Specimen:
Collect
- Self-Collect Vaginal Swab in ThinPrep PreservCyt Media
Also Acceptable:
- Self-Collect Vaginal Swab in Vaginal Self-Collect Kit
Submit
- 20 mL (Min:10 mL) Self-Collect Vaginal Swab in ThinPrep PreservCyt Media. Submit Ambient.
Special Handling
- State source. Follow manufacturer's FDA labeling for self-collection. FDA-cleared for self-collected vaginal specimens obtained in a healthcare setting for primary HPV screening in adults 25 years or older with a cervix. Not validated for medico-legal use, including suspected sexual abuse. Only self-collection using FDA-approved/cleared devices for Cobas® HPV is permitted.
Rejection Criteria
- Any specimen not using FDA-approved vaginal self-collect device; any specimen not submitted in ThinPrep PreserveCyt Media; improper labeling; specimen >30 days old; frozen specimens; leakage; insufficient quantity; name discrepancies; patient <25 years; patient without a cervix; non-vaginal source; excessively bloody specimen
Stability
Ambient: 1 Month(s); Refrigerated: 1 Month(s); Frozen: Unacceptable; Incubated: Unacceptable
Methodology
- Real-Time Polymerase Chain Reaction
Performed
Mon-Fri
Reported
1-4 Day(s)
CPT Codes
- 87626
Interpretive Data
Please see report for interpretive data.
This test was performed on a self-collected vaginal specimen obtained in a healthcare setting using the Cobas HPV assay for detection of high-risk Human Papillomavirus (HPV) DNA types 16, 18, and other high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). Self-collected vaginal specimens are validated for high-risk HPV detection only and do not permit reflex cytology (Pap testing). Cytologic evaluation requires a clinician-collected cervical specimen.
Patients with positive high-risk HPV results from a self-collected specimen should follow-up in accordance with current professional medical guidelines, prior screening history, and individual risk factors. Sensitivity may be affected by specimen collection techniques, patient factors, viral load, stage of infection, and potential interfering substances. Human beta-globulin amplification is included to assess specimen adequacy.
This test was performed on a self-collected vaginal specimen obtained in a healthcare setting using the Cobas HPV assay for detection of high-risk Human Papillomavirus (HPV) DNA types 16, 18, and other high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). Self-collected vaginal specimens are validated for high-risk HPV detection only and do not permit reflex cytology (Pap testing). Cytologic evaluation requires a clinician-collected cervical specimen.
Patients with positive high-risk HPV results from a self-collected specimen should follow-up in accordance with current professional medical guidelines, prior screening history, and individual risk factors. Sensitivity may be affected by specimen collection techniques, patient factors, viral load, stage of infection, and potential interfering substances. Human beta-globulin amplification is included to assess specimen adequacy.
Components
- 5291 - HPV16
- 5292 - HPV18
- 5293 - HPV, HIGH-RISK, OTHER
- 5294 - ANATOMICAL SOURCE
Last Updated: March 25, 2026 @ 6:54 pm
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