Content of the kit		Specimen
PRINCIPLE OF THE TEST Chlamydia Trachomatis is one of the most common sexually transmitted pathogens. It is a major cause of cervicitis, urethritis, endometritis, and pelvic inflammatory disease in women.  Serious complications can result in salpingitis, infertility, and ectopic pregnancy. The C.T. Test is an immunochromatographic assay, which utilizes a unique combination of monoclonal and polyclonal antibodies to selectively identify C.T. antigen in endocervical or endourethral swab specimens, with a high degree of sensitivity. CONTENT OF THE KIT The C.T. Test kit contains the following items to perform the assay: 1. C.T. test strips. 2. Female swabs (Male swabs need to be ordered separately). 3. Extraction buffer. 4. Instructions for use. PRECAUTIONS The C.T. Test strip should be stored at room temperature  2-30oC (40-86oF). The test strip is sensitive to humidity as well as to heat.  Perform the test immediately after removing the test strip from the foil pouch.  Do not use it beyond the expiration date.		SPECIMEN COLLECTION AND PREPARATION Female Patients:  Rub the swab vigorously over the infected endourethral lining and endocervical cells on the canal wall.  As Chlamydia are intracellular organisms, firm contact must be made with the canal wall for proper specimen collection.  The rubbing action dislodges the endothelial cells and allows the swab to absorb the bacteria.  Improper collection will result in poor visual reading and may cause invalid results.  Vaginal specimens are not useful. SPECIMEN STORAGE  If a swab is not extracted immediately, store it refrigerated for up to 5 days, preferably in a transportation tube.  Do not freeze.  Swabs may be transported to the test site under ambient conditions.  Transport media should not be used. SPECIMEN PREPARATION Bring all samples to room temperature prior to testing. Add 6 drops of the extraction buffer into the test tube.  Place the specimen swab in the tube and swirl it vigorously to mix the reagents for about 15 seconds.  Then incubate the mixture at room temperature for 10 minutes with the swab in the tube. Swirl the swab vigorously for 15 seconds, then expunge as much liquid as possible from the swab by pressing and rotating the fiber portion against the wall of the tube.  Discard the swab.  Mix the contents of the tube by gentle swirling. The swab extract can be tested immediately or remain at room temperature for up to 3 hours without affecting test results.

PROCEDURE OF THE TEST 
1. Remove the test strip from its foil pouch.
2. Holding the strip vertically, carefully dip it into the extracted specimen. Do not immerse the strip past the maximum line . 
3. Interpret test results at 10 to 20 minutes. Do not interpret after 30 minutes.

INTERPRETATION OF THE TEST
1. As the test kit begins to work, a color band will appear in the left section of the Result Window to show that the test is working properly. This band is the Control Band (C).
2. The right section of the result window indicates the test results. If another color band appears in the right section of the Result Window, this band is the Test Band (T).

WARNINGS
1. For in vitro diagnostic use only.
2. Do not eat or smoke while handling specimens.
3. Wear protective gloves while handling specimens. Wash hands thoroughly afterwards.
4. Avoid splashing or aerosol formation.
5. Clean up spills thoroughly using an appropriate disinfectant.
6. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they were infectious waste, in a biohazard container.
7. Do not use the test kit if the pouch is damaged or the seal is broken.