Specimen Collection and Handling

Submit only one of the Following:

URINE:

1. Patient must not have urinated for at least 2 hours prior to sampling.

2. Collect 10-50 mL of first catch urine (first part of the stream) in a sterile container without preservatives.

3. Seal the container and label.

4. Transfer enough urine with pipet into the tube provided in the Aptima® PCR Urine Sample Packet. The fluid level must fall between the 2 black lines on the urine transport tube.

5. Urine specimens are accepted for both males and females.

6. According to the MMWR, the sensitivity of detecting CT/GC infections by any NAAT test can be up to 10% lower in a female urine specimens compared to a vaginal or endocervical swab, while the specificity is the same. For female patients, a vaginal swab is the preferred specimen.

To Process:

1. Send refrigerated and transport promptly.

2. Specimen must be received in the laboratory the same day as collected.

VAGINAL SWAB (Preferred Female Specimen):

1. Collect using the Aptima® Multitest Swab Specimen Collection Kit supplied by NorDx (see below)

2. Insert dry swab into vagina (do not pre-wet in PCR media) and rotate swab for 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.

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

6. Send at 2-30°C.

SPECIMEN SOURCE IS REQUIRED ON REQUEST FORM FOR PROCESSING

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. 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.