1. OnSite Gonorrhea Rapid Test (Strip)
How To Run
OnSite Gonorrhea Rapid Test (Strip)
(Catalog: R0085S)

2. N. gonorrhoeae and Gonorrhea
Gonorrhea infected by Neisseria gonorrhoeae (N. gonorrhoeae), a gram-negative diplococcus
After chlamydia, gonorrhea is the most commonly sexually transmitted disease in the world
infect more than 106 million people each year
820,000 new cases in U.S. annually
drug-resistant gonorrhea spreads since 2008
N. gonorrhoeae

3. Current Diagnosis Methods Nucleic Acid Amplification
Gram Stain
Culture Isolation
Nucleic Acid Amplification
OnSite Gonorrhea
Rapid Test
Sensitive and specific
Time consuming
Specialist
Expensive
Biochemistry test
Non-culture, rapid, simple, inexpensive

4. OnSite Gonorrhea Rapid Test
(Swab Test)

5. Intended Use Strip format (swab test)
Qualitative detection of the oxidase activity of N. gonorrhoeae
in less than 1 minute
in the secretary specimen from urogenital system
Used as a screening test for diagnosis of infection with N. gonorrhoeae

6. Test Principle
Detect the activity of oxidase produced during gonococcus replication in the infected site
The test strip is pre-coated with the substrate of oxidase. The swab specimen if contains the enzyme, will react to the substrate, forming a color substance
The result can be visually interpreted by color change
Sample Pad

7. Kit Components Individually sealed foil pouches containing:
1 test strip
1 swab
1 desiccant
Package insert

8. Materials Required and Not Provided
Protection sheet
Disposable gloves
Clock or timer
Biohazard container

9. Precautions Precautions Explanation
Read entire package insert before testing
Pay attention to updated information
Do NOT open the pouch unless ready to test
Test device become moisture when expose to humidity air, affect flow
Do NOT use components in any other type of test kit
Component in each kit is unique
Do NOT use expired devices
Expired product gives error result
Bring all reagents to room temperature (15-30°C) before use
Cold reagent has different viscosity, affect flow migration and results
Do NOT perform the test in a room with strong air flow as the specimens might evaporate before reach
Strong air flow causes specimen evaporation during assay, leads to error result

10. Preparation for Assay Set up work area with a clean protection sheet
Wear protective clothing and disposable gloves

11. Preparation for Assay
Bring all kit components to room temperature (15-30°C) prior to testing

12. Preparation for Assay Double check product’s name and expiration date
Product Name
Expiration Date
Do not use expired test device

13. Perform Assay Open pouch, and take out the test strip and swab
Collect specimen with swab
Do not open pouch unless ready to run the test

14. Specimen Collection and Handling
For Male
Swab discharges from the opening of the urinary tract
If no discharge is present, insert the swab 2-3 cm into the urinary tract, gently rotate the swab and retrieve the swab
For Female
Swab discharges from the vaginal opening
For more accurate results, insert swab into cervix or vagina for half a minute, rotate and retrieve the swab
Soak the swab with saline first if discharge is too viscous
Don’t apply blood, sperm, or others from non-urogenital system
Collect cervical discharges without blood if in menstrual period
Don’t take any vaginal medicine for 3 days prior to this test
Test the specimen immediately. Avoid drying out the specimen

15. Perform Assay Apply the swab onto the orange sample pad
Keep the strip flat on the bench
Set up timer
wait for seconds to read result

16. Read Assay Result Negative Result orange light green Positive Result
dark green dark blue
Positive test result should be confirmed by other confirmative tests
Having sex 3 days prior to testing may lead to false test result

17. Perform Assay
Discard the used swab, test strip and protection sheet into biohazard container after interpreting the result

18. Limitation of Test
The assay procedure and the assay result interpretation MUST be followed closely when testing the sepecimen from individual subjects. For optimal test performance, proper sample collection and storage procedures are critical. Failure to follow the procedure may give inaccurate results
Limited to the qualitative detection of N. gonorrhoeae oxidase in secretary specimen from urogenital system. The intensity of the test color does not correlate with the amount of the oxidase in the specimen
A negative test result:
does not preclude the possibility of exposure to or infection with N. gonorrhoeae
can occur if the quantity of the oxidase present in the specimen is below the detection limits of the assay, or is not present during the stage of disease
The result should only be interpreted in conjunction with other diagnostic procedures and clinical findings

19. Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA USA
Telephone: 1 (858) Fax: 1 (858)

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