| High Risk HPV -ThinPrep (8000101329) | |
|---|---|
| Test Mnemonic: | HPVTHINPREP |
| Specimen Requirements: | See Liquid Based Thin-Layer PAP – Cytology information in the Laboratory Survival Guide for this information. |
| Test Included: | HPV - High Risk |
| Collection: | See Liquid Based Thin-Layer PAP – Cytology information in the Laboratory Survival Guide for this information. |
| Container: | ThinPrep® |
| Minimum Volume: | See Liquid Based Thin-Layer PAP – Cytology information in the Laboratory Survival Guide for this information. 1 mL must be available to transfer to an Aptima® Specimen Transfer tube in order to perform HPV testing. |
| Storage/Transport: | See Liquid Based Thin-Layer PAP – Cytology information in the Laboratory Survival Guide for this information. |
| Specimen Preparation: | See Liquid Based Thin-Layer PAP – Cytology information in the Laboratory Survival Guide for this information. |
| Stability: | ThinPrep® vials for HPV testing are stable at room temperature or refrigerated (2 – 30°C) for up to 30 days. Storage can be extended to 105 total days refrigerated. Once an aliquot is transferred from a ThinPrep® vial to an Aptima® Specimen Transfer tube, the specimen may be store refrigerated or at room temperature for up to 60 days. |
| Causes for Rejection: | See Liquid Based Thin-Layer PAP – Cytology information in the Laboratory Survival Guide for this information. |
| Reference Range: | Negative |
| Turnaround Time: | 1 - 4 days |
| Methodology: | Qualitative Transcription-Mediated Amplification |
| Performed: | |
| Lab: | Clinical Microbiology |
| Synonyms: | HPV, High Risk HPV, Human Papillomavirus, Genital Warts |
| Clinical Indication: | This test is used to detect human papillomavirus (HPV) from samples collected using the ThinPrep® collection system. The 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 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. This test does not discriminate between the 14 high-risk types. HPV testing concurrent with cytology (“co-testing”) is indicated in women 30 years and older. Reflexive HPV testing is indicated in women 25 to 29 years old with ASCUS cytology results. |
| CPT 4 Code: | 87624 |
| Note: | This 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. Negative results are not intended to prevent women from proceeding to colposcopy. Negative results indicate HPV E6/E7 mRNA was not detected. Personal lubricants and anti-fungal agents may interfere with the performance of this assay. ThinPrep® specimens can be used for HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis testing. The use of this test has not been evaluated for the management of HPV vaccinated women, women with prior ablative or excisional therapy, hysterectomy, who are pregnant or who have other risk factors (e.g., HIV+, immunocompromised, history of sexual transmitted infection). |
| When ordering tests for which Medicare or Medicaid reimbursement will be sought, physicians should only order tests that are medically necessary for the diagnosis or treatment of the patient. Components of the organ or disease panels may be ordered individually. The diagnostic information must substantiate all tests ordered and must be in the form of an ICD-10 code or its verbal equivalent. | |