Specimen Requirements

1. Obtain an adequate sampling of endocervix and cervix using a broom-type collection device or a combination endocervical brush/spatula.

A. If using a broom-like device, insert central bristles deep enough into endocervical canal so that outer bristles are in full contact with ectocervix. Gently rotate broom 5 times. Immediately rinse broom in PreservCyt solution by pushing broom into bottom of vial 10 times, forcing bristles apart. As a final step, swirl broom vigorously to release any additional material. Failure to adequately rinse collection device may result in a specimen with low cellularity. Discard collection device. Do not leave collection device head in vial.

B. With a plastic or wooden spatula thoroughly scrape entire ectocervix with emphasis on squamocolumnar junction. Rinse spatula into PreservCyt Solution by swirling spatula vigorously in vial 10 times. Discard spatula. Use an endocervical brush to obtain an adequate sampling from endocervix by inserting brush into cervix until only bottommost fibers are exposed. Slowly rotate to and turn in 1 direction. Immediately rinse broom in PreservCyt solution by pushing endocervical brush against PreservCyt solution vial wall. Swirl brush vigorously to release any additional material. Failure to adequately rinse collection device may result in a specimen with low cellularity. Discard collection device. Do not leave collection device head in vial.

2. Tighten cap so that torque-line on cap passes torque-line on vial.

3. Label PreservCyt vial with patient’s full first and last name, date of birth, and date of collection.

4. Complete a gynecologic cytology requisition form. Include the following information:

A. Patient’s full first and last name

B. Date of birth

C. Medical record or Social Security number

D. Date of collection

E. Submitting physician’s name. Include names of physicians to receive cytology report copies.

F. Specimen source

G. Date of last menstrual period

H. Hormonal status

I. Exogenous hormone therapy

J. Presence of IUD

K. DES exposure

L. History of cervical abnormality, cervical malignancy or extragenital malignancy

M. History of chemotherapy

N. History of radiation therapy

O. History of gynecologic surgery, cryosurgery, electrocautery or laser surgery

P. Current abnormal findings or patient complaints

Q. High-risk factors for cervical cancer

5. The ThinPrep vial containing cytologic specimen is stored and transported between 15° C (59° F) and 30° C (86° F).

6. Specimen rejection criteria is based on improper specimen labeling, collection, handling, or submission:

A. Specimen that has leaked into plastic biohazard bag

B. No gynecologic cytology requisition form

C. Name on requisition does not match name on slide

D. Unlabeled specimen container or slide. Two patient identifiers are required on specimen container

E. More than 1 ThinPrep vial in biohazard bag.

F. No physician’s name

HPV TESTING

This is an FDA approved direct from ThinPrep vial test using specimen remaining from gynecologic cytology test. ACOG recommends HPV screening in conjunction with Pap Test for women >30 years of age. HPV test is used in assessment of ASC-US specimen to help determine if increased surveillance with colposcopy is needed. Specimen is a sample of endocervical/cervical/vaginal epithelium collected in a ThinPrep vial containing PreservCyt solution with a minimum volume of 4 mL remaining of original specimen. The method for this test is the Cervista^TM HPV HR which is a qualitative, in vitro diagnostic test for the detection of DNA from 14 high-risk HPV types, namely, types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Submitting physician will receive a separate report. There are 3 ways to order HPV test on gynecologic cytology requisition:

1. Ordering physician requests reflex HPV testing whenever current Pap test is reported as atypical squamous cells of undetermined significance. ASC-US.

2. Ordering physician requests HPV testing on all abnormal cytology results.

3. Ordering physician requests HPV testing on all cytology results.

4.  Ordering physician requests HPV testing plus 16 18.

Alternatively, ordering physician may request add on HPV testing after receiving cytology report by handwriting “Do HPV test” on report and faxing report copy to Pathology Office.