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COVID-19 Antigen Rapid Test(Saliva samples)

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COVID-19 Antigen Rapid Test is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of COVID-19. As a point-of-care test with a 15 min testing time, COVID-19 Antigen test allows effective screening of COVID-19 infection on a large scale.

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Product Description

COVID-19 Antigen Rapid Test Specification

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

Rapid Test Antigen Saliva Features

Fast. You can read the result within 5-10 minutes, faster than PCR test. 

Simple. Easy to use and easy to get the specimen, no equipment required, no PCR lab required.

Convenient. Can be used in many places like station, airport, hospital, school and very convenient. 


Antigen Rapid Test Kit Test Principle

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.


Antigen Saliva Test Kit Components

(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


COVID-19 Antigen Rapid Test - UDXBIO

 

 

Materials required but not provided

(8) Timing device

(9) Waste bag

Swab Antigen Test SAMPLE COLLECTION

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.

Swab Antigen SalivaSamples:

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.



antigen test and rapid test - UDXBIO 



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.

 

antigen test saliva - UDXBIO

 

Saliva Antigen Test Kit TEST PROCEDURES

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.

 

 

rapid test antigen saliva - UDXBIO


Rapid Saliva Antigen Test RESULTS INTERPRETATION

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.


rapid test antigen saliva - UDXBIO