Collection Manual: GC & CT Collection for DNA amplification (Neisseria gonorrhea & Chlamydia trachomatis)

Description: – Samples for GC and/or CT DNA tests are collected utilizing the techniques and materials for the Digene Cervical Sampler™. High-risk HPV DNA testing may also be performed on the same sample when the brush (but not the swab) is utilized. The sampling target is the cervical os. Samplers are intended for female cervix only.

Digene Cervical Sampler™ (brush kit or swab kit), requisition form, biohazard transport bag.

1. Complete a requisition form.
White copy to the lab. Lack of data may result in specimen delay or rejection. Include:
• Clinician name, location and date of service.
• Patient demographics: Name, address, phone number, date of birth and social security number.
• Insurance information: copy of insurance card(s) or face sheet.
• Indicate the test(s) to be performed and the reason for the order: Check Gonorrhea and/or Chlamydia, then indicate if the order is due to pregnancy, treatment follow-up, history of STD or other.

2. Select the appropriate sampler and label the vial.
• Digene makes collection kits with a brush sampler and a swab sampler. Select the brush kit for routine use. Use the swab kit when there is concern for cervical bleeding.
• Write the patient’s first and last name on the vial. Unlabelled vials must be returned.

3. Collect the sample.
• Collect the GC/CT sample after the Pap test (if applicable) and prior to acetic acid or iodine use.
• Remove excess mucous from the cervical os/ectocervix with a cotton swab. Discard the swab.
• Select the kit desired collection device, brush or swab.
• FEMALE SWAB SPECIMEN COLLECTION KIT. Insert the swab into the endocervical canal and rotate 180º x 5 turns, alternating left and right. Rub swab over entire transformation zone. Withdraw swab, avoiding contact with vaginal wall. Note: two swabs come with the kit, one for cleaning the cervix and one for sample collection.
• CERVICAL SAMPLER WITH BRUSH. Use the brush sampler. Insert the brush into the os until the largest outer bristles touch the ectocervix. DO NOT INSERT THE BRUSH COMPLETELY INTO THE CERVICAL CANAL. Rotate it 3 full turns in a counter-clockwise direction.

4. Secure the sample for transport.
• Insert the swab/brush to the bottom of the transport vial. Snap off the shaft at the score line, leaving the swab/brush in the vial. Recap the vial tightly.
• Seal the vial in the zip-loc portion of the transport bag & put the requisition form in the outer sleeve.

5. Refrigeration is not required.
NOTE: High-risk HPV DNA TESTING can also be performed from the Digene Cervical Brush Collection Kit, but cannot be performed from the Digene Female Swab Specimen Collection Kit.