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

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

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Alltest

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The Chlamydia Rapid Test is a self-test that can be performed at home for the qualitative detection of Chlamydia trachomatis antigens. For women, the test can be performed using a vaginal swab specimen, while for men, a urethral swab specimen is used. The test can help detect Chlamydia infection. The test is intended for in vitro diagnostic use only.

Chlamydia trachomatis is one of the most common causative agents of sexually transmitted infections. It is particularly important to note that the infection may often be asymptomatic: according to the instructions for use, approximately 70% of women with cervical infection and around 50% of men with urethral infection do not experience symptoms.

If left untreated, the infection may lead to various complications. In women, it may be associated with cervicitis, urethritis, pelvic inflammatory disease, as well as an increased risk of ectopic pregnancy and infertility. In men, urethritis and epididymitis may also develop.

When might it be advisable to perform the test?

Since Chlamydia infection may also be present without symptoms, the absence of symptoms alone does not rule out infection. If symptoms occur, the instructions for use mention, among others, the following:
  • unusual or abnormal vaginal discharge,
  • urethral discharge or urethral discomfort,
  • painful urination,
  • frequent or urgent need to urinate,
  • lower abdominal discomfort,
  • bleeding between periods or after sexual intercourse,
  • in men, pain, swelling or tenderness of the epididymis.

Test specifications

Product name: Chlamydia Rapid Test – for home self-testing for women and men
Specimen: female vaginal swab specimen / male urethral specimen
Package: 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](mailto:info@alltests.com.cn)
EC REP: MedNet GmbH, Hansestraße 91, 48165 Münster, Germany; +49 251 32266-0; [info@medneteurope.com](mailto:info@medneteurope.com)

Specimen collection for women

1. Before collecting the specimen, wash your hands thoroughly with soap and rinse with clean water.
2. Remove the supplied sterile female swab from its packaging.
3. Insert the swab into the vagina and leave it in place for approximately 30 seconds.
4. Carefully remove the swab, making sure it does not come into contact with any other external surface.

The collected specimen must be used immediately for testing. According to the instructions for use, specimens should not be collected during menstruation.

Specimen collection for men

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

1. Wash your hands thoroughly.
2. Remove the sterile male urethral swab from its packaging.
3. Carefully insert the swab approximately 2–4 cm into the urethra.
4. Rotate the swab 360° in one direction, then leave it in place for 10 seconds.
5. Carefully remove the swab, making sure it does not come into contact with any other external surface.

Test procedure

Perform the test immediately after collecting the swab specimen.

1. Remove the cap from the Buffer 1 tube and place the tube in the tube holder provided in the box.
2. Place the swab containing the specimen into Buffer 1. Squeeze the bottom of the tube and rotate the swab 15 times, then let it stand for 2 minutes.
3. Break Buffer 2 at its narrowest breaking point and add its entire contents to the tube containing Buffer 1.
4. While squeezing the tube, rotate the swab another 15 times. The solution may turn slightly green or blue. Then let it stand for 1 minute.
5. Press the swab against the side of the tube and withdraw it while squeezing the tube so that as much liquid as possible remains in the tube.
6. Close the tube, then open the small dropper cap.
7. Remove the test cassette from the foil pouch and place it on a clean, level surface.
8. Turn the buffer tube upside down and add 3 full drops of the prepared solution to the specimen well of the test cassette. Start the timer and do not move the test afterwards.
9. Read the result after 10 minutes. The result must not be interpreted after 20 minutes.

Interpretation of results

POSITIVE – C + T lines
If two colored lines appear – one in the C (control) region and one in the T (test) region – the result is positive. This indicates that the test detected Chlamydia trachomatis antigen in the specimen.

The intensity of the T test line may vary depending on the amount of antigen present in the specimen. A faint but clearly visible T line must also be interpreted as a positive result.

If the result is positive, consult a doctor and show them the test result. The doctor can determine whether further testing is necessary.

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

This indicates that the test did not detect Chlamydia trachomatis antigen or that the amount present is below the detection limit of the test. If symptoms persist, medical consultation is recommended even in the case of a negative result.

INVALID – no C line
If the C control line does not appear, the test result is invalid. The most common reasons are insufficient specimen volume or incorrect performance of the test procedure. In this case, the test must be repeated using a new test.

Test performance

The performance data provided by the manufacturer are based on a clinical study involving 220 participants, in which PCR testing was used as the reference method.

Sensitivity: 96.0%
Specificity: 98.3%

Important information

The Chlamydia Rapid Test does not replace medical diagnosis or consultation with a healthcare professional. In the event of a positive result, consult a doctor. If symptoms persist, medical evaluation is also recommended despite a negative result.

The test is not suitable for monitoring the success of treatment, as Chlamydia antigen may remain present even after appropriate antimicrobial treatment. An excessive amount of blood in the swab specimen may cause a false-positive result.

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