【INTENDED USE】
The Gonorrhea Rapid Test (Swab) is a rapid visual immunoassay for the qualitative presumptive detection of Neisseria gonorrhoeae in female cervical swab and male urethral swab specimens. This kit is intended for use as an aid in the diagnosis of Gonorrhea.For professional in vitro diagnostic use only.
【INTRODUCTION】
Gonorrhea is a sexually transmitted disease caused by the bacterium Neisseria gonorrhoeae. Gonorrhea is one of the most common infectious bacterial diseases and is most frequently transmitted during sexual intercourse, including vaginal, oral and anal sex. The causative organism can infect the throat, producing a severe sore throat. It can infect the anus and rectum, producing a condition called proctitis. With females, it can infect the vagina, causing irritation with drainage (vaginitis). Infection of the urethra may cause urethritis with burning, painful urination, and a discharge. When women have symptoms, they often note vaginal discharge, increased urinary frequency, and urinary discomfort. Spread of the organism to the fallopian tubes and abdomen may cause severe lower-abdominal pain and fever. The average incubation for Gonorrhea is approximately 2 to 5 days following sexual contact with an infected partner. However, symptoms may appear as late as 2 weeks. A preliminary diagnosis of Gonorrhea can be made at the time of examination. In women, Gonorrhea is a common cause of pelvic inflammatory disease (PID). PID can lead to internal abscesses and long-lasting, chronic pelvic pain. PID can damage the fallopian tubes enough to cause infertility or increase the risk of ectopic pregnancy. A smear or swab of urethral or cervical discharge may be taken and tested using a Gonorrhea Rapid Test.
【PRINCIPLE】
The Gonorrhea Rapid Test (Swab) detects Neisseria gonorrhoeae through visual interpretation of color development on the internal strip. Gonorrhea Antigen-specific monoclonal antibody is immobilized on the test region of the membrane. During testing, the specimen reacts with monoclonal anti-Gonorrhea antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient Gonorrhea antigen in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
【CONTENTS】
• Rapid test cassette with desiccant.
• Sampling Swab
• Reagent 1
• Reagent 2
• Extraction Tube
• Package insert
【WARNINGS AND PRECAUTIONS】
• Immunoassay for in vitro diagnostic use only.
• Do not use after expiration date.
• The test should remain in the sealed pouch until use.
• The used test should be discarded according to local regulations.
【STORAGE AND STABILITY】
• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Keep away from direct sunlight, moisture and heat.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
【SAMPLE COLLECTION AND STORAGE】
The quality of specimen obtained is of extreme importance. Detection of gonorrhea antigen requires a vigorous and thorough collection technique that provides adequate amount of antigen. Do not use 0.9% sodium chloride to treat swabs before collecting specimens.
For female cervical specimens: ·Use the swab provided with the kit. ·Before specimen collection, remove excess mucus from the endocervical area with a cotton ball and discard. The swab should be inserted into the endocervical canal, past the squamocolumnar junction until most of the tip is no longer visible. This will permit acquisition of columnar or cuboidal epithelial cells, which are the main reservoir of the gonococcus organism. Firmly rotate the swab 360o in one direction (clockwise or counterclockwise) for 15 seconds, and then withdraw the swab. Avoid contamination from exocervical or vaginal cells. If the swab may be tested immediately, replace the swab into the extraction tube.
For male urethral specimens: ·Standard wire-shafted fiber-tipped swabs or cytology brushes (not provided) should be used for urethral specimen collection. Instruct the patients not to urinate at least one hour prior to specimen collection. ·Insert the swab 2-4 cm into the urea, rotate for 3-5 seconds and withdraw it. If the swab may be tested immediately, replace the swab into the extraction tube. Do not place the swab in any transport device containing medium. Transport medium interferes with the assay, and viability of organisms is not required for the assay. If immediate testing is not possible, patient samples should be placed in a dry transport tube for storage or transport. The swabs may be stored for 4 hours at room temperature (15-30°C) or 24 hours refrigerated (2- 8°C). Do not freeze. All specimens should be allowed to reach a room temperature of 15- 30°C before testing.
【OPERATION】
Allow the test, specimen, reagents, and/or controls to reach room temperature (15- 30C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Extract the Chlamydia antigen according to the specimen type. For Female endocervical or Male urethral swab specimens:
• Place a clean extraction tube in the workstation. Add 5 drops of Ragent 1 to the extraction tube.
• Immerse the patient swab into the extraction tube and wait 2 minutes. While waiting, use a circular motion to roll the swab against the side of the extraction tube so that the liquid is expressed from the swab and can reabsorb
• Add 6 drops of Reagent 2. Squeeze the swab firmly against the tubetoexpelasmuch liquid as possible from the swab for 1 minute. Discard the swabfollowingguidelines for handling infectious agents. Fit the dropper tipontopoftheextraction tube.
• The extracted specimen can remain at room temperature for 60minuteswithout affecting the test result. For Male urine specimens:
• Add 6 drops of Reagent 2 to the urine pellet in the centrifuge tube, thendrawthe liquid up and down with a pipette to vigorously mix until the suspensionishomogeneous.
• Transfer all the solution in the centrifuge tube to an extractiontube. Letstandfor 2 minute. Hold the Reagent 2 bottle upright and add 5 drops of Reagent1tothe extraction tube. Vortex or tap the bottom of the tube to mix thesolution.Letstand for 1 minutes.
• Fit the dropper tip on top of the extraction tube.
3. Add 2 drops (approximately 50 µL) of extracted specimenfromtheextraction tube to the specimen well (S) of the test cassette. Avoid trapping air bubbles in the specimen well (S), anddonot addanysolution to the result window. As the test begins to work, color will migrate across the membrane.
4. Wait for the colored band(s) to appear. The result shouldbereadat10minutes. Do not interpret the result after 20 minutes.
【INTERPRETATION OF RESULTS】
POSITIVE: The presence of two lines as control line (C) andtest line(T)within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result windowindicates a negative result.
INVALID: If the control line (C) is not visible within the result windowafterperforming the test, the result is considered invalid. Some causesofinvalidresults are because of not following the directions correctly or the test mayhave deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
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