Audited Supplier
GOCL
IVD Reagent
Rapid Test + Buffer + Swab
Urine or Endocervical Swab
Within 5 Mins
2~30 º C
Immunochromatography
24 Months
Dewei
25tests/Box
1000tests/carton
China
Product Description
| Storage | 2~30 º C |
| Specimen | Urine Endocervical Canal Swab |
| Component | Rapid Test + Extraction Buffer + Swab |
| Principle | Colloidal gold rapid tests |
| Reading | Within 5mins |
| Package | 25tests/box |
| Trademark | Dewei |
| Origin | China |
INTENDED USE
The Chlamydia and Gonorrhea Rapid Test Combo is a rapid visual immunoassay for the qualitative presumptive detection of Chlamydia trachomatis and Neisseria gonorrhoeae 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 and Gonorrhea infection.
PRINCIPLE
The Chlamydia and GonorrheaRapid Test Combo detects Chlamydia trachomatis and Neisseria gonorrhoeae 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.
OPERATION
Allow the test, specimen, reagents, and/or controls to reach room temperature (15-30°C) prior to testing.
• 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.
As the test begins to work, color will migrate across the membrane.
INTERPRETATION OF RESULTS
Positive (+)
Two colored bands appear on the membrane of each window.
Negative (-)
Only one colored band appears, in the control region (C) of each window.
Invalid
Control band fails to appear of each window.
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 and Gonorrhea 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 (+)
Two colored bands appear on the membrane of each window.
Negative (-)
Only one colored band appears, in the control region (C) of each window.
Invalid
Control band fails to appear of each window.
PRODUCT IMAGES
COMPANY IMAGE
PRODUCTION LINE
PERFORMANCES
