Parameter of COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | |
Material | pp |
Specimen | Saliva |
Sensitivity | 90.47% |
Specificity | 99.23% |
Accuracy | 95.32% |
Test type | Antigen |
Test time | 15 minutes |
Test method | Colloidal Gold |
Keep temperature | 2-30℃ |
Certification | CE, ISO 13485 2016 |
Shelf-life | 24 months |
Package | Carton Box, 1 test/kit, 5 tests/kit, 20 tests/kit, 25 tests/kit, 50 tests/kit |
l Fast. You can read the result within 5-10 minutes, faster than PCR test.
l Simple. Easy to use and easy to get the specimen, no equipment required, no PCR lab required.
l Convenient. Can be used in many places like station, airport, hospital, school and very convenient.
COVID-19 Antigen Rapid Test is based on colloidal gold immunochromatography assay.During the test, specimens and detection
buffer are applied to the test cartridges. If there are SARS-CoV-2 nucleocapsid antigens in the specimens, they will bind to colloidal
gold-labeled antibodies against SARS-CoV-2 N protein on conjugation pad forming virus antigen-antibody-colloidal gold complex
(complex T).
During lateral flow, the complex T move along nitrocellulose membrane toward one end of the absorbent paper. When passing the
line T (coated with another monoclonal antibody against virus N protein), the complex T is captured by capture antibody resulting in
coloring on line T; when passing the line C, residual colloidal gold-labeled is captured by quality-control antibody resulting in coloring
on line C.
(1) Test cartridge
(2) Pre-filled extraction buffer tube
(3) Nozzles to extraction tube
(4) Saliva transfer pipette
(5) Paper rack
(6) Instructions for use
(7) Paper Cup
Materials required but not provided
(8) Timing device
(9) Waste bag
1. Before running the assay, ensure the test area is sanitized. Open the kit and ensure all materials described in “Reagents and Materials Provided” are included and the kit is not expired. Obtain a timing device (clock, watch or timer) and read the Instructions for Use.
2. Wash or sanitize hands thoroughly.
3. Fold/assemble the sample extraction tube rack.
4. Remove one pre-filled extraction tube from the sealed pouch and close the pouch with the unused tubes. Hold the tube upright and,
before opening it, tap the bottom of the tube on a clean, flat surface to ensure that any liquid on the seal is moved down into the tube.
5. Carefully remove the foil seal from the extraction tube, and place the open tube in the sample extraction tube rack. Dispose the foil
seal into a waste bag. Keep the bag to later collect other used items.
1. Before collecting oral fluid relax your cheeks and gently massage cheeks with fingers for 15-30 seconds, Place the tongue against the upper and lower jaws and roots to enrich the oral fluid.
2. Gently spit oral fluid into the collection bag.The sample is now ready for processing using the kit.
3. Fill the saliva till the lower scale mark of saliva transfer pipette and the volume will be around 150uL. Transfer saliva specimen into the pre-filled extraction buffer tube with the transfer pipette.
Note: saliva is highly viscous. Please strictly follow the instructions described above. Adding excessive or insufficient saliva sample may cause inaccurate results.
4. Squeeze the pipette no less than 5 times to mix the saliva sample with sample extraction solution.
5. Insert the Nozzles to extraction tube firmly on the Pre-filled extraction buffer tube. Put the tube still for 1 minute to release viral antigens.
6. Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection.
Restore the test devices and specimens to room temperature (15-30°C ) prior to testing.
1. Remove the cassette device from the sealed pouch just prior to testing. Lay the device on a clean, flat surface and label with
specimen ID/name.
2. Invert the sample extraction tube and slowly add 2~3 drops of the extracted specimen into the sample well of the cassette device
by gently squeezing the sample tube.
3. Set the timing device for 15 minutes.
4. Read the results after 15 minutes. Note: The result might be visible after a shorter time, however, it should only be interpreted between
15-20 minutes after dispensing the sample material onto the cassette device.
5. Collect all used items (Paper Cup,Saliva pipette，cassette, sample extraction tube, foil seal and nozzle, and potentially used gloves)
into the waste bag. Close the bag and dispose in a biohazard trash can.
6. Thoroughly wash or sanitize hands and any used surfaces/tools for the procedure.
Alternative procedure for specimens stored in VTM:
Add 70 µL of the VTM specimen directly into the sample well of the cassette device and proceed to step 3 above.
Note: This method is only recommended for samples stored in VTM not containing pH indicator dye, as the dye color might interfere with
the assay.
1. Negative results: coloring on C line appear only.
2. Positive results: coloring on both T line and C line. (Note: Faint line should be regard as coloring)
3. Invalid results: no coloring appear on C line regardless of T line coloring.
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