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 specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high-risk types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 without further specific differentiation.
Limitations
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.
Specimen Requirements
Specimen
Cervical cells in liquid-based cytology transport
Volume
2 mL
Minimum Volume
1 mL (Note: This volume does not allow for repeat testing.)
Container
ThinPrep® vial or SurePath™ vial
Collection Instructions
Brush/spatula technique: Insert the brush into the endocervical canal until only the bottommost fibers are exposed. Slowly rotate the brush 1/4 to 1/2 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.
SurePath™ Vial:When using the SurePath™ vial, the cervical broom must be used for specimen collection. Insert the broom into the cervical os and rotate five times. Place the broom head into the CytoRich™ preservative fluid in the SurePath™ collection vial. Tightly cap the vial.
Storage Instructions
Maintain liquid-based cytology specimens at room temperature.
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 more than six months old in ThinPrep® vial; frozen specimen; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patients; specimen more than four weeks old in SurePath™ vial; excessively bloody specimens
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 507385 | HPV, cobas high-risk/16/18 | 507386 | HPV other hr types | 71431-1 | ||
| 507385 | HPV, cobas high-risk/16/18 | 507387 | HPV 16 | 77399-4 | ||
| 507385 | HPV, cobas high-risk/16/18 | 507388 | HPV 18 | 77400-0 | ||
| 507385 | HPV, cobas high-risk/16/18 | 019054 | 11502-2 | |||
| Order Code | 507385 | |||||
| Order Code Name | HPV, cobas high-risk/16/18 | |||||
| Order Loinc | ||||||
| Result Code | 507386 | |||||
| Result Code Name | HPV other hr types | |||||
| UofM | ||||||
| Result LOINC | 71431-1 | |||||
| Order Code | 507385 | |||||
| Order Code Name | HPV, cobas high-risk/16/18 | |||||
| Order Loinc | ||||||
| Result Code | 507387 | |||||
| Result Code Name | HPV 16 | |||||
| UofM | ||||||
| Result LOINC | 77399-4 | |||||
| Order Code | 507385 | |||||
| Order Code Name | HPV, cobas high-risk/16/18 | |||||
| Order Loinc | ||||||
| Result Code | 507388 | |||||
| Result Code Name | HPV 18 | |||||
| UofM | ||||||
| Result LOINC | 77400-0 | |||||
| Order Code | 507385 | |||||
| Order Code Name | HPV, cobas high-risk/16/18 | |||||
| Order Loinc | ||||||
| Result Code | 019054 | |||||
| Result Code Name | ||||||
| UofM | ||||||
| Result LOINC | 11502-2 |