Donor, Chlamydia trachomatis/Neisseria gonorrhoeae, RNA, TMA

Test Code
17385


CPT Codes
87491, 87591

Preferred Specimen
Endocervical or urethral (males only) swabs collected in Aptima® Combo 2 Assay Unisex Swab Collection Kit or
Vaginal swabs collected in the Aptima® Combo 2 Assay Vaginal Swab Collection Kit or Multi-test Collection Kit or

2 mL urine using Aptima® Urine Specimen Collection Kit or
2 mL unpreserved urine transferred into the Aptima® urine transport medium within 24 hours of collection and before being assayed


Minimum Volume
2 mL urine


Instructions
⁠⁠⁠⁠⁠⁠⁠Please note: This test is to be used for the screening of DONORS of human cells, tissues, and cellular and tissue-based products for infectious diseases.

Room temperature stability for raw urine: 24 hours before transfer into Aptima®. Urine in Aptima® 30 days.

If freezing, must freeze within 7 days of collection.

For Shipper collection please see detailed instructions in Test Resources.


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Swabs
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year

Urine
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year


Methodology
Transcription-Mediated Amplification (TMA)

Setup Schedule
Set up: Daily; Report available: 24 hours


Clinical Significance
This test is intended to be used as the primary screening test for the diagnosis of infection with Chlamydia trachomatis or Neisseria gonorrhoeae and is required for screening all potential semen or egg donors for in vitro fertilization or other reproductive procedures; reactive results may be sufficient to consider a donor ineligible.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.