Neisseria gonorrhoeae Assay

GeneXpert Xpert CT/NG collection device
Submit one of the following:

Vaginal/Endocervical (Red top):
1. In obtaining specimen, clean area of inflammatory cells using larger swab. Discard swab.
2. Use second small swab to scrape epithelial cells and insert into media tube.
3. Snap off shaft at score line. Use care to avoid splashing contents.
4. Cap tube tightly.
5. Label tube with patient’s name (first and last) and date and actual time of collection. 

 Urine (Yellow top):
1. The patient should not have urinated for at least 1 hour prior to specimen collection.
Female patients should not cleanse the labial area prior to collecting the specimen. Male subjects should not cleanse the tip of penis prior to collecting specimen.
2. Direct patient to provide first-catch urine (approximately 20 to 50 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution which may reduce test sensitivity.
3. Ensure that the urine is well mixed in the urine cup before transferring a sample to the Xpert CT/NG Urine Transport Reagent tube.
4. Open the packaging of a disposable transfer pipette provided in the kit.
5. Remove the cap from the Xpert CT/NG Urine Transport Reagent tube and from the urine collection cup.
6. Insert the transfer pipette into the urine cup so that the tip is near the bottom of the cup. Transfer approximately 7 mL of urine into the Xpert CT/NG Urine Transport Reagent tube using the disposable transfer pipette. The correct volume of urine has been added when the level reaches the black dashed line on the label of the Xpert CT/NG Urine Transport Reagent tube.
7. Replace the cap on the Xpert CT/NG Urine Transport Reagent tube and tighten securely.
8. Invert the collection tube 3-4 times to ensure that the specimen and reagent are well mixed.
9. Recap the urine cup securely.
10. Label the transport tube with sample identification information, including date of collection, as required. Take care not to obscure the fill line on the transport tube. 

Self Collection (Red top):
This method is also approved for self-collected specimens.  Please provide patient with Collection Kit and Instruction directions. 

The following specimens will not be tested:
1. Specimen not transported in proper holding media
2. Improper swab used in obtaining specimen
3. Insufficient fluid volume
4. Multiple swabs in holding media
5. No swab in transport media