SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag)

The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in human throat and nasal secretions.

Product Details

SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag)


A rapid test for the qualitative detection of antigens to the novel coronavirus SARS-CoV-2 in human throat and nasal secretions. For professional in vitro diagnostic use only.


PACKING SPECIFICATIONS

40 T/kit, 20 T/kit, 10 T/kit, 1 T/kit.


INTENDED USE

The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in human throat and nasal secretions.


PRINCIPLE

The SARS-CoV-2 Antigen Rapid Test is for detection of SARS-CoV-2 antigens. Anti-SARS-CoV-2 monoclonal antibodies are coated in the test line and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-SARS-CoV-2 antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with another Anti-SARS-CoV-2 monoclonal antibodies in the test region. The complex is captured and forming a colored line in the Test line region. The SARS-CoV-2 Antigen Rapid Test contains anti-SARS-CoV-2 monoclonal antibodies conjugated particles and another anti-SARS-CoV-2 monoclonal antibodies are coated in the test line regions.


Materials Provided

1) Foil pouches, with test cassettes and desiccants


2) Assay buffer


3) Sterile swab and specimen collection tube


4) Instruction for use


Materials Required But Not Provided


1) Specimen collection container

2) Timer


TEST PROCEDURE


Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.


1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.


2. Place the test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer.


See illustration below.

TEST PROCEDURE

3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.

INTERPRETATION OF RESULTS

INTERPRETATION OF RESULTS

- Positiv e (+): Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the T line region.

*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of SARS-CoV-2 present in the specimen. Therefore, any shade of color in the test line region should be considered positive and recorded as such.

- Negativ e (-): One colored line appears in the control line region(C). No line appears in the T line region.

- Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit

immediately and contact your local distributor.


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R&D


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