CE ISO 10 Minutes Chlamydia Rapid Test Kit Cassette Swab Sampling Test
[INTENDED USE]
The Chlamydia Rapid Test (Swab/Urine) is a rapid visual immunoassay forthe 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.
[CONTENTS]
• Rapid test cassette with desiccant
• Buffer 2 vials(Reagent 1 & Reagent 2)
• Disposable swab
• Package insert
[OPERATION]
Allow the test, specimen, reagents, and/or controls to reach roomtemperature (15- 30℃) 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 3 drops (approximately 100 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.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.
[ABOUT US]
DEWEI Medical Equipment Co., Ltd is a leading and professional manufacturer of IVD products,it is a high-tech enterprise specialized in developing, manufacturing and marketing of Clinical Laboratory analyzer & reagents, such as Hematology Analyzer & Reagents, Virus RNA Preservation & Extraction Kits, Urine Sediment Reagents and Washing Solutions.
DEWEI products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
Qulity is primary concern, DEWEI team is strict on quality control systems thus our products have CE, ISO, CFDA and other international standards certificates.
The view of DEWEI is to be the most professional and respected enterprise in IVD field, DEWEI will go on providing best service to you by the outstanding R&D and cost-effective products.
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