Specimen:
Collect
- Gynecological Sample in ThinPrep PreservCyt Media
Submit
- 20 mL (Min:10 mL) Gynecological Sample in ThinPrep PreservCyt Media. Submit Ambient.
Special Handling
- Follow manufacturer's instructions.
This test is FDA cleared for primary screening in adult women age 21 years and above with a cervix. This test has not been FDA cleared or evaluated for individuals younger than 21 years of age for primary screening, or for individuals without a cervix.
Reflex tests HPV Genotype 16 & 18/45 and Pap will be added for positive high-risk HPV results at additional cost.
Rejection Criteria
- Improper collection; ThinPrep submitted with brush or broom still in vial; inadequate specimen; improper labeling; specimen more than 1 month old in ThinPrep vial; frozen specimen; leaky specimen; insufficient quantity; name discrepancies; specimen submitted on male patients; excessively bloody specimens; specimens submitted on patient less than 21 years of age.
Stability
Ambient: 30 Day(s); Refrigerated: 30 Day(s); Frozen: Unacceptable; Incubated: Unacceptable
Methodology
- Target Amplified Nucleic Acid Probe
Performed
Mon-Fri
Reported
1-4 Day(s)
CPT Codes
- 87624
Interpretive Data
Please see report for interpretive data.
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 (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). The Aptima HPV Assay does not discriminate between the different HPV types.
If the Aptima HPV Assay is positive it will reflex to the Aptima HPV Genotype assay that detects HPV 16 and HPV 18/45. Positive Aptima HPV assays will also reflex to PAP cytology per the ASCCP 2019 guidelines.
The HPV assay is for medical use only and has not been evaluated in cases of suspected abuse or forensic purposes. Detection of high-risk HPV mRNA is dependent on the number of viral copies present in the specimen and may be affected by specimen collection methods, patient factors, stage of infection, and the presence of interfering substances. The Aptima HPV Assay should be interpreted in conjuction with other laboratory and clinical data available to the clinician.
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 (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). The Aptima HPV Assay does not discriminate between the different HPV types.
If the Aptima HPV Assay is positive it will reflex to the Aptima HPV Genotype assay that detects HPV 16 and HPV 18/45. Positive Aptima HPV assays will also reflex to PAP cytology per the ASCCP 2019 guidelines.
The HPV assay is for medical use only and has not been evaluated in cases of suspected abuse or forensic purposes. Detection of high-risk HPV mRNA is dependent on the number of viral copies present in the specimen and may be affected by specimen collection methods, patient factors, stage of infection, and the presence of interfering substances. The Aptima HPV Assay should be interpreted in conjuction with other laboratory and clinical data available to the clinician.
Components
- 5081 - HPV, HIGH RISK
- 5082 - ANATOMICAL SOURCE
Last Updated: April 23, 2026 @ 9:13 am
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