- MedMira Inc. (MIR) releases performance update on World Health Organization SARS-CoV2 Serology standards
- These WHO standards can serve as the foundation for the calibration of tests that quantify antibodies as per the CDC’s latest update
- Currently, a variety of molecular and serological assays are globally in use to detect SARS-CoV-2 infections and to measure antibody response to the SARS-CoV-2 infection and to COVID-19 vaccines
- The availability of International Standards will facilitate the development and eventually facilitate and harmonize the evaluation of diagnostics, vaccines, therapeutics and other products
- MedMira Inc. (MIR) is up at 13.81 per cent and is trading at C$0.16 at 10:22 am ET
MedMira Inc. (MIR) releases the World Health Organization (WHO) SARS-CoV-2 serology standards testing results.
The REVEALCOVID-19™ PLUS Total Antibody [PLUS] and the REVEALCOVID-19™ Nab-Y Competitive Neutralizing Antibody Test [Nab-Y] have achieved a 100 per cent agreement.
On March 29, 2021, the WHO announced the first International Standards for SARS-CoV-2 serology tests.
These WHO standards can serve as the foundation for the calibration of tests that quantify antibodies as per the CDC’s latest update on “the Interim Guidelines for COVID-19 Antibody Testing in Clinical and Public Health Settings.”
These panels and standards included 20/136 First WHO International Standard Anti-SARS-CoV-2 Immunoglobulin (Human); 20/B770 Anti-SARS-CoV-2 Verification Panel For Serology Assay; 20/268 1st International Reference Panel for Anti-SARS-CoV-2 Immunoglobulin; 20/162 NIBSC Anti-SARS-CoV-2 Antibody Diagnostic Calibrant; and the quality control standard, QCRSARSCoV2QC1.
According to WHO, accurate tests are key to ensure generating accurate data for studying the COVID-19 disease and interventions.
Currently, a variety of molecular and serological assays are globally in use to detect SARS-CoV-2 infections and to measure antibody response to the SARS-CoV-2 infection and to COVID-19 vaccines.
In support of the global response to COVID-19, WHO has highlighted the importance of the availability of International Standards and/or reference reagents for anti-SARS-CoV-2 antibody and for SARS-CoV-2 RNA.
The availability of International Standards will facilitate the development, validation and assessment of the assays and allow for comparability between results from different assays, thus eventually facilitate and harmonize the evaluation of diagnostics, vaccines, therapeutics and other products.
Vaccines and treatments for COVID-19 are rapidly being developed and reliable assays are needed for their evaluation.
“Regulators are working diligently on creating set standards to assess and evaluate COVID-19 related products. The establishment of the WHO first International Standards play a key role in this development and MedMira has already taken the initiative to comply with these standards and demonstrate our product performance,” said Hermes Chan, CEO of MedMira.
“Nab-Y was found to successfully determine the presence of these Neutralizing Antibodies from moderate to a high level. We believe this will be a well-received additional support to our various applications,” concluded Chan.
MedMira will provide further updates on regulatory progress when available.
MedMira is a leading developer and manufacturer of Rapid Vertical Flow®
diagnostics.
MedMira Inc. (MIR) is up at 13.81 per cent and is trading at C$0.16 at 10:22 am ET.
