Irvine, California: CovidRapid, Inc. received notice to distribute under Section IV.D of the Policy for Diagnostic Tests for Coronavirus-2019 to market their RapidCov antibody (serology) test kits for professional use and is pursuing an official FDA Emergency Use Application. The company is also pleased to announce it has secured distribution rights to two EUA authorized PCR testing kits and prepared to meet increasing US and global testing demand.
The CDC is recommending viral (PCR) testing in institutions of higher education (IHE) for individuals with signs or symptoms consistent with COVID-19 and asymptomatic individuals with recent known or suspected exposure to SARS-CoV-2 to control transmission. In addition, broader testing may be recommended in residence halls, laboratory facilities, and lecture rooms where the potential for rapid and pervasive spread of SARS CoV-2 exists. In areas of moderate to substantial community transmission, universities may consider testing some or all asymptomatic students, faculty, and staff to identify outbreaks and implement control measures. Given the severity of the pandemic, asymptomatic individuals pose a significant risk of infection and should be tested for presence of antibodies to identify and prevent cluster outbreaks.
Nursing home residents are at high risk for infection, serious illness and death from Covid-19. CovidRapid Inc. is ready to help with protocols consistent with CDC recommendation to help nursing homes prevent SARS CoV-2 from entering nursing homes, detecting cases quickly and stopping transmission.
CovidRapid Antibody Test Kit Attributes:
- Highly accurate, point-of-care test that provides results in under 15 minutes
- Independent clinical studies validated accuracy in Denmark as well as in a US CLIA lab
- Registered in Germany, Denmark, Columbia, Georgia, Philippines, Ukraine, Chile, Ecuador, Singapore, Peru and has the CE Mark of Conformity
- Requires no special skill or equipment to perform
- Blood test from a simple finger-prick, or whole/plasma/serum samples
- Lateral flow immunochromatography with colloidal gold detection
- Detect IgM & IgG antibodies to SARS CoV-2
The CovidRapid PCR Kit advantages:
- Accuracy: Real-time qPCR detection of SARS CoV-2, detects two distinct regions in ORF1ab and one region in N gene, oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash or nasal aspirate specimens and sputum. Testing limited to high complexity CLIA labs
- Speed: Our RT-LAMP detection kit can deliver results in 30 minutes
- Credibility: FDA EUA authorized with testing limited to high-complexity CLIA labs
CovidRapid Antibody kits can supplement PCR testing
While antibody tests cannot be used to form a sole diagnosis, they are a valuable diagnostic tool combined with PCR tests and offer several advantages. Antibodies are more stable than viral RNA and less sensitive to spoilage during collection, transport and testing. Antibodies are typically uniformly distributed in blood compared to varying viral loads depending upon where PCR samples are collected so less prone to false negatives. Most importantly antibody tests can be used in large scale, whole population testing to assess possible immunity to SARS-CoV-2 and identify asymptomatic carriers of the virus. According to a recent health report from the Chinese CDC, 80% of individuals infected by COVID-19 show mild symptoms or were asymptomatic.
We are Accepting Orders from US CLIA-Certified Labs and Front-Line Organizations Globally
Order requests can be made through www.coronavirusrapidkits.com or by calling 1-877-488-2684. Current manufacturing capacity is 6 million kits per month and scaling to meet increasing demand.