Chlamydia trachomatis (Ct) Antigen Rapid Test for Women and Men (1 pc/box)

Chlamydia trachomatis (Ct) Antigen Rapid Test for Women and Men (1 pc/box)

The one-step Chlamydia rapid test is designed for the qualitative detection of Chlamydia trachomatis antigens from human specimens: female cervical swabs, male urethral swabs, or male urine samples (for laboratory testing).

Chlamydia trachomatis can cause eye infections, infections of the reproductive system and other organs, and may contribute to the development of urethritis and cervicitis. It primarily affects the young adult population. The incubation period ranges from a few days to several months, most commonly 1–3 weeks.

Up to 70–80% of infected women and 50% of infected men show no clinical symptoms, making laboratory diagnosis essential. This product is available for professional use only.

Specifications

Product Name: Chlamydia trachomatis (Ct) Antigen Rapid Test for Women and Men (1 pc/box)

Sample Type: Female cervical swab, male urethral swab, or male urine (for laboratory testing)

Format: Cassette

Packaging: 1 pc/box

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

EC REP: CMC Medical Devices & Drugs S.L, C/Horacio Lengo Nº 18, CP 29006, Málaga, Spain, +34 951214054, info@cmcmedicaldevices.com

Expiry Date: 2027-08-02

Chlamydia Rapid Test Kit Contents

• 1 × Test cassette

• 1 × Sterile swab

• 1 × Reagent Solution A

• 1 × Reagent Solution B

• 1 × Extraction tube with dropper

• 1 × Tube stand

• 1 × English User Manual

I. Sample Collection Procedure for the Chlamydia Test

For female cervical samples:

1. Before sampling, remove excess mucus from the surface of the cervix with a separate swab or cotton ball and discard it.
2. Insert the provided swab into the endocervical canal so that it passes through the squamocolumnar junction until only the tip of the swab is visible inside the canal (~2–3 cm).
3. Rotate the swab firmly for 15–20 seconds without touching the vaginal wall or external cervical cells.
4. If the test is performed immediately, place the swab into the extraction tube.

For male urethral samples:

1. Use the swab provided in the kit. Ensure the patient has not urinated within at least 1 hour before collection.
2. Insert the swab 2–4 cm into the urethra, rotate it several times, and leave it in place for 5–10 seconds before withdrawing.
3. If the test is performed immediately, place the swab into the extraction tube.

II. Chlamydia Test Procedure

Please read the Instructions for Use carefully before performing the test.

Before use, allow the test kit to reach room temperature (20–30 °C). Do not open the inner packaging (foil pouch) until you are ready to use the test. For the most reliable results, perform the test immediately after opening the pouch.

After sample collection:

1. Place the extraction tube on the work surface and add 8 drops of Reagent A.

2. Insert the swab used for sampling into the extraction tube. Rotate the swab against the wall of the tube with circular movements for 2 minutes so that the liquid fully saturates the swab and then reabsorbs.

3. Add 8 drops of Reagent B into the tube. Press the swab firmly against the wall of the tube for at least 1 minute to extract as much liquid as possible.

4. Remove the swab from the tube and dispose of it appropriately (treat as potentially infectious material).

5. Place the dropper cap firmly onto the top of the extraction tube. The prepared sample can be stored at room temperature for up to 60 minutes without affecting the test result.

III. Chlamydia Testing

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

2. Add 3 drops of the prepared sample vertically into the sample well (S) of the cassette, avoiding the formation of air bubbles. Do not add any liquid into the result window! As the test runs, the colored solution will migrate along the membrane and react with the reagents in the test line area.

3. Wait for the colored line(s) to appear. The result must be read after 10 minutes. Do not interpret the result after 20 minutes, as it will be invalid.

IV. Interpretation of Results

• Positive: Two distinct red lines appear – one in the Control region (C) and one in the Test region (T). Any line appearing in the Test region (T), even a very faint line ranging from pink to red, should be considered a positive result.

• Negative: Only one red line appears in the Control region (C). No line appears in the Test region (T).

• Invalid: A red line appears only in the Test region (T), without a line in the Control region (C), or no red line appears at all. The most likely reasons are insufficient sample volume or incorrect test procedure.

Important Information

• The Chlamydia Rapid Test is intended for IN VITRO diagnostic use only.

• Do not use the test after the expiration date.

• Test results are invalid after 25 minutes.

• The thickness of the control line does not indicate a reagent quality issue; a clearly visible test result confirms that the reagent is effective.

• All specimens and reagents should be considered potentially hazardous and must be handled as if they were infectious materials after use.

• The product itself is not a biological hazard, but the reagent and specimen used during testing must be disposed of as infectious material.

Legal Notices

Professional Use

This product is an in vitro diagnostic (IVD) and intended exclusively for professional use by medical personnel. Use for self-testing is not permitted. The manufacturer/distributor accepts no liability for damages resulting from improper or unauthorized use.

Right of Withdrawal

In accordance with § 312g (2) No. 3 of the German Civil Code (BGB), there is no right of withdrawal for sealed goods which, for reasons of health protection or hygiene, are not suitable for return if their seal has been removed after delivery.

Disclaimer

The seller assumes no responsibility for compliance with legal regulations within the buyer’s procurement process. The seller’s responsibility is limited solely to the delivery of the ordered goods and the provision of information regarding their proper use.

Instructions