COVID-19 IgG/IgM Rapid Test

COVID-19 IgG/IgM Rapid Test (Serum/Plasma/Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to COVID-19 in human serum, plasma or whole blood as an aid in the diagnosis of primary and secondary COVID-19 infections.

COVID-19(Corona Virus Disease) is an infectious disease caused by the most recently discovered coronavirus. The most common symptoms of COVID-19 are fever, tiredness, and dry cough. Some people become infected but don't develop any symptoms and don't feel unwell. People can catch COVID-19 from others who carry the virus. The disease can spread from person to person through small droplets from the nose or mouth when a person with COVID-19 coughs or exhales. The incubation period for COVID-19 generally ranges from 1-14 days.

COVID-19 IgG/IgM Rapid Test

Features &Benefits

UNscience COVID-19 IgG/IgM Rapid Test (Serum/Plasma/Whole Blood) is is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.

Precise
Works with whole blood, serum, & plasma
Tests for both IgM and IgG antibodies
Sensitivity: 98.81% (95% CI: 97.25%, 99.61%)
Specificity: 98.02% (95% CI: 97.05%, 98.74%)
Validated by PCR and CT
Fast
Results in 10 minutes.
Intuitive visual interpretation
No special equipment needed

How it Works

UNscience COVID-19 IgG/IgM Rapid Test (Serum/Plasma/Whole Blood) is is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.

4 Simple Steps

  • 1.Sample collection and preparation. Keep the kit and sample to room temperature prior to testing.
  • 2.Add sample (20 μL of serum/plasma/whole blood) to the sample well by using a micropipette/dropper.
  • 3.Add buffer (1 drop for serum/plasma or 3 drops for whole blood) to the sample well immediately.
  • 4.Wait for the colored line(s) to appear and read the result at 10 minutes. The result is valid within 20 minutes.
4 Simple Steps

Results

  • IgM POSITIVE

    Colored lines should be in the control line region (C) and IgM test line region. No line appears in IgG test line region.

    Two lines appear
    Two lines appear
  • IgG and IgM POSITIVE

    Colored lines should be in the control line region(C), IgG line test region and IgM test line region. The color intensities of the lines do not have to match.

    Three lines appear
    Three lines appear
  • IgG POSITIVE

    Colored lines should be in the control line region(C) and IgG test line region. No line appears in IgM test line region.

    Two lines appear
    Two lines appear
  • NEGATIVE

    One colored line should be in the control line region (C). No line appears in IgG and IgM test line region(s).

    Two lines appear
  • INVALID

    Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new cassette. If the problem persists, discontinue using the test kit and contact your local distributor.

    Control line fails to appear
    Control line fails to appear
NOTE:The intensity of the color in the IgG and/or IgM test line region(s) will vary depending on the concentration of COVID-19 antibodies in the sample. Therefore, any shade of color in the IgG and/or IgM test line region(s) should be considered positive.

Kit Components & Storage

UNscience COVID-19 IgG/IgM Rapid Test (Serum/Plasma/Whole Blood) is is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.

Materials supplied
Materials supplied
Storage

The kit can be stored at room temperature or refrigerated (2-30℃). The test cassette is stable before the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date.

Limitations of COVID-19 IgM/IgG Rapid

1.COVID-19 Rapid Test is for in vitro diagnostic use only. The test should be performed using serum, plasma or whole blood samples only. Neither the quantitative value nor the rate of increase in COVID-19 antibody concentration can be determined by this qualitative test.

2. In the early onset of fever, anti-COVID-19 IgM concentrations may be below detectable levels.

3. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.

4. Results from immunosuppressed patients should be interpreted with caution.

5. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

6. If the test result is negative and clinical symptoms persist additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of COVID-19 infection.

FAQs

In order to test the detection relative sensitivity and specificity of the COVID-19 IgG-IgM combined antibody test, serum samples were collected from COVID-19 patients from multiple hospitals and Chinese CDC laboratories. The tests were done separately at each site. A total of 1585 cases were tested: 421 (positive) clinically confirmed (including PCR test) COVID-19-infected patients and 1164 negative. The test results showed that the product has a relative sensitivity of 98.81% (95% CI: 97.25%, 99.61%) and a relative specificity of 98.02% (95% CI: 97.05%, 98.74%).

The coronavirus testing kit price is mainly related to the quantity you required. Buy COVID-19 igm/igg rapid test kits please feel free to contact us. We will feedback you ASAP. (Normally in less than 24h.)

Please make sure the kit is recovered into room temperature and perform the kit under the room temperature(15℃~30℃). The results will be affected by high or low temperature.

Serum and plasma specimens may be stored at 2-8℃ for up to 3 days. For long-term storage, specimens should be kept below -20℃. Whole blood collected by venipuncture should be stored at 2-8℃ if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingertip should be tested immediately.

The test strip consists of a sample pad and a chromatographic membrane (the detection area is coated with a mouse anti-human IgM monoclonal antibody and a mouse anti-human IgG monoclonal antibody and goat anti-mouse IgG antibody), colloidal gold binding pad (coated with colloidal gold-labeled recombinant novel coronavirus (COVID-19) antigen and mouse lgG antibody), liner and absorbent pad.

The COVID-19 IgM/IgG rapid testing kit can be used to screen patients suspected of having been affected by the novel coronavirus. However, results of test should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods such as nucleic acid PCR test.