male urine specimens. For professional in vitro diagnostic use only.
Chlamydia Antigen INTENDED USE
The Chlamydia Rapid Test Device (Swab/Urine) is a rapid chromatographic immunoassay for the qualitative
detection of Chlamydia trachomatis in female cervical swab, male urethral swab and male urine specimens to
aid in the diagnosis of Chlamydia infection.
Chlamydia Antigen SUMMARY
Chlamydia trachomatis is the most common cause of sexually transmitted venereal infection in the world. It is
composed of elementary bodies (the infectious form) and reticulate or inclusions bodies (the replicating form).
Chlamydia trachomatis has both a high prevalence and asymptomatic carriage rate, with frequent serious
complications in both women and neonates. Complications of Chlamydia infection in women include cervicitis,
urethritis, endometritis, pelvic inflammatory disease (PID) and increased incidence of ectopic pregnancy and
infertility.1 Vertical transmission ofthe disease during parturition from mother to neonatecan result in
inclusion conjunctivitis pneumonia. In men, complications of Chlamydia infection include urethritis and
epididymitis. At least 40% of the nongonococcal urethritis cases are associated with Chlamydia infection.
Approximately 70% of women with endocervical infections and up to 50% of men with urethral infections are
asymptomatic.
Traditionally, Chlamydia infection has been diagnosed by detection of Chlamydia inclusions in tissue culture
cells. Culture method is the most sensitive and specific laboratory method, but it is labor intensive, expensive,
long (48-72 hours) and not routinely available in most institutions.
The Chlamydia Rapid Test Device (Swab/Urine) is a rapid test to qualitatively detect the Chlamydia antigen
from female cervical swab, male urethral swab and male urine specimens, providing results in 10 minutes.
The test utilizes antibody specific for Chlamydia to selectively detect Chlamydia antigen from female cervical
swab, male urethral swab and male urine specimens.
Chlamydia Antigen PRINCIPLE
The Chlamydia Rapid Test Device (Swab/Urine) is a qualitative, lateral flow immunoassay for the detection of
Chlamydia antigen from female cervical swab, male urethral swab and male urine specimens. In this test,
antibody specific to the Chlamydia antigen is coated on the test line region of the test. During testing, the
extracted antigen solution reacts with an antibody to Chlamydia that is coated onto particles. The mixture
migrates up to react with the antibody to Chlamydia on the membrane and generate a colored line in the test
line region. The presence of this colored line in the test line region indicates a positive result, while its
absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the
control line region indicating that proper volume of specimen has been added and membrane wicking has
occurred.
Chlamydia Antigen REAGENTS
The test device contains Chlamydia antibody coated particles and Chlamydia antigen coated on the
membrane.
Chlamydia Antigen PRECAUTIONS
• For professional in vitro diagnostic use only. Do not use after expiration date.
• The test device should remain in the sealed pouch until use.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Do not use test if pouch is damaged.
• Handle all specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout testing and follow standard procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens
are being tested.
• Humidity and temperature can adversely affect results.
• Use only sterile swabs to obtain endocervical specimens.
Chlamydia Antigen DIRECTIONS FOR USE
Allow the test device, specimen, reagents, and/or controls to reach room temperature (15-30°C) prior to
testing.
1. Remove the test device from the sealed foil pouch and use it as soon as possible. Best results will be
obtained if the test is performed immediately after opening the foil pouch.
2. Extract the Chlamydia antigen according to the specimen type.
For Female Cervical or Male Urethral Swab Specimens:
• Hold the Reagent A bottle vertically and add 5 full drops of Reagent A (approximately 300 µL) to the
extraction tube. Reagent A is colorless. Immediately insert the swab, compress the bottom of the tube and
rotate the swab 15 times. Let stand for 2 minutes.
• Fill the quantitative pipette for Reagent B up to the marked line (approximately 220 µL) then add the
Reagent B to the extraction tube. The solution will turn cloudy. Compress the bottom of tube and rotate the
swab 15 times until the solution turns toa clear color with a slight green or blue tint. If the swab is bloody, the
color will turn yellow or brown. Let stand for 1 minute.
•Press the swab against the side of the tube and withdraw the swab while squeezing the tube. Keep as
much liquid in the tube as possible. Fit the dropper tip on top of the extraction tube.
For Male Urine Specimens:
•Fill the quantitative pipette for Reagent B to the marked line (approximately 220 µL) then add the Reagent
B to the urine pellet in the centrifuge tube, then draw the liquid up and down with a pipette to vigorously mix
until the suspension is homogeneous.
• Transfer all the solution in the centrifuge tube to an extraction tube. Let stand for 1 minute. Hold the
Reagent A bottle upright and add 5 full drops of Reagent A (approximately 300 µL) then add to the extraction
tube. Vortex or tap the bottom of the tube to mix the solution. Let stand for 2 minutes.
•Fit the dropper tip on top of the extraction tube.
3. Place the test device on a clean and level surface. Add 3 full drops of the extracted solution (approximately
100 µL) to the specimen well (S) of the test device, andstart the timer. Avoid trapping air bubbles in the
specimen well (S).
4. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not read results after 20 minutes.
INTERPRETATION OF RESULTS (Please refer to the illustration above)
POSITIVE:Two distinct colored lines appear. One line should be in the control line region (C) and another
line should be in the test line region (T).
NOTE: The shade of color in the test line region (T) may vary, but it should be considered positive whenever
there is even a faint colored line.
NEGATIVE:One colored line appears in the control line region (C). No apparent colored line appears in the
test line region (T).
INVALID: Control line fails to appear. Insufficient sample volume or incorrect procedural techniques are the
most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If
the problem persists, discontinue using the test kit immediately and contact your local distributor.
Relative Sensitivity: 88.5% (76.6%-95.6%) Relative Specificity: 96.7% (90.6%-99.3%)
Accuracy: 93.7% (88.3%-97.1%) 95% Confidence Interval
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