COVID–19 Rapid Test
What is the Vivera Pharmaceuticals COVID–19 Rapid Test?
A lateral flow assay rapid test intended for the qualitative detection of IgM and IgG antibodies to SARS-CoV-2 in human serum or whole blood, the Vivera Pharma COVID-19 Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
What sets the Vivera Pharmaceuticals COVID-19 Rapid Test Apart?
1. Test Time
Accurate read times at 20 minutes after the test has been performed. A majority of the current testing requires either proprietary equipment or are third-party lab assays not designed for wide-spread use. These so called “PCR” tests do not lend themselves to immediate testing, and can take days for results.
2. On-Site Testing
Designed for use in CLIA approved high complexity lab settings, the test does not require a third-party lab for interpretation of results. The Vivera Pharmaceuticals COVID–19 Rapid Test is designed to be used by health care professionals on symptomatic patients immediately. Special training is not required. The tests are easy to use and require only 50µl of blood easily obtained via fingerstick or venous draw. Serum may also be used to test.
3. Less Invasive
No uncomfortable nasal swabs or extensive blood draws are required to perform the test. Many patients decline nasal swabs due to the potential for swelling or irritation.
4. Immune Response
As the pandemic continues, most patients earlier affected are now symptomatic or have been infected. The integrated lgM and lgG test cassette is able to determine infection timing (how long the patient has been sick) from 4-24 days at a sensitivity of 70% to 98.1% depending on infection length. While PCR tests may be able to determine per-symptomatic, active, infections, they are not designed to determine immune response (antibodies).
5. Scalability and Efficiency
Simple testing is vital for triage environments and mass testing situations, both vital methodologies for cataloging widespread infection. There is no need for specialized equipment -making this suitable for limited-resource CLIA environments that may not have access to expensive reagents or proprietary equipment. There is little delay in results -allowing medical teams to immediately determine the best treatment plan for patients. Serology antibody tests should be used as part of a larger screening protocol.
Click Here for Test Specifications
• Positive Percent Agreement (PPA): IgM 70.2%; IgG 86.8%; Overall 92.9%
• Negative Percent Agreement (NPA): IgM 100%; IgG 100%; Overall 100%
• Specificity: IgM 99.5%; IgG 99%
• Sensitivity: Days 4-10 IgM 70%; Days 11-24 IgM 92.3%; Days 11-24 IgG 98.1%
• Sample Type: Whole Blood or Serum
• Test Read Time: 20 minutes
• For Professional Use Only. Not for the Screening of Donated Blood.
• This Test has not Been Reviewed by the FDA.