CLIA Certified Lab for COVID-19 Testing accepted by airlines and governments.
The Centers for Medicare & Medicaid Services regulates all laboratory testing performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA).Biohackr Health is registered with CLIA operating under the certificate of Waiver. Our COVID-19 test and tests systems are under the CLIA Waiver specification and FDA’s Emergency Use Authorization.
WHAT IS COVID-19
COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in humans causing a contagious respiratory illness. COVID-19 can present with a mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medical conditions have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others not just while one is sick, but even before a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). A full list of symptoms of COVID-19 can be found at the following link: https://www.cdc.gov/coronavirus/2019- ncov/symptoms-testing/symptoms.html.
About the PCR Test
The AcculaTM SARS-CoV-2 Test performed on the Accula Dock or the SilarisTM Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of nucleic acid from SARS-CoV-2 in clinician-collected nasal or nasal mid-turbinate swab specimens or clinician-instructed self-collected (collected on site) nasal swab specimens, collected from individuals 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, that meet requirements to perform high, moderate, or waived complexity tests. The Accula SARS-CoV-2 Test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
About the Antigen Test
The BD VeritorTM System for Rapid Detection of SARS- CoV-2 is a type of test called an antigen test. Antigen tests are designed to detect proteins from the virus that causes COVID-19 in nasal swabs. The BD Veritor TM System for Rapid Detection of SARS-CoV-2 is only authorized for use in laboratories in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate, high and waived complexity tests. This test is authorized for use at the point of care (POC), i.e., in patient care settings operating under a CLIA certificate of Waiver, certificate of compliance, or certificate of accreditation.