Chlamydia Rapid Test (Swab/Urine)
【INTENDED USE】
The Chlamydia Rapid Test (Swab/Urine) is a rapid visual immunoassay for the qualitative presumptive detection of Chlamydia trachomatis in female cervical swab, male urethral swab and male urine specimens. This kit is intended for use as an aid in the diagnosis of Chlamydia infection.
【INTRODUCTION】
The genus Chlamydia includes three species: Chlamydia trachomatis, the recently described Chlamydia pneumoniae, primarily associated with humans, and Chlamydia psittasi, primarily associated with animals. Chlamydia trachomatis comprises 15 known serovars, is associated with trachomatis and gentourinary infection, and three serovars are associated with lymphogranuloma venereum (LGV). Chlamydia trachomatis infections are the most common bacterial sexually transmitted diseases. Approximately 4 million new cases occur each year in the United States, primarily cervicitis and nongonococcal urethritis. This organism also causes conjunctivitis and infant pneumonia. Chlamydia trachomatis infection 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 cervictis, urethritis, endometritis, pelvic inflammatory diseases (PID) and increased incidence of ectopic pregnancy and infertility. Vertical transmission of the disease during parturition from mother to neonate can result in inclusion conjunctivitis and pneumonia. In men, at least 40% of cases of nongonococcal urethritis are associated with chlamydia infection and epididymitis. Approximately 70% of women with endocervical infections and up to 50% of men with urethral infections are symptomatic.
Chlamydia psittasi infection is associated with respiratory disease in individuals exposed to infected birds and is not transmitted from human to human. Chlamydia pneumonia, first isolated in 1983, is associated with respiratory infections and pneumonia. Traditionally, chlamydia infection has been diagnosed by the detection of chlamydia inclusions in tissue culture cells. Culture method is the most sensitive and specific laboratory method, but it is labour intensive, expensive, lengthy (2-3 days) and not routinely available in most institutions. Direct tests such as immunofluorescence assay (IFA) require specialized equipment and a skilled operator to read the result.
【PRINCIPLE】
The Chlamydia Rapid Test detects Chlamydia trachomatis through visual interpretation of color development on the internal strip. Antigen-specific lipopolysaccharide (LPS) monoclonal antibody is immobilized on the test region of the membrane. During testing, the specimen reacts with monoclonal anti-Chlamydia antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient chlamydia antigen in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
【MAIN CONTENTS】
• One pouch containing a rapid test cassette with desiccant.
• Reagent 1
• Reagent 2
• Swab
• Extraction Tube with tip
• Package insert
【PRECAUTIONS】
• For professional in vitro diagnostic use only.
• Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new extraction tube for each specimen obtained.
• Read the entire procedure carefully prior to testing.
• Do not eat, drink or smoke in any area where specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Do not interchange or mix reagents from different lots. Do not mix solution bottle caps.
• Humidity and temperature can adversely affect results.
• When the assay procedure is complete, dispose of swabs carefully after autoclaving them at 121°C for at least 20 minutes. Alternatively, swabs can be treated with 0.5% sodium hypochlorite (i.e., household bleach) for one hour before disposal.
• Used testing materials should be discarded according to local regulations.
• Do not use cytology brushes with pregnant patients.
【STORAGE AND STABILITY】
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
• Care should be taken to protect the components of this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.
【SAMPLE COLLECTION】
• The quality of specimen obtained is of extreme importance. Detection of chlamydia requires a vigorous and thorough collection technique which
provides cellular material rather than just body fluids. Do not use 0.9% sodium chloride to treat swabs before collecting specimens.
For female cervical specimens:
• Use the swab provided with the kit.
• Before specimen collection, remove excess mucus from the endocervical area with a separate swab or cotton ball and discard. The swab should be inserted 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 organisms. Firmly rotate the swab for 15 - 20 seconds without contamination with exocervical or vaginal cells.
• If the swab may be tested immediately, replace the swab into the extraction tube.
For male urethral specimens:
• Standard wire-shafted fiber-tipped swabs or cytology brushes (not provided) should be used for urethral specimen collection. Instruct the patients not to urinate at least one hour prior to specimen collection.
• Insert the swab 2-4 cm into the urea, rotate for 3-5 seconds and withdraw it. If the swab may be tested immediately, replace the swab into the extraction tube.
For male urine specimens:
• Collect 15-30 mL of clean first morning urine in a sterile urine cup. First morning urine specimens are preferred to achieve the highest concentrations of Chlamydia antigen.
• Mix the urine specimen by inverting the container. Transfer 10 mL of the urine specimen into a centrifuge tube, add 10 mL distilled water and centrifuge at 3,000 rpm for 15 minutes.
• Carefully discard the supernatant, keep the tube inverted and remove any supernatant from the rim of tube by blotting onto absorbent paper.
• If the test is to be conducted immediately, treat the urine pellet according to the Directions for Use.
• Do not place the swab in any transport device containing medium. Transport medium interferes with the assay, and viability of organisms is not required for the assay. If immediate testing is not possible, patient samples should be placed in a dry transport tube for storage or transport. The swabs may be stored for 4 hours at room temperature (15-30°C) or 24 hours refrigerated (2- 8°C). The urine specimens can be stored refrigerated (2-8°C) for 24 hours. Do not freeze. All specimens should be allowed to reach a room temperature of 15- 30°C before testing.
【DIRECTION OF USE】
Allow the test, specimen, reagents, and/or controls to reach room temperature (15- 30°C) prior to testing.
1. Remove the test cassette 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 endocervical or Male urethral swab specimens:
• Place a clean extraction tube in the workstation. Add 5 drops of Ragent 1 to the extraction tube.
• Immerse the patient swab into the extraction tube and wait 2 minutes. While waiting, 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 can reabsorb.
• Add 6 drops of Reagent 2. Squeeze the swab firmly against the tube to expel as much liquid as possible from the swab for 1 minute. Discard the swab following guidelines for handling infectious agents. Fit the dropper tip on top of the extraction tube.
• The extracted specimen can remain at room temperature for 60 minutes without affecting the test result.
For Male urine specimens:
• Add 6 drops of Reagent 2 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 2 minute. Hold the Reagent 2 bottle upright and add 5 drops of Reagent 1 to the extraction tube. Vortex or tap the bottom of the tube to mix the solution. Let stand for 1 minutes.
• Fit the dropper tip on top of the extraction tube.
3. Add 2 drops (approximately 50 µL) of extracted specimen from the extraction tube to the specimen well (S) of the test cassette.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window.
As the test begins to work, color will migrate across the membrane.
4. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
【INTERPRETATION OF RESULTS】
POSITIVE:
The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE:
The presence of only control line (C) within the result window indicates a negative result.
INVALID:
If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
For further operation or performance details, please refer to final instruction manual.
Your message must be between 20-3,000 characters!