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Chlamydia Antigen Rapid Test (Swab/Urine)

Categories Urological Supplies
Delivery Time: within 3 working days(depends on your quantity)
Place of Origin: China
Sample Price: Depending on the present product price
Category: Urological Supplies
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    Chlamydia Antigen Rapid Test (Swab/Urine)


    STORAGE AND STABILITY

    Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

    SPECIMEN COLLECTION AND PREPARATION

    The Chlamydia Rapid Test Device (Swab/Urine) can be performed using female cervical swab, male urethral swab and male urine specimens.

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

    To collect Female Cervical Swab Specimens:

    • Use the swab provided in the kit. Alternatively, any plastic-shaft swab may be used.

    Before specimen collection, remove excess mucus from the endocervical area with a 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 the Chlamydia organism. Firmly rotate the swab 360o in one direction (clockwise or counterclockwise), let stand for 15 seconds, then withdraw the swab. Avoid contamination from exocervical or vaginal cells. Do not use 0.9% sodium chloride to treat swabs before collecting samples.

    If the test is to be conducted immediately, put the swab into the extraction tube.

    • To collect Male Urethral Swab Specimens:

    Standard plastic- or wire-shaft sterile swabs should be used for urethral specimen collection. Instruct patients not to urinate for at least one hour prior to specimen collection.

    Insert the swab into the urethra about 2-4 cm, rotate the swab 360o in one direction (clockwise or counterclockwise), let stand for 10 seconds, then withdraw. Do not use 0.9% sodium chloride to treat swabs before collecting samples.

    If the test is to be conducted immediately, put the swab into the extraction tube.

    To collect 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.

    It is recommended that specimens be processed as soon as possible after collection. If immediate testing is not possible, the patient swab specimens should be placed in a dry transport tube for storage or transport. The swabs may be stored for 4-6 hours at room temperature (15-30°C) or 24-72 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 room temperature (15-30°C) before testing.

    MATERIALS

    Materials Provided

    Test devices Test tubes Dropper tips Sterile female cervical swabs (for ICH-502 only)

    Reagent A (0.2M NaOH) Reagent B (0.2N HCl)

    Workstation Quantitative pipette Package insert

    Materials Required But Not Provided

    Timer Urine cup (for male urine specimens only)

    Centrifuge tube (for male urine specimens only)

    Positive control Sterile male urethral swabs

    Sterile female cervical swabs (for ICH-502S only) Negative control

    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 to a 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, and start 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.

    Product Tags:

    clean room swabs

      
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