Test Directory
381 Gonorrhea (NG), Urine
Specimen Type
Specimen Stability
Reference Range
Urine
30 days Room Temp or Refrigerated in Aptima® Urine Collection Kit
Not Detected
Specimen Requirements
2mL urine using Aptima® Urine Specimen Collection Kit
Method
Target Capture, TMA: Transcription-Mediated Amplification (NAT) and Dual Kinetic Assay (DKA). All specimens testing positive in the screening assay are confirmed in a confirmatory assay targeting different regions of the nucleic acid of the organism. This assay has been cleared for use by the FDA on some specimen types. For other specimen types where this assay has not been cleared or approved by the FDA; Pathology, Inc. has validated this test and determined its performance characteristics. This individual validation has not been cleared nor approved by the U.S. FDA. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes only. It should not be regarded as investigational nor for research. Pathology, Inc. is certified under CLIA as qualified to perform high-complexity testing.
Schedule
Mon-Sat
Turn-Around Time
24-48 hrs
Instructions/Notes
Fill Aptima® Urine tube to lines marked on device.
Urine in sterile urine container must be transferred to Aptima® Urine Collection Kit within 24hrs of collection.
Urine in sterile urine container must be transferred to Aptima® Urine Collection Kit within 24hrs of collection.
Clinical Utility
To screen for or diagnose an infection with Neisseria gonorrhoeae, which causes the sexually transmitted disease gonorrhea.
CPT Codes
87591
