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

• Every order is shipped carefully sealed, in 100% discreet packaging with a neutral sender name.

• The price includes 5% VAT.

• This product can be ordered for professional use.

Gonorrhea Rapid Test

Gonorrhea (“the clap”) is a sexually transmitted disease caused by the bacterium Neisseria gonorrhoeae. Gonorrhea is one of the most common infectious bacterial diseases and is most often spread through sexual intercourse, including vaginal, oral and anal sex. The pathogen can infect the throat, causing a severe sore throat. It can infect the anus and rectum, causing proctitis. In women, it can infect the vagina, causing irritation and discharge (vaginitis). Infection of the urethra can cause a burning sensation, painful urination and discharge.

When it causes symptoms in women, vaginal discharge, increased urge to urinate and discomfort during urination are common. Spread of the infection to the fallopian tubes and the abdominal cavity can cause severe lower abdominal pain and fever. The incubation period of gonorrhea is on average about 2-5 days after sexual contact with an infected partner. However, symptoms may appear later, even after 2 weeks. A preliminary diagnosis of gonorrhea can be established by testing. In women, gonorrhea is a common cause of pelvic inflammatory disease (PID). The test can be ordered for professional use.

Gonorrhea Rapid Test Specification

Product name: Gonorrhea Rapid Test Kit
Specimen: female endocervical and male urethral swab specimen
Package size: 1 pc/box
Format: Cassette test
Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - ,MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com
EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA,The Hague,Netherlands, peter@lotusnl.com
Expiry date: 31/03/2028

Contents of the Gonorrhea Rapid Test Kit

• 1 test cassette
• 1 sterile swab
• 1 Reagent A
• 1 Reagent B
• 1 extraction tube and cap
• 1 instructions for use in Hungarian

Test Procedure

Read the Instructions for Use carefully before performing the test! Collect the specimen as described in the instructions for use.

Before use, allow the test, the specimen, the reagents and/or the controls to reach room temperature (15°C–30°C).

After specimen collection:

1. Remove the test device from the sealed foil pouch and use it as soon as possible. The best results are obtained if the test is performed immediately after opening the foil pouch.

2. Prepare the gonorrhea antigen sample according to the specimen type.

• 2.A 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, squeeze the bottom of the tube and rotate the swab 15 times. Let stand for 2 minutes.
• 2.B Hold the Reagent B bottle vertically and add 4 full drops of Reagent B (approximately 200 μL) to the extraction tube. The solution will become turbid. Squeeze the bottom of the tube and rotate the swab 15 times until the solution turns a slight green or blue tint. If the swab is bloody, the color will be yellowish or brown. Let stand for 1 minute.
• 2.C Press the swab against the side of the tube and remove the swab while squeezing the tube. Keep as much liquid as possible in the tube. Fit the dropper tip onto the top of the extraction tube.

3. Place the test on a clean, level surface. Add 3 drops of the extracted solution (approximately 100 μL) to the sample well (S) of the test, 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.

Interpretation of Results

Positive

Two colored lines appear on the membrane. One line appears in the control region (C) and the other line appears in the test region (T).

Negative

Only one colored line appears in the control region (C). No visible colored line appears in the test region (T).

Invalid

No line is visible in the control region. Any test result in which no line is visible in the control region within the specified reading time must be considered invalid. Please repeat the test with a new test. If the problem persists, contact your local distributor!

Performance of the Gonorrhea Rapid Test

Female endocervical specimens:

• Relative sensitivity: 91.8% (80.4%-97.7%)*
• Relative specificity: 96.4% (87.7%-99.6%)*
• Overall agreement: 94.3% (88.0%-97.9%)*
  *95% confidence interval

Male urethral specimens:

• 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

The test may only be used by competent professionals and healthcare workers! Carbon Web Kft. accepts no responsibility for use for self-testing purposes.

ATTENTION!
Under Hungarian Government Decree 45/2014 (II. 26.), for health protection or hygiene reasons this product cannot be returned after delivery; therefore, the 14-day right of return does not apply to this product. Section 29 (1) The consumer may not exercise the right under Section 20 (the consumer's right of withdrawal) in respect of (e) a product in sealed packaging which, for health protection or hygiene reasons, cannot be returned once opened after delivery.

Carbon Web Kft. is not responsible for the fulfillment of the legal obligations related to the Buyer's procurement procedure, as this falls within the Buyer's competence; its responsibility is limited exclusively to the information on intended use and to the goods delivered.