How To RunOnSite Gonorrhea Rapid Test

(Strip)(Catalog: R0085S)

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 worldo infect more than 106 million people each yearo 820,000 new cases in U.S. annuallyo drug-resistant gonorrhea spreads since 2008 N. gonorrhoeae

Current Diagnosis Methods

Gram Stain Culture Isolation

Nucleic Acid Amplification

OnSite GonorrheaRapid Test

• Sensitive and specific• Time consuming• Specialist

• Expensive• Time consuming• Specialist

• Biochemistry test• Non-culture, rapid,

simple, inexpensive

OnSite Gonorrhea Rapid Test(Swab Test)

• Strip format (swab test)

• Qualitative detection of the oxidase activity of N. gonorrhoeae o in less than 1 minuteo in the secretary specimen from urogenital system

• Used as a screening test for diagnosis of infection with N. gonorrhoeae

Intended Use

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

Kit Components

• Individually sealed foil pouches containing: o 1 test strip o 1 swab o 1 desiccant

• Package insert

Materials Required and Not Provided

• Protection sheet

• Disposable gloves

• Clock or timer

• Biohazard container

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

Preparation for Assay

• Set up work area with a clean protection sheet

• Wear protective clothing and disposable gloves

Preparation for Assay

• Bring all kit components to room temperature (15-30°C) prior to testing

Do not use expired test device

• Double check product’s name and expiration date

Product Name

Expiration Date

Preparation for 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

Perform Assay

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

• Apply the swab onto the orange sample pad

• Keep the strip flat on the bench• Set up timer• wait for 10-20 seconds to read

result

Perform Assay

Negative Result

Positive Result

orange light green

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

Read Assay Result

• Discard the used swab, test strip and protection sheet into biohazard container after interpreting the result

Perform Assay

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: o does not preclude the possibility of exposure to or infection with N.

gonorrhoeaeo 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

Technical Support

Contact Info.:10110 Mesa Rim Rd. San Diego, CA 92121 USAEmail Address: tech@ctkbiotech.com Telephone: 1 (858) 457-8698Fax: 1 (858) 535-1739

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