See Specimen Submission Instructions for test requisition, specimen labeling and specimen packaging requirements.

Test Description

Aptima^® HPV (Human Papillomavirus) – 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.

Indications

1. To screen patients 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 high-risk 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.

Note: The Aptima HPV assay is designed to enhance existing methods for the detection of cervical disease and should be used in conjunction with clinical information derived from other diagnostic and screening tests, physical examinations, and full medical history in accordance with appropriate patient management procedures.

Specimen Requirements

Cervical specimen collected using routine pap specimen collection technique. Collect cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer’s instructions.

Acceptable specimen for Aptima^® HPV assay

1. ThinPrep Pap Test vials containing PreservCyt Solution with broomtype or cytobrush/spatula collection devices according to the manufacturer’s instructions.

Note: The Internal Control monitors the target capture, amplification, and detection steps of the assay, it is not intended to control for cervical sampling adequacy.

*Contamination of the specimen vaginal lubricants (containing Polyquaternium 15) greater than 0.025% w/v or v/v, antifungal cream (containing tioconazole) greater than 0.075% w/v may interfere with the performance of the assay.

Stability

ThinPrep® collection vials are stable for 30 days at ambient temperatures for HPV HR

Reference Range

Test is reported as:

1. Negative (Normal reference value) – Negative results indicate HPV E6/E7 mRNA was not detected.
2. Positive – Positive results indicate the presence of HPV E6/E7 mRNA of any one or more of the high-risk types.
3. Invalid – recommend recollection.
4. Inadequate – ThinPrep liquid cytology specimens containing less than 1 mL after ThinPrep Pap Test slide preparation are considered inadequate for the Aptima HPV assay.

CPT Code

87624