Introducing EDI’s COVID-19 Nucleocapsid IgG Quantitative ELISA Kit

By: PR.com

San Diego, CA, October 14, 2020 --(PR.com)-- Epitope Diagnostics has proudly introduced an immunoassay kit exclusively for the quantitative detection of human COVID-19 IgG antibodies (Catalog Number KT-1034: EDI COVID-19 Nucleocapsid IgG Quantitative ELISA Kit). With proven results from clinical testing, Epitope Diagnostics, Inc. is eager to continue cooperating and collaborating with the scientific community to combat the current COVID-19 pandemic.

The EDI™ COVID-19 Nucleocapsid IgG Quantitative ELISA Kit is designed, developed, and produced for the quantitative measurement of human anti-COVID-19 (anti-SARS-CoV-2) IgG antibody in serum. The test uses a series of calibrators and controls in order to determine a standard curve, which allows for specific, concentration-based results of patient samples. In the fight against COVID-19, it is crucial that researchers and healthcare providers have access to quantitative patient data in order to more fully understand their current disease stage. Additionally, this kit may be used as a reference method during the development of therapeutic treatments.

Based on the success of EDI’s qualitative COVID-19 assays since March 2020 and the numerous requests from end users and researchers, EDI has created the nucleocapsid COVID-19 quantitative IgG ELISA kit. While EDI’s current portfolio of COVID-19 antibody kits all target the nucleocapsid protein of the SARS-CoV-2 virus and can be used to trace disease progression, the quantitative COVID-19 IgG test will provide the additional information necessary to identify recovered patients as plasma donors for potentially life-saving treatments. This test will help to set the standard for donor identification, an essential step in the further development of future plasma transfusion-based or donor antibody-based treatments. Additionally, as quantitative tests have yet to become readily available on the market, the use and registration of EDI’s COVID-19 Nucleocapsid IgG Quantitative ELISA Kit will pave the way and provide the right tool for improved safety measurement, as well as provide more valuable, in-depth, quantified COVID-19 specific antibody concentration data directly related to the course of disease progression.

In short, this kit uses the same materials and test principle as the well-established KT-1032: EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit, but brings the following advantages:

1. COVID-19 IgG concentrations may now be reported at more than just OD levels, allowing multiple serum samples on a single patient to be compared despite different sample drawing or testing dates, allowing for monitoring of the immune response over time.

2. It becomes possible to standardize COVID-19 IgG measurements.

The EDI™ COVID-19 Nucleocapsid IgG Quantitative ELISA Kit, EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit, and EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit are CE IVD marked in Europe and IVD marked in the United States. All kits are available now. For more information, contact the Epitope Diagnostics customer service department at cs@epitopediagnostics.com or by telephone at +1 (858) 693-7877.

Current COVID-19 Product List:

1. KT-1034, EDI™ COVID-19 Nucleocapsid IgG Quantitative ELISA Kit
2. KT-1032, EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit
3. KT-1033, EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit

The following papers utilize the EDI™ Novel Coronavirus COVID-19 IgG or IgM ELISA Kits:

1. Ahn JY et al. Use of Convalescent Plasma Therapy in Two COVID-19 Patients with Acute Respiratory Distress Syndrome in Korea. J Korean Med Sci. 2020;35(14):e149. Published 2020 Apr 13. doi:10.3346/jkms.2020.35.e149
2. Ambroise Pare Hospital, Evaluation report of the EDI test at Ambroise Paré Hospital. Assistance Publique Hospitaux de Parix. Published 2020 May 14.
3. Alexander Krüttgen et al. Comparison of four new commercial serologic assays for determination of SARS-CoV-2 IgG. Journal of Clinical Virology. 2020;128:104394. Published 2020 Apr 22. doi:10.1016/2020.104394
4. Charlton, C. L., et al. (2020). Evaluation of six commercial mid to high volume antibody and six point of care lateral flow assays for detection of SARS-CoV-2 antibodies. Journal of Clinical Microbiology. doi:10.1128/jcm.01361-20
5. Christian Bundschuh et al. Evaluation of the EDI enzyme linked immunosorbent assays for the detection of SARS-CoV-2 IgM and IgG antibodies in human plasma. Clinica Chimica Acta. Published 2020 June 8. doi.org/10.1016/j.cca.2020.05.047
6. “Convalescent Plasma Appears Safe for Children With Severe COVID-19.” Clinical OMICs - Molecular Diagnostics in Precision Medicine, 10 Sept. 2020, www.clinicalomics.com/topics/patient-care/therapeutics/convalescent-plasma-appears-safe-for-children-with-severe-covid-19/?utm_medium=newsletter.
7. Denise Roland. HEALTH Blood of Recovered COVID-19 Patients Is Becoming a Hot Commodity. Wall Street Journal. Published 2020 May 29.
8. Jeffrey D. Whitman, et al. Test performance evaluation of SARS-CoV-2 serological assays. MedRXiv. Published 2020 Apr 29. doi:10.1101/2020.04.25.20074856 [Not certified by peer review]
9. Margo Egger, et al. Comparison of the Elecsys® Anti-SARS-CoV-2 immunoassay with the EDITM enzyme linked immunosorbent assays for the detection of SARS-CoV-2 antibodies in human plasma. Clinica Chimica Acta. Published 2020 May 28. doi/10.1016/j.cca.2020.05.049
10. Renata Varnaite, et al. Expansion of SARS-CoV-2-specific Antibody-secreting Cells and Generation of Neutralizing Antibodies in Hospitalized COVID-19 Patients. BioRXiv. Published 2020 May 29. doi/10.1101/2020.05.28.118729

Contact Information:
Epitope Diagnostics, Inc.
Darrell Fang
858-693-7877
Contact via Email
www.epitopediagnostics.com

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