COVID-19 IgG ELISA Kit

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SKU: OKVC00002 Category:

Description

Predicted Species Reactivity Human
Application ELISA
Kit Principle Aviva Systems Biology Covid-19 IgG ELISA Kit (OKVC00002) is a two-step solid-phase ELISA assay in which microwells were precoated with SARS-CoV-2 recombinant antigens. The serum/plasma specimen is added, and all anti SARS-CoV-2 antibodies IgG if present in the specimen will bind to the recombinant antigens during the first incubation. After washing away all unwanted substances of the specimen, SARS-CoV-2 specific IgG antibodies are detected by the addition of IgG-HRP to form an antigen- antibody-HRP enzyme complex on the microwell surface during the second incubation. Upon addition of TMB substrate, the HRP enzyme converts it into a blue color signal. The intensity of the color is directly proportional to the concentration of SARS-Cov-2 IgG antibodies in the specimen.
Kit Reproducibility Intra-lot Repeatability: Three Covid-19 IgG positive sera were run on one lot of Covid-19 IgG, CV < 12%
Inter-lot Reproducibility: Three Covid-19 IgG positive sera were run on three of Covid-19 IgG, CV < 18%
Additional Information Cross-reactivity: Sera from samples of Flu A, Flu B, HCV, HBsAg, M. pneumonia, were run on Covid-19 IgG ELISA. There are no cross reactivities observed.
Reconstitution and Storage Store COVID-19 IgG ELISA Kit as indicated in product manual.
Sample Type Serum, Plasma
Sensitivity 158/167 = 94.61% (95%) credibility interval: (91.1%~97.6%)
Datasheets/Manuals Click here to download product manual. As variation between lots may occur, always reference the lot-specific manual received with each kit.
Target Reference 1. Pr. Yazdan Yazdanpanah, Chair of GloPID R https://www.glopid-r.org @GloPID_R, 2019 Novel Coronavirus Global Research and Innovation Forum: Towards a Research Roadmap.
2. Guan WJ, Ni ZY, Hu Y, et al. Clinical Characteristics of Coronavirus Disease 2019 in Chinaexternal icon. N Engl J Med. February 28, 2020. DOI: 10.1056/NEJMoa2002032.
3. Wang W, Xu Y, Gao R, et al. Detection of SARS-CoV-2 in Different Types of Clinical Specimensexternal icon. JAMA. Published online March 11, 2020. DOI:10.1001/jama.2020.3786.
4. Kakimoto K, Kamiya H, Yamagishi T, et al. Initial Investigation of Transmission of COVID-19 Among Crew Members During Quarantine of a Cruise Ship – Yokohama, Japan, February 2020. MMWR Morb Mortal Wkly Rep. ePub: March 17, 2020. DOI: http://dx.doi.org/10.15585/mmwr.mm6911e2external iconexternal icon.
Specificity 418/419 = 99.76% (95%) credibility interval: 97.08%~99.99%)
Assay Info Qualitative two-step solid-phase ELISA
Intended Use Covid-19 IgG ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of IgG-class antibodies to SARS-CoV-2 virus in human serum or plasma.
Warning The test kit does not contain any viable infectious agents. However all samples must be considered as potentially infectious. 
Do not ingest the reagents. Avoid contact with eyes, skin and mucose. Wear protective clothing and disposable gloves. Do not allow smoking or eating where antigen containing materials are being handled.
Preclude any pipetting by mouth.
Handle all samples and test components as though capable of transmitting infection. Clean spills thoroughly using an appropriate intermediate-to high level disinfectant. Decontaminate and dispose of specimens and all potentially contaminated materials as if they contain infectious agents.
Avoid splashing or aerosol formation.
Avoid contacting Substrate Reagent or Stop solution with the skin or other mucose membranes. In case of contact, wash thoroughly with water.
Introduction Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by infection with the SARS-CoV-2 virus(1,2). Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In severe cases, infection can cause pneumonia, severe acute respiratory syndrome (SARS), kidney failure and death(2). Coronaviruses (CoV) are a large family of RNA viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARSCoV)(3). The 2019 Novel Coronavirus, formerly known as 2019-nCoV and now known as SARS-COV-2 is a new strain of coronavirus that was first identified during an outbreak in Wuhan, China which started in December 2019. SARS-CoV-2 virus can spread from infected people (4).
Gene Symbol SARS-COV-2

 

Kit Component Amount
Twelve (12) 1×8-well strips coated with SARS-CoV-2 recombinant proteins. The strip are packaged in a strip holder and sealed in the foiled envelope with desiccant. 12 1×8-well strips
Sample diluent 11 ml
Negative control 0.5 ml
Positive control (Deactivated, not infective) 0.5 ml
Anti human IgG- HRP conjugates 6 ml
Wash Buffer (30x concentrate) 25 ml
TMB substrate 11 ml
Stop solution 11 ml
Product insert 1 set

Protocol

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