OnSite Gonorrhea Rapid Test (Strip) How To Run OnSite 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 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

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

OnSite Gonorrhea Rapid Test (Swab Test)

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

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: 1 test strip 1 swab 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

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

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

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

Perform Assay 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

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

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

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

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