INTENDED USE

The Gonorrhea Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Neisseria gonorrhoeae in female cervical swab and male urethral swab specimens to aid in the diagnosis of Gonorrhea infection.

MATERIALS

• Materials Provided

1. Test devices
2. Test tubes
3. Dropper tips
4. Sterile polyester tipped applicator (Sterile female cervical swabs)
5. Reagent A
6. Reagent B
7. Workstation
8. Package insert

• Materials Required But Not Provided

1. Timer
2. Sterile male cervical swabs
3. Positive control
4. Negative control
5. Urine Cup (for male urine specimens only)
6. Centrifuge tube (for male urine specimens only) 

STORAGE & STABILITY

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30℃). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.