Specimen Collection and Handling

Submit only one of the following:

VAGINAL SWAB (Preferred Female Specimen):

Collect using the Aptima® Multitest Swab Specimen Collection Kit, supplied by NorDx, as follows:

1. Insert dry swab into vagina (do not pre-wet in PCR media) and rotate swab for 30 seconds to ensure adequate sampling.

2. Transfer swab to the tube of Aptima® PCR Medium and break swab into the tube at the scored black line on the shaft.

3. Leave swab in the transport medium and replace the tube cap securely to prevent leaking.

4. Label the transport tube according to policy and transport to the lab for testing.

5. SPECIMEN SOURCE IS REQUIRED ON REQUEST FORM FOR PROCESSING

ENDOCERVIX (Alternate Female Specimen):

Collect using the Aptima® Unisex Swab Specimen Collection Kit, supplied by NorDx, as follows:

1. Remove excess mucus from the exocervix using one of the swabs provided in the collection kit and DISCARD this swab.

2. Insert the second swab into the endocervix and rotate for 15 – 30 seconds to ensure adequate sampling.

3. Transfer swab to the tube of Aptima® PCR Medium and break swab into the tube at the scored black line on the shaft.

4. Leave swab in the transport medium and replace the tube cap securely to prevent leaking. (Cause for rejection: receipt of transport medium with no swab.)

5. Label the transport tube according to policy and transport to the lab for testing.

6. SPECIMEN SOURCE IS REQUIRED ON REQUEST FORM FOR PROCESSING

Vaginal swab is the optimal female specimen type for this assay. Use of other specimen types such as First-catch Urine, ThinPrep vial, or M-4 endocervical samples may reduce assay sensitivity.

Replens® lubricant, spermicidal agents and feminine powder sprays may interfere with the assay lead to a result of INVALID. These products should not be used prior to specimen collection.

OTHER ACCEPTABLE SPECIMENS INCLUDE:

SOURCE TYPES: Cervical, Urethral, Penile, Vaginal.

1. Endocervical swab in M-4 transport media

2. BD ProbeTec swab, ThinPrep® vial.

These specimen types are not FDA-Approved and assay sensitivity may be affected.

This test has been approved by the U.S. Food and Drug Administration (FDA) for use with the following specimen types:

1) self-collected vaginal swabs collected with a Aptima PCR Female Swab Sample kit in a clinical setting,

2) male urine specimens that have been stabilized in Aptima PCR media within 24 hours of collection. Use of other specimen types may adversely affect assay performance.

See test code CTGCU for urine sources and CTGCO for oral, anal, or rectal swabs.