The Ecotest COVID-19 rapid test is a Health Canada authorized device that uses an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG antibodies in human whole blood samples collected from a minimally invasive fingerstick blood collection process, as well as in serum and plasma samples.

Each test kit contains the following components:

• Individually packed test devices
• Disposable pipettes
• Sterile safety lancet
• Buffer
• Package insert
• Alcohol prep pad

How it works:

The Ecotest COVID-19 antigen rapid test detects anti-SARS-CoV-2 IgG/IgM antibodies in human whole blood, serum or plasma samples. If these antibodies are present (indicating current or recent COVID-19 infection), they bind to the SARS-CoV-2 antigens that are combined with coloured particles on the conjugate pad.

As the specimen moves along the test strip by capillary action and interacts with reagents present on the membrane, this complex is captured by anti-human IgM and/or anti-human IgG antibodies and becomes immobilized on the test region(s). Consequently, coloured particles are captured at the internal control region of the test.

How to take the test:

The test device should be stored at 2-30°C when not in use. Allow the test device, specimen, buffer, and/or controls to reach room temperature (15- 30°C) prior to testing.

1. The pouch should be brought 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 level surface. Label the test with patient or control identification.

3. Twist off the cap of the buffer ampule.

4. Obtain the sample and put it in the sample well of cassette as per specifics below:

For Serum or Plasma Specimens

With the provided disposable pipette, draw the specimen up to the Fill Line, and transfer all the specimen (approximately 5 μL) into the specimen well of the test device, then add 3 drops of buffer and start the timer.

For Venous Whole Blood Specimens

With the provided disposable pipette, draw the specimen above the fill line (avoid the specimen the bubble of the disposable pipette) and transfer one drop of the specimen into the specimen well of the test device, then add 3 drops of buffer and start the timer.

For Fingerstick Blood Specimens

• Clean the puncture site with the alcohol prep pad provided.
• Carefully remove the cap from the safety lancet. Push the safety lancet firmly against the puncture until it pricks the finger.
• Using the provided disposable pipette, draw the specimen above the fill line (avoid the specimen bubble of the disposable pipette) and transfer one drop of the specimen into the specimen of the test device, then add 3 drops of buffer and start the timer.

5. Wait for the coloured line(s) to appear. Read results at 15 minutes.

How to read the results:

A positive test result is indicated by the presence of one or two red line on the test region(s), which demonstrates a positive result for the specific IgG and/or IgM antibodies, while the control line (C) changes from blue to red.

A negative test result is indicated by the absence of red line(s) on the test region(s), while the control line (C) changes from blue to red.