REVEALCOVID-19™ Total Antibody Test Sensitivity and Cross-Reactivity Analysis
HALIFAX, Nova Scotia, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Today, MedMira Inc. (MedMira) (TSXV: MIR) reports findings to further emphasize the high sensitivity of REVEALCOVID-19™ Total Antibody Test 7 days post symptom onset as well as highlights the test’s zero cross-reactivity (i.e. no false positive results) with HIV positive samples.
Sensitivity and Specificity of REVEALCOVID-19™ Total Antibody Test
According to the recent scientific evidence, antibodies to the SARS-CoV-2 virus are generally detected in blood 1-3 weeks post symptom onset. To evaluate the sensitivity and specificity of MedMira’s REVEALCOVID-19™ Total Antibody Test, blood specimens positive and negative for the antibodies to the SARS-CoV-2 virus, the causative agent of COVID-19, were assessed. Positive blood samples were collected from individuals with the confirmed COVID-19 diagnosis, while negative blood specimens were sourced before the COVID-19 pandemic. The following REVEALCOVID-19™ Total Antibody Test sensitivity and specificity values were observed:
- Sensitivity: >7 days after symptom onset – 99.1% (105/106); (95% CI: 94.8%; 99.8%)
* FDA acceptance criteria is currently set at 90%
- Specificity: 98.9% (281/284); (95% CI: 96.9%; 99.6%)
* FDA acceptance criteria is currently set at 95%
To assess whether REVEALCOVID-19™ Total Antibody Test produces false positive results with the HIV positive samples (i.e. evaluate test’s cross-reactivity), 50, out of the aforementioned 284 negative specimens, were collected from patients with confirmed HIV diagnosis. No cross-reactivity has been observed for REVEALCOVID-19™ Total Antibody Test.
MedMira’s Role in the Pandemic Crisis and the Future of REVEALCOVID-19™ Total Antibody Test
“Quality and excellent performance of all our products is to be expected. REVEALCOVID-19™ Total Antibody Test has been shown to detect the presence of total antibodies to SARS-CoV-2 just over 7 days post onset of COVID-19 symptoms.” Hermes Chan, CEO of MedMira continues, “High-quality serological antibody testing is not only key in the overall surveillance of the COVID-19 pandemic, but also serves as a crucial tool in the assessment of the vaccine effectiveness. The accelerated process of the vaccine development strongly relies on the availability of serological tests that can help assess the extent of the induced production of antibodies to the SARS-CoV-2 virus.”
MedMira is under review by the US FDA to obtain FDA Emergency Use Authorization (EUA). However, while awaiting the approval, REVEALCOVID-19™ Total Antibody Test can be distributed in the U.S. according to Section IV.D of the Policy for Coronavirus Disease-2019 Test. In addition, MedMira received in May 21, 2020 right to sell in all countries accepting CE mark.
MedMira is a leading developer and manufacturer of Rapid Vertical Flow® diagnostics. The Company’s tests provide hospitals, labs, clinics and individuals with instant disease diagnosis, such as HIV and Hepatitis C, in just three easy steps. The Company’s tests are sold globally under the Reveal®, Multiplo® and Miriad® brands. Based on its patented Rapid Vertical Flow® Technology, MedMira’s rapid HIV test is the only one in the world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira’s corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit medmira.com. Follow us on Twitter and LinkedIn.
This news release contains forward‐looking statements, which involve risk and uncertainties and reflect the Company’s current expectation regarding future events, including statements regarding possible regulatory approval and launch of the REVEALCOVID-19TM Total Antibody Test, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Chief Financial Officer,
+1 902 450 1588