Fujibio Chlamydia Test Kit

What Is a Chlamydia Infection?

Chlamydia is a common sexually transmitted infection (STI) caused by bacteria. People who have chlamydia often do not have outward symptoms in the early stages. That might make you think you shouldn’t worry. However, chlamydia can cause health problems in the later stages, including preventing women from getting pregnant or even endangering their pregnancies.

If you have unprotected sex with someone whose STI status you’re not certain of, get tested for chlamydia and other STIs. You should get tested every time you might have been exposed. The treatment for chlamydia is oral antibiotics given either in multiple doses or just one dose. Waiting too long to treat it can cause serious complications. Make sure you talk to a doctor as soon as you think you might have been exposed.

Diagnosing Chlamydia

When you see a doctor about chlamydia, you will likely be asked about your symptoms. If you don’t have any, your doctor may ask why you think you might have the infection. In this case, it’s important to talk about how you think you were exposed.

The most effective diagnostic test for chlamydia is to swab the vagina in women and to test the urine in men. If there is a chance the infection is in your anus or throat, these areas may be swabbed as well.

You can perform the testing of the swab by using Fujibio Chlamydia Test Kit. 

Fujibio Chlamydia Rapid Test Kit intended for in vitro diagnostic use in the rapid, qualitative detection of Chlamydia trachomatis directly from female endocervical swab and male urethral swab, in addition to ocular specimens from symptomatic patients. The test is intended for use as an aid in the diagnosis of Chlamydia infections. 

The one step Chlamydia test is a rapid qualitative immunoassay based on the immunochromatographic principle. (In the assay procedure, a clinical specimen is obtained and place into an extraction tube containing extraction solution. A. after two minutes. Extraction Solution B is added to the tube. 3 drops (approximately 150 ul) of extracted samples is added to the sample well).

The membrane is pre-coated with anti-genus specific lipopolysaccharide (LPS) monoclonal antibody on the test band (T) region and goat anti-mouse antibody on the control band (C) region. During testing, the sample is allowed to react with the colloidal gold particles which have been coated with monoclonal anti-chlamydia antibody, and then migrates laterally across the membrane by capillary action .

If the sample contains Chlamydia antigen , a colored band with a specific anti-body chlamydia antibody-mydia colloidal gold particle complex will form on the membrane in the test band (T) region. If Chlamydia antigen is not present, a pink line will only form on control band (C) region. To serve as a procedural control, a colored band at the control band (C) region will always appear regardless of the presence of Chlamydia antigen.

SPECIMEN COLLECTION AND HANDLING

The quality of specimen obtained is of extreme importance. Detection of Chlamydia requires a vigorous and through collection technique which provides cellular material rather than just body fluids.

For Female endocervical specimens:

• Before specimen collection, use a swab or cotton ball to remove excess mucus from the endocervical area and discard.
• Use the swab provided with the kit or any shafted swabs with rayon of Dacron tips. The swab should be interested into the endocervical canal past the squamocolumnar junction, until most of the tip is no longer visible. This will permit acquisition of columnar or cuboidal epithelial cells which are the main reservoir of Chlamydia organism. Firmly rotate the swab for 15-20 second and withdraw without contamination of exocervical or vaginal cells.
• Alternative endocervical specimens can be collected with a cytology brush (Not provided. Caution: do not use cytology brushes with pregnant patients). Insert the cytology brush into the endocervical canal past the squamocolumnar junction. Leave in place two to three seconds. Rotate the cytology brush two full turns , and then withdraw the brush without touching any vaginal surface.
• Place the swab in the extraction tube, if the test is to be conducted immediately.

For Male Urethral Specimens:

• Use standard wire-shafted fiber-tripped swabs(not provided) for urethral specimen collection. 
• Instruct the patient not to urinate at least one hour prior to specimen collection.
• Insert the swab into the urethra about 2-4cm, rotate for 3-5 seconds and withdraw it. 
• Place the swab to the extraction tube , if the test is to be conducted immediately.
• Do not place the swab in any transport device containing medium since transport medium inferences with the assay.
• If immediate testing is not possible, the patient sample should be placed in a dry transport tube for storage or transport. The swabs maybe stored for 4 hours at room temperature (10-30) or 24 hours at refrigerated (4-8). Do not freeze. All specimens should be allowed to reach a room temperature of 10-30 before testing.

TEST PROCEDURE

• Review ‘specimen collection’ instructions. Do not open pouches until ready to perform the assay. Test reagents and specimen should be brought to room temperature before testing.
• To avoid cross contamination, do not allow the tip of the reagent bottle to come in contact with sample swabs of extraction tubes.

A. Specimens and control extraction:

A1. Preperation of endocervical or urethral swab specimens;

• Place a new extraction tube in the designated area of the workstation. Add 6 drops of extraction solution A to extraction tube.
• Immerse the patient’s swab into the extraction tube, and extracts 2 minutes at room temperature. During extraction, use a circular motion to roll the swab against the side of the extraction tube so that the liquid is expressed from the swab and reabsorbed.
• At the end of the extraction time, add 6 drops of solution B. squeeze the swab firmly against the tube to expel as much liquid as possible from the swab. Discard the following guidelines for handling infectious agents.
• The extracted specimen can remain at room temperature for 60 minutes without affecting the result of the Chlamydia test.

A2. Preparation of positive and negative controls:

• Place a new extraction tube in the designated area of the workstation. Add 6 drops of extraction solution A to extraction tube.
• Add two drops of the positive or negative control solution to a sterile Dacron swab. Allow the swab to be absorbed into the swab.
• Immerse the swab into the extraction tube, and extract 2 minutes at room temperature. During extraction, use a circular motion to roll the swab against the side of the extraction tube so that the liquid is expelled from the swab and reabsorbed.
• At the end of the extraction time, add 6 drops of extraction Solution B. squeeze the swab firmly against the tube to expel as much liquid as possible from the swab. Discard the swab following guidelines for handling infectious agents.

B. Test Procedure:

• Follow instructions for specimen collections and extraction.
• Remove the antigen test device from its protective pouch and place it on a clean, dry, and level surface. Label the device with patient or control identification.
• Place the cap of the extraction tube. Add 3 drops (approximately 150 ul) of extracted sample from extraction tube to the sample well.
• Wait for test band (S) to appear.the test results should be read in 10 minutes after adding the extracted specimen to the sample well. Depending on the amount of Chlamydia antigen organisms on the swab, positive result maybe visible as soon as 1 minute, however to confirm a negative result the complete reaction time of 15 minutes if required. Do not interpret result after 15 minutes.

Invalid:

• No line appears in the control region. Under no circumstances should a positive sample be identified until the control line (C) forms in the viewing area. If the control line does not form, the test result is inconclusive and the assay should be repeated.

 Treating Chlamydia

The good news is that chlamydia is easy to treat. Since it’s bacterial in nature, it’s treated with antibiotics. Azithromycin is an antibiotic usually prescribed in a single, large dose, but the dose may also be spread out over 5 days. Doxycycline is an antibiotic that must be taken twice per day for about one week.

Your doctor may prescribe other antibiotics. No matter which antibiotic you are given, you will need to follow the dosage instructions carefully to make sure the infection clears up fully. This can take up to two weeks, even with the single-dose medicines. Don’t have sex during the treatment time. Unfortunately, you can get chlamydia again if you’re exposed, even if you’ve had it and it was treated.