facilities located in the United States applying for a CLIA certificate are able to begin testing for COVID-19 as quickly as possible (in most cases, 48–72 hours). Once the laboratory has identified a qualified laboratory director and has provided all required information on the CMS-116 application, a CLIA number will be assigned. Once the CLIA number has been assigned, the laboratory can begin testing as long as applicable CLIA requirements have been met. Laboratories that perform waived testing must follow manufacturer’s instructions. 24. If my Skilled Nursing Facility/ Nursing Facility already holds a CLIA Certificate of Waiver, can we begin performing COVID-19 testing? Yes. If your facility already holds a CLIA Certificate of Waiver it can begin performing COVID-19 testing that has been authorized by the FDA for use in Point of Care settings (i.e., in patient care settings operating under a CLIA Certificate of Waiver) or Certificate of Waiver settings. You may need to consult with your State Agency (CLIA State Agency Contacts) for further guidance regarding any state requirements. 25. If my Skilled Nursing Facility/ Nursing Facility already holds a CLIA Certificate of Waiver, am I required to update my test menu with CMS? Facilities holding a CLIA Certificate of Waiver are generally not required to update their test menus with CMS. However, States may have more stringent requirements so you may need to consult with your State Agency (CLIA State Agency Contacts) for further guidance. 26. How does my Skilled Nursing Facility/ Nursing Facility obtain the instrument, test kits and disposables? HHS will be distributing testing instruments and all of the disposables for performing the test. The CMS CLIA program regulates facilities that perform testing on patient specimens to ensure accurate, reliable and timely results. Questions related to obtaining the instruments, test kits and all of the disposables for performing the test, payment issues for SNF/NF testing, or any other SNF/NF questions are outside the scope of the CLIA program and should be referred to the following mailbox: DNH_TriageTeam@cms.hhs.gov 8/8 | Page 27. My Skilled Nursing Facility/ Nursing Facility is located in a CLIA Exempt State (Washington or New York). Will we be able to get one of the new test systems? Yes. Although Washington State’s Medical Test Site program and New York State’s Clinical Laboratory Evaluation Program are exempt from CLIA, they do authorize a SNF /NF to have a certificates that are equivalent to CLIA certificates, including the CLIA Certificate of Waiver. Nursing homes in Washington State are issued a CLIA Certificate of Waiver in addition to a Washington State License and those in New York State are issued a Limited Service Laboratory Registration. Nursing homes in these states will also be included in the HHS distribution program. For those SNFs/NFs located in New York State, please refer to the following link: https://protect2.fireeye.com/url?k=5dee6edc-01ba77a0-5dee5fe3-0cc47adc5fa2- d45645ac8b1d5c6a&u= About the Test Introduction The Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1 . The SARS-CoV-2 is a β-coronavirus, which is an enveloped non-segmented positive-sense RNA virus2 . It is spread by human-to-human transmission via droplets or direct contact, and infection has been estimated to have a mean incubation period of 6.4 days and a basic reproduction number of 2.24-3.58. Among patients with pneumonia caused by SARS-CoV-2, fever was the most common symptom, followed by cough3 . The main IVD assays used for COVID-19 employ real-time reverse transcriptase-polymerase chain reaction (RT-PCR) that takes a few hours4 . The availability of a cost-effective, rapid pointof-care diagnostic test is critical to enable healthcare professionals to aid in the diagnosis of patients and prevent further spread of the virus5 . Antigen tests will play a critical role in the fight against COVID-196 . Test Principle Panbio™ COVID-19 Ag Rapid Test Device contains a membrane strip, which is pre-coated with immobilized anti-SARS-CoV-2 antibody on the test line and mouse monoclonal anti-chicken IgY on the control line. Two types of conjugates (human IgG specific to SARS-CoV-2 Ag gold conjugate (binds to the nucleocapsid protein) and chicken IgY gold conjugate) move upward on the membrane chromatographically and react with anti-SARS-CoV-2 antibody and pre-coated mouse monoclonal anti-chicken IgY respectively. For a positive result, human IgG specific to SARS-CoV-2 Ag gold conjugate and anti-SARS-CoV-2 antibody will form a test line in the result window. Neither the test line nor the control line are visible in the result window prior to applying the patient specimen. A visible control line is required to indicate a test result is valid. Intended Use Panbio™ COVID-19 Ag Rapid Test Device is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasal swab specimens from individuals who meet COVID-19 clinical and / or epidemiological criteria. Panbio™ COVID-19 Ag Rapid Test Device is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the