At a glance: The Pinnacle covID RAD rapid antigen test contains 25 test cassettes, buffer solution, swabs, extraction tubes and dropper tips, package insert and quick reference guide for sample collection and results interpretation. The test is performed using a nasal (nasopharyngeal) swab with no additional equipment. For Professional Use Only. For In Vitro Diagnostic Use Only. Ships September 10, 2020. For questions or ordering information, call 1-877-465-0826.
The Pinnacle Cov-ID RAD Rapid Antigen Detection Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2 in nasopharyngeal specimen (NP) from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate and high complexity tests, or by similarly qualified non-U.S. laboratories and as applicable, Point of Care (POC) testing.
The Antigen AdvantageCovid-19 antibody testing requires viral load time of at least four days to detect an active infection. When a patient is infected with SARS CoV-2, the antigen is immediately present and thus immediately detectable using the full-length Spike S1 Subunit RBD Antigen.
Earliest Possible DiagnosisAs with any disease state, early detection is key. The covID RAD Rapid Antigen Detection test represents the earliest theoretical detection time, in both time to detectability with antigen testing (~1 day), and time to results interpretation at just 15 minutes with covID RAD.
Fastest Sampling TimecovID RAD is a lateral flow immunoassay utilizing a nasal sample. Performing the test is similar to performing a rapid strep or flu test. After collecting the sample, three drops from the extraction buffer are placed into the sample well. Results are available in 15 minutes.
covID RAD was designed to test patients in 15 minutes or less using the same principles as CLIA waived streptococcus and influenza tests. After collecting the nasal swab, add six drops of buffer to the extraction tube and insert the patients sample. Remove the swab after swiringling the sample in the extraction tube with buffer for several seconds. Place the included dropper tip onto the sample, and add three drops to the sample well of the cassette. Results are ready in 15 minutes.
The Pinnacle covID RAD antigen test reveals if a person is currently infected with the SARS-CoV-2 pathogen. Once the infection has gone, the antigen disappears.
Unlike nucleic acid based tests such as PCR, which detect the presence of genetic material, antigen tests detect proteins or glycans, such as the spike proteins found on the surface of the SARS-CoV-2 virus.
covID RAD meets providers needs by affording rapid results, significantly less expensive than PCR tests - with instant results, and can be more amenable to point-of-care use, which could make them more suitable for testing in the community and in remote regions.
Pinnacle is working with clinical research organizations to study the Pinnacle covID RAD test with nasal, oral, and saliva test kits. Early research shows higher SARS-CoV-2 titers detected from saliva than nasopharyngeal swabs from inpatients. Additionally, we are working with several universities to assess the viability of utilizing the covID NEO antibody test plus the covID RAD antigen test as a primary screening mechanism to allow schools and industry return to a safe environment with no risk of infection. This product is currently for sale under FDA EUA guidelines.
Email the covID RAD email box for specific questions about test functionality or ordering and we'll get back to you within two hours.
For Professional Use Only. For In Vitro Diagnostic Use Only. For Emergency Authorization Use Only. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary for patient management.
The Pinnacle Cov-ID RAD Rapid Antigen Detection Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures. The Pinnacle Cov-ID RAD Rapid Antigen Detection Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.