative result does not necessarily mean that the patient has not been exposed to the virus. A positive result does not necessarily mean that the patient has or will develop cervical cancer, as 90% of women spontaneously clear the virus in three years. |
| Additional Tests Performed: |
| Patient Preparations: | The test is validated for patients with a cervix/vagina only (women and transgender men). The specimen is collected in the same manner as a Pap smear. |
| Specimen Requirements: | Collect cells from the uterine cervix using cytobrush, broom (Cervex Brush), and/or spatula. Cells are transferred into a ThinPrep vial. Vaginal Only swabs are not a validated specimen type for this test. |
| Specimen Handling & Transport: | Tightly seal the ThinPrep Pap test vial and place in biohazard bag. Add one absorbent cloth to the bag. Place requisition form with HPV order in biohazard bag sleeve. Transport via courier or shipping carrier with a tracking option strongly preferred. Store at controlled room temperature. |
| Collection Kit/Container: |
ThinPrep Kit #16 and Mailers
|
| Collection Instructions: | 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: BROOM-LIKE DEVICE--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. BRUSH--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 one-fourth to one- half 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. SPATULA--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. |
| Unacceptable Conditions: | If the ThinPrep Pap test vial leaks during transportation, there may not be enough specimen to proceed with testing. Specimens received more than 6 weeks after collection may be rejected. |
| Requisition Form: |
WSLH Cytology Form 141
|
| Required Information: | Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. |
| Results Include: | HPV Detected or Not Detected for the 14 high risk HPV types in the cocktail, including 16/18. Not Detected: None of the 14 high risk HPV viral types have been detected. Detected: At least one of the 14 high risk HPV viral types have been detected. When detected, genotype will be reported as 16, 18, Other High Risk, or a combination thereof. Unsatisfactory: The specimen lacked the minimal requirements to successfully assess HPV detection. |
| Limitations: | Avoid specimen collection during menses, if possible. 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. HPV Detected results should be confirmed with additional studies as clinically indicated by ASCCP Management Guidelines (web application for the ASCCP Management Guidelines: https://app.asccp.org/). A not detected result does not necessarily mean that the patient has not been exposed to the virus. A detected result does not necessarily mean that the patient has or will develop cervical cancer. 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 thus 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. |
| Additional Tests Recommended: | ThinPrep Pap testing or Surgical Biopsy may be recommended in conjunction with HPV testing depending on patient’s age ,andclinical history (co-testing). The HPV test may also serve as reflex confirmation of an ASCUS diagnosis from a ThinPrep Pap test. |
| Additional Comments: | Pap test cytology testing in association with HPV DNA testing allows for more complete follow-up and treatment. A ThinPrep Pap test is ordered as a reflex test for HPV-Protocol tests for which the result is positive for HPV. |
| Methodology: | HPV DNA amplification |
| Includes: | Amplification and detection of HPV DNA found in cytology specimens, specifically gynecologic specimens or Pap smears. The HPV Test is a qualitative multiplex assay that provides detection of 14 high-risk HPV types (16,18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), as well as specific genotyping information for HPV Types 16 and 18. The method used by WSLH is cobas 4800 by Roche (Indianapolis, IN). |
| CPT Code: | 87624 |
| Price: | $64.00 |