Test Code CT/NG C. trachomatis and N. gonorrhoeae, NAAT
Additional Codes
LAB1376
Collection Method
- Sterile urine collection
- Endocervical / Vaginal
Minimum Volume
7ml for urine specimen
or
1 Endocervical / Vaginal Swab
Container
Swab collected with the Xpert Swab Specimen Collection Kit or Sterile Urine Cup
Acceptable Specimens
Urine, Endocervical / Vaginal Swab
Reference or Target Ranges
Negative
Critical Value
Positive C. trachomatis and/or positive N. gonorrhoeae results.
Reportable Units
Positive or Negative
Reasons for Rejection
• Other sample types or collection devices will not be accepted. The Xpert Swab and Urine Specimen Collection Kits are intended to be used with the transport reagent tube and/or swab provided. The use of transport reagent tubes or swabs from any other source could affect the performance of the assay.
• Expired specimens.
• Specimens stored or transported outside the allowed stability limits.
• Patient self-collect swabs collected at home or without supervision of a qualified medical provider are not acceptable.
• Spilled or leaked specimens where there is insufficient liquid remaining to meet the minimum test run volume. Minimum test volume = 50 uL of reagent/sample mixture.
Specimen Stability
Specimen Type | Stability |
Urine Male |
15°C to 30° C: 45 days 2°C to 30° C : 45 days Do Not Freeze |
Urine Female |
15°C to 30° C: 3 days 2°C to 30° C : 45 days Do Not Freeze |
Endocervical / Vaginal Swab |
15°C to 30° C: 60 days 2°C to 30° C : 60 days Do Not Freeze |
Performance Information
Days and Time Performed | 24/7 |
Expected Turn Around Time | Stat: 1 hour Routine: 4 hours |
Stat Availabilty | Yes |
Performing Bench | CPH Microbiology |
Methodology/Method Description | Cepheid GeneXpert |
CPT Codes
0353U
Last review/edit date
March 2024