What Is A SARS-CoV-2 Rapid antigen Test And How Does It Work

What Is A SARS-CoV-2 Rapid antigen Test And How Does It Work

How the SARS-CoV-2 Rapid Antigen Test works

The SARS-CoV-2 Rapid Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx.

his test is intended to detect specific antigens from the SARS-CoV-2 virus in individuals suspected of COVID-19. The test is intended for professional use only.

【SAMPLE COLLECTION】

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.

Remove mucus from the nose.

Wash or sanitize hands thoroughly.

Fold/assemble the sample extraction tube rack.

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.

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.

Open the swab package. Note: Do not touch the swab’s absorbent tip, so be sure to open the package on the opposite end.

Hold head in a vertical position and look slightly downwards .

Nasal Swab Samples:

Carefully insert the entire absorbent tip of the swab in one nostril and rotate at least 5 times. Be sure that the absorbent tip of the swab scrapes against the nasal wall.

Remove swab from nostril and, using the same swab, repeat step 1 in the other nostril.

Insert the absorbent tip of the swab into the extraction buffer tube and swirl the swab at least 5 times.

Squeeze the tube against the submerged swab several times to facilitate extraction of the specimen. Remove the swab, place it back in its original wrapping and dispose into the waste bag.

Place the nozzle onto the extraction tube and ensure it is attached firmly.

【TEST PROCEDURES】

Restore the test devices and specimens to room temperature (15-30°C ) prior to testing.

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.

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.

Set the timing device for 15 minutes.

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.

Collect all used items (swab, 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.

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.

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UDXBIO’s response to the COVID-19 pandemic

Our commitment to help put a stop to the COVID-19 pandemic. UDXBIO is deeply committed to supporting the global response to put an end to the COVID-19 pandemic. Around the world, we are working with urgency, passion and purpose each and every day to deliver high quality tests that are essential for healthcare systems and patients alike.

Reliable, high quality tests to deliver effective results. As a diagnostics testing, we have a responsibility to deliver effective solutions for patients fast. Testing is a critical part in fighting this unprecedented global healthcare emergency and we are proud to be able to contribute.