Gonorrhea Rapid Test Kit

The Neisseria gonorrhoeae bacteria is the source of gonorrhea, a sexually transmitted illness (STD). The urethra in both men and women, as well as the cervix, uterus, and fallopian tubes in women, are among the reproductive tract's mucous membranes that are infected by N. gonorrhoeae. The Gonorrhea Rapid Test Kit is a qualitative, lateral flow immunoassay for the detection of gonorrhea antigen from female cervical swab and male urethral swab specimens. In this test, antibody specific to the gonorrhea antigen is coated on the test line region of the test. During testing, the extracted antigen solution reacts with antibody against gonorrhea antigen that is coated onto particles. The mixture migrates up the test strip to react with the antibody against gonorrhea antigen on the membrane and generate a colored line in the test line region. The presence of this colored line in the test line region (T) indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region (C) indicating that proper volume of specimen has been added and membrane wicking has occurred

Reagents

The test contains neisseria gonorrhoeae antibody as the capture reagent, another neisseria

gonorrhoeae antibody as the detection reagent. A goat anti-mouse IgG antibody is employed in the

control line system.

Storage and Stability

Store as packaged in the sealed pouch at room temperature or refrigerated (4-30℃ or 40-86℉).

The test device is stable through the expiration date printed on the sealed pouch.

The test must remain in the sealed pouch until use.

Specimen

The Neisseria Gonorrhoeae Ag Test can be performed using female cervical swab and male urethral swab specimens. The quality of specimens obtained is of extreme importance. Detection of Gonorrhea antigen requires a vigorous and thorough collection technique that provides adequate amount of antigen

Sensitivity and Specificity

Relative sensitivity: 91.55%; Relative specificity: 96.05% 

Overall agreement: 93.88% 

 

 

1. Remove the Gonorrhea Rapid Test Kit 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. Hold the reagent A bottle vertically and add 4 full drops of reagent A (approximately 200 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. Stand by 2 minutes.

3. Hold the reagent B bottle vertically and add 4 full drops reagent B (approximately 200µL) to the

tube. Reagent B is pale yellow. The solution will turn cloudy. Compress the bottom of tube and

rotate the swab 15 times until the solution turns to a clear color with a slight green or blue tint. If

the swab is bloody, the color will turn yellow or brown. Stand by 1 minute.

 

4. 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.

5. Transfer 3 drops of processed specimen (approximately 90μl) to the specimen well(S) of the test

device, then start the timer.See illustration below.

6. Wait for the red line(s) to appear. Read the result at 15 minutes. Do not read the Gonorrhea Rapid Test Kit result after 20

minutes

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