COVID-19 IgG/IgM Immunodetection Kit

Product Discontinued

COVID-19 IgG/IgM Immunodetection Kit Summary

• Description: COVID-19 IgG/IgM Immunodetection Kit (Whole Blood/ Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies against SARS-COV2 in human whole blood, serum or plasma. This test contains two test lines: an IgG line and an IgM line. During an immune response to infection, IgM antibodies appear in the early stage, followed by the emergence of IgG during the mid to late disease stages.
  
• A primary COVID-19 infection is characterized by the presence of detectable IgM antibodies 3-7 days after the onset of infection.
• A secondary COVID-19 infection is characterized by the elevation of COVID-19-specific IgGs. In the majority of the cases, this is also results in elevated levels of IgM.

Detection:
The biological sample is added to SARS-COV-2 antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane by capillary action where, in the presence of SARS-COV2 IgM or IgG complexes, it reacts with anti-human IgM antibodies or anti-human IgG antibodies, respectively. If the sample contains IgM antibodies against COVID-19, a colored line will appear in the IgM test line. Similarly, if the sample contains IgG antibodies against COVID-19, a colored line will appear in the IgG test line.

Antigens:
Colloidal gold labeled COVID-19 Spike and Nucleocapsid recombinant proteins expressed in E. coli
• Specificity: No cross-reactivity was observed with parainfluenza virus, influenza A virus, influenza B virus, Chlamydia pneumoniae, Mycoplasma pneumoniae, adenovirus, respiratory syncytial virus, hepatitis B surface, type C Hepatitis virus, Treponema pallidum, human immunodeficiency virus, EB virus, measles virus, cytomegalovirus, enterovirus 71, mumps virus, HKU1 virus, OC43 virus, NL63 virus, 229E virus and chicken pox-zoster virus.
• Sensitivity: 1U/mL for IgM and 0.5U/mL for IgG
• Kit Type: Immunodetection Kit

Applications/Dilutions

• Dilutions:
  • Immunoassay

Reactivity Notes

Use in SARS-CoV-2 reported in scientific literature (PMID:33412411)

Packaging, Storage & Formulations

• Storage: Store at 4C. Do not freeze.

Notes

The COVID-19 IgG/IgM Immunodetection Kit, catalog number NBP2-89106, was developed by an independent third-party, and was not manufactured by Novus Biologicals or any Bio-Techne brand. This product is not for use in diagnostic procedures and is Research Use Only. Futhermore, this product does not have Emergency Use Authorization (EUA) from the FDA.

Background

Coronaviruses are a class of RNA viruses widely found in birds and mammals, including humans. Seven coronaviruses are known to cause human infection. The four common types (HCoV-229E, HCoV-OC43, HCoV-NL63 and HCoV-KHKU1) cause common cold symptoms. Two are zoonotic coronaviruses implicated in the severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) outbreaks in 2003 and 2012, respectively. COVID-19 is the pneumonia disease caused by SARS-CoV-2, which is highly infectious. Both SARS-CoV-2 and SARS-CoV originated from coronaviruses in bats and were transmitted to humans through intermediate hosts. SARS-CoV-2 and SARS-CoV are homologous, with their RNA sequences sharing ~80% identity.

Limitations

This product is for research use only and is not approved for use in humans or in clinical diagnosis. Kits are guaranteed for 6 months from date of receipt.

Publications for COVID-19 IgG/IgM Kit (NBP2-89106)(1)

Publication using NBP2-89106

• Ishigaki H, Nakayama M, Kitagawa Y et al. Neutralizing antibody-dependent and -independent immune responses against SARS-CoV-2 in cynomolgus macaques Virology 2020-12-01 [PMID: 33412411] (SARS-CoV-2)

FAQs for COVID-19 IgG/IgM Kit (NBP2-89106). (Showing 1 - 10 of 11 FAQ).

1. For NBP2-89106 COVID-19 IgG/IgM Immunodetection Kit, we kindly ask you for more information about test validation, cross-reactivity with other viruses or if you any paper that we can read about.
   • Unfortunately, because NBP2-89106 is such a new product we don't have any publications that list it's use. However, as the manual states: No cross-reactivity was observed with parainfluenza virus antibody, influenza A virus antibody, influenza B virus antibody, Chlamydia pneumoniae antibody, Mycoplasma pneumoniae antibody, adenovirus antibody, respiratory syncytial virus antibody, hepatitis B surface antibody, type C Hepatitis virus antibody, Treponema pallidum antibody, human immunodeficiency virus antibody, EB virus antibody, measles virus antibody, cytomegalovirus antibody, enterovirus 71 antibody, mumps virus antibody, chicken pox-zoster virus.
2. Can this covid kit be used for diagnostic purposes?
   • NBP2-89106 COVID-19 IgG/IgM Immunodetection Kit does not have CE, IVD, FDA, or any other approvals or certifications for diagnostic use or screenings. We understand that the FDA is allowing many COVID-19 products to be used with emergency use authorization (EUA), but we currently do not have this authorization, nor is it in the pipeline to be approved for diagnostic or clinical use. 
3. i had one question about COVID-19 IgG/IgM Rapid Test Kit. this kit comes in strip? on website its mentioned 40 test
   • No, this COVID-19 IgG/IgM Rapid Test Kit contains 40 test cassettes that are individually packaged.
4. Did you submit an EUA to FDA already,and is it already available in the market?
   • Thank you for your interest in our COVID-19 IgG/IgM Rapid Test Kit Catalog #NBP2-89106.  Please make note that this kit is qualitative and only validated for RUO.  This kit does not have CE, IVD, FDA, or any other approvals or certifications for diagnostic use or screenings.
5. I would like to order your testing kits. do you include lancets with the kit for blood prick?
   • There are no lancets in the kits - just the test strips. Please note that this kit is qualitative and only validated for RUO. This kit does not have CE, IVD, FDA, or any other approvals or certifications for diagnostic use or screenings. If you have any additional questions about our kit, you can contact us via email.
6. do you have any sensitivity/specificity numbers for NBP2-89106?
   • 1585 copies of 2019-nCoV novel coronavirus clinical serum samples were studied, and the test results of this kit indicate:Relative sensitivity: 98.81% (95%CI*: 97.25%-99.61%)Relative specificity: 98.02% (95%CI*: 97.05%-98.74%)*Please note, these kits are for Research Use Only
7. this test tests for both IgG and IgM on the same test strip?
   • The test for IgM and IgG is on the same test strip. Please see the manual for more information
8. Where is this product made? Is it FDA approved?
   • This kit is manufactured in China. It is not FDA approved or approved for diagnostic or therapeutic use. This kit is RUO.
9. COVID-19 IgG/IgM Immunodetection Kit. Whole blood only?
   • This kit will work with whole blood, serum, and plasma. However, the kit is not approved for diagnostics; it is for research only.
10. can I buy the Ab you used in this kit NBP2-89106
    • No, sorry we do not sell the components of this kit separately.
11. From the NBP2-89106 kit, which antigen does it recognize?
    • The antigens recognized in this kit are the spike and Nucleocapsid
Show All 11 FAQs.