TruQuick™ Chlamydia
TruQuick Chlamydia is a rapid 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 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 inclusion bodies (the replicating form). C. 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 of the disease during parturition from to neonate can result in inclusion conjunctivitis or pneumonia. In men, complication of Chlamydia includes 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 (18-72 hours) and not routinely available in most situations.
Allow the test, reagents, specimens, and/or controls to reach room temperature (15-30 C)
prior to testing.
- Remove the Test Cassette from the pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
- Extract the Chlamydia antigen according to the specimen type.
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- For Female Cervical or Male Urethral Swab Specimen:
- Hold the Extraction Reagent 1 bottle vertically and add 5 drops of Reagent 1 (approx. 300 μL) to the Extraction Tube. Extraction Reagent 1 is colorless. Immediately insert the swab, compress the bottom of tube and rotate swab 15 times. Let stand for 2 minutes.
- Hold the Extraction Reagent 2 bottle vertically add 6 drops of Reagent 2 (approx. 250 μL) to the Extraction Tube. The solution should turn turbid. Compress the bottom of tube and rotate the swab 15 times until the solution turns clear with a slight green or blue tint. If the swab is bloody, the color will turn yellow or brown. Let stand 1 minute.
- Press the swab against the side of 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 Extraction Tube.
- For Male Urine Specimens:
- For Female Cervical or Male Urethral Swab Specimen:
Hold the Extraction Reagent 2 bottle vertically and add 6 drops of (approx. 250 μL) Reagent 2 to the urine pellet in the centrifuge tube, then shake the tube vigorously until the suspension is homogeneous.
Transfer all the solution in the centrifuge tube to an Extraction Tube. Let stand for 1 minute. Hold the Extraction Reagent 1 bottle upright and add 5 drops of (approx. 300 μL) Reagent 1 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. -
- Place the Test Cassette on a clean and level surface. Add 3 full drops of the extracted solution (approx. 100 μL) to the specimen well of the Test Cassette, then start the timer. Avoid trapping air bubbles in the specimen well.
- Wait for the color to appear. Read the result at 10 minutes; do not interpret the result after 20 minutes.
- Sanders JW, et al. Evaluation of an enzyme immunoassay for detection of chlamydia trachmatis in urine of asymptomatic men. J Clin Microbiol 1994;32,24-27.
- Jaschek G, et al. Direct detection of chlamydia trachomatis in urine specimens from symptomatic and asymptomatic men by using a rapid polymerase chain reaction assay. J Clin Microbiol 1993;31,1209-1212.
- Schachter J. Sexually transmitted Chlamydia trachomatis infection. Postgraduate Medicine, 1982;72, 60-69.