HPV High Risk and HPV Genotyping 16, 18/45 (Aptima® HR HPV and 16, 18/45 Assay) -IVD

We automatically reflex to genotyping for the oncogenic types 16 and 18/45 for HPV positive cases.  These genotypes are responsible for 75% of all squamous cell cervical cancers and 94% of cervical adenocarcinomas.  https://www.medscape.com/viewarticle/731407

TEST:   CPT: 87624 (HR HPV), 87625 (HR HPV + Genotyping)

Expected Turnaround Time 2-5 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the report is sent to the ordering provider.  Additional time should be allowed for confirmatory, or reflex tests. 

Additional Documentation

SPECIMEN COLLECTION GUIDE

SAMPLE REPORT

Specimen Requirements

Specimen

Cervical cells in liquid-based cytology ThinPrep® collection vial

Collection

Click on the ThinPrep® vial image for a color guide

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 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.

Storage Instructions

Store and transport specimens at room temperature (15 to 30°C). DO NOT freeze.

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. For HPV: specimen more than three months old in ThinPrep® vial.

Test Details

Use

The Aptima HPV assay is an in vitro nucleic acid amplification test for the qualitative detection 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 assay does not discriminate between the 14 high-risk types.

HPV Genotyping 16, 18/45 test is used to test High-Risk HPV positive cases to determine if types 16, 18/45 are present.  It gives two results: type 16 and type 18/45.

The use of the test is indicated: 1. To screen women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy 2. In women 30 years and older, the Aptima HPV assay can be used with cervical cytology to adjunctively screen to assess the presence or absence of highrisk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

Limitations

Patient should avoid douches 48 to 72 hours prior to examination.  Specimen should not be collected during or shortly after menstrual period.

Methodology

Nucleic acid amplification (NAAT)