Description
Information from
This test is used to detect Chlamydia trachomatis, one of the three known types of chlamydia. The chlamydia infection is
the most common sexually transmitted disease. In Germany, between 300,000 and 500,000 new infections per year
is estimated at between. Young adults (15 to 25 years) who change sexual partners frequently and newborn babies of infected mothers are at risk of
are most often affected. Infections without sexual contact (e.g. by swimming pools) are very rare but do occur.
Chlamydia trachomatis infections are most often asymptomatic. However, they can lead to complaints such as
eye infections, arthritis, urinary tract infections. In addition, untreated infection often leads to infertility and increases
the risk of ectopic pregnancy and premature birth. In developing countries, Chlamydia trachomatis is the most common
cause of blindness in newborn babies.
Treatment of Chlamydia trachomatis is particularly important in pregnancy. The infected mothers are about. 50% pass on the infection
your newborn baby. The most common complications in newborns are conjunctivitis and pneumonia. This immunological test is suitable for the analysis of cell samples from the cervix and is therefore only for women. In case of a positive result, it is also recommended to test your sexual partner. This in vitro diagnostic test for Chlamydia based on the immunological principle is strictly for self-testing only.
Test objective
Diagnosis of Chlamydia trachomatis infection.
The importance of the test
Chlamydia trachomatis is one of the most common sexually transmitted diseases today.
The young age group is most affected. Diagnosis is complicated by the fact that after the initial, often mild symptoms (urinary problems, yellowish discharge in women), the infection may persist in the asymptomatic stage. An infected person can continue to be infected or an untreated infection can cause further complications. The most important of the complications is that, starting from the vagina, the upper parts of the reproductive organs can become chronically inflamed, which can lead to infertility. The test can be a significant aid to diagnosis, as the disease is often asymptomatic or has mild symptoms that do not prompt the person to seek medical attention.
Biological background
Chlamydia trachomatis is an intracellular bacterium, one of the Chlamydia species that cause human disease.
How the test works
Immunochromatography for antigen detection.
Accessories for the test
Packed test cassette with aspirator, sample collection tube with puff solution, sterile sampling swab and instructions for use
Guide. Please take a timing device with you.
Important notes
This test should not be used during pregnancy or menstruation or for three days after menstruation or
in the case of urinary tract infection.The substances used in the test (antibodies) are potentially infectious substances, but all
do not pose a hazard when the test component is used as intended. For prevention, please use the test
wash your hands thoroughly after use.
Components: the test strip consists of membranes coated with antibodies against Chlamydia trachomatis.
MISSION
Avoid passing urine for at least one hour before sampling to avoid false results. Calm
take the test at the following location. Use only the sample swab provided and check that the packaging is not damaged before use. If so, contact the manufacturer.
Choose a comfortable position, such as for inserting a tampon. Gently insert the swab into your vagina up to the cervix (the top of the vagina). Rotate the tampon for 30 seconds, then slowly pull the tampon out.
PREPARATION OF THE SAMPLE
1. There is a deliberately small amount of puffing solution in the sampling tube. Immerse the sampler containing the sample
swab directly into the tube so that the swab reaches the bottom of the tube. Swirl the swab in the solution and squeeze
several times against the pipe wall to ensure that the sample is properly mixed with the puff solution.
2. Wait 5 minutes. During the waiting time, the swab should remain in the tube. Waiting time too long or too short False
can lead to. Before removing the swab from the tube, press it against the wall.
3. Close the sampling tube and shake gently. Hold the tube with the cap up and then remove the cap.
4. Place 2 drops of solution in the “S” part of the test cassette as shown in the illustration. Make sure that the liquid does not get directly on the
to the scoreboard area.
5. Wait 15 minutes. Waiting longer than 20 minutes will invalidate the test. The test result is positive if
after the 15-minute reaction time, 2 purple stripes appear in the scoreboard area (at the “C” and “T” lines), even if
the “T” line is faint. Positive results can often be seen within 15 minutes.
The test result is negative if only a purple line appears in the “C” region. The negative result will only be visible at the very end of the 15-minute waiting time.
The test is invalid if there is no purple line in region “C”, or only one purple line in region “T”, or the whole control region turns purple.
Possible causes include damaged packaging, improper storage, or a mistake during the test. Please keep the devices and contact the manufacturer.
Do not read the results after 20 minutes. Dispose of the test accessories with your household waste after you have read the result.
Always talk to your doctor before making an important health decision!
ADDITIONAL COMMENTS
Advice on the test results:
If the test result is positive, see your doctor. Please take this guide with you to your doctor to get a fuller picture of the type of test you used.
If the test result is negative, you are most likely not infected with Chlamydia trachomatis, but regular medical check-ups are still recommended.
Performance characteristics
In a clinical benchmarking study with 596 participants, the test showed a diagnostic sensitivity of 85.7% and a diagnostic specificity of 98.3% compared to the PCR method. The lay testing was carried out with 56 participants,
54 of whom correctly interpreted the result.
Detection limit: The detection limit for a positive result is ~250 EB/μL.
