Test Details
Methodology
Nucleic acid amplification (NAA)
Result Turnaround Time
2 - 4 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This test detects 14 High Risk HPV types in self-collected vaginal swabs processed into ThinPrep® vials. HPV 16 and HPV 18 are specifically identified, whereas the other 12 High Risk types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) are reported in a pool.
Special Instructions
The appropriate collection for this test requires a Copan FLOQSwab 552C.RM and a Thinprep® vial. These products are available as a kit using PeopleSoft No. 144747.
Limitations
Specimen collection during the menstrual cycle has not been evaluated.
Results of this test should only be interpreted in conjunction with information available from clinical evaluation of the patient and patient history. The cobas® HPV Test has been validated for use with vaginal specimens collected with Copan FLOQSwabs® 552C.RM and suspended in PreserCyt® Solution. Assay performance has not been validated for use with other collection media and/or collection devices. Use of other collection media and/or collection devices may lead to false positive, false negative or invalid results.
Detection of high-risk HPV is dependent on the number of copies present in the specimen and may be affected by specimen collection methods, patient factors, stage of infection and the presence of interfering substances. Prevalence of HPV infection in a population may affect performance. Positive predictive values decrease when testing populations with low prevalence or individuals with no risk of infection.
Infection with HPV is not an indicator of cytologic HSIL or underlying high-grade CIN, nor does it imply that CIN2, CIN3 or cancer will develop. Most women infected with one or more high-risk HPV types do not develop CIN2, CIN3 or cancer. Women who are positive for high-risk HPV by the cobas® HPV Test from a clinician-collected cervical specimen or a self-collected vaginal specimen should follow-up with a clinician to determine management.
A negative high-risk HPV result does not exclude the possibility of future cytologic HSIL or underlying CIN2, CIN3 or cancer, but indicates a low likelihood of CIN2, CIN3 or cancer.
Reliable results are dependent on adequate specimen collection, transport, storage and processing. The effects of other potential variables such as vaginal discharge, use of tampons, douching, etc. and specimen collection variables have not been evaluated.
Specimen Requirements
Specimen
Vaginal swab collected with Copan FLOQSwab 552C.RM
Volume
2 mL
Minimum Volume
1 mL (Note: This volume does not allow for repeat testing.)
Container
ThinPrep® vial
Collection Instructions
The vaginal swab is collected using the Copan FLOQSwab 552C.RM and placed into a ThinPrep® vial containing PreservCyt solution.
Patient Self Collection:
1. Patient should wash hands with soap and water prior to collecting the specimen.
2. Twist and pull cap to remove the FLOQSwab from the plastic sleeve.
3. Hold the FLOQSwab at the red mark.
4. Standing in a comfortable position, use the free hand to spread the skin of the vaginal opening, while carefully inserting the swab up to the red mark.
5. Gently rotate the swab for 10-30 seconds.
6. Place the swab back into the tube until you hear a CLICK. After collection, hand the swab to a health care professional for processing. Wash hands with soap and water.
Healthcare Professional FLOQSwab Processing:
1. Handle the collected sample with care.
2. Carefully uncap the ThinPrep® vial and place it on a stable, flat surface.
3. Slowly pull the FLOQSwab cap off to remove the swab from the tube. Minimize touching the inner walls of the tube as you remove the FLOQSwab.
4. Hold the vial with one hand then with the other hand place the FLOQSwab tip into the vial until the FLOQSwab tip is fully immersed in the medium and touching the bottom of the vial.
5. Holding onto the vial, swirl the FLOQSwab along the inner vial wall for 20 seconds while ensuring the swab remains immersed in the medium. Be careful not to splash.
6. Carefully draw the FLOQSwab up along the inner vial wall until the tip is no longer immersed in the medium. Hold the tip against the inner vial wall to drain fluid off of the swab. Place the FLOQSwab into the tube and discard.
7. Re-cap the vial and tighten until the lines on the cap and vial meet or slightly overlap to prevent leakage. Store upright.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 30 days (stability provided by manufacturer or literature reference) |
| Refrigerated | 30 days (stability provided by manufacturer or literature reference) |
| Frozen | Not acceptable |
Storage Instructions
Maintain liquid-based cytology specimens at room temperature.
Patient Preparation
In the three days prior to self-collection of a vaginal sample, use of vaginal ovules, creams or washes, vaginal contraceptives or condoms should be avoided.
In the two days prior to self-collection of a vaginal sample, sexual intercourse and ultrasound scans or gynecological examinations should be abstained from.
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; specimen more than one month old in ThinPrep® vial; frozen specimen; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; non-vaginal source submitted; specimen submitted in SurePath™ vial; excessively bloody specimens; ThinPrep® vial containing the vaginal swab