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Aptima® HPV (Human Papillomavirus) 16, 18/45 Genotype Assay

Updated

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

Test Description

Aptima® HPV (Human Papillomavirus) 16, 18/45 Genotype – 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 Aptima HPV 16 18/45 genotype assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45.

Indications

  1. In women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. 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 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. 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 16 18/45 genotype assay is not intended for use as a stand-alone assay. The assay should be performed only as a follow-up to an Aptima HPV assay positive result, and should be interpreted in conjunction with cervical cytology test results.

Specimen Requirements

Cervical specimen collected using routine pap specimen collection technique.

Acceptable specimen for Aptima® HPV (Human Papillomavirus) 16, 18/45 Genotype 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 1% w/v, antifungal cream (containing tioconazole) greater than 0.03% w/v, mucus greater than 0.3% w/v, intravaginal hormones (containing progesterone) greater than 1% w/v, Trichomonas vaginalis greater than 3 x 104 cells/mL) may interfere with the performance of the assay.

Stability

ThinPrep® collection vials are stable for 30 days at ambient temperatures for HPV 16, 18/45.

Reference Range

Test is reported as:

  1. Negative 16, Negative 18/45 (Normal reference value)
  2. Negative for HPV 16 and Positive for HPV 18/45
  3. Positive for HPV 16 and Negative for HPV 18/45
  4. Positive for HPV 16 and Positive for HPV 18/45
  5. Invalid – recommend recollection.
  6. 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

87625  

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