Donor Chlamydia trachomatis/Neisseria gonorrhoeae RNA, TMA
Also known as: C. trachomatis/GC, Donor, Donor, C. trachomatis/N.gonorrhoeae, DONOR TESTING ONLY
Use
This test is intended for donor screening of Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid (RNA), using transcription-mediated amplification (TMA) assays. It is performed in accordance with FDA requirements for donor testing where, until specific FDA-approved donor screening assays are available for these pathogens in HCT/P donors, diagnostic-grade tests labeled for detection in asymptomatic, low-prevalence populations are used as part of the RCDAD screening panel. It screens potential donors of human cells, tissues, and cellular and tissue-based products for these sexually transmitted pathogens in a donor context.
Special Instructions
Test is intended for donor (blood and HCT/P) screening at Quest’s dedicated donor testing facility in Chantilly, Virginia. It must utilize FDA-licensed, approved, or cleared diagnostic assays without modification or lab-developed test variants, as required by donor testing regulations.
Limitations
As donor testing, this test must use unmodified FDA-licensed or cleared diagnostic assays; any lab-developed modifications are prohibited. It is applicable only in low-prevalence, asymptomatic donor populations and is not a replacement for diagnostic testing in symptomatic individuals.
FDA Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
Result Turnaround Time
3 days
Related Documents
For more information, please review the documents below
Specimen
Urine
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
First-catch urine; patient should not urinate for at least one hour prior to collection