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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