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
Detection of HPV type 16 and types 18,45 in cervical specimens where high-risk HPV types have been detected.
Special Instructions
This test can be ordered when a high-risk, HPV-positive test result has been obtained at a non−LabCorp test facility or as an add-on test if the positive high-risk HPV test was performed at LabCorp.
Limitations
A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may produce a false-negative result.
Specimen Requirements
Specimen
Cervical cells in liquid-based cytology transport
Volume
ThinPrep® vial
Minimum Volume
ThinPrep® vial 2 mL (Note: This volume does not allow for repeat testing.)
Container
ThinPrep® vial
Collection Instructions
ThinPrep® Vial − Broom or Brush/Spatula:
Broom-like collection technique: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and then rotate the brush five times. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to release additional cellular material. Discard the collection device. Tighten the cap on the ThinPrep® vial so that the torque line on the cap passes the torque line on the vial.
Brush/spatula technique: Insert the brush into the endocervical canal until only the bottommost fibers are exposed. Slowly rotate the brush ¼ to ½ turn in one direction. Do not over-rotate the brush. Then, rotate the brush in the PreservCyt® solution 10 times while pushing against the wall of the ThinPrep® vial. Swirl the brush vigorously to release additional material. Discard the brush. Obtain an adequate sample from the ectocervix using a plastic spatula. Swirl vigorously in the ThinPrep® vial 10 times and discard the spatula. Tighten the cap on the ThinPrep® container so that the torque line on the cap passes the torque line on the vial.
Storage Instructions
Maintain specimen at room temperature. Specimens in ThinPrep® vials must be processed within 21 days of collection for HPV.
Patient Preparation
Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period.
Causes for Rejection
Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patient; specimen submitted in vial that expired according to manufacturer's label; frozen specimen; SurePath™ vial. For HPV: specimen more than 21 days old in ThinPrep® vial.
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 507810 | HPV Genotypes 16/18,45 | 507811 | HPV Genotype 16 | 59263-4 | ||
| 507810 | HPV Genotypes 16/18,45 | 507812 | HPV Genotype 18,45 | 75694-0 | ||
| 507810 | HPV Genotypes 16/18,45 | 019054 | 11502-2 | |||
| Order Code | 507810 | |||||
| Order Code Name | HPV Genotypes 16/18,45 | |||||
| Order Loinc | ||||||
| Result Code | 507811 | |||||
| Result Code Name | HPV Genotype 16 | |||||
| UofM | ||||||
| Result LOINC | 59263-4 | |||||
| Order Code | 507810 | |||||
| Order Code Name | HPV Genotypes 16/18,45 | |||||
| Order Loinc | ||||||
| Result Code | 507812 | |||||
| Result Code Name | HPV Genotype 18,45 | |||||
| UofM | ||||||
| Result LOINC | 75694-0 | |||||
| Order Code | 507810 | |||||
| Order Code Name | HPV Genotypes 16/18,45 | |||||
| Order Loinc | ||||||
| Result Code | 019054 | |||||
| Result Code Name | ||||||
| UofM | ||||||
| Result LOINC | 11502-2 |