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Epic Code LAB1230097 PAP Test

Important Note

The APTIMA HPV Assay has only been validated for use with cervical specimens collected in PreservCyt Solution using a broom-type or cytobrush/spatula collection device.

Test Name Alias

Pap Test Co-Testing | Pap Test HPV Reflex | Pap Test No HPV | Thinprep | Papanicolaou test | Pap Smear | GYN CYTOLOGY

Interface Order Alias

1230097

Clinical Information

See "Resources" section in the upper left corner.

Ordering Instructions

Electronic ordering (Epic, eSHare) - Option for HPV co-testing or HPV reflex are located within the test

For Anal Rectal Cytology, please see test LAB2111297 Medical Cytology

Specimen Requirements

Label all specimens with 2 patient identifiers (Full patient legal name & date of birth or Spectrum Health Medical Record Number, MRN)

Gynecological Collection

Includes vaginal/cervical cytology collection and Thin Prep Pap Test methods.

Suggestions for adequate smear:

  • Patient should avoid douches 48-72 hours prior to examination.
  • Do Pap smear prior to bimanual exam.
  • Visualize entire cervix
  • Do ectocervical scraping first and then endocervical sample by gently rotating brush to reduce bleeding caused by brush.
  • Small amounts of blood will not interfere with cytologic evaluation, but large amounts preclude cytologic evaluation.
  • Use of lubricating jelly will interfere with cytologic examination.  Please refer to Hologic Letter, located in the resource section to the left.
  • Do not use wooden collection devices.

 

Thin Prep Pap Test Collection

Broom-Like Device Protocol

  1. Obtain an adequate sampling from the cervix by inserting 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 broom in a clockwise direction five times.
  2. Rinse broom into the PreservCyt solution vial by pushing the broom into the bottom of the vial 10 times, forcing the bristles apart. As a final step, swirl the broom vigorously to further release the material. Discard the collection device.

Endocervical Brush/Spatula Protocol

  1. Obtain an adequate sampling from the ectocervix using a plastic spatula.
  2. Rinse the spatula into the PreservCyt solution vial by swirling the spatula vigorously in the vial 10 times. Discard the spatula.
  3. Obtain an adequate sampling from the endocervix using an endocervical brush device. Insert the brush into the cervix until only the bottom most fibers are exposed. Slowly rotate ¼ or ½ turn in one direction. Do not over-rotate!
  4. Rinse the brush in the PreservCyt solution by rotating the device in the solution 10 times while pushing against the PreservCyt vial wall. Swirl the brush vigorously to further release material. Discard the brush.

Specimen Container

  1. Tighten the cap so that the torque line on the cap passes the torque line on the vial.
  2. Record the patient’s full name and date of birth or Spectrum Health MRN on the vial
  3. Record the patient information and medical history, including pertinent clinical history (birthdate and LMP), source (Vag or Ecto/Endo) and if the pap test is a screening or diagnostic test on the Anatomic Pathology Requisition.
  4. Place the vial and requisition in a specimen bag for transport to the cytology laboratory.

 

Federal regulations mandate that the following pertinent information be included on the requisition/order:

  • Last Menstrual Period (LMP)
  • Source of Specimen
  • Patient’s Full Name
  • Birthdate
  • Clinical History
  • Physician’s Name

History of surgery, exogenous hormones, DES exposure, history of carcinoma, radiation, chemotherapy, abnormal vaginal bleeding, previous abnormal paps are necessary for complete cytologic evaluation.

Specimen Stability

  • PreservCyt solution – store the vials at 15to 30oC (59o to 86oF) without cells.
  • Once the vials contain cells, they are preserved for approximately 4 weeks at 4to 37oC (39.2o to 98.6oF).
  • Laboratory Retention: 30 days

 

When transporting solution vials containing cells to the laboratory, make sure the vial is tightly sealed. Align the mark on the cap with the mark on the vial to prevent leakage.

 

Reflex Information

Link: Algorithm 

Is HPV Requested?

a. If NO HPV testing is desired, select NO and only the pap test will be ordered.

b. If YES, HPV testing is desired, select one of two options:

i. CO-TESTING (30-64 y/o)

1. If Co-testing is selected, the HPV test will be ordered and performed regardless of the pap test final diagnosis.

2. Note: Co-testing is recommended for patients age 30-64.

ii. HPV REFLEX (see link below for criteria)

1. If reflex is selected the HPV test will only be performed in the following scenarios:

a. The pap test final diagnosis is NIL and the patient is between ages 30-64.

b. The pap test final diagnosis is ASCUS and the patient is between ages 21-64.

c. The pap test final diagnosis is LSIL and the patient is between ages 25-64 and is not pregnant.

c. The HPV Genotype test will automatically reflex for all patients between the ages of 30-64 with a NIL pap test diagnosis and a positive HPV test diagnosis.

1. Note: Add on HPV and HPV Genotype tests can be added up to 4 weeks from the collection date.

Test Frequency

Available Monday – Friday, usual TAT 5 days

Reference Range

An interpretive report will be provided

Performing Department

Cytology

Performing Department Laboratory Location

Corewell Health Reference Laboratory, Grand Rapids, MI
Corewell Health Blodgett Laboratory, Grand Rapids, MI

Methodology

Methodology not available at this time

CPT

88175
For routine screen, Medicare and Blue Cross CPT Code is G0123.
If indicated, corresponding professional fees will also apply.

CDM Code

Unavailable

Epic Test ID

1230101015

LOINC

GYN INTERPRETATION: 19762-4
GYN SPECIMEN ADEQUACY: N/A
HPV REQUESTED?: N/A
VAGINA HPV REQUESTED: N/A

Additional Information

This test replaces the following tests

LAB3338 (52) - Pap test - HPV if ASCUS or AGUS

LAB3339 (55) - Pap test - HPV if NIL, ASCUS or AGUS

LAB4 (47) - Pap Test - No Reflex HPV

 

Reviewed Date

4/7/2023