Gonorrhea (Tripper) Rapid Test (1 pc/box)

Gonorrhea (Tripper) Rapid Test Kit (1 pc/box)

Gonorrhea, also known as tripper or “the clap,” is a sexually transmitted infection caused by the bacterium Neisseria gonorrhoeae. It is one of the most common bacterial STIs worldwide. Transmission occurs through vaginal, oral, or anal sexual contact. The pathogen can infect the throat, causing severe sore throat, the anus and rectum causing proctitis, and in women, the vagina leading to irritation and discharge (vaginitis). Urethral infection causes burning, painful urination, and discharge.

In women, symptoms may include vaginal discharge, increased urinary frequency, and discomfort during urination. Untreated infections can spread to the fallopian tubes and abdominal cavity, causing severe lower abdominal pain and fever. The incubation period is typically 2–5 days after exposure, but symptoms may appear up to 2 weeks later. Gonorrhea is a common cause of pelvic inflammatory disease (PID) in women.

This rapid test allows for preliminary diagnosis through antigen detection and is intended for professional use by trained healthcare personnel.

Test Specifications

Product Name: Gonorrhea (Tripper) Rapid Test Kit

Sample Type: Female cervical and male urethral swab samples

Packaging: 1 test/box

Test Format: Cassette

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3rd Floor, Building 4, No. 1418, Moganshan Road, Hangzhou, Zhejiang, China

Authorized Representative: Lotus NL B.V., Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands

Expiration Date: September 2026

Kit Contents

• 1 test cassette

• 1 sterile swab stick

• Reagent A bottle

• Reagent B bottle

• 1 extraction tube with cap

• 1 user manual in English

Testing Procedure

Before performing the test, please read the Instructions for Use carefully! Collect the sample according to the instructions provided in the manual. Before testing, bring all components to room temperature (15°C-30°C).

After sample collection:

1. Remove the test device from its sealed pouch and use immediately for optimal results.

2. Collect a gonorrhea antigen sample using the provided sterile swab according to instructions.

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

2.B Hold the Reagent B bottle vertically and add 4 full drops of Reagent B (approximately 200 μL) into the extraction tube. The solution will become cloudy. Squeeze the bottom of the tube and rotate the swab 15 times until the solution turns slightly green or blue. If the swab is bloody, the color will turn yellowish or brown. Let it stand for 1 minute.

2.C Press the swab against the inner wall of the tube and remove it while squeezing the tube to extract as much liquid as possible. Keep as much solution as possible in the tube. Attach the dropper tip firmly onto the top of the extraction tube.

3. Place the test cassette on a clean, flat surface. Add 3 drops of the extracted solution (approximately 100 μL) into the sample well (S), then start the timer. Avoid trapping air bubbles in the sample well (S).

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

Result Interpretation

Positive
Two colored lines appear on the membrane: one line in the Control region (C) and another line in the Test region (T).

Negative
Only one colored line appears in the Control region (C). No visible line appears in the Test region (T).

Invalid
No line appears in the Control region (C). Any result without a visible control line within the specified reading time must be considered invalid. Please repeat the test with a new device. If the problem persists, contact your local distributor.

Gonorrhea Rapid Test Performance

Female Cervical Samples:

• Relative Sensitivity: 91.8% (80.4%–97.7%)*

• Relative Specificity: 96.4% (87.7%–99.6%)*

• Overall Agreement: 94.3% (88.0%–97.9%)*

Male Urethral Samples:

• Relative Sensitivity: 91.7% (81.6%–97.2%)*

• Relative Specificity: 95.8% (85.7%–99.5%)*

• Overall Agreement: 93.5% (87.1%–97.4%)*

*95% Confidence Interval

Rechtliche Hinweise

Professionelle Anwendung

Dieses Produkt ist ein In-vitro-Diagnostikum (IVD) und ausschließlich für die professionelle Verwendung durch medizinisches Fachpersonal vorgesehen. Eine Anwendung zur Eigenkontrolle ist nicht zulässig. Der Hersteller/Vertreiber übernimmt keine Haftung für Schäden, die aus einer nicht bestimmungsgemäßen Nutzung resultieren.

Widerrufsrecht

Gemäß § 312g Abs. 2 Nr. 3 BGB besteht kein Widerrufsrecht für versiegelte Waren, die aus Gründen des Gesundheitsschutzes oder der Hygiene nicht zur Rückgabe geeignet sind, wenn ihre Versiegelung nach der Lieferung entfernt wurde.

Haftungsausschluss

Der Verkäufer übernimmt keine Verantwortung für die Einhaltung gesetzlicher Vorschriften im Rahmen des Beschaffungsverfahrens des Käufers. Die Verantwortung des Verkäufers beschränkt sich ausschließlich auf die Lieferung der bestellten Ware und die Bereitstellung von Informationen zur bestimmungsgemäßen Verwendung.

Instructions