COVID-19 Antigen Saliva Test Device

Intended Use

COVID-19 Antigen Saliva Test Device is an in vitro immunoassay. The assay is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from saliva sample. COVID-19 Antigen Saliva Test Device is intended for professional use.

What is the science underlying COVID-19 Antigen Saliva Test Device？

The COVID-19 Antigen Saliva Test Device detects SARS-CoV-2 viral antigens through visual interpretation of color development. Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-CoV-2 antibodies conjugated to colored particles are immobilized on the conjugated pad. A sample is added to the extraction buffer which is optimized to release the SARS-CoV-2 antigens from specimen.

During testing, target antigens, if present in the saliva samples, will be released into the extraction buffer individually packed in the kit. Consequently, the extracted antigens will bind to anti-SARS-CoV-2 antibodies conjugated to colored particles. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 antibodies at the test region. Excess colored particles are captured at the internal control zone.

The presence of a colored band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking is working.

Materials

● Individually packed test devices

● Extraction buffer

● Extraction tube

● Nozzle with filter

● Individually packed swabs

● Tube stand

● Package insert

● Specimen collection bag

Benefits

● Easy sampling

● Rapid detection within 15 minutes

● Less painful and more convenient for collecting saliva samples

● Individual buffer that can reduce the pollution caused by man-made operation

Test Procedure

Bring the test device, reagents and specimens and/or controls to room temperature (15~30℃) before use.

1. For each specimen, open the foil pouch just before testing and remove the test device, and put it on a clean, level surface. Label the tube with the patient identification. For best results, the assay should be performed within one hour.

2. Insert the tube into the tube stand.

3. Unscrew the buffer, and add all the buffer into the extraction tube.

4. Take a deep breath in, cough hard (about 3-5 times), and spit out the saliva into the specimen collection bag.

5. Insert the swab into the specimen collection cup and fully immersed in about 5-10s.

6. Remove the swab from the specimen collection cup and insert the swab into the extraction tube. Mix well and squeeze the swab 10-15 times by compressing the walls of the tube against the swab.

7. Roll the swab head against the inner wall of the tube as you remove it. Try to release as much liquid as possible. Dispose of the used swab in accordance with your biohazard waste disposal protocol.

8. Insert nozzle into sample extraction tube. Invert the tube and add 3 drops of solution into the sample well by gently squeezing the tube.

9. Read results at 15 minutes. Do not read the results after 30 minutes.

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