· 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.
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
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.
The novel coronaviruses (SARS-CoV-2) belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
The COVID-19 Antigen Rapid Test Cassette (Saliva) is a lateral flow immunoassay based on the principle of the double-antibody sandwich
[SPECIMEN COLLECTION AND PREPARATION]
DO NOT place anything in the mouth including food, drink, gum or tobacco products for at least 30 minutes prior to collection.
Use the collection tube and saliva collector to collect saliva. Insert the saliva collector into the collection tube, then put the saliva collector close to lips and let the saliva flow into the collection tube. The volume of saliva needs to be at the scale mark (approx.300μL). If the volume of saliva is too much, use a dropper to remove the excess saliva until the final solution at the scale mark (approx. 300μL).
[INTERPRETATION OF RESULTS]
antibody conjugated with color microparticles is used as detector and sprayed on conjugation pad. During the test, SARS-CoV-2 antigen in the specimen interacts with SARS-CoV-2 antibody conjugated with color microparticles making antigen-antibody labeled complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the pre-coated SARS-CoV-2 nucleocapsid protein monoclonal antibody. A colored test line (T) would be visible in the result window if SARS-CoV-2 antigens are present in the specimen. Absence of the T line suggests a negative result. The control line (C) is used for procedural control, and should always appear if the test procedure is performed properly.
[WARNINGS AND PRECAUTIONS]
Specimen Transport and Storage
Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection.
· For in vitro diagnostic use only.
· For healthcare professionals and individuals trained in point of care settings.
· Do not use this product as the sole basis to diagnose or exclude
Note: Allow the test cassettes, reagents and specimens to equilibrate to room temperature (15-30℃ or 59-86℉) prior to testing.
1. Place the collection tube with saliva collector which has saliva in the work station. Unscrew the lid of an extraction reagent. Add all of the extraction reagents into the collection tube.
SPAN BIOTECH LTD.