Test Code CTPCO ThinPrep with Human Papillomavirus (HPV) Co-Test-Screen with p16/Ki67 Dual Stain Reflex, Varies
Ordering Guidance
1. Mayo Clinic Laboratories' clients need prior laboratory approval to order cytology testing.
2. This test is not approved for patients outside the ages of 30 to 65 years. If this test is ordered and the patient is outside the ages of 30 to 65 years, it will be canceled and automatically reordered by the laboratory as one of the following:
-STPCO / ThinPrep with Human Papillomavirus (HPV) Co-Test-Screen, Varies if the patient is older than 65 years.
-STHPV / ThinPrep Screen with Human Papillomavirus (HPV) Reflex, Varies if the patient is younger than 30 years.
3. This test is not approved on vaginal specimens. Testing ordered on vaginal specimens will be canceled and automatically reordered by the laboratory as one of the following:
-STPCO if the patient is older than 30 years
-STHPV If the patient is younger than 30 years
Necessary Information
1. An acceptable cytology request must accompany specimen containers and include the following:
Patient's name
Medical record number
Date of birth
Sex
Specimen source (exact location and procedure used)
Date specimen was collected
Name and pager number of ordering healthcare professional
2. Submit any pertinent history or clinical information.
Specimen Required
Patient Preparation: For optimal interpretation, Papanicolaou (Pap) smears should be collected near the middle of the menstrual cycle. No douching, lubricant use, or sexual intercourse for 24 hours before specimen collection.
Only 1 aliquot may be removed from PreservCyt sample vial prior to performing the ThinPrep Pap test, regardless of the volume of the aliquot (maximum aliquot volume: 4 mL).
Submit only 1 of the following specimens:
Specimen Type: Cervical
Supplies: Thin Prep Media with Broom Kit (T056)
Container/Tube: ThinPrep/PreservCyt vial
Specimen Volume: 16 mL
Collection Instructions:
1. Obtain adequate sampling from cervix using a broom-like collection device. If desired, use lukewarm water to warm and lubricate the speculum. Insert the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix. Push gently and rotate the broom in a clockwise direction 5 times.
2. Rinse the broom as quickly as possible into the PreservCyt solution vial by pushing broom into bottom of vial 10 times, forcing the bristles apart.
3. As a final step, swirl broom vigorously to further release material. Discard the broom collection device.
4. Tighten cap on vial so that the torque line on the cap passes the torque line on the vial.
5. Specimen vial must be labeled with a minimum of 2 unique identifiers (patient's name and medical record number or date of birth).
6. Bag ThinPrep specimens individually as they tend to leak during transport.
7. Place labels on the vial and on the bag.
Specimen Type: Ectocervix and endocervix
Supplies: Thin Prep Media with Spatula and Brush Kit (T434)
Container/Tube: ThinPrep/PreservCyt vial
Specimen Volume: 16 mL
Collection Instructions:
1. Obtain an adequate sampling from the ectocervix using a plastic spatula. If desired, use lukewarm water to warm and lubricate the speculum. Select contoured end of plastic spatula and rotate it 360 degrees around the entire ectocervix while maintaining tight contact with ectocervical surface.
2. Rinse spatula as quickly as possible into the PreservCyt solution vial by swirling spatula vigorously in vial 10 times. Discard the spatula.
3. Next, obtain an adequate specimen from endocervix using an endocervical brush device. Insert the brush into the cervix until only the bottommost fibers are exposed. Slowly rotate one-quarter or one-half turn in 1 direction. Do not over-rotate.
4. Rinse the brush as quickly as possible in the PreservCyt solution by rotating the device in the solution 10 times while pushing against the PreservCyt vial wall.
5. Swirl brush vigorously as final step to further release material. Discard the brush.
6. Tighten the cap so that the torque line on the cap passes the torque line on the vial.
7. Specimen vial must be labeled with a minimum of 2 unique identifiers (patient's name and medical record number or date of birth).
8. Bag ThinPrep specimens individually as they tend to leak during transport.
9. Place labels on the vial and bag.
Forms
Useful For
Screening for cervical carcinoma or intraepithelial lesions and the presence or absence of high-risk human papillomavirus (HR-HPV) when screening women aged 30 to 65 years for possible cervical neoplasia
Aiding in triaging women with abnormal Papanicolaou (Pap) smear results
Aiding in triaging women with positive HR-HPV but negative Pap smear results
Aiding in triaging women aged 30 to 65 years with NILM (negative for intraepithelial lesion or malignancy) and 12 other HR-HPV positive test results using the cobas 4800 HPV Test in adjunctive cervical cytology and HR-HPV screening, to determine the need for referral to colposcopy
Additional Tests
Test ID | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
HPV | HPV with Genotyping, PCR, ThinPrep | Yes | Yes |
Reflex Tests
Test ID | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
TPSPC | Physician Interp Screen | No | No |
CINPC | CINtec IHC Multiplex, PC | No | No |
Testing Algorithm
When this test is ordered, a ThinPrep Papanicolaou (Pap) cytology screen and human papillomavirus (HPV) high-risk DNA detection with genotyping by polymerase chain reaction test will be performed.
If the ThinPrep Pap results are abnormal, a pathologist will review the case at an additional charge.
If the cytology screen results are negative for intraepithelial lesion or malignancy and HPV test results are positive, p16/Ki67 dual stain immunocytochemistry will be performed at an additional charge.
Special Instructions
Method Name
Light Microscopy/Real-Time Polymerase Chain Reaction (PCR)/Immunocytochemistry as needed
Reporting Name
ThinPrep HPV CoTest w CINtec+ReflexSpecimen Type
VariesSpecimen Minimum Volume
See Specimen Required
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Varies | Ambient (preferred) | 42 days | THIN PREP |
Refrigerated | 42 days | THIN PREP |
Reference Values
ThinPrep PAPANICOLAOU
Satisfactory for evaluation. Negative for intraepithelial lesion or malignancy.
HUMAN PAPILLOMAVIRUS (HPV)
Negative for HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68
CINtec PLUS Cytology, Immunocytochemical dual stain for p16/Ki-67 has been performed.
Result: Negative
Interpretation
Standard reporting, as defined by the Bethesda System is utilized.
Human papillomavirus (HPV):
A positive result indicates the presence of HPV DNA due to 1 or more of the following genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.
A negative result indicates the absence of HPV DNA of the targeted genotypes.
CINtec PLUS Cytology:
If no cervical epithelial cells show simultaneous brown cytoplasmic immunostaining and red nuclear immunostaining, the CINtec PLUS Cytology test result is considered negative.
For patients with a Papanicolaou (Pap) smear result of atypical squamous cells of undetermined significance and who are positive for high-risk HPV (HR-HPV), consider referral for colposcopy if clinically indicated.
For women aged 30 years and older with a negative Pap smear result but who are positive for HPV-16 or HPV-18, consider referral for colposcopy if clinically indicated.
For women aged 30 to 65 years with a negative Pap smear, positive HR-HPV test result, but negative HPV-16 and HPV-18 and CINtec Plus positive, consider referral for colposcopy if clinically indicated
For women aged 30 to 65 years with a negative Pap smear, positive HR-HPV test result, but negative HPV-16 and HPV-18 and CINtec Plus negative, consider repeat testing by both cytology and a HR-HPV test in 12 months.
Clinical Reference
1. Lorincz AT, Richart RM. Human papillomavirus DNA testing as an adjunct to cytology in cervical screening programs. Arch Pathol Lab Med. 2003;127(8):959-968
2. Wright TC Jr, Schiffman M. Adding a test for human papillomavirus DNA to cervical-cancer screening. N Engl J Med. 2003;348(6):489-490
3. Nayar R, Wilbur DC, eds. The Bethesda System for Reporting Cervical Cytology: Definitions, Criteria, and Explanatory Notes. 3rd ed. Springer International Publishing; 2015
4. Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. J Low Genit Tract Dis. 2012;16(3):175-204
5. Walboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999;189(1):12-19
6. de Sanjose S, Quint WG, Alemany L, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010;11(11):1048-1056
7. Wright TC Jr, Stoler MH, Sharma A, et al. Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV+, cytology-negative results. Am J Clin Pathol 2011;136(4):578-586
8. Package insert: CINtec PLUS Cytology. Roche Diagnostics; version 1018621US Rev D, 06/2024
9. Massad LS, Einstein MH, Huh WK, et al. 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors [published correction appears in J Low Genit Tract Dis. 2013 Jul;17(3):367]. J Low Genit Tract Dis. 2013;17(5 Suppl 1):S1-S27
10. Sherman ME, Lorincz AT, Scott DR, et al. Baseline cytology, human papillomavirus testing, and risk for cervical neoplasia: a 10-year cohort analysis. J Natl Cancer Inst. 2003;95(1):46-52
11. Clarke MA, Cheung LC, Castle PE, et al. Five-year risk of cervical precancer following p16/Ki-67 dual-stain triage of HPV-positive women. JAMA Oncol. 2019;5(2):181-186. doi:10.1001/jamaoncol.2018.4270
12. Wentzensen N, Clarke MA, Bremer R, et al. Clinical evaluation of human papillomavirus screening with p16/Ki-67 dual stain triage in a large organized cervical cancer screening program [published correction appears in JAMA Intern Med. 2019 Jul 1;179(7):1007. doi:10.1001/jamainternmed.2019.2636.]. JAMA Intern Med. 2019;179(7):881-888. doi:10.1001/jamainternmed.2019.0306
13. Wright TC Jr, Stoler MH, Ranger-Moore J, et al. Clinical validation of p16/Ki-67 dual-stained cytology triage of HPV-positive women: Results from the IMPACT trial. Int J Cancer. 2022;150(3):461-471. doi:10.1002/ijc.33812
Day(s) Performed
Monday through Friday
Report Available
5 to 15 daysPerforming Laboratory

Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
88142
G0123 (Government payers)
G0124 (Government payers, if appropriate)
88141 -TPSPC (if appropriate)
88344 -CINTC/CINPC (if appropriate)
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
CTPCO | ThinPrep HPV CoTest w CINtec+Reflex | 47527-7 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
616074 | Interpretation | 69965-2 |
616075 | Participated in the Interpretation | No LOINC Needed |
616076 | Report electronically signed by | 19139-5 |
616077 | Addendum | 35265-8 |
616078 | Gross Description | 22634-0 |
CY092 | Pap Test Source | 22633-2 |
CY093 | Clinical History | 22636-5 |
CY094 | Menstrual Status (LMP, PM, Pregnant) | 8678-5 |
CY095 | Hormone Therapy/Contraceptives | 8659-5 |
616079 | Disclaimer | 62364-5 |
616080 | Case Number | 80398-1 |