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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.


Secondary ID

616073

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

Specimen Type

Varies

Specimen 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

Reject Due To

SurePath vial Reject

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.

Method Description

The ThinPrep Pap specimen is processed on a T2000 or T5000 processor, producing a slide that is stained with a Papanicolaou stain. The stained slides are examined microscopically.(Instruction manuals: ThinPrep 2000 System Operator's Manual. Hologic; MAN-02585-001 Rev. 006, 02/2017; ThinPrep 5000 Processor Operator's Manual. Hologic; MAN-02203-001 Rev. 002, 2016)

 

The cobas HPV test is a qualitative real-time PCR test that detects 14 high-risk HPV genotypes. The test uses primers to define a sequence of approximately 200 nucleotides within the polymorphic L1 region of the HPV genome. A pool of HPV primers present in the Master Mix is designed to amplify HPV DNA from 14 high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). An additional primer pair targets the human beta-globin gene (330 base pair amplicon) as an internal control to monitor the entire sample preparation and PCR amplification process. Fluorescent oligonucleotide probes bind to polymorphic regions within the sequence defined by these primers. The test utilizes a low titer positive and a negative control.(Package insert: cobas HPV: Qualitative nucleic acid test for the cobas 6800/8800 Systems. Roche Diagnostics; Rev. 2.0, 03/2021)

 

The CINtec PLUS Cytology test is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a and Ki-67 proteins in cervical specimens collected by a clinician using an endocervical brush/spatula or broom collection device and placed in the ThinPrep Pap Test PreservCyt Solution. The CINtec PLUS Cytology test includes a ready-to-use cocktail of primary antibodies that contains a mouse monoclonal antibody directed against human p16INK4a (p16) protein (clone E6H4), and a recombinant rabbit monoclonal antibody directed against human Ki-67 protein (clone 274-11AC3V1) for use on the BenchMark ULTRA instrument with 3,3'-diaminobenzidine tetrahydrochloride and Fast Red detection systems.(Package insert: CINtec PLUS Cytology. Roche Diagnostics; version 1018621US Rev D, 06/2024)

Day(s) Performed

Monday through Friday

Report Available

5 to 15 days

Specimen Retention Time

14 days after report issued

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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