Gonorrhea Rapid Test – for Home Self-Testing for Women and Men (1 test/box)

The test can be performed using a vaginal swab sample in women or a urethral swab sample in men. The test may help detect gonorrhea infection.

Gonorrhea is a common sexually transmitted bacterial infection. It is most commonly transmitted through vaginal, oral or anal sexual contact. The infection can affect, among other areas, the urethra and the female reproductive organs and may cause complications if not treated appropriately.

Gonorrhea can cause different symptoms in women and men. The instructions for use mention, among others, the following symptoms:

• painful urination or a burning sensation when urinating,
• frequent or urgent need to urinate,
• discharge from the urethra,
• discomfort around the urethra,
• unusual or abnormal vaginal discharge,
• lower abdominal pain or a feeling of pressure,
• bleeding between periods or after sexual intercourse,
• in men, pain, swelling or tenderness of the epididymis.

According to the instructions for use, the average incubation period of gonorrhea is approximately 2–5 days after sexual contact with an infected partner; however, symptoms may take up to 2 weeks to appear.

Product name: Gonorrhea Rapid Test – for home self-testing for women and men

Sample: female vaginal swab sample / male urethral swab sample

Pack size: 1 test/box

Format: test cassette

Manufacturer: Hangzhou Alltest Biotech Co., Ltd., Ltd., 550 Yinhai Street, Hangzhou Economic and Technologic Development Area, 310018, Zhejiang, China; Phone: +86-571-56267891; info@alltests.com.cn

EC REP: MedNet GmbH, Hansestraße 91, 48165 Münster, Germany; +49 251 32266-0; info@medneteurope.com

1. Before collecting the sample, wash your hands thoroughly with soap and then rinse them with clean water.

2. Remove the supplied sterile female swab from the pouch.

3. Insert the tip of the swab into the vagina.

4. Firmly rotate the swab 360° in one direction.

5. Hold it in place for 15 seconds, then carefully remove it. Make sure that the swab does not come into contact with any other external surface during removal.

The collected sample must be used immediately for testing. According to the instructions for use, a female sample must not be collected during menstruation.

Do not urinate for at least 1 hour before collecting the sample.

1. Wash your hands thoroughly.

2. Remove the supplied sterile male urethral swab from the pouch.

3. Carefully insert the tip of the swab approximately 2–4 cm into the urethra.

4. Rotate it 360° in one direction, then leave it in place for 10 seconds.

5. Carefully remove the swab, making sure that it does not come into contact with any other external surface.

Allow the test and buffer solutions to reach room temperature (15–30 °C) before use.

1. Remove the cap from the Buffer 1 tube and place the tube in the holder provided in the packaging.

2. Place the swab containing the sample into Buffer 1. Squeeze the bottom of the tube and rotate the swab 15 times, then leave it to stand for 2 minutes.

3. Break the Buffer 2 ampoule at its narrowest point, then pour its entire contents into the tube containing Buffer 1.

4. While squeezing the tube, rotate the swab another 15 times, then leave it to stand for 1 minute.

5. Press the swab against the wall of the tube and remove it while squeezing the tube so that as much liquid as possible remains in the tube.

6. Close the tube with the large cap, then open the small dropper cap.

7. Remove the test cassette from the sealed foil pouch and place it on a clean, level surface.

8. Turn the buffer tube upside down and add 3 full drops of the solution to the sample well marked S on the test cassette. Start the timer and do not move the cassette during the test.

9. Read the result after 10 minutes. The result must not be interpreted after 30 minutes.

If two coloured lines appear – one in the C (control) region and one in the T (test) region – the result is positive.

A positive result means that the test has detected Neisseria gonorrhoeae antigen in the sample. The intensity of the test line may vary: a faint but visible T line must also be interpreted as a positive result.

In the event of a positive result, consult a doctor immediately and show them the test result. The healthcare professional will determine whether further testing or treatment is necessary.

If only the C control line appears and there is no line in the T region, the result is negative.

This means that the test did not detect gonorrhea antigen in the sample. However, if symptoms persist or worsen, consult a healthcare professional even if the result is negative.

If the C control line does not appear, the test result is invalid. In this case, the test must be repeated using a new test.

The appearance of the control line confirms that the test has functioned correctly; therefore, the result can only be interpreted if the C line is visible.

The performance data provided by the manufacturer were determined in a clinical study involving 220 participants – 110 women and 110 men – and compared with a PCR reference method.

Diagnostic sensitivity: 96.0%

Diagnostic specificity: 98.3%

Agreement rate: 97.3%

The Gonorrhea Rapid Test does not replace a medical diagnosis or consultation with a healthcare professional. In rare cases, false-positive or false-negative results may occur; therefore, medical evaluation is recommended in the event of a positive result or persistent symptoms.

The test is not suitable for monitoring the effectiveness of treatment because bacterial antigens may remain present even after appropriate antibiotic treatment. An excessive amount of blood on the swab may cause a false-positive result.

The kit must be stored at 2–30 °C, must not be frozen, and is intended for single use only.