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COVID-19 (SARS-CoV-2) IgG ELISA Kit

INTENDED USE

Human COVID-19 (SARS-CoV-2) IgG ELISA kit can be used measuring levels of human IgG antibodies directed to SARS-CoV-2 (COVID-19 IgG) in samples of plasma or serum. Using this assay a positive result is indicated by a specificity level of 99.24%.

BACKGROUND

Coronaviruses are characterised as single-strand RNA, enveloped viruses which have the ability to cause respiratory illness in humans. A new coronavirus was discovered in December 2019 in Hubei Province of China in the city of Wuhan, this was later named SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2). This virus was found to be responsible for causing illness which were referred to as coronavirus disease 2019 (COVID-19). Within three months this virus was declared a pandemic since it had spread rapidly around the world.

Currently, many tests have been developed in order to investigate COVID-19 for example simple detection of the virus present in human samples, to analysing antibody responses when exposed to individual virus proteins. Since COVID-19 is relatively new and an emerging infection, there are many gaps in our understanding on the antibody response and viral kinetics. These test are essential in providing critical information that will allow monitoring and control of the infection possible and potentially the development of vaccines and other effective therapeutic treatments. It must be noted that IgG represents the most abundant immunoglobulin which is produced following a response to an antigen, furthermore, its levels are maintained within the body following the initial exposure over a long term response.

COVID-19 IGG ELISA KIT CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

  • SARS-CoV-2 Antigens Coated Microtiter Strips (IgG).
  • Calibrator A (Negative Control).
  • Calibrator B (Cut-Off Control).
  • Calibrator C (Positive Control).
  • Sample Dilution Buffer.
  • Enzyme Conjugate (IgG).
  • TMB Substrate Solution.
  • Washing Buffer (20x Conc.).
  • Stop Solution.

SENSITIVITY

The minimum detection sensitivity level of human IgG to SARS-CoV-2 (COVID-19-IgG) using this COVID-19 IgG ELISA kit was to a specific cut-off point and a positive result was indicated by a 99.24% specificity.

ASSAY CHARACTERISTICS

– SARS-CoV-2 ELISA: IgG
– Cut-Off: 10 U
– Positive: > 11 U
– Equivocal: 9 – 11 U
– Negative: < 9 U
– Diagnostic Specificity: 99.24 %
– Cross Reactivity: No significant evidence of false-positive results due to cross-reactions. However, cross reactions with antibodies to Respiratory syncytial virus cannot be excluded.

REFERENCES

  1. Protective immunity after COVID-19 has been questioned: What can we do without SARS-CoV-2-IgG detection? Cell Immunol. 2020 (353): 104114. Melgaço JG, Azamor T, Ano Bom APD.
  2. Immune Phenotyping Based on the Neutrophil-to-Lymphocyte Ratio and IgG Level Predicts Disease Severity and Outcome for Patients With COVID-19. Front Mol Biosci. 2020 (7): 157. Zhang B., et al.
  3. Comparison of four new commercial serologic assays for determination of SARS-CoV-2 IgG. J Clin Virol. 2020 (128): 104394. Krüttgen A., et al.
  4. Analysis of COVID-19 convalescent plasma for SARS-CoV-2 IgG using two commercial immunoassays. J Immunol Methods. (486): 112837. DomBourian M.G., et al.

ADDITIONAL INFORMATION

  • Full Name: COVID-19 (SARS-CoV-2) IgG ELISA Kit
  • Reactivity: Human
  • Sample Type: Plasma, Serum
  • Sensitivity: Cut-Off Point

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