COVID-19 IgM/IgG Rapid Test Kit


Price : $367.13 /Box ( 1 Box = 25 Pieces )
Box 400+800+1200+1600+2000+
Pieces 10,000+20,000+30,000+40,000+50,000+
Discount 0%5%10%15%20%
Price $14.69$13.95$13.22$12.48$11.75
Total $146,852$279,000$396,600$499,200$587,500
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This product carries a minimum bulk order quantity of 400 boxes.
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This COVID-19 Rapid Test Kit is suitable for the qualitative detection of SARS-CoV-2 IgM/IgG antibodies in human serum, plasma, or whole blood. Common signs of infection with SARS-CoV-2 include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. SARS-CoV-2 can be excreted through respiratory secretions or transmitted through oral fluids, sneezing, physical contact, and through air droplets.

  • This product has not received EUA approval.
  • As per FDA’s guidance on March 16th, 2020, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:
  • COVID-19 rapid test kits have not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Following-up with a molecular diagnostic testing should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • As stated on FDA’s guidance, this product is for CLIA certified high-complexity laboratories, or healthcare professionals for point of care settings.

Limitation of COVID-19 IgM/IgG Rapid Test

  • The product is designed only for use with human serum, plasma, or whole blood samples for the qualitative detection of SARS-CoV-2 IgM and IgG antibody.
  • As in case of all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test but should rather be made after all the clinical findings have been evaluated and should be confirmed by other conventional detection methods, such as molecular diagnostics and CT.
  • A false negative may occur if the amount of SARS-CoV-2 IgM or IgG antibody is below the detection level of the kit.
  • If the product gets wet prior to use, or is stored improperly, it may cause incorrect results.
  • The test is for qualitative detection of SARS-CoV-2 IgM or IgG antibody in human serum, plasma, or blood samples, it does not indicate the quantity of the antibodies present.
How Does COVID-19 IgM IgG Rapid Test Kit Work?

The COVID-19 IgM/IgG antibody rapid test is a fast and effective method for screening IgM and IgG antibodies against SARS-CoV-2. This test can also suggest information on the stage of infection.

Both Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies are produced during the primary immune response. As the body’s largest antibody, IgM is the first antibody to appear in response to an initial exposure to antigens. IgM provides the first line of defence during viral infections, followed by the generation of adaptive, high affinity Immunoglobulin G (IgG) responses for long-term immunity and immunological memory. IgG is usually detectable about 7 days after the IgM appears.

Specification

Made in Canada

IgG sensitivity of 92.88%, specificity of 99.06% and accuracy of 96.17%

IgM sensitivity of 87.54%, specificity of 98.43% and accuracy of 93.33%

Sample Volume: 20µL fingertip blood and whole blood sample, or 10µL serum and plasma

Detection Method: Colloidal Gold

Detection Time: 10 – 15 minutes

Suitable for Point of Care Testing, no need for extra equipment

Packaging Dimensions

17.78*6.35*7.62 cm

Weight

1.07 KG

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