HPV High Risk Screen, Self Check with Genotype
Test Summary
Human papillomavirus (HPV) is a small, non-enveloped, double-stranded DNA virus, with a genome of approximately8000 nucleotides. There are more than 140 different HPV genotypes and approximately40 different genotypes can infect the human anogenital mucosa. Fourteen HPV genotypes are classified as carcinogenic or high-risk (HR) 16,18,31,33,35,39,45,51,52,56,58,59,66,68. Please note that one of these, HPV66, was recently categorized as "possibly carcinogenic" based on its relatively low prevalence in invasive cervical carcinomas. Self- collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained. Self- collection using PCR-based HPV tests in cervical cancer screening programs is generally accepted and desirable because it increases access and participation to screening in unscreened or under screened women, and settings or regions with inadequate or lack of health care infrastructure and the needed logistics to perform a pelvic exam.
Aliases
N/A
Specimen Collection
Special Instructions
This vaginal self-collect sample must be collected at a provider's office. Add on cerivical pap testing to this sample is not permitted.
Preferred Specimen
1 FLOQ SWAB #552C.RM suspended in a pap vial of Preservcyt solution.
Minimum Volume
1 FLOQSwab suspended in 1 pap vial of PreservCyt® Solution
Instructions
PATIENT INSTRUCTIONS for COPAN FLOQSwab vaginal collection: Wash your hands with soap and water before starting. Open the swab just before use and be careful not to touch any surfaces with the swab tip. Twist and pull cap to remove swab from the tube. Hold the swab at the red mark. 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. Gently rotate the swab for 10 to 30 seconds. Place the swab back into the tube until you hear a CLICK. After collection, hand over the swab for processing. PROVIDER INSTRUCTIONS for suspension of FLOQSwab into a pap vial of PreservCyt® Solution: Carefully uncap the vial containing medium and place it on a stable, flat surface. 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. 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. 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. 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. Re-cap the vial and tighten until the lines on the cap and vial meet or slightly overlap to prevent leakage. Store upright.
Patient Preparation
In the 3 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 2 days prior to self-collection of a vaginal sample, sexual intercourse and ultrasound scans or gynecological examinations should be abstained from.
Storage
Self-collected vaginal specimens suspended in PreservCyt® Solution may be stored at 2-30°C for up to 1 month after the date of collection prior to testing
Transport Temperature
Specimens collected in PreservCyt® Solution can be transported at 2-30°C.
Specimen Stability
The vaginal COPAN FLOQSwab should be suspended into a pap vial of PreservCyt® Solution by the provider immediately after patient collection.
Limitations
Reliable results depend on proper sample collection, storage and handling procedures. Products containing carbomer(s), including vaginal lubricants, creams and gels may interfere with the test and should not be used during or prior to collecting cervical specimens. Use of over-the-counter products Dove Advanced Care Clear Finish Antiperspirant Dry Spray, Replens™, RepHresh™ Vaginal Gel and RepHresh™ Clean Balance™ Kit has been associated with false-negative results. Use of Metronidazole Vaginal Gel has been associated with false-negative results. HPV is not recommended for evaluation of suspected sexual abuse and for other medico-legal indications.
Other Acceptable Specimens
N/A
Unacceptable Specimens
N/A
Order Code
HPVSC
EPIC (Premier) Code
Includes
N/A
CPT Code
87626
Billing Code
300099
CPT Statement
Methodology
Polymerase Chain Reaction (PCR)
FDA Status
FDA Approved
Physician Attestation of Informed Consent
N/A
Testing Laboratory
2308 Sandridge Drive
Moraine OH, 45439
Department
Reference Range
NOT DETECTED
Setup Schedule / Expected Turnaround Time
Tuesday and Thursday; Reports availabe: 5 days
Specimen Collection
Special Instructions
This vaginal self-collect sample must be collected at a provider's office. Add on cerivical pap testing to this sample is not permitted.
Preferred Specimen
1 FLOQ SWAB #552C.RM suspended in a pap vial of Preservcyt solution.
Minimum Volume
1 FLOQSwab suspended in 1 pap vial of PreservCyt® Solution
Instructions
PATIENT INSTRUCTIONS for COPAN FLOQSwab vaginal collection: Wash your hands with soap and water before starting. Open the swab just before use and be careful not to touch any surfaces with the swab tip. Twist and pull cap to remove swab from the tube. Hold the swab at the red mark. 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. Gently rotate the swab for 10 to 30 seconds. Place the swab back into the tube until you hear a CLICK. After collection, hand over the swab for processing. PROVIDER INSTRUCTIONS for suspension of FLOQSwab into a pap vial of PreservCyt® Solution: Carefully uncap the vial containing medium and place it on a stable, flat surface. 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. 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. 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. 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. Re-cap the vial and tighten until the lines on the cap and vial meet or slightly overlap to prevent leakage. Store upright.
Patient Preparation
In the 3 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 2 days prior to self-collection of a vaginal sample, sexual intercourse and ultrasound scans or gynecological examinations should be abstained from.
Storage
Self-collected vaginal specimens suspended in PreservCyt® Solution may be stored at 2-30°C for up to 1 month after the date of collection prior to testing
Transport Temperature
Specimens collected in PreservCyt® Solution can be transported at 2-30°C.
Specimen Stability
The vaginal COPAN FLOQSwab should be suspended into a pap vial of PreservCyt® Solution by the provider immediately after patient collection.
Limitations
Reliable results depend on proper sample collection, storage and handling procedures. Products containing carbomer(s), including vaginal lubricants, creams and gels may interfere with the test and should not be used during or prior to collecting cervical specimens. Use of over-the-counter products Dove Advanced Care Clear Finish Antiperspirant Dry Spray, Replens™, RepHresh™ Vaginal Gel and RepHresh™ Clean Balance™ Kit has been associated with false-negative results. Use of Metronidazole Vaginal Gel has been associated with false-negative results. HPV is not recommended for evaluation of suspected sexual abuse and for other medico-legal indications.
Other Acceptable Specimens
N/A
Unacceptable Specimens
N/A
Result Information
Methodology
Polymerase Chain Reaction (PCR)
Testing Laboratory
Reference Range
NOT DETECTED
Setup Schedule / Expected Turnaround Time
Tuesday and Thursday; Reports availabe: 5 days