PrEP Use Only: Chlamydia/Gonococcus, Urine or Urogenital Swab, NAA
Also known as: Pre-exposure prophylaxis screening for Ct/GC, Urine or Urogenital (Aptima®) Swab Source
Use
This test is for PrEP use only. Testing includes detection of Chlamydia trachomatis or Neisseria gonorrhoeae in urine or swab specimens.
Special Instructions
The test is designated for PrEP use and can only be used with urine or swab specimens collected with Aptima® kits. It's important to follow the strict guidelines for specimen collection to ensure accurate results. Any other specimens like rectal or pharyngeal swabs need to be ordered as different tests. Proper collection and transport of specimens are crucial to prevent contamination and ensure the integrity of results.
Limitations
The test has specific requirements for specimen collection that must be adhered to. It cannot be used in conjunction with routine chemistry or urine culture due to differences in collection techniques. Using a first-catch urine sample is critical to maintain test sensitivity, while clean catch midstream specimens are unsuitable for this testing. Furthermore, any deviation from the storage instructions or using improper transport containers can lead to specimen rejection.
Methodology
PCR-based (Nucleic acid amplification)
Biomarkers
LOINC Codes
- 64017-7
- 43304-5
- 43305-2
Result Turnaround Time
2-3 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
One swab (endocervical, vaginal or urethral) or 2 mL of a 20 mL to 30 mL urine collection
Minimum Volume
One swab (endocervical, vaginal or urethral) or 2 mL of a 15 mL urine collection
Container
Aptima® swab (Multitest or Unisex) or Aptima® urine specimen transport
Collection Instructions
Endocervical, vaginal, or urethral swabs should be collected using Aptima® kits, ensuring proper handling and transport in the designated containers. First-catch urine specimens should be collected without urination for at least one hour prior, using a urine collection cup free of preservatives, and transferred to an Aptima® urine collection device.
Storage Instructions
Maintain specimen at room temperature or refrigerate (2°C to 30°C)
Causes for Rejection
Specimens with incorrect patient identification, unlabeled specimens, improper transport conditions, leaked specimens, expired transport containers, inappropriate source for test, or improper specimen volume will be rejected. Certain swabs and containers are not compatible with this testing, including any non-Gen-Probe® swabs, wooden-shafted swabs, bacterial swabs, and specimens collected in inappropriate media.