Accurate rapid antigen test kit Covid-19 Antigen Rapid Test Kit
COVID-19 Antigen Rapid Test Kit is a solid phase
immunochromatographic assay for the in vitro qualitative detection
of nuleocapsid protein antigen from 2019 Novel Coronavirus in human
oral saliva specimen.
This test kit provides only a preliminary test result for COVID- 19
infection as a clinically-assisted diagnosis.Testing is only
limited to professional laboratories.
COVID-19 is an acute respiratory infectious disease. People are
generally susceptible. Currently, the patients infected by novel
coronavirus are the main source of infection, asymptomatic infected
people can also be an infectious source.
| SPECIMEN COLLECTION AND HANDLING |
| 1. | Gargle with clean water before sampling |
| 2. | Unscrew the lid of the Extraction Tube, insert the saliva specimen
collection funnel and screw it tightly. |
| 3. | Cough up secretions deep in the throat, accumulated in the oral
cavity. |
| 4. | Use a saliva specimen collection funnel to collect fresh secretions
in the oral cavity, reach the oral secretion scale mark. |
| 5. | Unscrew the funnel to allow the secretions to slip into the
extraction buffer, tighten the funnel immediately and shake the
collection tube. |
| 6. | Rotate to remove the funnel, place the white tip into the
collection tube. |
The main manifestation include fever, fatigue and dry cough. Nasal
congestion, runny nose, sore throat, myalgia and diarrhea are found
in a few cases.Coronaviruses are enveloped RNA viruses that are
distributed broadly among humans, other mammals, and birds and that
cause respiratory, enteric, hepatic, and neurologic diseases.
MATERIALS SUPPLIED
Individually pouched test cassettes (25): Monoclonal anti-SARS
antibodies
Single use Extraction Tubes with extraction solution and integrated
dispensing tip (25) Single use saliva specimen collection funnels
(25)
Instruction for Use Sheet (1)
MATERIALS REQUIRED BUT NOT PROVIDED IN KIT
Timer
MATERIALS AVAILABLE AS AN OPTIONAL ACCESSORY
Positive Control Negative Control
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 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.
9. Test is only for oral saliva specimens If test other specimens
such as nasal, throat or nasopharyngeal swab specimens or
serumplasmaurine specimens, the results are only for research.
10. Sample collection and handling procedures require specific
training and guidance.
11. Do not pour sample from the Extraction Tube into the Test
Cassette sample well. Use the provided dispensing tip of Extraction
Tubes when adding the sample to the Test Cassette.
