Specimen Requirements

Female Patient Cervical/Endocervix:

1. Remove excess mucus from cervical and surrounding mucosa using the cleaning swab (large cotton-ended swab provided). Discard this swab.

2. Insert the Copan flocked collection swab into the endocervical canal.

3. Gently rotate swab clockwise for 10-30 seconds in the endocervical canal to ensure adequate sampling.

4. Withdraw swab carefully, avoiding any contact with vaginal mucosa.

5. Remove cap from swab specimen transport tube and immediately place the specimen collection swab into the transport tube.

6. Carefully break the swab shaft at the scoreline; use care to avoid splashing of contents.

7. Recap the swab specimen and transport tube tightly.

8. After collection, transport and store swab specimen transport tube at 2-30° C. Assay within 60 days of collection.

Female Patient Vaginal:

1. Do not use the large cotton-ended swab. Discard.

2. Insert the Copan flocked collection swab into the vagina.

3. Gently rotate swab clockwise for 10-30 seconds in the vagina to ensure adequate sampling.

4. Withdraw swab carefully.

5. Remove cap from swab specimen transport tube and immediately place the specimen collection swab into the transport tube.

6. Carefully break the swab shaft at the scoreline; use care to avoid splashing of contents.

7. Recap the swab specimen and transport tube tightly.

8. After collection, transport and store swab specimen transport tube at 2-30° C. Assay within 60 days of collection.

Urine, Male or Female:

1. The patient should not have urinated for at least 1 hour prior to sampling.

2. Direct the patient to provide a first-catch urine (approximately 20-30 mL of initial urine stream) into a urine collection cup. Collection of larger volumes of urine may reduce test sensitivity. The urine cups have markings showing volume levels. Female patients should not cleanse the labial area prior to providing the specimen. Male patients should not cleanse the tip of the penis.

3. Urine specimens must be transported to the laboratory at 2-8° C in the primary colleciton device (urine cup).

4. Urine specimens must be maintained at 2-8° C and must be preserved within 4 days of collection.  Urine specimens stored at room temperature must be preserved within 4 hours of collection.

5. BD culture transport tube or catheterized urine are not acceptable specimens.

Limitations:

This test has not been evaluated in pregnant women, or in patients with a history of hysterectomy. The test has not been evaluated in patients less than 18 years of age or older than 78 years of age.