Customization: | Available |
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Kit Size: | 25 Tests |
Storage: | 2-30°c |
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INTENDED USE
The Gonorrhea Rapid Test (Swab) is a rapid visual immunoassay for the qualitative presumptive detection of Neisseria gonorrhoeae in female cervical swab and male urethral swab specimens. This kit is intended for use as an aid in the diagnosis of Gonorrhea.For professional in vitro diagnostic use only.
CONTENTS
• Rapid test cassette with desiccant.
• Sampling Swab
• Reagent 1
• Reagent 2
• Extractieatures
• Package inser
Features
• Result is available in 10-15 minutes
• Easy to read result, no equipment required
• Store at room temperature
• Reliable with CE certificate
• No cross-reactivity with other related viruses
Qualification | ||||
Cat. No. | Test Item | Format | Specimen | Qualification |
GON-DS02 | Gonorrhea | Strip/Cassette | Swab | CE |
OPERATION
Allow the test, specimen, reagents, and/or controls to reach room temperature (15- 30C) 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 tubetoexpelasmuch liquid as possible from the swab for 1 minute. Discard the swabfollowingguidelines for handling infectious agents. Fit the dropper tipontopoftheextraction tube.
• The extracted specimen can remain at room temperature for 60minuteswithout affecting the test result. For Male urine specimens: • Add 6 drops of Reagent 2 to the urine pellet in the centrifuge tube, thendrawthe liquid up and down with a pipette to vigorously mix until the suspensionishomogeneous.
• Transfer all the solution in the centrifuge tube to an extractiontube. Letstandfor 2 minute. Hold the Reagent 2 bottle upright and add 5 drops of Reagent1tothe extraction tube. Vortex or tap the bottom of the tube to mix thesolution.Letstand for 1 minutes.
• Fit the dropper tip on top of the extraction tube.
3. Add 2 drops (approximately 50 µL) of extracted specimenfromtheextraction tube to the specimen well (S) of the test cassette. Avoid trapping air bubbles in the specimen well (S), anddonot addanysolution 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 shouldbereadat10minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
POSITIVE: The presence of two lines as control line (C) andtest line(T)within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result windowindicates a negative result.
INVALID: If the control line (C) is not visible within the result windowafterperforming the test, the result is considered invalid. Some causesofinvalidresults are because of not following the directions correctly or the test may have
1.Are you a Manufacturer?
Yes,we are manufacturer based in Foshan,China with 100 workers,more than 5000 square meter non-dust workshop,advanced automate machines and professional R&D team ensure the high quality,speedy delivery and large production capacity.
2.Can we put our logo/text om the product or package?
Yes,we can do OEM or even ODM.All of our products can be customized.
3.Can you provide free samples?
Yes, free sample are available.
4.How long is your production time?
Our production time is usually two weeks after receiving the deposit and four weeks for one contaoner order quantity.
5.How to make the payment?
By T/T,L/C,Paypal,Western union and made in China is also acceptable.