[INTENDED USE]
· Do not use this product after the expiration date.
· Please read all the information in this leaflet before performing the test.
· The test cassette should remain in the sealed pouch until use.
· All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
The COVID-19 Antigen Rapid Test Cassette (Saliva) is a lateral flow
· The used test cassette should be discarded according to federal, state immunoassay intended for the qualitative detection SARS-CoV-2 and local regulations. nucleocapsid antigens in saliva from individuals who are suspected of COVID-19 by their healthcare provider.
Results are for the identification of SARS-CoV-2 nucleocapsid antigen.
[COMPOSITION]
Materials Provided
Discard the saliva collector; Cover the collection tube with the dropper tip Antigen is generally detectable in saliva during the acute phase of infection.
· 20 Test Cassettes: each cassette with desiccant in individual foil pouch onto the collection tube. Shake the collection tube more than three times Positive results indicate the presence of viral antigens, but clinical
· 20 Extraction Reagents: ampoule containing 0.3 mL of extraction reagent vigorously to mix the saliva and the extraction reagent, then squeeze the correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results do not rule out SARS-CoV-2 infection and should not be
· 20 Saliva Collectors
· 20 Collection tubes
· 20 Droppers
· 1 Work Station
· 1 Package Insert
mixed solution ten times to allow the saliva to be thoroughly mixed. used as the sole basis for treatment or patient management decisions,
Materials Required but not Provided
including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of
· Timer
clinical signs and symptoms consistent with COVID-19, and confirmed with
[STORAGE AND STABILITY]
a molecular assay, if necessary for patient management.
The COVID-19 Antigen Rapid Test Cassette (Saliva) is intended for use by medical professionals or trained operators who are proficient in performing
Store as packaged in the sealed pouch at temperature (4-30℃ or 40-86℉). The kit is stable within the expiration date printed on the labeling.3. Remove the test cassette from the sealed pouch.
4. Reverse the collection tube, holding the tube upright, transfer 3 drops (approximately 100μL) slowly to the specimen well (S) of the test cassette,
lateral flow tests. The product may be used in any laboratory and
· Once open the pouch, the test should be used within one hour. Prolonged
then start the timer.
non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation.
exposure to hot and humid environment will cause product deterioration.
· The LOT and the expiration date were printed on the labeling.
5. Wait for colored lines to appear. Interpret the test results at 15 minutes. Do not read results after 20 minutes.
Rebecca Yan
Product Manager
Span Biotech Ltd.
Tel: +86(755)89589611
Cell Phone:+8618823462100(WhatsApp)
Web:
bio-equip.cn
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