ThinPrep® Pap Test

The Pap test is a valuable screening test for cervical cancer and its precursors. As with any laboratory test, both false negative and false positive results may occur. Positive results should be confirmed with additional studies as clinically indicated.

 

Use of Test

Evaluation of cervical-vaginal specimen for premalignant, malignant and inflammatory changes. Includes evaluation of the cervix, endocervix, ectocervix, vagina and vulva.

Collection Technique

Container identification may be affixed with a label or hand-printed and must include: patient’s full legal name, DOB, DOS and specimen source.

Speculum should be warmed and rinsed in saline solution; no lubricant should be used. Obtain an adequate sampling from the cervix using one of the methods below:

BROOM-LIKE DEVICE

    • 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 five (5) times.
    • Immediately and vigorously swirl the cell contents into the ThinPrep® vial, swirling the brush around the bottom of the vial at least 10 times for at least 10 seconds.

BRUSH

    • Insert the central bristles of the brush into the endocervical canal so that the bottom of the brush is visible at base of os.
    • Slowly rotate the brush in a clockwise direction ¼-½ turn. NOTE that over-rotating the brush may cause excessive bleeding leading to an unsatisfactory Pap test.
    • Immediately and with some force, vigorously swirl and twirl the brush against the edges of the ThinPrep® vial at least 10 times for at least 10 seconds.

SPATULA

    • Using a plastic spatula, insert the small end of the spatula into the ectocervix
    • Rotate the spatula one full turn in a clockwise direction
    • Quickly place the spatula into the vial and forcefully swish in the liquid against the ThinPrep® vial 10 times for at least 10 seconds

PLEASE NOTE: Make sure vial is properly closed to prevent spilling or leakage.

WSLH cytology requisition form #141 must include:

  • Patient’s full legal name
  • Full address, especially if patient has third-party insurance (commercial or government)
  • Clinic medical record number, if available
  • Date of birth
  • Date of collection
  • Specimen source
  • Clinician’s name, clinic address, phone and fax number
  • Date of last menstrual period (LMP)
  • Pertinent clinical history
  • Result of previous Pap test
  • Payment information

Test Kit

ThinPrep® Pap Kit #16

ThinPrep® Pap Kit #16 with Broom

Diagnostic Range

  • Negative for Intraepithelial Lesions or Malignancy (NILM)
  • Atypical Squamous Cells of Undetermined Significance (ASC-US)
  • Atypical Squamous Cells cannot rule out High-grade Lesion (ASC-H)
  • Atypical Glandular Cells of Undetermined Significance (AGC)
  • Low-grade Squamous Intraepithelial Lesion (LSIL)
  • Human Papillomavirus (HPV)
  • Mild Dysplasia (MLD)
  • Mild Dysplasia with Human Papilloma Virus (MLH)
  • High-grade Squamous Intraepithelial Lesion (HSIL)
  • Moderate Dysplasia (MOD)
  • Severe Dysplasia (SEV)
  • Carcinoma in situ (CIS)
  • Endocervical Adenocarcinoma in situ (AIS)
  • Positive for Squamous Carcinoma (SQCA)
  • Positive for Endocervical Adenocarcinoma (AEC)
  • Positive for Endometrial Adenocarcinoma (AEM)
  • Unsatisfactory for evaluation

Limitations

  • Do not collect specimen during menses
  • Specimens that do not meet basic requirements of cell volumes or that are not well-preserved/or visualized may be non-diagnostic and rendered unsatisfactory for evaluation.
  • Abnormal findings must be correlated with history and other test results.
  • The Pap test is a valuable screening test for cervical cancer and its precursors. As with any laboratory test, both false negative and false positive results may occur. Positive results should be confirmed with additional studies as clinically indicated.

Availability

Monday-Friday

Turnaround Time

7 days

PLEASE NOTE: Results may be delayed or the sample rejected if pertinent and/or required information needs clarification or is missing.

Test Codes

95000    THIN

Specimen Submission Requirements

ThinPrep® Kit #16 and Mailers. This kit is intended for collection and shipment of cervico-vaginal (gynecologic) specimens for analysis of pre-malignant or malignant disease. This kit is NOT SUITABLE for collection of specimens for chlamydia or other infectious diseases.

Contents of kit:

  • 1 ThinPrep® vial
  • Absorbent paper
  • Biohazard bag
  • Cytobrush and spatula or cytobroom
  • Styrofoam mailers
  • Mailing Labels

Mandatory Requirements

  • Label ThinPrep® vial with patient’s full legal name, date of birth (DOB) and date of service (DOS)
  • Complete WSLH requisition form #141.
  • Collect specimen and transfer to ThinPrep® vial.

PLEASE NOTE: Close vial cap tightly and check for possible leakage.

 

Mailing Requirements

  • Wrap absorbent paper around the ThinPrep® vial
  • Place the vial in a biohazard bag
  • Place the completed requisition form in the sleeve of the biohazard bag
  • Label the styrofoam mailer with the following:
    • Your laboratory/clinic’s address
    • WSLH Cytology Department address
    • Diagnostic specimen label
    • Shipping label: 49 CFR 173.4
  • Place the bag in a styrofoam mailer

PLEASE NOTE: The specimen does not need to be refrigerated or packed with ice.