381 Neisseria Gonorrhea (NG), Urine

Specimen Type Specimen Stability Reference Range
Random Urine
  or
GYN Fluid
30 Days, Ambient or Refrigerated in Aptima® Urine Collection Kit Not Detected

Specimen Requirements

Random Urine
Container: APTIMA Urine Collection Kit
Temperature: RefrigeratedPreferred Specimen: Random Urine
Container: APTIMA Urine Collection Kit
Temperature: Refrigerated
  or
Alternate Specimen: GYN Fluid
Container: YourSwab (BD ESwab)
Temperature: Ambient

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

2mL urine using Aptima Urine Specimen Collection Kit. NOTE: Make sure that urine falls between the black fill level lines on the Aptima tube.

Clinical Utility

To screen for or diagnose an infection with Neisseria gonorrhoeae, which causes the sexually transmitted disease gonorrhea.

CPT Codes

87591

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