FDA-approved test for routine cervical cancer screening in combination with cervical cytology (PAP smear) in women >=30 years. Follow-up test for abnormal cytology results in individuals >=21 years with a cervix.
Patient Preparation
Females should avoid high concentrations of antifungal cream or contraceptive jelly, and should not douche prior to time of collection.
Collect
Cervical specimens with the ThinPrep Pap Test Collection kit.
Specimen Container
Specimen Preparation
Performed in Laboratory - Vortex ThinPrep PreservCyt solution and transfer 1 mL to an APTIMA Specimen Transfer Tube
Storage/Transport Temperature
Room temperature or Refrigerated.
Unacceptable Conditions
Specimens in any media other than indicated above.
If HPV, High Risk is positive, HPV Genotypes 16, 18/45 will be performed at an additional charge (CPT Code: 87625)
Ordering Recommendations
FDA-approved test for routine cervical cancer screening in combination with cervical cytology (PAP smear) in women >=30 years. Follow-up test for abnormal cytology results in individuals >=21 years with a cervix.
EPIC Order Code
LAB1854
Sunquest Code
HPVHRT
Synonyms
LAB1854
HPV HR E6/E7 TMA
HPV RNA
Nucleic Acid Amplification Test (NAAT)
HPV
Human Papillomavirus
CPT Codes
87624; add 87625 if genotyping performed
Reference Interval
Negative
Interpretive Data
This test detects E6/E7 viral messenger RNA of the high-risk types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 associated with cervical cancer and its precursor lesions. Cross-reactivity with low-risk HPV genotypes 26, 67, 70, and 82 may occur. Sensitivity may be affected by specimen collection methods, stage of infection, and the presence of interfering substances. Results should be interpreted in conjunction with other available laboratory and clinical data.
This test is intended for medical purposes only and is not valid for the evaluation of suspected sexual abuse or for other forensic purposes. HPV testing should not be used for screening or management of atypical squamous cells of undetermined significance (ASCUS) in women under age 21.
HPV Genotypes 16, 18/45: This test detects E6/E7 viral messenger RNA of the high-risk HPV types 16, 18, and 45 only. The American Cancer Society (ACS), American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP) jointly recommend an age-based approach to cervical cancer screening; the ACS issued its own recommendations in 2020. Testing options vary depending on the individual’s age but include cytology and co-testing. There is no routinely recommended screening test for other HPV-related cancers. Sensitivity may be affected by specimen collection, stage of infection, and the presence of interfering substances. HPV results should be interpreted in conjunction with laboratory and clinical data. This test is intended for medical purposes only.
Collection
Ordering Recommendations
FDA-approved test for routine cervical cancer screening in combination with cervical cytology (PAP smear) in women >=30 years. Follow-up test for abnormal cytology results in individuals >=21 years with a cervix.
Patient Preparation
Females should avoid high concentrations of antifungal cream or contraceptive jelly, and should not douche prior to time of collection.
Collect
Cervical specimens with the ThinPrep Pap Test Collection kit.
Specimen Container
Specimen Preparation
Performed in Laboratory - Vortex ThinPrep PreservCyt solution and transfer 1 mL to an APTIMA Specimen Transfer Tube
Storage/Transport Temperature
Room temperature or Refrigerated.
Unacceptable Conditions
Specimens in any media other than indicated above.
If HPV, High Risk is positive, HPV Genotypes 16, 18/45 will be performed at an additional charge (CPT Code: 87625)
Ordering
Ordering Recommendations
FDA-approved test for routine cervical cancer screening in combination with cervical cytology (PAP smear) in women >=30 years. Follow-up test for abnormal cytology results in individuals >=21 years with a cervix.
EPIC Order Code
LAB1854
Sunquest Code
HPVHRT
Synonyms
LAB1854
HPV HR E6/E7 TMA
HPV RNA
Nucleic Acid Amplification Test (NAAT)
HPV
Human Papillomavirus
Fees & Codes
CPT Codes
87624; add 87625 if genotyping performed
Clinical & Interpretive
Reference Interval
Negative
Interpretive Data
This test detects E6/E7 viral messenger RNA of the high-risk types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 associated with cervical cancer and its precursor lesions. Cross-reactivity with low-risk HPV genotypes 26, 67, 70, and 82 may occur. Sensitivity may be affected by specimen collection methods, stage of infection, and the presence of interfering substances. Results should be interpreted in conjunction with other available laboratory and clinical data.
This test is intended for medical purposes only and is not valid for the evaluation of suspected sexual abuse or for other forensic purposes. HPV testing should not be used for screening or management of atypical squamous cells of undetermined significance (ASCUS) in women under age 21.
HPV Genotypes 16, 18/45: This test detects E6/E7 viral messenger RNA of the high-risk HPV types 16, 18, and 45 only. The American Cancer Society (ACS), American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP) jointly recommend an age-based approach to cervical cancer screening; the ACS issued its own recommendations in 2020. Testing options vary depending on the individual’s age but include cytology and co-testing. There is no routinely recommended screening test for other HPV-related cancers. Sensitivity may be affected by specimen collection, stage of infection, and the presence of interfering substances. HPV results should be interpreted in conjunction with laboratory and clinical data. This test is intended for medical purposes only.
