Sign in →

Test Code LAB0203414 Human Papillomavirus (HPV) Detection with Genotyping, High Risk Type, PCR

Methodology

APTIMA HPV uses target capture, target amplification by Transcription-Mediated Amplification (TMA), and detection of amplification products (amplicon) by the Hybridization Protection Assay (HPA).

The APTIMA HPV Assay is a test for the qualitative dectection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16,18,31,33,35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.

The APTIMA HPV 16, 18/45 Genotype Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18 and 45 in cervical specimens from women with APTIMA HPV Assay positive results.  The genotype assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does NOT differentiate between HPV 18 and HPV 45.

Performing Laboratory

CentraCare Laboratory Services

Specimen Requirements

Specimen must be collected using SurePath Test Pack (PrepStain/AutoCyte PREP) Cervical Collection Kit. This collection method is not FDA approved for HPV testing and does not require approval.

 

Specimen Type: Cervix

Container/Tube: SurePath Test Pack (PrepStain/AutoCyte PREP) Cervical Collection Kit

Specimen Volume: Entire collection

Collection Instructions:

1. Specimen source is required.

2. Collect specimen using SurePath Test Pack.

3. Also send remaining specimen left after processing for PrepStain/AutoCyte PREP plus additional SurePath preservative fluid for a total volume of 6 mL.

4. SurePath (PrepStain/AutoCyte PREP) vial must contain remaining 800 mcL of specimen left in centrifuge tube after processing on AutoCyte PREP system plus 5.2 mL of SurePath preservative fluid. A polypropylene, screw-capped vial is also acceptable.

5. Label vial with patient’s name (first and last), medical record number or date of birth, date and actual time of collection, specimen source, and name of ordering physician. Indicate “SurePath” on vial.

6. Bag SurePath (PrepStain/AutoCyte PREP) specimens individually as they have a tendency to leak during transport. Also place a patient identification label on transport bag.

7. Specimen containing CytoRich Red preservative fluid is not acceptable.

Specimen Transport Temperature

Ambient <7 days/Frozen NO

Reference Values

Negative

Day(s) Test Set Up

Detection:  Monday through Friday

Genotyping:  Positive specimens reflex to genotyping . 

Test Classification and CPT Coding

Test Classification:

This test was developed and its performance characteristics determined by CentraCare Laboratory Services. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code:

87624 (HPV High Risk)

87625 (HPV Genotype)