Gonorrhea Rapid Test

Intended Use

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. Gonorrhea Rapid Test is intended for use as an aid in the diagnosis of Gonorrhea.

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 Device (Swab).

Materials

● Individually packed test devices

● Extraction tubes & tips

● Reagent A

● Reagent B

● Package insert

● Sterilized swabs

● Workstation

Test Procedure

Allow the test, specimen, reagents, and/or controls to reach room temperature (15 30°C) prior to testing.

1. Remove the test device 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 Gonorrhea antigen according to the specimen type.

● Hold the Reagent A bottle vertically and add 5 full drops of Reagent A (approximately 300 µL) to the extraction tube. Reagent A is colorless. Immediately insert the swab, compress the bottom of the tube and rotate the swab 15 times. Let stand for 2 minutes.

● Hold the Reagent B bottle vertically and add 4 full drops of Reagent B (approximately 200 µL) to the extraction tube. The solution will turn turbid. Compress the bottom of tube and rotate the swab 15 times until the solution turns clear with a slight green or blue tint. If the swab is bloody, the color will turn yellow or brown. Let stand for 1 minute.

● Press the swab against the side of the tube and withdraw the swab while squeezing the tube. Keep as much liquid in the tube as possible. Fit the dropper tip on top of the extraction tube.

3. Place the test on a clean and level surface. Add 3 drops of the extracted solution (approximately 100 µL) to the specimen well (S) of the test, then start the timer. Avoid trapping air bubbles in the specimen well (S).

4. Wait for the colored line(s) to appear. Read the result at 10 minutes. Do not interpret the result after 20 minutes.

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