| Classification: | Biological Diagnostics |
|---|---|
| Certification: | CE, ISO13485 |
| Model No.: | Cassette/Card/Device |
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The fast test cassette, part of the kit, can detect the virus in just 10-15 minutes.
The test kit can shorten the testing time, provide easier and faster operation and make rapid diagnosis of suspected patients and on-site screening of people in close contact.
MATERIALS SUPPLIED
20 sealed pouches each containing a test cassette, a dropper and a desiccant
Buffer
1 package insert
1 alcohol pad for disinfection use
1 Lancet (for fingerstick whole blood only)
MATERIAL REQUIRED BUT NOT PROVIDED
1. Centrifuge (for plasma only)
2. Timer
3. Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)
STORAGE AND STABILITY
The kit can be stored 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.
WARNINGS AND PRECAUTIONS
1. For professional In Vitro diagnostic use only. Do not use after expiration date.
2. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.
3. Do not use it if the tube/pouch is damaged or broken.
4. Test is for single use only. Do not re-use under any circumstances.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Humidity and temperature can adversely affect results.
8. Do not perform the test in a room with strong air flow, ie. electric fan or strong air-conditioning.
Features & Benefits
• Fast results as soon as 2-15 minutes
• Facilitates patient treatment decisions quickly
• Simple, time-saving procedure
• Little specimens, only 5 μL of serum/plasma or 10 μL of whole blood specimens
• All necessary reagents provided & no equipment needed
• High sensitivity and specificity
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