Testing Kit

The only device that tests for both IgM and IgG antibodies with proven good clinical performance compared with RT-PCR.

  • In vitro diagnostic test
  • Qualitative determination of COVID-19’s IgM and IgG antibodies
  • 10μL whole blood / serum / plasma
  • Result after 15 minutes.
  • For Professional use only
  • CE TüV Rheinland ISO 13485:2016

The COVID-19 Rapid Individually wrapped test kit contains 1x Test device + 1x Safety Lancet 26G • Buffer • Pipette • Alcohol pad

 

Specifications and Features:

The Test COVID-19 IgM/IgG Rapid Test is an in vitro diagnostic test for the qualitative determination of COVID-19’s IgM and IgG antibodies in human whole blood, serum, plasma and fingertip blood.

The test kit consists of test devices and buffer. It is for in vitro diagnostic use only and can be used in point-of-care testing settings and central laboratories.

The test kit is based on immunoassay technology.

The test devices contain:

  1. Conjugate pad: recombinant SARS-CoV-2 antigen labelled with colloidal gold and quality control antibody gold marker.
  2. NC membrane: coated with two detection lines (IgG line and IgM line) and one quality control line (C line). The IgM line coated with mouse anti-human IgM monoclonal antibody detects the COVID-19 IgM antibody. The IgG line coated with mouse anti-human IgG monoclonal antibody detects the COVID-19 IgG antibody. The C line coated with quality control antibody. When sample is added to the sample well of the test device, it will move forward along the test device.If the sample contains IgM antibodies, antibodies will bind to the virus antigen labelled with colloidal gold, then forms a sandwich complex with the coated anti-human IgM monoclonal antibody at IgM line, IgM line will appear purplish red, prompting the COVID-19 IgM antibody is positive.If the sample contains IgG antibodies, antibodies will bind to the virus antigen labelled with colloidal gold, then forms a sandwich complex with the coated anti-human IgG monoclonal antibody at IgG line, IgG line will appear purplish red, prompting the COVID-19 IgG antibody is positive.If either line IgG or IgM does not show colour, the negative result will be displayed. The test device also contains a quality control line C, whether there is a test line or not, quality control line C should display purplish red. Test result will be invalid if quality control line C does not show colour, this sample needs to be retested

 

Interpretation of Results

1. Positive result:

  1. The COVID-19 IgM antibody is detected if the quality control line C and the detection line IgM are both coloured, and the detection IgG line is not coloured, that means the COVID-19 IgM antibody is positive.
  2. The COVID-19 IgG antibody is detected if the quality control line C and the detection IgG line are both coloured, and the detection IgM line is not coloured, that means the COVID-19 IgG antibody is positive.
  3. The COVID-19 IgG and IgM antibodies are detected if the quality control line C, the detection line IgM and IgG are both coloured, that means both the COVID-19 IgG and IgM antibodies are positive.

2. Negative result:
If there is only quality control line C is coloured, IgG and IgM detection lines are not coloured, the COVID-19 IgM/IgG antibody is not detected, that means the result is negative.

3. Invalid result:
If the quality control line C is not coloured, no matter whether the detection line IgG/IgM is coloured or not, the result is invalid and needs to be tested again.

Limitations
  • The test result cannot be used for diagnosis of COVID-19. If the result does not match the clinical evaluation, please do more testing.
  • Do not use highly haemolytic samples.
Instructions for use:
  1. Take out the test kit and leave it at room temperature for a minimum of 30 minutes.
  2. Put a test device on a dust-free clean surface.
  3. Apply 10μL whole blood/serum/plasma/fingertip blood onto the sample well of a Test Device,
  4. Apply 2 drops (about 60-80μL) of buffer onto the sample well of a Test Device.
  5. Read the result after 15 minutes.

Note: For in vitro diagnostic use.

 

Composition:

Each test kit contains the test device, buffer and package insert.

The test device contains:

  1. Binding pad: recombinant COVID-19 antigen labelled with colloidal gold and quality control antibody gold marker.
  2. NC membrane: coated with two detection lines (IgG line and IgM line) and one quality control line (C line).

 

  1. The IgM line coated with rat anti human IgM monoclonal antibody detects the COVID-19 IgM antibody.
  2. The IgG line coated with rat anti human IgG monoclonal antibody detects the COVID-19 IgG antibody. The C line coated with quality control antibody.
Storage and Handling
  • Store the test kit in a cool, dry place between 2-30°C (36-86°F). Keep away from light. Exposure to temperature and / or humidity outside the specified conditions may result in inaccurate results.
  • Do not freeze or refrigerate.
  • Use the test kits at temperatures between 18-25°C.
  • Use the test kits between 10-90% humidity.
  • Do not use your test kits beyond the expiry date (printed on the foil pouch and box label).
    Note: The test kit is recommended to store between 2-8°C if it is not used in a short time.
Clinical Performance

From the results of 200 negative and positive samples, we can confirm that COVID-19 IgM/IgG rapid test has good clinical performance compared with RT-PCR.

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